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The role of pharmacists and emergency contraception

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Title:
The role of pharmacists and emergency contraception an assessment of pharmacy school curricula in the U.S. and the knowledge, attitudes, and dispensing practices of Florida pharmacists
Physical Description:
Book
Language:
English
Creator:
Richman, Alice R
Publisher:
University of South Florida
Place of Publication:
Tampa, Fla
Publication Date:

Subjects

Subjects / Keywords:
Plan B
Theory of Planned Behavior
Subjective Norms
Perceived Behavioral Control
Intention to Dispense
Dissertations, Academic -- Community and Family Health -- Doctoral -- USF   ( lcsh )
Genre:
non-fiction   ( marcgt )

Notes

Summary:
ABSTRACT: Emergency contraception is a safe and effective form of contraception that is 75%-89% effective in preventing pregnancies within 120 hours of unprotected intercourse. Emergency contraception is a type of hormonal contraception, containing high doses of estrogen and progestin (ethinyl estradiol plus levonorgestrel) or progestin only (levonorgestrel). Wider access to emergency contraception has the potential to decrease the number of unintended pregnancies and abortions in the U.S. The Food and Drug Administration (FDA) has previously denied any over-the-counter (OTC) access to emergency contraception and only recently approved it for OTC status for women 18 years old and over; therefore, pharmacists continue to play a critical role in providing access to emergency contraception. For example, pharmacists can answer women's questions, dispel misconceptions, advise medical colleagues, and provide important information about the medication to clients.Although emergency contraception is a safe and effective medication, many pharmacists and pharmacies throughout the U.S. have either refused to fill prescriptions of emergency contraception or have refused to carry and stock emergency contraception. Pharmacists' perceptions and practice affect whether women have access to this form of contraception and whether pharmacies carry this medication. In addition, pharmacists' behavior, professional conduct, and ethical practice and training have major implications for public health and access to care for women, children, and families. This study has two purposes: First, because the attitudes and dispensing practices among pharmacists may be related to their understanding of the medication, a review of pharmacy school curricula in the U.S. was conducted, and involved (a) an assessment of course content related to emergency contraception and (b) an analysis of how this content is perceived by pharmacy students.The second purpose of the study is to assess emergency contraception knowledge, attitudes, subjective norms, perceived behavioral control, and dispensing practices of pharmacists and to determine if pharmacists' emergency contraception knowledge, attitudes, subjective norms, and perceived behavioral control are predictive of their dispensing practices. To reach these ends, a mixed-methods study design was employed using mixed methods data analysis techniques including coding methods, univariate, bivariate, and logistic regression.
Thesis:
Dissertation (Ph.D.)--University of South Florida, 2008.
Bibliography:
Includes bibliographical references.
System Details:
Mode of access: World Wide Web.
System Details:
System requirements: World Wide Web browser and PDF reader.
Statement of Responsibility:
by Alice R. Richman.
General Note:
Title from PDF of title page.
General Note:
Document formatted into pages; contains 313 pages.
General Note:
Includes vita.

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University of South Florida Library
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University of South Florida
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All applicable rights reserved by the source institution and holding location.
Resource Identifier:
aleph - 002006359
oclc - 384139911
usfldc doi - E14-SFE0002721
usfldc handle - e14.2721
System ID:
SFS0027038:00001


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ABSTRACT: Emergency contraception is a safe and effective form of contraception that is 75%-89% effective in preventing pregnancies within 120 hours of unprotected intercourse. Emergency contraception is a type of hormonal contraception, containing high doses of estrogen and progestin (ethinyl estradiol plus levonorgestrel) or progestin only (levonorgestrel). Wider access to emergency contraception has the potential to decrease the number of unintended pregnancies and abortions in the U.S. The Food and Drug Administration (FDA) has previously denied any over-the-counter (OTC) access to emergency contraception and only recently approved it for OTC status for women 18 years old and over; therefore, pharmacists continue to play a critical role in providing access to emergency contraception. For example, pharmacists can answer women's questions, dispel misconceptions, advise medical colleagues, and provide important information about the medication to clients.Although emergency contraception is a safe and effective medication, many pharmacists and pharmacies throughout the U.S. have either refused to fill prescriptions of emergency contraception or have refused to carry and stock emergency contraception. Pharmacists' perceptions and practice affect whether women have access to this form of contraception and whether pharmacies carry this medication. In addition, pharmacists' behavior, professional conduct, and ethical practice and training have major implications for public health and access to care for women, children, and families. This study has two purposes: First, because the attitudes and dispensing practices among pharmacists may be related to their understanding of the medication, a review of pharmacy school curricula in the U.S. was conducted, and involved (a) an assessment of course content related to emergency contraception and (b) an analysis of how this content is perceived by pharmacy students.The second purpose of the study is to assess emergency contraception knowledge, attitudes, subjective norms, perceived behavioral control, and dispensing practices of pharmacists and to determine if pharmacists' emergency contraception knowledge, attitudes, subjective norms, and perceived behavioral control are predictive of their dispensing practices. To reach these ends, a mixed-methods study design was employed using mixed methods data analysis techniques including coding methods, univariate, bivariate, and logistic regression.
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The Role of Pharmacists and Emergency Contraception: An Assessment of Pharmacy School Curricula in the U.S. and the Knowledge, Attitudes, and Dispensing Practices of Florida Pharmacists. by Alice R. Richman A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy Department of Community and Family Health College of Public Health University of South Florida Major Professor: Ellen Daley, Ph.D. Julie Baldwin, Ph.D. Jeffrey Kromrey, Ph.D. Kathleen O’Rourke, Ph.D. Kay Perrin, Ph.D. Date of Approval: October 15, 2008 Keywords: Plan B, Theory of Planned Behavi or, Subjective Norms, Perceived Behavioral Control, Intention to Dispense, Mixed Methods Copyright 2008, Alice R. Richman

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Dedication To those in the past, present, and future working for reproductive health and freedom.

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Acknowledgments There are many people who have guided and supported me throughout this process. Dr. Ellen Daley, thank you for being my chair and for your endless support and guidance throughout my doctoral program and in the writing of this dissertation, for being a role model, a friend, for always lifting me up, for believing in me, and for understanding that work shoul d be peppered with laughter. Dr. Julie Baldwin, thank you for your heartfelt support and encouragement throughout my doctoral edu cation and research. Dr. Jeffery Kromrey, thank you for countless hours of statistical guidance, emails on weekends, and for your uncanny ability to make difficult concepts understandable. Dr. Kathleen O’Rourke, thank you for your unswerving support and friendship over the years, your critical eye, and your ab ility to get me to think critically about methodology and statistics. Dr. Kay Perrin, thank you for your support, your continuous expert advice and feedback on all aspects of my dissertati on, and for never being too busy to talk. My parents, Jack and Carol Richman, thank you for your unwavering, unconditional love and support in my academic endeavors and with a ny life choice I’ve made. I am who I am because of you. My sister, Erica Richman, thank you for your statistical advice and for al ways being my biggest a dvocate. Thank you to my grandparents, Sol and Elizabeth Richman, w ho taught me the value of education and family. And last but not least, thank you to friends and colleagues who provided both emotional and tangible support throughout this journey: Debbie Gulick, Duane Olivier, Lawrence Rosenfeld, Lisa Nugent, Tom Ro ss, Karissa Morton, and Linda Simkin.

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i Table of Contents List of Tables ................................................................................................................ .......v List of Figures ............................................................................................................... ..... ix Abstract ...................................................................................................................... ..........x Chapter One: Introduction .................................................................................................1 Statement of the Problem .........................................................................................1 History of Emergency Contraception ......................................................................8 Need for the Study .................................................................................................12 Purpose of the Study ..............................................................................................13 Research Questions ................................................................................................14 Assumptions ...........................................................................................................15 Delimitations ..........................................................................................................16 Limitations .............................................................................................................16 Definitions of Relevant Terms ...............................................................................16 Chapter Two: Literature Review .....................................................................................20 Review of Related Research ..................................................................................20 Overview of Emergency Contraception .................................................................21 Epidemiology: Knowledge & Attitudes of Emergency Contraception .................24 Women’s Knowledge.................................................................................24 Women’s Attitudes ....................................................................................27 Health Care Professionals’ Knowledge Attitudes, & Practice of Emergency Contraception ...................................................................................................30 Provider Knowledge ..................................................................................31 Provider Attitudes ......................................................................................33 Provider Prescribing Practices ...................................................................34 Pharmacists’ Knowledge, Attitudes, & Dispensing Practices of Emergency Contraception ...................................................................................................37 New Literature .......................................................................................................42 Summary & Recommendations for Future Research ............................................43 Women’s Knowledge & Attitudes .............................................................43 Health Care Professionals’ K nowledge, Attitudes, & Practice..................44 Pharmacists’ Knowledge, Attit udes, & Dispensing Practices ...................46 The Theory of Reasoned Action ............................................................................48 The Theory of Planned Behavior ...........................................................................50

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ii Chapter Three: Methods ...................................................................................................55 Purpose of the Study ..............................................................................................55 Research Questions ................................................................................................56 Overview of Study Design .....................................................................................58 Pharmacy School Curricula Review ......................................................................59 Target Population & Sampling Frame .......................................................59 Sampling Plan ............................................................................................59 Pharmacy Student Focus Groups ...........................................................................62 Target Population & Sampling Frame .......................................................62 Focus Group Discussion Guide .................................................................62 Sampling Plan ............................................................................................64 Pharmacist Questionnaire ......................................................................................67 Target Population & Sampling Frame .......................................................67 Power Analysis—Sample Size ..................................................................68 Sampling Plan ............................................................................................71 Data Collection ......................................................................................................75 Instrument Development ............................................................................75 Measures ....................................................................................................79 Reliability and Validity Measures .............................................................83 Validity: Face, Content, and Construct ......................................................83 Reliability: Stability and Equivalence .......................................................88 Background Characteristics ...........................................................89 Dispensing Practices ......................................................................90 Knowledge .....................................................................................91 Attitudes .........................................................................................92 Subjective Norms ...........................................................................92 Perceived Behavioral Control ........................................................92 Data Analysis .........................................................................................................94 Qualitative Data Analysis Plan ..............................................................................95 Researcher Bias ..........................................................................................97 Trustworthiness ..........................................................................................99 Quantitative Data Analysis Plan ..........................................................................101 Univariate & Bivariate Analyses .............................................................101 Multivariate Analyses ..............................................................................102 Linking Datasets ..................................................................................................104 Chapter Four: Results ....................................................................................................106 Introduction ..........................................................................................................106 Research Questions ..............................................................................................106 Section I: Pharmacy School Curricula Review ....................................................108 Pharmacy Practice/Training .....................................................................115 Role of Pharmacists: Counseling/Education ............................................115 Controversy ..............................................................................................116 Drug Therapy ...........................................................................................118 Knowledge for Best Patient Care .............................................................118

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iii Section II: Pharmacy Student Focus Groups .......................................................119 Paper and Pencil Pre-Survey Results .......................................................120 Focus Group Discussion Analysis ...........................................................122 Knowledge ...................................................................................123 Teaching Instruction ....................................................................130 Projected Dispensing Practices ....................................................131 Summary ..............................................................................................................143 Section III: State-wide Pharmacist Survey ..........................................................144 Quantitative Data Analysis: Univariate & Bivariate Analysis ................145 Univariate Analysis ......................................................................145 Bivariate Analysis ........................................................................161 Multivariate Analysis ...................................................................171 Final Model ..............................................................................................188 Summary of Results .................................................................................191 Additional Analyses .................................................................................192 Chapter Five: Discussion and Conclusions .....................................................................194 Section I: Synthesis of Research Findings ...........................................................194 Research Question 1: Pharmacy School Curriculum Review ..................194 Research Question 2: Pharmacy Student Focus Groups ..........................196 Research Question 3: State-Wide Pharmacist Survey .............................199 Key Findings/Conclusions for Entire Study ........................................................202 Study Limitations .....................................................................................205 Study Strengths ........................................................................................207 Section II: Discussion of Universal Perspective ..................................................208 Section III: Broader Implications for P ublic Health and Future Direction ..........210 Broader Implications for Public Health ...................................................210 Future Direction ...........................................................................212 Research .......................................................................................212 Policy ...........................................................................................213 Practice .........................................................................................214 Dissemination ..............................................................................215 References .................................................................................................................... ....217 Appendices .................................................................................................................... ...226 Appendix A. Oral contraceptives that can be used for Emergency Contraception in the United States ..............................................227 Appendix B. Package Inserts for Plan B and RU-486 ......................................229 Appendix C. History of Em ergency Contraception ..........................................236 Appendix D. Emergency Contraception St udies in a Comparative Context: Client knowledge & Attitude Studies ..........................................237

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iv Appendix E. Emergency Contraception St udies in a Comparative Context: Provider Knowledge, Attitudes, & Practice .................................241 Appendix F. Emergency Contraception St udies in a Comparative Context: Pharmacists’ Knowledge, Attitude s, & Dispensing Practices .....243 Appendix G. Pre-notice Letter to Academic Deans ..........................................244 Appendix H. Academic Dean Informed Consent Form ....................................245 Appendix I. Academic Dean Cover Letter & Survey ......................................246 Appendix J. Thank You/Reminder Letter to Academic Deans ........................248 Appendix K. Sample Recruitment Flyer ...........................................................249 Appendix L. Focus Group Informed Consent Form .........................................250 Appendix M. Pharmacist Pre-Notice Letter .......................................................255 Appendix N. Pharmacist Informed Consent Form ............................................256 Appendix O. Cover Letter to Pharmacists .........................................................257 Appendix P. Pharmacist Questionnaire ............................................................258 Appendix Q. Pharmacist Thank you/Reminder Postcard ..................................266 Appendix R. Panel of Experts Q&A .................................................................267 Appendix S. Description of Survey Variables ..................................................276 Appendix T. List of 91 Pharmacy Schools that Received Dean’s Survey ........285 Appendix U. Second Follow-up Letter to Deans ..............................................290 Appendix V. List of Course Titles Containing Emergency Contraception Course Content.............................................................................296 Appendix W. Focus Group Topical Guide .........................................................297 Appendix X. Panel of Experts Intervie w Guide for Review of Pharmacists’ Questionnaire ...............................................................................299 About the Author ................................................................................................... End Page

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v List of Tables Table 1. Sample Size (N) for Medium ES at Power = .80 for =.05 .................................70 Table 2. Sample Size Required for Each Leve l of Tolerance (1 to .5) in Logistic Regression, =.05 ...............................................................................................70 Table 3. Factor Pattern Matr ix for Knowledge Items ........................................................85 Table 4. Factor Pattern Matr ix for Attitude Items .............................................................85 Table 5. Factor Pattern Matrix for Subjective Norm Items ...............................................86 Table 6. Factor Pattern Matrix for Pe rceived Behavioral Control Items ...........................86 Table 7. Factor Pattern Matrix fo r Intention to Dispense Items ........................................87 Table 8. Percentage Agreements for Background Characteristics .....................................89 Table 9. Quantitative Results from Dean’s Survey .........................................................109 Table 10. A Typology of Required and Elect ive Courses that Contain Content on Emergency Contraception per the Responses from the Dean’s Survey ...........110 Table 11. Review of Retrieved Syllabi that Reported to Contain Content Material on Emergency Contraception from the Dean’s Survey ....................................113 Table 12. Paper and Pencil Focus Group Survey Data: Close-Ended Questions (N=21) ...............................................................................................................121 Table 13. Major Themes of what Students Learned in their Pharmacy School Classes and Representative Quotes ...................................................................129 Table 14. Major Themes of Projected Di spensing Practices and Representative Quotes ...............................................................................................................134 Table 15. Sociodemographics Characteristics of Study Sample (N=272) ......................146 Table 16. Demographics on Pharmacy Practice and Training (N=272) .........................148

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vi Table 17. Categorical Classifications for Knowledge .....................................................149 Table 18. Univariate Statistics fo r Knowledge Composite Variable ...............................150 Table 19. Categorical Classifications for Attitude ...........................................................152 Table 20. Univariate Statistics for Attitude Composite Variable ....................................153 Table 21. Univariate Statistics for Su bjective Norms Composite Variable .....................154 Table 22. Univariate Statistics for Pe rceived Behavioral Control Composite Variable ..........................................................................................................155 Table 23. Categorical Classificatio ns for Dispensing Practices ......................................156 Table 24. Means, Standard Deviations and Ranges for Dependent Variable Dispensing Practices .........................................................................................157 Table 25. Number of Times Pharmacists have Dispensed EC in the Last 12 months ...............................................................................................................158 Table 26. Categorical Classifications for Intention to Dispense ......................................160 Table 27. Univariate Statistics for Inte ntion to Dispense Plan B Composite Variable .............................................................................................................161 Table 28. Chi Square Results of Ever Dispensed EC by Sociodemographic Variables ...........................................................................................................162 Table 29. Chi Square Results of Dispensing EC by Prescription by Sociodemographic Variables ............................................................................164 Table 30. Chi Square Results of Dispensing EC OTC by Sociodemographic Variables ...........................................................................................................165 Table 31. Chi Square Results of Disp ensing EC by Practice and Training Variables ...........................................................................................................167 Table 32. Bivariate Results of Dispensing EC and Knowledge ......................................168 Table 33. Bivariate Results of Dispensing EC and Attitudes ..........................................169 Table 34. Bivariate Results of Disp ensing EC and Subjective Norms ............................170 Table 35. Bivariate Results of Dispensing EC and Perceived Behavior Control ............171

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vii Table 36. Bivariate Results of Intenti on to Dispense and Dispensing EC .......................171 Table 37. Logistic Regression Analysis for Knowledge and Dispensing Practices while Controlling for Socio-demographic Variables ........................................174 Table 38. Logistic Regression Analysis for Knowledge and Dispensing Practices while Controlling for Marital Status, Type of Pharmacy where Employed, Job Title, and Current Employment Status .....................................176 Table 39. Logistic Regression Analysis for Attitudes and Dispensing Practices while Controlling for Socio-demographic Variables ........................................178 Table 40. Logistic Regression Analysis for Attitudes and Dispensing Practices while Controlling for Marital Status, Type of Pharmacy where Employed, Job Title, and Current Employment Status .....................................180 Table 41. Logistic Regression Analysis for Subjective Norms and Dispensing Practices while Controlling for Socio-demographic Variables ........................181 Table 42. Logistic Regression Analysis for Subjective Norms and Dispensing Practices while Controlling for Type of Pharmacy where Employed and Current Employment Status ..............................................................................183 Table 43. Logistic Regression Analysis for Perceived Behavioral Control and Dispensing Practices while Cont rolling for Socio-demographic Variables ...........................................................................................................184 Table 44. Logistic Regression Analysis for Perceived Behavioral Control and Dispensing Practices while Control ling for Type of Pharmacy where Employed, Job Title, and Current Employment Status .....................................185 Table 45. Logistic Regression Analysis fo r Intention to Dispense Plan B and Dispensing Practices while Cont rolling for Socio-demographic Variables ...........................................................................................................186 Table 46. Logistic Regression Analysis fo r Intention to Dispense Plan B and Dispensing Practices while Control ling for Type of Pharmacy where Employed and Current Em ployment Status ......................................................188 Table 47. Logistic Regression Analys is for All Variables in Model ...............................190 Table 48. Summary Table of Main Findings ...................................................................191 Table 49. Summary Table of Two Knowledge Items ......................................................192

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viii Table 50: Oral contraceptives that can be Used for Emergency Contraception in the United States ...............................................................................................227 Table 51. Emergency Contraception Studies in a Comparative Context: Client Knowledge & Attitude Studies .........................................................................237 Table 52. Emergency Contraception Studies in a Comparative Context: Provider Knowledge, Attitudes, & Practice ....................................................................241 Table 53. Emergency Contraception St udies in a Comparative Context: Pharmacists’ Knowledge, Attitude s, and Dispensing Practices ........................243 Table 54. Description of Survey Variables ......................................................................276

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ix List of Figures Figure 1. Theory of Reasoned Action ................................................................................50 Figure 2. Theory of Planned Behavior ...............................................................................51 Figure 3. Modified Theory of Planned Behavior Applied to Research Study ...................54 Figure 4. Independent and De pendent Variables ...............................................................83 Figure 5. Categorical Classifications fo r Subjective Norms (whether each group listed thinks they should dispense) ...................................................................154 Figure 6. Categorical Classifications for Perceived Behavioral Control (How easy is it for you to...)................................................................................................155 Figure 7. Pharmacist and EC Access Model ....................................................................210 Figure 8. Emergency Contracep tion Health Access Model .............................................216 Figure 9: History of Emergency Contraception ...............................................................236

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x The Role of Pharmacists and Emergency Contraception: An Assessment of Pharmacy School Curricula in the U.S. and the Knowledge, Attitudes, and Dispensing Practices of Florida Pharmacists. Alice R Richman ABSTRACT Emergency contraception is a safe and effective form of contraception that is 75%-89% effective in preventing pregnancies within 120 hours of unprotected intercourse. Emergency contraception is a type of hormonal contraception, containing high doses of estrogen and proge stin (ethinyl estradiol plus levonorgestrel) or progestin only (levonorgestrel). Wider access to em ergency contraception has the potential to decrease the number of unint ended pregnancies and abortion s in the U.S. The Food and Drug Administration (FDA) has previously de nied any over-the-counter (OTC) access to emergency contraception and only recently approved it for OTC status for women 18 years old and over; therefore, pharmacists continue to play a critical role in providing access to emergency contraception. For ex ample, pharmacists can answer women’s questions, dispel misconceptions, advise me dical colleagues, and provide important information about the medication to clients. Although emergency contraception is a safe and effective medication, many pharmacists and pharmacies throughout the U.S. have either refused to fill prescriptions of emergency contraception or have refused to carry and stock emergency contraception. Pharm acists’ perceptions a nd practice affect whether women have access to this form of contraception and whether pharmacies carry

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xi this medication. In addition, pharmacists’ be havior, professional conduct, and ethical practice and training have major implicati ons for public health and access to care for women, children, and families. This study has two purposes: First, becau se the attitudes and dispensing practices among pharmacists may be related to their unde rstanding of the medication, a review of pharmacy school curricula in the U.S. was conducted, and involved (a) an assessment of course content related to emergency contracep tion and (b) an analysis of how this content is perceived by pharmacy students. The second purpose of the study is to assess emergency contraception knowledge, attitudes, subjective norms, pe rceived behavioral control, and dispensing practices of phar macists and to determine if pharmacists’ emergency contraception knowledge, attit udes, subjective norms, and perceived behavioral control are predictive of their dispensing practices. To reach these ends, a mixed-methods study design was employed using mixed methods data analysis techniques including coding met hods, univariate, bivariate, a nd logistic regression.

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1 Chapter One: Introduction Statement of the Problem The prevalence of unintended pregnanc y among women in the United States is disturbingly high. Indeed, it is the highest among all indus trialized nations (Grimes, 2002). Approximately half of all pregnancie s in the United States are unintended, with 48% of all women aged 15-44 having at le ast one unintended pregnancy throughout their lifetime (Henshaw, 1998). Unintended pregnanc ies result in consequences that have a profound effect on the physical mental, social, economic, and developmental well-being of women, children, and their families (Misra, 2001). Unintended pregnancy can be life-changi ng for all involved. Of the estimated 50% of pregnancies in the U.S. that are unintended (approximately three million annually), almost half (47%) result in abortion, 40% result in an unplanned birth and 13% result in miscarriage (Brown & Eisenberg, 1995). Although in the U.S. the medical risks involved with abortion are relatively small, the psychological impact and the emotionally taxing decision process can be gr eat (Major et al., 2000). In general, women with unintended pr egnancies are more likely to receive insufficient or delayed prenatal care, part icipate in unhealthy pregnancy behaviors like smoking and drinking (Hellerstedt et al., 1998), and give birth to low birth weight infants (Brown & Eisenberg, 1995) than women with intended pregnancies. Likewise, women with unintended pregnancies are more likely to have a preterm delivery (Orr, Miller,

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2 James, & Babones, 2000), report higher ra tes of maternal depression (Brown & Eisenberg, 1995), and have a greater rate of infant mortality (Brown & Eisenberg, 1995) than women with intended pregnancies. Furthermore, women with unintended pregnancies have a greater risk of physical abuse and violence a nd are less likely to achieve educational, financial, and careers goals (Brown & Eisenberg, 1995) than women with intended pregnancies, all of which can result in poor pregnancy, birth, and health outcomes. If 40% of unintended pregnancies result in an unplanned birth in the U.S., 21% of all pregnancies (both intended and unintended) will result in an unplanned birth. Children from these pregnancies are more likel y to exhibit poor health and development and for many reasons are more likely to live ap art from one or both parents, usually the father (Brown & Eisenberg, 1995). Children who live with only one parent, usually the mother, score lower on standardized tests, ha ve lower grade point averages, more erratic school attendance, behavioral problems, and co nsequently are more likely to drop out of high school, never attend college, or drop out of college, if attended, as compared with children from similar soci al class backgrounds and liv ing arrangements (Brown & Eisenberg, 1995). The potentially negative health outcomes associated with unintended pregnancy coupled with the disturbingl y high rates of unintended pr egnancy in the U.S. should highlight the need for careful scrutiny of this public health problem. Healthy People 2010 is a set of health objectives for the nation to works towards throughout the first decade of this century. Healthy People 2010 objectives are developed through scientific knowledge and build on objectives pursued over the past two decades. Through Healthy

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3 People 2010, the field of public health has iden tified a priority to decrease the rate of unintended pregnancies from 70% to 30% by year 2010 (US Department of Health and Human Services (DHHS), 2000). Of the 50% of the pregnancies in the Unite d States that are unintended, half are a result of contraceptive failure (Henshaw, 1998). The high rate of unintended pregnancy in this group highlights the need for additi onal methods of birth control. While waiting for additional forms of birth control to be developed, a currently effective yet underutilized method of preventing unintende d pregnancy, emergency contraception, is available. Emergency contraception is a type of hormonal contraception, containing high doses of estrogen and progestin (ethinyl estradiol plus levono rgestrel) or progestin only (levonorgestrel). This medica tion is 75%-89% effective in preventing pregnancies when taken within 72 hours (3days ) after sexual intercourse (American Medical Women’s Association (AMWA), 1996; Kaiser Fa mily Foundation, 2000). Recent studies conducted on the Yuzpe regimen of emerge ncy contraception show that the 72 hour window may be restrictive and have extende d effectiveness up to 120 hours (5 days); however the earlier a woman accesses emergency contraception, the more effective the medication will be (ACOG News Releas e, 2003; Ellertson et al., 2003). There is one dedicated product currently on the market that is packaged as emergency contraception in the U.S. cal led Plan B, a progestin-only form of contraception and is orally administered wh ere one pill is taken within 120 hours of unprotected intercourse and a second pill is taken 12 hours later. However, there are 20 other forms of birth control pi lls that the FDA has said are safe and effective to use as

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4 emergency contraception (Princeton Univer sity & Reproductive Health Professionals, 2006). These pills and their dosing regimen are shown in Appendix A. Post-coital contraception is typically taken orally in pill form although the insertion of an intrauterine contraceptive device (IUD) by a trained medical provider can be used as post-coital contraception as we ll (Princeton University & Reproductive Health Professionals, 2006). Emergency contraception is not effective if the woman is already pregnant (Trussell, Duran, Shochet, & Moore, 2000) and is a safe form of contraception approved by the FDA in 1997 (FDA Fe deral Register, 1997), with no known contraindications (Grimes & Raymond, 2002). This form of contraception is important in that, unlike most forms of contraception, it is effective post sexual intercourse; it can be used as a back-up method of birth control when other birth control methods are not used appropriately, a condom slips or breaks, a pill is forgotten, or in cases of rape. This post-coital feature of emergency contraception is where it received its nickname as the “morning after pill” because it is effective after sexual intercourse. Because half of all unintended pregnancies are a result of contraception failure (Henshaw, 1998), and because this backup method of birth control that can be used post sexual intercourse but before pregnancy, it is ideal for sexually active individuals. According to the American College of Obstetrics and Gynecologists (ACOG), wider access and acceptability of emergenc y contraception could reduce the number of unintended pregnancies by half (ACOG, 2001) and could prevent one million abortions annually (Trussell, Steward, Guest, & Hatcher, 1992). However, it is within the first 24 hours after unprotected intercourse that emerge ncy contraception is the most effective in

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5 preventing pregnancy (Downing, 2001); therefore, access is a critical issue for this type of contraception. Women who have to wait for a doctor’s appointment or for the workweek to begin may delay treatment and thus decrease the efficacy of the medication, or may not be able to procure the medication at all. Because most pharmacies are open late hours and are open on weekends, when mo st typical doctor’s offices and clinics are not (Boonstra, 2002), pharmacies have been su ggested as critical venues for emergency contraception distribution (Van Riper & Hellerstedt, 2005). There are three main barriers to emergency contraception access that seem to perpetuate a lack of awareness and utilization of this method of birth control. First, there are certain misunderstandings in the pub lic’s perception that surround emergency contraception. Second, health care providers and professionals do not prescribe it or neglect to inform women of its availability and third, inadequate e ducation is provided to women about emergency contraception. Misunderstandings in the public’s perception surround emergency contraception. One common myth is that emergency cont raception acts as an abortificient (Jackson, Schwarz, Freddman, & Darney, 2003) or that it is the same as RU-486, a medical abortion (Grimes & Raymond, 2002). These misc onceptions represent one way in which the definitional lines become blurred when abortion and emergency contraception are discussed. Please see Appendix B for the pa ckage inserts of both Plan B and RU-486. Health care providers and profe ssionals may make emergency contraception difficult to obtain, primarily due to the misconceptions discussed above. Women who are seeking these contraceptive pills may be forced to go through long appointments, unnecessary procedures such as physical exams, pregnancy tests and pelvic exams and

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6 pay high prices (Trussell et al., 2000). In a ddition, physicians refuse to prescribe it; many pharmacies refuse to stock it; and many pharmacists will not fill prescriptions of emergency contraceptive pills (Henders on, 2000). In fact, up until March 3, 2006, WalMart pharmacies refused to stock emergenc y contraceptive pills. This policy was particularly troublesome because Wal-Mart is the “world’s larg est retailer and the nation’s fifth largest distributor of pharmaceu ticals” (AMWA, 1996, p. 1) and in the case of some rural and poorer areas, may be the onl y pharmacy in town. Therefore, a policy decision made by a private pharmacy can directly limit access and eliminate choice to one of the most vulnerable populations (AMWA, 1996). Although long overdue, WalMart has finally begun carrying the medication due to claims that were filed against them for refusing to fill prescriptions and fr om pressure from women’s rights groups (CNN.com, 2006; Wal-Mart news releases, 2006) Lastly, what Henderson (2000) calls the “paucity of prospective information provided to reproductive age wome n” (p. 2) refers to the inadequate education women receive about emergency contraception. If women have no knowledge about emergency contraception, they cannot be expected to ask for it. Part of the reason that women have an inadequate knowledge base regarding emer gency contraception is that clinicians do not inform women of this option on a re gular basis (Trussel l et al., 2000), and pharmaceutical companies fail to adequately market it (Cates & Raymond, 1997). These barriers to emergency contracepti on are troubling and should be examined in greater detail. Because time is such a critical factor in terms of access and effectiveness of emergency contraception, strategies to improve access to emergency contraception have been primarily focused on collaborative drug therapy agreements with

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7 pharmacists or through advocating for emer gency contraception to go over-the-counter (OTC). Collaborative drug therapy agreements with pharmacists refer to pharmacists’ prescribing privileges for specific medications while following a set protocol. Currently 44 states in the U.S. allow these types of agreements with pharmacists for certain medications. Expansion access programs such as these allow non-physicians to prescribe and distribute emergency contraception while working in conjunction with physicians and advanced registered nurse practitioners, thereby expandi ng the range of providers (Gardner, Hutchings, Fuller, & Downing, 2001). In total, nine states allow pharmacist s to dispense emergency contraception without a doctor’s prescripti on under specific circumstances while following particular guidelines (Alan Guttmacher Institute (AGI), 2006). Of those nine, seven states (Washington, California, Alaska, Hawaii, New Hampshire, Massachusetts, and Vermont) currently have collaborative drug thera py agreements where women can acquire emergency contraception without a pr escription from pharmacies under doctorpharmacist agreements, and three states (C alifornia, Maine, and New Mexico) allow pharmacists to dispense emergency contrace ption without a prescription under a stateapproved protocol. In additi on, only one state, Illinois, has mandated that pharmacies that stock emergency contraception must fill prescriptions of the medication (AGI, 2006; Tanne, 2005). Conversely, while eight states have expanded access programs for emergency contraception, eight states have adopted restri ctions (AGI, 2006). Four states (Arkansas, Georgia, Mississippi, and South Dakota) allow pharmacists to refuse to fill prescriptions of contraception including prescriptions of emergency contraception. Two states

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8 (Indiana and Texas) added language under their Medicaid coverage that excluded emergency contraception services, and tw o states (Arkansas and North Carolina) restricted emergency contraceptives from their contraception c overage mandate (AGI, 2006). History of Emergency Contraception A brief review of emergency contracep tion in the U.S. may provide further background on this important issue (see Appendi x C for a graphic representation of its history). Emergency contraception pills have been administered to women since the 1960s. Packets of birth control pills were t ypically cut up to dispense the required dose to women with instructions for use to a void pregnancy after sex. These pills were initially administered by feminist clinics, college health clinic s, and a few Planned Parenthood clinics (Castle & Coeytaux, 2000). In 1996, one year prior to the FDA approval of emergency contraception, a national campaign was created and sponsored by the Reproductive Health Technologies Project and Princeton University to conn ect consumers and clinicians to useful information on emergency contraception through an emergency contraception hotline (1888-NOT-2-LATE), an emergency contrace ption website (not-2-late.com), and announcements and advertising in the medi a (radio, television, and outdoor events) (Ellertson, Shochet, Blanchard, & Trussell, 2000). The national website and hotline are still active today connecting consumers to provi ders at the local level anywhere in the U.S. Almost three decades after emergency cont raceptive pills were first administered to women, on February 25, 1997, the FDA approved six brands of oral contraceptives to

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9 be used as emergency contraception and deem ed them both safe and effective when used in prevention of a pregnancy (FDA Federal Re gister, 1997). Even after this approval, there was no dedicated, labeled product ma nufacturer of emergency contraception until September 1998 and therefore few marketing e fforts were initiated before this time. In 1997, the State of Washington be gan an innovative program where collaborative prescription agreements allowed pharmacists to prescribe emergency contraception to women (Wells et al., 1998) This two year project was funded by the Packard Foundation, operated by the Program for Appropriate Technology in Health (PATH) and worked in collaboration with the Washington State Board of Pharmacy, Washington State Pharmacists Association, University of Washington Department of Pharmacy and Elgin/DDB (a public relations fi rm that has worked with the Reproductive Health Technologies Project) (Wells et al ., 1998). Their goals were to educate pharmacists, facilitate prescrip tive protocols, help link client s with prescribers, increase awareness of emergency contraception to women, and to evaluate the effectiveness of the project. The Washington State project evaluators esti mate that after the first four months of program initiation, 207 unintended pregnanc ies and 103 abortions have been prevented through this service (Wells et al., 1998). In addition, progr am evaluation demonstrated an increase in prescriptions written per w eek and an increase in the number of calls inquiring about the medication after the initia tion of this program (Wells et al., 1998). This project has demonstrated that pharmacist collaborative prescription agreements such as this one can play a vital role in maki ng emergency contraception available and thus decreasing unintended pregnancy and abortion in the U.S.

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10 In September 1998, Gynetics marketed Prev en™, the first dedicated emergency contraception product for women. In July 1999, Women’s Capital Corporation marketed Plan B™, the first progestin-only form of emergency contraception. Throughout this period, not only were re searchers and pharmaceutical companies supporting the need for increased access to emergency contraception through advanced supply or OTC access, but many organizati ons in the field were supporting making emergency contraception more readily availabl e. The American College of Obstetrics and Gynecologists (ACOG) have endorsed making emergency contraception available OTC (2001) and the American Medical A ssociation (AMA) has disseminated policy statements in support of expanding access to emergency contraception to make the pills “more readily available” (2002). In 2001, a petition was filed by the Center for Reproductive Ri ghts to the FDA on behalf of over 70 organizations, including medical public health, and others in support of emergency contraception for OTC access (CRR, n. d.). In 2003, Women’s Capital Corporation, the makers of Plan B (a type of emergency contraception), filed a second petition to the FDA in support of OTC emergency contraception. On December 16, 2003, the FDA’s Reproduc tive Health Drugs Advisory and Nonprescription Drugs Panel supported maki ng Plan B available OTC by a 27-4 vote—a major success for public health and reproductive rights advocates in the United States. However, on May 6th, 2004, the FDA struck down the recommendation from its own committee. The rejection was based on the assumption that there was not enough evidence that Plan B could be used safe ly by adolescent women under 16 years of age without provider supervision.

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11 The FDA rejection letter stat es that “before this app lication can be approved, you would have to provide data demonstrating that Plan B can be used safely by women under 16 years of age without th e professional supervision of a practitioner licensed by law to administer the drug” (Galson, 2004, p. 2). The letter also stipulated that alternatively, more information could be provided to support Plan B as a prescription only product for women under 16 years of ag e and a nonprescription product for women over 16 years of age. After this decision was handed down by the FDA, the makers of Plan B submitted an application for OTC access to emergency co ntraception for women 16 years and older. Many feel that because unintended pregnancy among adolescent women is a concern in the U.S., it is imperative that they too are provided with access to safe contraceptive choices and that they are not excluded from future emergency contraception OTC policies. In fact, teens y ounger than 18 years old have th e highest percentage (82-83%) of unintended pregnancy in the U.S. (Hensh aw, 1998) and the U.S. has the highest teen pregnancy rate of all industri alized nations (Feijoo, 2001). For years, the FDA was criticized for dr agging its feet in granting any proposals for OTC access despite the fact that it fit all of the requirements for an OTC drug, and then on August 24, 2006 to the surprise of many, the FDA approved OTC access for Plan B. However, the approval of OTC acce ss is for women 18 years and older with prescriptions required for those 17 years ol d and under (FDA News, 2006). Plan B is to be stocked and held at pharmacies behind the counter so that it may be dispensed with a prescription for those less than 18 years of age or by proof of age for those over 17 years of age (FDA News, 2006).

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12 Need for the Study Although the decision by the FDA to approve OTC access to emergency contraception for women over 17 years of age is a step forward, it is not enough. Whether emergency contraception is dispense d through a prescription to women less than 18 years of age or OTC to women over 17 years of age, pharmacists will continue to play a crucial role in access to this medicati on. For women over 17 years of age requesting emergency contraception OTC, pharmacists ma y be the first contact to a health care professional for these women as Stacie Ga rnett from the Emergency Contraception Network stated the day emergency contracep tion went OTC, “Training for pharmacists will be more important than ever as they become the first contact for women seeking EC” (S. Garnett, personal co mmunication, August 24, 2006). In addition, for women who seek emer gency contraception by prescription, pharmacists can either aid or inhibit the doctor/patient rela tionship. Some pharmacists have refused to fill prescriptions of emergency contraception. When a doctor writes a patient a prescription for emergency contraceptio n, it is the intention of the doctor to give the patient the medication. If the patient then takes her prescription to a pharmacist to fill the prescription and the pharmacist refuses to do so, the pharmacist is therefore inhibiting this doctor/patient relationship. For exampl e, in 2004, a pharmacist in Texas would not fill a rape survivor’s prescription for emergency contraception, citing moral objections for the refusal (Reuters, 2004). In October 2005, a pharmacist in Missouri who works at a local Target store refused to fill a pres cription of emergency contraception. Other reports of pharmacist refusal have come from Ohio and New Hampshire (Cantor & Baum, 2004).

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13 In addition to pharmacists refusing to fill prescriptions of emergency contraception, some pharmacies refuse to stock this medication. Pharmacists’ knowledge, attitudes, and dispen sing practices of emergency contraception may have an affect on whether women have access to emergency contraception and whether pharmacies carry the medication. Lack of acce ss to emergency contraception can result in unintended pregnancies, which may result in unplanned births or a bortions. Therefore, pharmacists’ behavior, professional conduct, and ethical practice a nd training all have major implications for public health and access to care for women, children, and families. Purpose of the Study This study has two purposes: First, becau se the attitudes and dispensing practices among pharmacists may be related to their unde rstanding of the medication, a review of pharmacy school curricula in the U.S. was conducted, and involved (a) an assessment of course content related to emergency contracep tion and (b) an analysis of how this content is perceived by pharmacy students. The second purpose of the study is to assess emergency contraception knowledge, attitudes, subjective norms, pe rceived behavioral control, and dispensing practices of phar macists and to determine if pharmacists’ emergency contraception knowledge, attit udes, subjective norms, and perceived behavioral control are predictive of their dispensing practices. This project provides importa nt state-level data for Fl orida, country-wide data on curricula for the U.S., and helped to identify geog raphic and demographic trends in pharmacist practices. This research a dvanced the state of knowledge, aided in formulating baseline data on pharmacists’ knowledge and practice, and provided a venue with which to make recommendations of ways to strengthen pharmacy school curricula.

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14 In addition, this research may work towa rds the goals of mainstreaming emergency contraception and reducing unintended pregnanc y and the need for abortion in the U.S. Research Questions Question 1: What do the 91 accredited schools of pharmacy in the U.S. teach about emergency contraception? Question 1a: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are prov ided in the required courses at the 91 accredited schools of pharmacy in the U.S.? Question 1b: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are prov ided in the elective courses at the 91 accredited schools of pharmacy in the U.S.? Question 2: How is emergency contraception co urse content taught at accredited schools of pharmacy as perceived by fourth year pha rmacy students at the four accredited schools of pharmacy in Florida? Question 2a: What did pharmacy students l earn about emergency contraception in their pharmacy school classes? Question 2b: How was emergency contrace ption taught in their pharmacy school classes? Question 2c: What are the projected emergency contraception dispensing practices of pharmacy students? Question 3: What is the relationship among emergency contraception knowledge, attitudes, subjective norms, perceived behavi oral control, intention to dispense, and dispensing practices of Florida pharmacists registered with the Board of Pharmacy?

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15 Question 3a: Is emergency contracepti on knowledge predictive of dispensing practices of Florida pharmacists? Question 3b: Are attitudes about emer gency contraception predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3c: Are subjective norms ab out emergency contraception (whether important people such as colleagues, s upervisors, corporate headquarters, and peers think they should dispense emergency contraception) predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3d: Is perceived behavioral contro l, the perceived ease or difficulty of dispensing emergency contraception, predic tive of dispensing practices of Florida pharmacists? Question 3e: Is intention to dispense emergency contraception predictive of dispensing practices of Florida pharmacists? Question 3f: Are emergency contrace ption knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense taken together, predictive of emergency contraception dispensing practices of Florida pharmacists? Assumptions 1. The pharmacists will report their kno wledge, attitudes, subjective norms, perceived behavioral control, a nd dispensing practices accurately. 2. The pharmacy students will report their pe rceptions about the education they received as well as their perceptions about future dispensing pr actices accurately.

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16 3. The academic Deans of the accredited sc hools of pharmacy will report what is covered in their curricula concerning emergency contraception accurately. Delimitations The following delimitations are imposed on this study: 1. Results are only generalizable to English literate pharmacists re gistered with the Board of Pharmacy in the state of Florida. 2. Results from the quantitative data are ge neralizable to only accredited schools of pharmacy in the U.S. 3. Results from the qualitative data by de finition cannot be generalized to all pharmacy students. Limitations The following are limitations of this study: 1. Pharmacists who respond to the survey ma y be motivated to respond due to their attitudes about emergency contraception (both positive and negative attitudes). 2. Results of the study cannot be generalized to all pharmacists in the U.S. or all pharmacy students in the U.S. 3. Results from the study are based upon se lf-reports which means that reported behaviors and educational instruction may be a proxy for actual behavior and instruction. Definitions of Relevant Terms Abortion : Termination of pregnancy before the fetu s is viable and capable of extrauterine existence, usually less than 20 weeks of gestation (or when the fetus weighs less than 500g) (Lowdermilk & Perry, 2004).

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17 Birth Control : Practices employed by couples that permit sexual intercou rse with reduced likelihood of conception and birth. The term birth control is ofte n used synonymously with such terms as contraception, fertility co ntrol, and family planning. Birth control includes abortion to prevent a birth, whereas family planning methods explicitly do not include abortion (Population Reference Bureau, n. d.). Conception : Union of the sperm and ovum resulting in fertilization; formation of the onecelled zygote (Lowdermilk & Perry, 2004). Contraception : Prevention of impregnation or c onception (Lowdermilk & Perry, 2004). Depression : An intense and pervasive sadness with severe and labile mood swings (Lowdermilk & Perry, 2004). Emergency Contraception : A type of hormonal contracep tion, containing high doses of estrogen and progestin (ethinyl estradiol plus levonorgestrel) or progestin only (levonorgestrel). Emergency contracepti on is 75%-89% effec tive in preventing pregnancies when taken with in 120 hours (5 days) after sexual intercourse (Planned Parenthood, n. d.) Family Planning : The conscious effort of couples to regulate the number and spacing of births through artifici al and natural methods of contra ception. Family planning connotes conception control to avoid pregnancy and abor tion, but it also includes efforts of couples to induce pregnancy (Population Reference Bureau, n. d.). Infant Mortality : Number of deaths per 1000 chil dren 1 year of age or younger (Lowdermilk & Perry, 2004).

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18 Intended Pregnancy : Where the pregnancy is reported to have happened at the “right time” or occurring later than desired due to infertility or other problems becoming pregnant (Brown & Eisenber g, 1995; Santelli, et al., 2003). Low Birth Weight (LBW) : An infant birth weight of less than 2500g (Lowdermilk & Perry, 2004). Miscarriage : Spontaneous abortion; lay term usually referring to the loss of the fetus (Lowdermilk & Perry, 2004). Pharmacist : a health professional trained in the art of preparing and dispensing drugs (Word Reference, n. d.). Pharmacology : The science of drugs, including their composition, uses, and effects. The characteristics or properties of a drug, especi ally those that make it medically effective (The Free Dictionary n. d.). Pregnancy : Period between conception through co mplete birth of the products of conception. The usual duration of pregna ncy in the human is 280 days, 9 calendar months, or 10 lunar months (Lowdermilk & Perry, 2004). Preterm Birth : Birth occurring before 37 weeks of gestation (Lowdermilk & Perry, 2004). Plan B : Plan B consists of two white tablets, each contain glevonorgestrel .75mg. The first tablet is taken within 72 hours of unprot ected intercourse, and the second tablet is taken 12 hours later (American Pharmaceutical Association (AphA) spec ial report, 2000). Preven : see Yupze Regimen of Emer gency Contraception below. Unintended Pregnancy : Unintended pregnancy is classi fied as either unwanted or mistimed. Unwanted refers to where the cu rrent pregnancy occurred when no children or

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19 no more children were desired and mistimed refers to when the woman may have wanted to be pregnant at some point in her life but that the current pre gnancy occurred earlier than desired (Brown & Eisenberg, 19 95; Santelli, J et al., 2003). Yupze Regimen of Emergency Contraception (AKA Preven) : Preven or the Yupze regimen consists of four blue tablets, each containing ethinyl estradiol 50ug and levonorgestrel .25mg. Two tablets are taken in itially, followed by a second dose of two tablets 12 hours later (Apha special report, 2000).

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20 Chapter Two: Literature Review Review of Related Research This literature review examines the ex isting and current literature on emergency contraception and specifically examines the literature on emergency contraception knowledge, attitudes, and dispensi ng practices of pharmacists. The review begins with a brief overview of emergency contraception in cluding mechanism of action, side effects, contraindications, and teratoge nicity. Next, the review focuses on the current level of knowledge and attitudes about emergency c ontraception among women followed by an exploration of the research conducted on the knowledge, attitudes, and prescribing practices of emergency contraception among h ealth care professionals such as physicians, nurses, and midwives. Because little re search has been conducted on pharmacists specifically, examining these relationships among other health care professionals will help inform this study. Next, the literature review examines the few studies that have been conducted on the relationship between knowledge, attitudes, and dispensing practices of pharmacists. Lastly, this review introduces the reader to the Theory of Reasoned Action and Theory of Planned Behavior and will demonstrate how th e concepts from these theories directly inform the hypothesis and resear ch questions of this study.

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21 Overview of Emergency Contraception Emergency contraception is a type of hormonal contraception, containing high doses of estrogen and progestin (ethinyl estradiol plus levono rgestrel) or progestin only (levonorgestrel). This medica tion is 75%-89% effective in preventing pregnancies when taken within 72 hours (3days ) after sexual intercourse (American Medical Women’s Association (AMWA), 1996; Kaiser Family Foundation, 2000). Recent studies conducted on the Yuzpe regimen (estrogen a nd progestin) of emergency contraception show that the 72 hour window ma y be restrictive and have extended effectiveness up to 120 hours (5 days); however the earlier a woman accesses emergency contraception, the more effective the medication will be (AC OG News Release, 2003; Ellertson et al., 2003). The mechanism of action of emergency contraception is the same as oral contraceptives that are admi nistered daily. Emergenc y contraception works through inhibiting events that are nece ssary for a pregnancy to occu r. Emergency contraception can work in a number of ways to inhibit: 1) Ovulation—can suppress luteinizing horm one that is needed for ovulation; 2) Fertilization—can inhibit movement of egg or sperm; 3) Transport—can inhibit the path of th e fertilized egg to the uterus; or 4) Implantation—can change the endometrium so that the blastocyst is not able to implant (American Pharmaceutical Association special report, 2000). Emergency contraception is not effective if the woman is already pregnant and therefore does not disrupt an existing pre gnancy (Trussell, Duran, Shochet, & Moore,

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22 2000). It is a safe form of contracep tion approved by the FDA in 1997 (FDA Federal Register, 1997). Currently, there is only one dedicated pr oduct on the market that is packaged as emergency contraception in the U.S. called Plan B. Plan B is a progestin-only form of contraception and is orally administered and consists of two white pills containing .75 mg of levonorgestrel, where one pi ll is taken within 120 hours of unprotected intercourse and a second pill is taken 12 hours later. In the past, there was a product on the market called Preven (also known as the Yuzpe regimen) that was packaged as emergency contraception; however this product is no l onger being manufactured. In addition, there are 20 other forms of birth control pills that th e FDA has said are safe and effective to use as emergency contraception (Princeton Univers ity & Reproductive Health Professionals, 2006). Whether a woman uses Plan B or one of the other 20 forms of birth control pills, emergency contraceptives are sa fe to use with few side e ffects. Common side effects include: nausea, vomiting, fatigue, breast tende rness, headache, abdominal pain, and dizziness. If these side effects do occur wh en taking emergency contraceptives, they go away within a few days of treatment (A merican Pharmaceutical Association (AphA) special report, 2000). The side effects listed above were much more common with Preven (estrogen and progestin) and studies have shown that these si de effects are lessened with the use of Plan B (progestin only). For example, a study conducted by the World Health Organization found that in comparing Plan B to Preven, Plan B caused less nausea (23% vs 51%), less vomiting (6% vs 19%), less dizziness (11% vs 17%), and less fatigue (17% vs 29%) (n.

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23 a., 1998). In addition to these adverse effect s, irregular vaginal bl eeding can occur after use but the spotting is not se rious. In addition, a woman’s menstrual period after using emergency contraception may be lighter or heavier than usual depending on the woman (American Pharmaceutical Associati on (AphA) special report, 2000). Contraindications for the use of oral contraceptive combinations as emergency contraception that include ethinyl estradiol (estrogen) include an increased risk of thrombosis and ischemic stroke. However, the British Medicines Control Agency found that over 13 years and approximately four million doses of emergency contraception, only three cases of thromboembolism and three cases of stroke were detected (Vasilakis, Jick, & Jick, 1999). Nonetheless, it is r ecommended that women with a history of thromoembolic disease or stroke should not use emergency contraception as combined estrogen and progesterone and it has been suggested that perhaps they should use Plan B which is levonorgestrel only (American Ph armaceutical Association (AphA) special report, 2000; Van Look & Stewart, 1998). Contraindications for Plan B include : being pregnant, undiagnosed abnormal genital bleeding, and an allergy to progesterone Although being pregnant is listed as a contraindication of emergency contraception, it is listed for the most part because it would not be efficacious during a pregnancy rath er than any ill effects that it may have on an established pregnancy. In fact, using or al contraceptives duri ng a pregnancy has not been found to hurt the fetus (American Ph armaceutical Association (AphA) special report, 2000). Overall, emergency contracep tion is a safe form of contraception with very few side effects an d contraindications.

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24 Epidemiology: Knowledge & Attit udes of Emergency Contraception In order for emergency contraception to be used as a physician-prescribed, overthe-counter (OTC), or pharmacist-provide d medication, women, men, and health care professionals must know of its availability and must understand how it should be used. Recent research findings have suggested a lo w but increasing level of knowledge about emergency contraception among patients and health care providers (Conard & Gold, 2004). Women’s Knowledge Studies in many countries, in cluding those in Europe, As ia, Africa, Middle East, and North America have assessed wome n’s level of knowledge of emergency contraception and found that these rates vary greatly. For example, in a study conducted in India where participants were given a pa per-based questionnaire, neither the abortion clients surveyed (n=500) nor the college students surveyed (n=110) were familiar with emergency contraception (Tripathi, Rathor e, & Sachdeva, 2003). By contrast, a nationally representative population-base d study in Switzerland administered a computerized questionnaire to 4,283 sexually active adolesce nts aged 16 to 20 years old and found that 89% reported having heard of emergency contracep tion (Ottesen, Narring, Renteria, & Michaud, 2002). Similarly, in the United Kingdom, 78% of the 78 women who filled out a paper-based survey while atte nding an abortion clinic were familiar with emergency contraception (Mathew & Urquhart, 2 005). However, in Iran only 8% of the 250 married women ages 15-48 interviewe d knew about emergency contraception (Babaee, Jamali, & Ali, 2003). See Appendix D for a list of emergency contraception knowledge and attitude studies in a comparative context.

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25 Not only do women’s levels of knowledge about emergency contraception vary from place to place, but another striking finding and commonality among the knowledgebased studies is that in most studies, a larger pe rcentage of women report having heard of emergency contraception than the percenta ge of women who actually understand its correct mechanism of action. For example, although Ottesen et al. (2002) found that 89% of women in Switzerland had heard of em ergency contraception, another prospective study that employed a paper-based survey sampled women requesting emergency contraception in Switzerland (n=365) and f ound that 42% of women incorrectly thought that the pills had to be taken within 24 hours of unprotected intercourse and 13% of the women incorrectly thought that emerge ncy contraception was 100% effective in preventing pregnancy (Nguyen, BianchiDemmicheli, & Ludicke, 2003). Similarly, a U. S. study provided a paper-based survey to 297 Latina women attending family planning clinics in Texa s and found that 17% of Spanish-speaking women and 41% of English-speaking Latina women had heard of emergency contraception and 25% incorrectly believed th at emergency contraception would end an existing pregnancy (Romo, Berenson, & Wu, 2004). Also in the U.S., 77% of the 158 women surveyed an inner-city emergency department had heard of emergency contraception, although only half of those who had heard of it knew how to use it. In addition, of those who had heard of it, 26% were not aware of the correct timing, 24% were not aware that it was available in the U.S., and 45% were not aware that a prescription was required for use (Abbott, Feldhaus, Houry, & Lowenstein, 2004). In a similar study, 82% of the 188 women sampled from a Boston community had heard of emergency contraception but onl y about half of t hose women knew how

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26 emergency contraception worked (Chuang & Freund, 2005). Also, among a sample of post-partum women from an inner-city public hospital (n=371) in the U.S., 36% of women had heard of emergency contracep tion and only 7% unders tood the appropriate timing for use (Jackson, Schwarz, Freedman, & Darney, 2000). In countries where emergency contraception is available OTC such as Nigeria and Sweden, 58% of the 880 Nigerian female undergraduate students sampled were familiar with emergency contraception but only 18% knew the 72 hour protocol for use and 49% believed that the pills needed to be take n within 24 hours of unprotected intercourse (Aziken, Okonta, & Ande, 2003). In a st udy conducted in Sweden, 98% of the 800 women studied were aware of emergency cont raception but 38% were not aware of the effectiveness of emergency contraception wh en taken on the first day and 59% were not aware of the effectiveness when taken on th e third day (Larsson, Eu renius, Westerling, & Tyden, 2004). Although there is a disparity between the percentage of women who have heard of emergency contraception and the percentage of women who understand its mechanism, there is reason to believe that both of these percentages ar e increasing over time. A study conducted in 1996 in the U.S. recruited wo men from a hospital-based clinic and drug treatment center (n=133) and th en recruited a different sample of women from the same clinic in 2002 (n=139). Both groups of women were inte rviewed and guided by almost identical questionnaires. The resear chers found that between 1996 and 2002, the percentage of clients who had ever heard of emergency contraception grew from 44% in 1996 to 73% in 2002 and comprehension of timing for use increased from 20% in 1996 to 51% in 2002 (Aiken, Gold, & Parker, 2005).

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27 Although overall knowledge about emergenc y contraception has been increasing over the years, many misconceptions about em ergency contraception still remain. One U.S.-based study examined the knowledge and attitudes of emergency contraception among women and men ages 18-21 (n=97) atte nding a university th rough the use of a 25item paper-based questionnaire. This study found that almost half of the participants thought that emergency contraception was the same as RU-486, an abortifacient (Corbett, Mitchell, Taylor, & Kemppainen, 2005). Si milarly, another U.S.-based study conducted a telephone survey among students attendi ng Princeton University (n=550) and found that study participants were confused be tween emergency contraception and RU-486 (Harper & Ellertson, 1995). It is clear from these studies that although women’s knowledge of emergency contraception varies, more women have h eard of emergency contraception than know how to use it. That is, women may be aw are that emergency contraception exists; however, they are not aware of th e issues of timing, effectivene ss, and how to obtain it. This finding demonstrates the need for educ ational efforts to address these deficits. Educational efforts should not only promote awareness of emergency contraception but should present specific information about the medication such as correct timing for use, availability, level of effectiveness, proper use, and possible side effects. Women’s Attitudes Much like knowledge, women’s attitudes to wards emergency contraception vary. In many studies, women tended to have positiv e attitudes about emergency contraception. For example, in the study of Iranian wome n (n=250) where 8% of women had heard of emergency contraception, 77% of the wome n surveyed were found to have a positive

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28 attitude about it and reported that they would be willing to use it in th e future or tell other people about it after they were informed of what the medication was and how it worked. Because the percentage of women who had heard of emergency contraception was so low, attitude was measured af ter each participant was read a paragraph explaining what it was and how it worked (Babaee et al., 2003). Positive attitudes were also found in ot her studies. Among the Swedish women studied (n=800), 90% agreed that access to emergency contraception is positive (Larsson et al., 2004). Of the 76 women surveyed in an abortion clinic in the UK, 90% of the women said they would consider using emer gency contraception in the future (Mathew & Urquhart, 2005). And in the study of women recruited from a U.S. urban hospital and drug treatment center (n=139), over half of th e women thought that there may be a future need to use emergency contraception, and of those that perceived a future need, 95% reported that they would use it if needed (Aiken et al., 2005). Although most studies found pos itive attitudes towards emergency contraception, two studies found attitudes that were not as positive. In the study conducted in the inner city emergency department in the U.S. (n= 158), 51% of women repor ted that they would think about using emergency contraception if they needed it; however 17% reported moral or religious objections to its use (A bbott et al., 2004). Als o, among the university men and women that were surveyed in th e U.S. study (n=97), 100% of the women who reported to be unlikely to choose emergency contraception said that they would feel judged or embarrassed if they had to ask for it (Corbett et al., 2005). Unfortunately, the article did not mention how many women repor ted to be unlikely to choose emergency contraception.

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29 Some researchers conducted further invest igations into women’s attitudes about emergency contraception and discovered a re lationship between a pproval of emergency contraception and political and religious view s. Harper and Ellertson (1995) found that political and religious affiliations were signi ficant predictors of student attitudes. Specifically, they found that Democrats (86%) were more approving of emergency contraception than Republican s (71%) or Independents (63.5 %). Also, highly religious students were less likely to recommend emergency contraception to women than those who were not religious. Harper and Ellertson (1995) also found a positive correlation between emergency contraception knowledge and attitudes, that is, when the level of knowledge about emergency contraception increased, so did the po sitive attitudes about its use. In fact, the odds of the favorable attitudes of emergency contraception were 148% higher among participants that understood the side effects when compared to those who did not. This relationship between knowle dge and attitudes was also demonstrated among Latina women surveyed in the U.S. (n=297). These researchers found that only half of women who have heard of emergency contraception said that they would be willing to use it in the future and those who did not comprehend the action of emergency contraception were even less likely to say that they would use it in the futu re (Romo et al., 2004). In contrast to these findings, the U.S. based study of 371 post-partum women from an inner-city public hospital found that while two-thirds of these women reported a willingness to use emergency contraception in the future, only 7% understood the correct timing for use (Jackson et al., 2000). This finding that willingness to use the medication was high even though comprehension of timin g was low seems to conflict with the

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30 previous study that found that the willingn ess to use emergency contraception decreased as the comprehension of action decreased. In summary, women’s attitudes about em ergency contraception vary. However, in most studies, women held positive att itudes about emergency contraception. In addition, there seems to be little consistenc y in the relationship between knowledge and attitudes. For example, some studies s howed high knowledge and positive attitudes, some studies showed low knowledge and positiv e attitudes for future use, while other studies showed low knowledge and negative a ttitudes towards emergency contraception. However, one thing that can be surmised is that education should be provided to women who are willing to use emergency contraception but are unfamiliar with it. It is important to note that in some studies approval of the bi rth control pill was re lated to political or religious views. These views may account for the studies that found high knowledge and low attitudes about emergency contraception; however more research is needed to uncover these relationships. Healthcare Professionals’ Know ledge, Attitudes, and Practice of Emergency Contraception Several studies have assessed healthcar e professionals’ knowledge, attitudes, and prescribing practices of emergency contracep tion. For the purposes of this literature review and study, the research conducted on healthcare professionals is reported separately from the research conducted on pharmacists. This section will focus on studies conducted on all other healthcare professionals exce pt for pharmacists and the next section will focus solely on pharmacist s. In addition, the terms health care professionals and providers will be used interchangeably.

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31 Provider Knowledge Overall, provider studies on knowledge about emergency contraception have found that while most providers have gene ral knowledge about em ergency contraception, detailed knowledge is low. For example, one U.S.-based study mailed a questionnaire to 236 pediatricians and 121 surveys were return ed. They found that all but one doctor responded that they had heard of emerge ncy contraception but around half of the pediatricians did not know the timing of em ergency contraception or that it was FDAapproved (Sills, Chamberlain, & Teach, 2000). See Appendix E for a list of provider knowledge, attitude, and prescribi ng practice studies in a compar ative context. In another U.S.-based study, 954 pediatrici ans were mailed a five-page survey and 233 responded. Findings indicated that pedi atricians had a lack of detailed knowledge about emergency contraception. For exampl e, 72.9% of respondents could not identify the FDA-approved methods for emergency contraception and roughly 72% of respondents could not identify the correct timing for the dr ug (Golden et al., 2001). Low levels of knowledge were also found in a study conducted on 180 family planning providers in Turkey where only half of the providers knew the correct timing and dose interval of emergency contraception. In addition to this lack of detailed knowledge, these providers had major miscon ceptions about emergency contraception (Uzuner et al., 2005). Over 39% of responde nts believed that emergency contraception causes abortion and 31.1% thought that it was ha rmful for the fetus. In addition, almost 79% of respondents incorre ctly thought that pill use may increase unprotected intercourse and 75% thought that use will lead to men giving up on condom use. Interestingly,

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32 female providers had more negative impressi ons regarding the above statements than male providers (Uzune r et al., 2005). Another U.S.-based study conducted on 78 providers consisting of family physicians and nurse providers explored provider perceived knowledge and actual knowledge. Among the 78 providers, 96% reporte d that they were knowledgeable on the indications for use and 78% reported that th ey understood the prot ocols for prescribing emergency contraception, although knowledge inaccuracies were found between perceived and actual knowledge. Also, 44% of providers inaccurately thought that emergency contraception was an abortifaci ent (Wallace, Wu, We instein, Gorenflo, & Fetters, 2004). Another U.S.-based study gave self-adm inistered questionnaires to 102 providers including physicians, registered nurse pr actitioners, certified nurse midwives, and physician assistants and measured level of knowledge, attitudes, and practices of emergency contraception before and after an educational program. The educational program involved a training of providers through a lecture presentation and a review of a clinical manual. The clinical manual incl uded pertinent information about emergency contraception and each provider was given a c linical manual to keep. At baseline, onethird of the sample did not know the corre ct timing for emergency contraception. At follow-up, one year later, knowledge about emergency contraception significantly increased. However, at follow-up, providers still maintained limited knowledge about the medication’s side effects and modes of action. Overall this study found that an educational training for providers can he lp increase knowledge about emergency contraception; however the finding that there we re still a few gaps in knowledge suggests

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33 a need for even more education and trai ning (Beckman, Harvey, Sherman, & Petitti, 2001). In contrast to these studies where the general knowledge is high, some non-U.S. based studies found that even genera l provider knowledge about emergency contraception was absent. One study c onducted in Turkey found low levels of knowledge among 72 health care providers whic h included general practitioners, nurses, and midwives (Sevil, Yanikkerem, & Hatipog lu, 2006). These researchers used face-toface interviews as well as paper-based self administered questionnaires. They found that almost one in ten provider s surveyed was unfamiliar with the words ‘emergency contraception’ and they concluded that know ledge about emergency contraception among health care providers is inadequate. In addition, a study conducted on the knowledge, attitudes and practice of family planning among community health extension workers (n=232) in Nigeria found an absence of knowledge about emergency contraception (Onwuhafua, Kantiok, Olafimihan, & Shittu, 2005). Provider Attitudes In addition to low levels of knowledge and major misconceptions about emergency contraception, several studies iden tified negative attitudes towards emergency contraception. Golden et al. (2000) surveyed 233 practicing pediatricians and found that 68% of respondents felt uncomfortable pr escribing emergency contraception, with inexperience cited as the most common r eason (70%). Seventeen percent did not prescribe due to perceived tera togenic effects and 12% did not prescribe due to moral or religious reasons. In addition, 22% agreed that emergency contraception provision

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34 encourages adolescent risk-tak ing behavior and 52% said they would place restrictions on how many times they would dispense the drug to a patient (Golden et al., 2000). Another U.S.-based study conducted on 78 providers consisting of family physicians and nurse providers found genera lly positive attitudes towards prescribing emergency contraception, although the actual rate s of prescribing were low. Of the 78 providers studied, 90% thought th at the pill was an appropria te topic of discussion at women’s exams and felt that the benefits of emergency contraception outweighed the risks. However, due to fear of repeated pill use, 59% of providers said they would restrict how many times they prescribed em ergency contraception to a woman. Also, 14% thought that emergency contraception us e would discourage re gular contraceptive use, 16% were uncomfortable prescribing emergency contraception for religious or ethical reasons, and 7% said that they would not prescribe emergency contraception under any circumstances (Wallace, et al., 2004). Interestingly, in a 2001 in the U.S.-bas ed study that surveyed 102 providers and measured levels of knowledge, attitudes, and pr actices of emergency contraception before and after an educational program, follow -up knowledge and prescribing practices increased while attitudes about emergency contraception showed little change (Beckman et al., 2001). This finding ma y indicate the difficulty of pr oducing a change in provider attitudes. Provider Prescribing Practices In general, research conducted on provi der prescribing practices of emergency contraception has shown prescribing frequency among providers to be low, regardless of specialty. That is, most providers have pres cribed emergency contraception at one point

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35 or another, but report prescrib ing the medication less than five times per year (Delbanco et al. 1998; Gold, Schein, & Coupey, 1997; Sills et al., 2000; Chuang, Waldman, Freund, & Ash, 2004). Unlike the low rates of prescr ibing among U.S. providers, a national study of British health authorities found that the ma jority of physicians surveyed report that they prescribe emergency contraception a fe w times per week (Webb & Morris, 1993). A mail-based survey conducted in the nor theast region of the U.S. sought to compare emergency contraception prescrib ing practices among 282 providers and found that 94% of obstetricians/gynecologists, 76% of family practitioners, and 63% of general internists had ever prescribed emergency contraception. This study found that being female was a positive predictor (OR: 9.6, 95% CI: 3.2-29.1) and the Catholic religion was a negative predictor (OR: .39, 95% CI: .19-.79) for prescribing emergency contraception. In addition, 75% of the physicians surveyed (8 6% of general internists, 82% of family physicians, and 57% of obstetricians-gynecologi sts) reported infreque nt prescribing of emergency contraception (less than five tim es a year), regardless of their specialty (Chuang, et al., 2004). A study conducted in India found a very lo w level of prescribing of emergency contraception. Researcher s found that 84% of gynecol ogists and 41% of general practitioners were vaguely familiar with emergency contraception, although among those who had some knowledge, most were unsure of how to prescribe it. In fact, 51% of gynecologists and 17% of practiti oners reported ever prescribi ng it (Tripathi et al., 2003). It is interesting to note that in both of these st udies discussed above the prescribing frequency among providers is lo w; however, women hea lth care providers like gynecologists tended to ha ve a higher level of knowledge and a higher prescribing

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36 frequency of emergency contraception than non-women specific health care providers such as pediatrics or general practitioners. An additional U.S.-based study conducted on 78 providers consisting of family physicians and nurse providers, also found low prescribing practices (Wallace et. Al., 2004). Of the 78 providers studied, 74% reporte d that they have prescribed emergency contraception in the past, with an average of 3.2 times in the past year. In a U.S.-based study that surveyed 102 providers and measured level of knowledge, attitudes, and practices of emer gency contraception before and after an educational program, at baseline only 7% of providers reported prescribing emergency contraception once a month. At followup, prescribing frequency of emergency contraception significantly in creased (Beckman et al., 2001). For example, providers who prescribed emergency contraception at least once per year rose from 30% to 49% and providers who reported prescribing emer gency contraception at least once a month rose from 7% at baseline to 26% at fo llow-up. These findings indicate that an educational program may help increase the fr equency of provider prescription writing. Although many of these studies discussed measured knowledge, attitudes, and prescribing practices independent ly, very few studies have eval uated provider practices in relation to provider knowledge and attitudes. One study found that knowledge about emergency contraception was significantly related to prescribing practice whereas attitudes about emergency contraception were not found to be significant predictors of prescribing it (Sills et al., 2000). For example, two of the knowledge variables, knowledge of the timing of emergency cont raception and knowledge that it is FDAapproved, were predictive of emergency cont raception counseling and prescribing. In

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37 contrast, none of the attitude variables in cluding, (a) whether they thought emergency contraception causes a risk of congenital malformation, (b ) concern about giving or prescribing the medication, (c) whether it shoul d be used in rape cases, or (d) whether a provider thought that the side effects of were serious, were predictive of prescribing writing or counseling. This study suggests that knowledge, not attitudes, is a significant predictor of emergency contraception prescrib ing. However, another study found just the opposite. Gold et al. (1997) found that four out of the eight negativ e attitude variables did correlate to failure to prescribe emergenc y contraception. In addition, another study performed a cross-sectional survey of 96 faculty physicians and found that 42% of physicians intended to prescribe emergency contraception for teenagers, whereas 65-77% of the sample intended to prescribe to othe r identified groups. Th is study also found that intention to prescribe was a ssociated with positive att itudes but physicians’ knowledge about emergency contraception was not found to be significant (Sable, Schwartz, Kelly, Lisbon & Hall, 2006). This discrepancy in re search findings merits further inquiry into determining the predictors of emerge ncy contraception pr escription writing. Pharmacists’ Knowledge, Attitudes, & Dispen sing Practices of Emergency Contraception In the only study of its kind, Van Riper and Hellerstedt (2005) assessed pharmacist knowledge, attitudes, and dispensi ng practices of emergency contraception among South Dakota pharmacists. A 14-item survey was mailed to all registered pharmacists (n=810) in South Dakota to assess their attitudes, knowledge, and dispensing practices of emergency contraception and 62% responded. Among respondents, only 54% of pharmacists worked in pharmacies th at carried emergency contraception. For those that carried the me dication, 67% of pharmacists had dispensed emergency

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38 contraception in 2003 but 24% reported th at they were not comfortable providing counseling to clients about the medication. Di spensing practices did no t vary by gender. Findings also suggested that ther e was low knowledge about emergency contraception among South Da kota pharmacists, as 37% were unaware that the medication is similar in its mechanism to or al contraceptives. In addition, 74% of pharmacists either incorrectly agreed or were uncertain about whether emergency contraception can cause birth defects when ad ministered to pregnant women and 85% of respondents either incorrectly agreed or were uncertain about the stat ement that repeated use of the medication can pose health risks. Only 5% of the sample correctly answered all five of the knowledge questions on the survey (Van Riper & Hellerstedt, 2005). In contrast to dispensing behaviors, knowledge and attitudes about emergency contraception did vary by sex where more female pharmacists opposed making emergency contraception over-the-counter. One limitation of this study is that th e researchers did not include enough questions about attitudes towards emergency contraception and did not question whether the pharmacist had personal or moral object ions about dispensing the medication. In addition, this study did not ask questions about knowledge of other contraceptive medications to assess whether there was a l ack of knowledge about al l contraceptives or just emergency contraception. Although there have been no other publishe d state-wide studies on the knowledge, attitudes, and dispensing pract ices of pharmacists, there have been, however, a handful of studies that assessed pharmacists’ kn owledge and attitudes about emergency contraception and one study that assesse d pharmacists’ knowledge, attitudes, and beliefs

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39 towards prescribing emergency contraception. These five studies will be discussed below in chronological order. Please s ee Appendix F to view these studies in a comparative context. In 1999, a study was conducted by the Planned Parenthood of New York City. They conducted a phone survey of 100 retail pharmacists who practiced in New York City and only 3 out of 100 pharmacists surv eyed provided correct information about emergency contraception, while 38 pharmacist s did not know it was available in the U.S. (Draut, 1999). In their ar ticle, Planned Parenthood comp iled some interesting quotes provided by pharmacists upon bei ng called and asked about em ergency contraception. They are as follows: “…never heard of the morning-after pill…”, “Don’t have it…don’t know anything about it”, “There ’s no morning-after pill av ailable in this country.”, “…it’s used to induce periods and it starts contractions..it is abortion”, “It must be taken within one day, that’s why it’s called the morning-after pill.” (p. 2-3). The second study, conducted by Bennett, Pe traitis, D’Anella, and Marcella in 2003, randomly selected pharmacies in Penns ylvania and assessed pharmacist knowledge (accuracy of information provided to client) and availability of emergency contraception through employing “mystery callers”. Thes e mystery callers called the pharmacy and spoke to 315 pharmacists. They asked que stions that assessed knowledge and assessed whether the particular pharmacy could dispen se emergency contraception that day. The findings from the study indicated that knowledge about and access to emergency contraception was limited. In fact, 30% of the pharmacists surveyed did not provide the correct timing required for emergency contr aception administration where 23% thought it needed to be taken within 24 hours and 7% thoug ht it needed to be ta ken within 48 hours.

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40 In addition, 13% of the pharmaci sts said that emergency co ntraception would cause an abortion (Bennett et al. 2003). Sixty-five percent of the pharmaci sts sampled reported that they would not be able to fill a prescr iption of emergency contraception that day. Of those who reported that the medication coul d not be filled that day, 79% said the medication was not in stock, 6% replied that it was against store policy, 7% reported that it conflicted with person al beliefs, and 8% did not provide a reason. A potential limitation of this study is that attitude of the pharmacist was measured by the mystery caller recording the attitude she felt from the pharmacist toward her after the call ended. This variable was measured on a 5-point graded scale, from very unpleasant to most pleasant (Bennett et al., 2003). The third study, conducted in Indiana, mailed a surv ey to chief pharmacists (n=948) at 1361 pharmacies and assessed pharm acists’ attitudes towards practice with adolescents (Conard, Fortenberry, Blythe, & Orr, 2003). The study’s main goal was to address pharmacists’ attitudes and practice w ith adolescents concer ning all medications, and although emergency contraception wasn’t the focus of the study, it was included in the list of medications. One interesting finding from this stu dy was that although the majority of pharmacists dispensed medication to adolesce nts, 57% reported feeling inadequately trained for handling adolescent-related issues Another important finding was that 48% of the pharmacists surveyed did not dispense emergency contraception. Age was found to be a significant factor in that pharmacist s under 45 years of age were more likely to report dispensing emergency contraception; however no differences were found for sex (Conard et al., 2003).

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41 Of the 59% of pharmacists who have di spensed emergency contraception to adolescents, 83% said that they felt uncomfortable dispensing it. There were no differences in feelings of comfort based on age or sex (Conard et al, 2003). These findings that emergency contraception is una vailable at pharmacies and that pharmacists either don’t dispense or ar e uncomfortable dispensing em ergency contraception to adolescents is of concern in that it places barriers to access to emergency contraception for adolescents. A fourth study, conducted in Sweden, where emergency contraception is sold both over-the-counter and in cl inics and hospitals, assessed attitudes towards emergency contraception and its OTC availability am ong pharmacists and pharmacy staff (n=237) and nurse-midwifes (n=163) through a mail-ba sed survey (Aneblom, Lundborg, Carlsten, Eurenisu, & Tyden, 2004). The reason this st udy chose to survey pharmacists, pharmacy staff, and nurse-midwives is because these individuals represent the professionals in Sweden that are the main providers and counselors of emergency contraception. The findings showed that both study groups had positive attitudes towards emergency contraception and towards the OTC administration of emergency contraception; however nurse midwives demons trated more favorable attitudes than the pharmacist group. In addition, verbal informa tion and counseling to clients on issues of emergency contraception was more commonl y reported by the nurse-midwife group than by the pharmacist group and both groups reported that they wanted more collaboration between health care providers (Aneblom et al., 2004). The fifth study, conducted in New Mexic o, sought to describe pharmacists’ knowledge, attitudes, and beliefs towards pr escribing emergency contraceptives through

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42 a mail-based questionnaire (Borrego et al., 2006 ). Of the 1392 questi onnaires that were delivered, 555 (40%) were returned but only 523 (38%) could be used. Overall, they found that although New Mexico pharmacists had positive attitudes and beliefs about prescribing emergency contraception, their knowledge about the medication was average. In addition, 40% of the sample had an in terest in becoming certified to prescribe emergency contraception in their state-appr oved emergency contraception prescribing training program. New Mexico is one of three states (Ca lifornia, Maine, and New Mexico) that allow pharmacists to dispense emergency c ontraception without a prescription under a state-approved protocol. Ph armacists who had an intere st in becoming certified to prescribe emergency contraception were mo re likely to be male, non-Hispanic, nonChristian, to report liberal or moderate political views, and to say that they had employer approval, time, and privacy at their pharmacy to prescribe emergency contraception. New Literature Since the original writing of this literature review, a few pertinent studies have been published and will be addressed here. One study has been published describing the knowledge, attitudes, and pract ices among pharmacists in Puer to Rico (Fuentes & AzizeVargas, 2007). Pharmacists attending a natio nal conference were su rveyed. Although it was found that emergency contraception knowledge was low among these pharmacists, they were in support of a non-prescr iption emergency contraception policy. Another study assessed st udent pharmacist knowledge and attitudes surrounding emergency contraception (Evans, Patel, & Stranton, 2007). A group of pharmacy students were sent an electronic surv ey measuring knowledge, attitudes, and

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43 demographics. Researchers found that religi ous and political views played a role in determining student attitudes about emergency contraception. They also found that high levels of knowledge equates to more suppor t and fewer concerns regarding use of emergency contraception. This study aids in strengthening the results of this study in terms of need for effective t eaching and efficient learning. Another few provider studies were publis hed since this literature review, one concerning a cross-sectional survey faculty phys icians about intention to educate patients about emergency contraception at four U.S. universities (Kelly, Sa ble, Schwartz, Lisbon, & Hall, 2008), and one study that assessed prov ider knowledge, attit udes, practice, and barriers at a military treatmen t facility in the U.S. (Chung-Park, 2008). The first study found that attitudes and peer expectations ar ound educating predicted intention to educate patients about emergency contraception among faculty physicians. The second study found low knowledge among the sample of provi ders such that there was a discrepancy between what providers perceived know ing and actual knowledge. The first study concludes that attitudes and beliefs should be addressed wh en creating interventions and the second study calls for better education among providers. Summary & Recommendations for Future Research Women’s Knowledge & Attitudes Overall, women’s knowledge and attitudes about emergency contraception vary. In terms of women’s knowledge, more wome n are aware that emergency contraception exists; however, they are not aware of the i ssues of timing, effec tiveness, and how to obtain it. This finding demonstrates the need for educational effo rts to address these deficits. Educational efforts should not only promote awareness of emergency

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44 contraception but should present specific information about the medication such as correct timing for use, availability, level of effectiveness, proper use, and possible side effects. In terms of women’s attitudes toward s emergency contraception, most women had positive attitudes about the medication and these attitudes were not dependent on level of knowledge. In fact there was little consistency in the relationship between knowledge and attitudes of emer gency contraception. For example, some studies showed high knowledge and positive attitudes, some studies showed low knowledge and positive attitudes for future use, while other studies showed low knowledge and negative attitudes towards the medication. Future research could examine the relationship between emergency contraception knowledge and at titudes among women and determine what causes these inconsistencies. However, one th ing that can be surmised is that education should be provided to women who are willi ng to use emergency contraception but are unfamiliar with it. Another interesting finding was that in some studies, approval of the pill was related to political or religious vi ews. These views may account for the studies that found high knowledge and low attitudes about emergency contraception; however more research is needed to uncover these relationships. Health Care Professionals’ Know ledge, Attitudes, & Practice When comparing the provider studies, it becomes evident there is a paucity of detailed knowledge about emergency contra ception among providers and there are major misconceptions that seem to persist. It seem s that providers, speci fically those who work with women of childbearing age and whose dut y it is to care for the health of women, should have both salient a nd specific knowledge about emergency contraception.

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45 Unfortunately, these studies show that prec ise knowledge among h ealthcare professionals is inadequate. Therefore, these findings sugge st that training is needed for healthcare professionals. Healthcare providers need more detailed information about emergency contraception which would most likely increas e the rate of knowledge and use by clients, decrease the misconceptions held by provi ders, and increase provider prescribing frequencies. Future research could test these hypotheses. Although the knowledge that providers ha ve about emergency contraception is generally consistent in the literature, provide r attitudes tend to vary with some reporting positive and some reporting negative attitudes. This finding may be due to the fact that people are different and there may be as ma ny varying attitudes as there are people. However, more research is needed in this area. Another interesting finding was the gender differences detected in three of the health care provider studies. One study found that women health care providers were more likely than male health care providers to have negative att itudes towards emergency contraception, the second study found that th ey were more likely than their male counterparts to say that em ergency contraception should not go over-the-counter (OTC), and the third study found that being female was a positive predictor of prescribing emergency contraception. The first two studi es point towards female providers having more negative attitudes towards emergency contraception than male providers but the third study demonstrates that women provi ders are more likely to prescribe the medication. These gender differences are notew orthy and should be explored in greater detail.

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46 In general, results from studies show low prescribing rates of emergency contraception among health care providers in the U.S. One study found that being female was a positive predictor and being Catholic was a negative predictor of prescribing emergency contraception. Two other studies found that knowledge was a predictor of prescribing emergency contraception but c onflicted on whether provider attitude was a significant predictor of emergency contraceptio n prescription writing. More research is needed to uncover these relationships and inc onsistencies and to determine what predicts prescribing practices. Also, gi ven the high abortion rate in th is country, efforts should be taken to increase the number of emergency contraception prescriptions that are written which may aid in a decrease in abortion and unintended pregnancy rates in the U.S. Pharmacists’ Knowledge, Attit udes, & Dispensing Practices A major finding from the pharmacist studies is that many pharmacies in the U.S. do not carry emergency contraception. This finding is troublesome in that access is certainly limited if pharmacies do not carry th e medication. Another major finding is that there are many pharmacists that do not f eel comfortable dispensing emergency contraception to adolescents and also do not feel confident in counseling women about emergency contraception. Perhaps future re search could test if comfort levels in counseling women and dispensing the medi cation would increase if knowledge about emergency contraception was increased and misconceptions were dispelled. Much like the health care provider literatu re, when viewing the pharmacist studies it becomes apparent that there is a lack of detailed knowledge and understanding about emergency contraception among pharmacists and major misconceptions persist as a result. These studies show that precis e knowledge among pharmacists is inadequate

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47 suggesting that training is needed for pharm acists. Pharmacists need more detailed information about emergency contraception wh ich may result in an increased rate of knowledge and use by clients, a decrease in the misconceptions held by pharmacists, increased provider dispensing frequencies, as well as increased comfort in counseling about emergency contraception. Future resear ch is needed to test these hypotheses. Although studies have shown that the know ledge that pharmacists have about emergency contraception is generally low, mo re research is needed in determining the attitudes of pharmacists as th ey tended to vary with some reporting positive and some reporting negative attitudes. In addition, given that there is only one study that measured the self-reported emergency contraception dispensing prac tices of pharmacists, more research is needed to understand the pr escribing practices of pharmacists. It is also important to note that there is limited research on emergency contraception and pharmacists as there have onl y been five U.S.-based studies concerning these topics. In addition, no other study except the Van Riper and Hellerstedt (2005) South Dakota study, assessed pharmacists’ attitu des, knowledge, and dispensing practices of emergency contraception. However, Van Riper and He llerstedt (2005) failed to determine whether pharmacist knowledge and attitudes about emer gency contraception predict dispensing practices. The proposed study will be the first to test these relationships. Given the low levels of knowledge detect ed among pharmacists in the few studies conducted, it is imperative to find out what pharmacists are learning about emergency contraception in school. Therefore, this st udy proposes to perform a curricula review of

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48 all 91 accredited schools of pharmacy in the U.S. to determine what is being taught about emergency contraception to pharmacy students. This study has two purposes: First, becau se the attitudes and dispensing practices among pharmacists may be related to their unde rstanding of the medication, a review of pharmacy school curricula in the U.S. w ill be conducted, and will involve (a) an assessment of course content related to emer gency contraception and (b) an analysis of how this content is perceived by pharmacy students. The second purpose of the study is to assess emergency contraception knowledge, attitudes, subjective norms, perceived behavioral control, and di spensing practices of pharmac ists and to determine if pharmacists’ emergency contraception knowle dge, attitudes, subjective norms, and perceived behavioral control are predic tive of their dispensing practices. The Theory of Reasoned Action The theory that will guide this research, the Theory of Planned Behavior (TPB), is an extension of the earlier Theory of R easoned Action (TRA) which was developed by Ajzen and Fishbein (1980; Fishbein & Ajzen, 1975). The Theory of Reasoned Action was first introduced in 1967 (Fishbein, 1967), and is based on the assumption that people are rational beings who make informed deci sions based on available information. Thus, the theory is called the Theory of Reasoned Action because it assumes that people consider the implications of their actions before deciding wh ether to perform a particular behavior (Ajzen & Fishbein, 1980). The Theory of Reasoned Action’s prim ary purpose is to both predict and understand behavior. The Theory also postulate s that behavioral intention is the most important predictor of behavior. That is, pe ople typically behave in line with their

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49 intentions. Therefore, a secondary purpose of the TRA is to unders tand the determinants of intentions. Following in line with the th eory, behavioral intention is determined by two factors, (a) personal att itudes toward the behavior a nd (b) social influence or subjective norms. Personal attitudes toward a behavior refer to a person’s judgment in performing the behavior. For example, whet her a person believes performing a behavior is good or bad is a personal judgment towards a particular behavior. Social influence or social norms, the second determinant of intenti on, refers to the perc eived social pressures to perform or not perform a particular behavior In general, a pers on intends to perform a behavior when they have a positive attitude towards the behavior and when they perceive that important people think they should engage in the behavior (Aj zen & Fishbein, 1980). See Figure 1 for a graphic representation of the Theory of Reasoned Action. The TRA also postulates that both attit ude and social norms play a role in behavioral intention; however th e relative weights of these fa ctors in terms of influencing intention differ from person to person (Ajzen & Fishbein, 1980). For example, take two women who are deciding whether or not to us e birth control pills. Both women have the same attitudes and social norms towards using the pill; they both want to use the pill (attitude towards behavior) but feel social pressure not to use the pill (social norms), however, one woman decides to use the pill and the other does not. This difference could be because one woman places more emphasis on her attitudes to determine her intention to use the pill and the other woman places more emphasis on social pressures to determine her intention to use the pill. Eith er way, both of their at titudes and perception of social pressures were the same but the re lative weights of the attitudes and social factors varied and thus th e behavior was different (A jzen & Fishbein, 1980).

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50 Figure 1. Theory of Reasoned Action The Theory of Planned Behavior The Theory of Planned Behavior (TPB), which was developed after the Theory of Reasoned Action (TRA), include s an additional construct, perceived behavioral control Whereas the Theory of Reasoned Action was deve loped to deal with volitional behaviors, the Theory of Planned Behavior was devel oped to incorporate behaviors that are not altogether volitional. For example, a sm oker may intend to quit smoking but when tries to quit, is unable to do so. Control over behavior is thus viewed on a continuum with one extreme including something such as voting fo r a particular candidate in a voting booth where the selection is performed at will a nd the other extreme includes actions like sneezing or decreasing one’s blood pressure where people have limited control (Ajzen, 1988). Although these examples are extremes, th e point is that many factors can interfere with the relationship between intention and behavior. Ajzen’s Theory of Planned Behavior was developed in an attempt to present a conceptual framework that addresses this incomplete volitional control (Ajzen, 1985; Ajzen & Madden, 1986; Schifter & Ajzen, 1985). The TPB postulates that there are three (rather than the two addressed in the TRA) determinants of intention. The two that were addressed in the Theory of Reasoned Acti on, (a) attitude toward behavior and (b) Attitude toward the b ehavio r Subjective Norm Behavioral Intention Behavior

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51 subjective norms, are still pres ent and then a third determinan t, (c) perceived behavioral control is addressed in the Theory of Planned Behavior Perceived behavioral control refers to how difficult or easy the behavior is to perform and according to Ajzen, this difficulty or ease of the behavior is “assume d to reflect past experience as well as anticipated impediments and obstacles” (1988, p. 132). See Figure 2 for a graphic representative of the Theory of Planned Behavi or. In general, there is a direct positive relationship between the three determinants. That is, as attitude and subjective norms towards the behavior become more favorable the perceived behavi oral control becomes greater and the intention to pe rform a particular behavior increases as a result (Ajzen, 1988). Figure 2. Theory of Planned Behavior There are two important features of perceive d behavioral control. The first is that it has motivational implications for intentions That is, individuals who do not have the resources or the opportunities to perform a behavior and not likely to develop strong Perceived Behavioral Control Attitude toward the b ehavio r Subjective Norm Behavioral Intention Behavior

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52 behavioral intentions even though they may have favorable attitudes toward the behavior and feel that people important to them would approve of the behavior. This is why there is a straight line from perceived behavior al control to intention shown in figure 2, because attitude and subjective norm may not mediate the relationship between perceived behavioral control and intention (Ajzen, 1988). The second important feature of perceived be havioral control is that it may have a direct link to behavior as shown in figure 2. Perceived behavioral control can help predict behavior or it can bypa ss behavioral intention altoge ther which reflects the idea that perceived behavioral control can be a measure for actual control. Therefore, perceived behavioral control can predict behavior through inte ntions and can also predict behavior directly as a proxy measur e for actual control (Ajzen, 1988). This third determinant of intention is pa rticularly relevant to the proposed study because a pharmacists’ emergency contracep tion dispensing practices may vary based on the perceived difficulty or ease of dispen sing the medication. That is, emergency contraception dispensing practices of pha rmacists may not be under their volitional control and therefore this thir d determinant of intention may be relevant for the study. For example, if a pharmacist does not want to fill a prescription of emergency contraception but perceives that if she or he refuses that they may be fired, the pharmacists may decide to disp ense the medication anyway. Taking from the concepts, assumptions, and propositions of the TPB, it is hypothesized that if pharmacists intend to di spense emergency contraception then they will have a positive attitudes towards dispensi ng the medication and will perceive that important people think they should dispense the medication. In a ddition, there will be a

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53 positive relationship between attitudes, subjective norms, and perceived behavioral control. For example, if positive attitudes towards dispensing are high and if subjective normative beliefs are high (perception that im portant people think th ey should dispense the medication), than perceived control over the dispensing will also increase. As a result, the intention to dispense emerge ncy contraception will increase which will increase the actual behavior of dispensing. Likewise, if pharmacists do not intend to dispense emergency contraception, they will have negative attitudes towards dispensing the medication and will perceive that importa nt people think they should not dispense emergency contraception. In addition, if the attitudes and subjective norms are low, the perceived control over dispen sing the medication should also be low. This way, the intentions to dispense will be low and th e actual behavior of dispensing emergency contraception will be low as a result. See Figure 3 for a graphic representation of how this theory may be applie d to the research study. Although the Theory of Planned Behavior does not explicitly include knowledge as a predictor of behavior, it will be included in this study. Ajzen (1988) st ates, “at the most basic level of explana tion, behavior is assumed to be a function of salient information, or beliefs, relevant to the be havior” (p. 132). The theory follows that attitude toward a behavior is determined by beliefs about that behavior. Therefore if a person thinks that a certain behavior will lead to favorable outcomes, then the person will have a positive attitude toward the behavior and likewise, a person thinks that a certain behavior will lead to a negative outcome, th en the person will have negative attitudes toward performing the behavior. In additi on, a few of the provider studies found that

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54 knowledge, not attitudes, were predictive of emergency contraception prescribing practices and therefore, knowle dge will be added to the model as shown in Figure 3. *Figure 3: Modified Theo ry of Planned Behavior A pplied to Research Study *EC=Emergency Contraception Is it easy or difficult to dis p ense? Attitude toward dis p ensin g EC Do others think I should dis p ense EC? Intention to dispense or not to dis p ense Dispense EC or not Knowledge about EC

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55 Chapter Three: Methods This chapter describes the methods that were used to conduct this study and has been divided into eight sect ions: (1) purpose of the study, (2) research questions, (3) overview of study design, (4) pharmacy school curricula review, (5) pharmacy student focus groups, (6) pharmacist questionnaire, (7 ) data collection, and (8) data analysis. Purpose of the Study This study has two purposes: First, becau se the attitudes and dispensing practices among pharmacists may be related to their unde rstanding of the medication, a review of pharmacy school curricula in the U.S. was conducted, and involved (a) an assessment of course content related to emergency contracep tion and (b) an analysis of how this content is perceived by pharmacy students. The second purpose of the study was to assess emergency contraception knowledge, attitudes, subjective norms, pe rceived behavioral control, and dispensing practices of phar macists and to determine if pharmacists’ emergency contraception knowledge, attit udes, subjective norms, and perceived behavioral control are predictive of their dispensing practices. This project provided importa nt state-level data for Florida, national data on curricula for the U.S., and helped to identify geog raphic and demographic trends in pharmacist practices. Since no other studies have been conducted on these variables and on this topic, this research advances the st ate of knowledge, aided in formulating baseline data on pharmacists’ knowledge and practice, and provided a venue with which to make

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56 recommendations of ways to strengthen pha rmacy school curricula. In addition, this research works towards the goals of ma instreaming emergency contraception and reducing unintended pregnancy and the need for abortion in the U.S. Research Questions After a thorough review of the literat ure on emergency contraception knowledge, attitudes, and dispensing pract ices, a review of behavioral theories, and an understanding of the future recommendations suggested in th e existing literature, the following research questions emerged: Question 1: What do the 91 accredited schools of pharmacy in the U.S. teach about emergency contraception? Question 1a: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are provided in the required courses at the 91 accredited schools of pharmacy in the U.S.? Question 1b: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are provided in the elective courses at the 91 accredited schools of pharmacy in the U.S.? Question 2: How is emergency contraception course content taught at accredited schools of pharmacy as perceived by third or fourth y ear pharmacy students at the four accredited schools of pharmacy in Florida? Question 2a: What did pharmacy students l earn about emergency contraception in their pharmacy school classes? Question 2b: How was emergency contrace ption taught in their pharmacy school classes?

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57 Question 2c: What are the projected emergency contraception dispensing practices of pharmacy students? Question 3: What is the relationship among emergency contraception knowledge, attitudes, subjective norms, perceived behavi oral control, intention to dispense, and dispensing practices of Florida pharmacists registered with the Board of Pharmacy? Question 3a: Is emergency contracepti on knowledge predictive of dispensing practices of Florida pharmacists? Question 3b: Are attitudes about emer gency contraception predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3c: Are subjective norms ab out emergency contraception (whether important people think they should dispense emergency contraception) predictive of emergency contraception dispensing practices of Florida pharmacists? Question 3d: Is perceived behavioral contro l, the perceived ease or difficulty of dispensing emergency contraception, predic tive of dispensing practices of Florida pharmacists? Question 3e: Is intention to dispense emergency contraception predictive of dispensing practices of Florida pharmacists? Question 3f: Are emergency contrace ption knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense taken together, predictive of emergency contraception dispensing practices of Florida pharmacists?

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58 Overview of Study Design This research study employed a mixed methods study design involving both survey and focus group methods. The study invo lved three major res earch questions with sub-questions included within each of the th ree main questions. Each major research question contains three separate methods craf ted to address each i ndividual but related research question. Question #1 was addresse d through a brief web-based survey emailed to the Academic Deans of the 91 accredited sc hools of pharmacy in the U.S. Question #2 was addressed through focus groups with thir d and fourth year Doctor of Pharmacy (Pharm. D.) students at the f our accredited schools of pharmacy in Florida and Question #3 was addressed through a mixed-mode surv ey administered to a randomly selected group of pharmacists registered with the Florida Board of Pharmacy. Taken together, findings demonstrated what is intended to be taught to pharmacy students, what is actually being learned by pharmacy st udents, and how practicing pharmacists’ perceptions of emergency contra ception are associated with their dispensing practices. This research study examined bot h the education and practice of pharmacists. All activities were approved by the Univ ersity of South Fl orida Institutional Review Board. All records were stored in lock ed filing cabinets in a locked room. It was assumed that all study participants in this study including Deans, practicing pharmacists, and fourth year pharmacy students were able to both read and speak English and were able to complete the questionnaires pr esented to them without aid.

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59 Pharmacy School Curricula Review Target Population & Sampling Frame The first research question, what do the 91 accredited schools of pharmacy in the U.S. teach about emergency contraception, was addressed through a short web-based survey to the Deans at the 91 accredited school s of pharmacy in the U.S. The target population is Academic Deans at accredited scho ols of pharmacy in the U.S. In this case, the target population, the sampling frame, and the sample are the same because the survey will act as a census. Academic Dean s were chosen as the target population for this research question as they are the individuals who are most knowledgeable and responsible for their school curricula. In addition accredited schools of pharmacy were chosen as the target populati on because students must gradua te from an accredited school of pharmacy in order to become a licensed pharmacist in the U.S. Sampling Plan The following four letters were constructe d and emailed to all 91 Deans: (a) a prenotice, (b) an abbreviated informed consent form, (c) a cover letter and questionnaire, and (d) a thank you/reminder letter. Please see Appendix G for a copy of the Academic Dean email pre-notice, Appendix H for a copy of the abbreviated informed consent form, Appendix I for a copy of the Academic D ean cover letter and questionnaire, and Appendix J for a copy of the Academic Dean thank you/reminder letter. In addition to the survey and the informed consent form, all three letters, a prenotice, cover letter, and th ank you/reminder, were added to the survey process as recommended by the Dillman tailored desi gn method (Dillman, 2000). According to Dillman, the pre-notice email message should be delivered two to three days before the

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60 questionnaire is emailed out. The pre-notice has been shown to be important for email surveys as it alerts the recipi ent that the survey will be arri ving shortly and to not discard it when it does arrive (Dillman, 2000). After the pre-notice is delivered, the ques tionnaire followed a few days later. Dillman (2000) suggests that a brief cover lett er should be included directly before the survey. It has been shown that brevity for the cover letter is best as people are more likely to read an email that is shorter given the mass quantities of em ail that people have to sift through on a daily basis (Dillman, 2000). In addition to a pre-notice and cover letter, all email contacts were personalized as studies show that an individual is more likely to respond to an email addressed directly to them rather than a mass email, group, or listserve mailing (Dillman, 2000). In addition to a pre-notice and cover letter the third letter that should be included in an online survey is a thank you/reminder em ail. This email is designed to both thank individuals as well as remind them to fill out the survey. Attached to the thank you/reminder letter is a replacement electroni c questionnaire. Providing a replacement questionnaire with the follo w-up thank you/reminder letter ha s been shown to increase survey response rates (Dillman, 2000). A link to the web-based survey was ema iled to all 91 Deans. Email addresses were retrieved from school websites or by phone. The web-based survey was held on the University of South Florida Ultimate Surveyor program. Ultimate Surveyor is an electronic survey response program. It was em ployed to ensure confidentiality so that the Academic Deans felt more comfortable providing accurate and truthful information about their programs. Because this survey is elect ronic, a wavier of consent was requested and

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61 granted from the IRB as well as a waiver of written documentation. According to the IRB, a one page document including the basic elements provided in a longer informed consent form is all that is requir ed for a study of this nature. The survey asked Dean’s questions pertai ning to the curricula offered in their Pharm. D. programs, identified appropriate c ourse numbers and title s, and requested an electronic copy of ev ery syllabus in both required and elective courses that included objectives, course assignments, course readi ngs, and/or lectures concerning emergency contraception. These syllabi were retrieve d, reviewed, totaled, and summarized by the research investigator. The gathered data was entered into an EXCEL spreadsheet for analysis and reporting purposes. Names of the particular schools and Academic Deans were kept confidential and we re not linked to the data. In addition, where applicable, curricula information was searched for and re trieved from the school websites to amplify and cross check the information provided by th e Academic Deans. Course content is assumed to be up-to-date, however it will only be as up-to-date as the faculty that create the content and syllabi for the courses. To more fully understand the feasibility of this survey, five Academic Deans from schools of pharmacy in the U.S. were contacte d by email prior to sending out the actual survey. The email explained the study and i nquired as to whether they would respond to a survey of this nature. Three out of fi ve Academic Deans reported that they would respond to a survey of this nature, yielding a 60% response rate. Th e response from these emails provided an estimate of the feasibility of this survey. The Academic Deans survey was pilote d to the Academic Dean of the USF College of Public Health, and she said that sh e would complete it if it was sent to her;

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62 however it is not known how Academic Dean s for schools of pharmacy will respond. A 30% return rate was expected from the Acad emic Deans (N=24). This percentage was estimated from a review of email surveys which both reviewed and estimated response rates of email surveys over time (Sheehan, 2001) In addition, preparations were made to use curricula information provided on their school websites to search for emergency contraception course content had we not re ceived a good response rate from Deans. Pharmacy Student Focus Groups Target Population & Sampling Frame The second research question, how is emergency contra ception course content taught at accredited schools of pharmacy as pe rceived by fourth year pharmacy students at the four accredited sc hools of pharmacy in Florida, was answered through focus groups conducted at all four accredited Sc hools of Pharmacy in Florida: Florida Agricultural and Mechanical University, N ova Southeastern University, Palm Beach Atlantic University, and University of Florid a. These focus groups provided insight into how the curricula in pharmacy schools are operationalized and perceived by pharmacy students. For this research questio n, the target population was fourth year Pharm. D. students at accredited schools of pharmacy in the U.S. The sampling frame was fourth year Pharm. D. students at the four accred ited schools of pharmacy in the Florida and the samples for the focus groups were created through non-probability quota sampling. Focus Group Discussion Guide A focus group topical guide was created by an expert panel to (a) understand what pharmacy students learned about emergency contraception in their pharmacy school

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63 classes, (b) discover how they were taught about emergency contraception in their pharmacy school classes, and (c) find out wh at their projected emergency contraception dispensing practices will be upon becoming a pharmacist. The topical guide was developed prior to the focus group discussions by the researcher and panel of experts. The pane l of experts consisted of pharmacy faculty, recent pharmacy school graduates, practicing pharmacists, and a focus group expert. A list of topic areas was generate d that began with non-threateni ng issues leading into more specific questions. Topical areas and probing questions for the focus groups included but were not limited to the following: Knowledge (What do you know about emergency contraception? Where did you learn this information? What did you learn about emergency contraception in your pharmacy clas ses? Which classes talked about emergency contraception? Were these classes required or offered as an elective? How does what you learned in course instruction vary from what you learned or what you know from outside of class?) Instruction (What were you taught about emergency contraception in your pharmacy classes? How were you taught about emergency contraception? What kinds of methods of instru ction taught you about emergency contraception (e. g. lectures, cla ss discussions, course readings, assignments)? Practice (How do you feel about dispensing emergency contraception? Do you feel any differently about dispensing emergency contraception than you do dispensing any other medi cations? Where do your feelings about dispensing come from? Do you think you will dispense the medication upon becoming a pharmacist? What do you think about the recent move to allow emergency cont raception to be administered overthe-counter for women over 17 years of age? Does this change in administration status change your view s about emergency contraception? Have your classes discussed the disp ensing issues surrounding emergency contraception? Have your classe s brought up the new over-the-counter status of emergency contraception?)

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64 The qualitative methods employed in this study best address the issue of cognitive understanding or perceptions of course instruction on emerge ncy contraception in their pharmacy school classes because qualitative rese arch is able to capture complex human behaviors such as cognitive processes. Part nering the Academic Deans survey with the findings from the pharmacy student focus gr oups allowed for an enhanced understanding of pharmacy school curricula in the U.S. Not only did this study review emergency contraception pharmacy school curricula but these focus groups provided insight into how the curriculum is operationalized or transl ated to the pharmacy students it aims to teach. A limitation of focus group data in gene ral, and this research question in particular is that the information received from the pharmacy students is based solely on self-reporting, meaning that wh at pharmacy students report le arning about in their classes may not be reflective of actua l classroom instruction. No two students will learn the same way or remember the same material exactly the same a nd therefore eliciting pharmacy students’ perceptions about what they learned or were taught in pharmacy school is subjective. However, the focus groups provided an accurate picture of what these pharmacy students remember learning about emergency contraception and how they remember being taught this information. Sampling Plan Each of the four accredited schools of pharmacy in Florida were contacted and asked if focus groups could be conducted at their institutions. In addition, space to conduct the focus groups was requested. On e focus group per institution was conducted, equaling a total of four focus groups. Both fl yers as well as an email were disseminated

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65 to pharmacy students in an attempt to recruit study participants. If a school of pharmacy did not have a listserve of pharmacy students to email, then only flyers were used for recruitment. Flyers were placed into students’ mailboxes and places in convenient locations around the school. The flyer and email announced the focus group date and time and students had the ability to contact the researcher e ither by email or phone to sign up to participate. All four schools participated in the dissemination of the flyer to aid in the recruitment of students (see Appendix K fo r a sample of the recruitment flyer). The researcher held one focus group at each of the four institutions and each focus group attempted to recruit 8-10 students. If more than 10 students applied for any one focus group, the first 10 students to make contact with the re searcher were recruited for the focus group. Individuals were excluded fr om the study if they were first or second year students and if they were not worki ng towards their Pharm. D. degree. These criteria were selected because the Pharm. D. degree is the onl y degree that allows students to become practitioners or pharmacist s in various practice settings and this study sought to understand the rela tionships between emergency contraception practices and pharmacists. In addition, first and second y ear Pharm. D. students were excluded from this study because they may not have had th e course instruction that the focus groups explore. The Pharm. D. degree is typically a four year and full-time program where the first three years are dedicated to course work and then the la st year is dedicated to an advanced pharmacy practicum where the stud ents apply their class room training to clinical settings such as hosp itals, outpatient facilities, and community clinics. Therefore, third and fourth year Pharm. D. students were chosen so that they will have already had

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66 most of the course instruction for their degr ee which makes them able to answer the focus group questions. Study participants who met th e eligibility criteria were asked to sign an informed consent form prior to participation in the focus group. Please see Appendix L for a copy of the focus group informed consent form. St udents were given a $10 gift certificate to Starbucks for their participati on. Gift certificates were provi ded to study participants in an envelope directly before the focus group discussions. Participants received compensation before participation to show that they could leave the study at any time for any reason, as waiting until the end of the fo cus group to distribute the gift certificate could appear coercive. Focus groups were conducted for approximately one hour an d were tape recorded. Participants sat in a circle for the focus group discussions. Two personnel were present throughout the focus group discussions, a mode rator and a note taker. The moderator was the researcher and the note taker was an individual who has at least an undergraduate degree and was screened by the researcher to en sure that the individual can take notes. In addition, the note taker was tr ained by the researcher to understand the focus group topical guide and how to take notes properly. In total, 21 third and fourth year Pharm. D. students participated in the focus group discussions (8 from UF, 4 from FA MU, 5 from PBA, 4 from NOVA). Study participants met in a closed room, refreshme nts were served, and participants read and signed the informed consent form prior to participation in the focus group. After informed consent was procured, the paper a nd pencil survey was administered. Focus groups were conducted for approximately one hour and were tape recorded. Participants

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67 sat in a circle at a table for the discussions Two study personnel (a moderator and notetaker) were present throughout the focus gr oup discussions. After each focus group, the note taker presented a summary of the main ideas that had been identified in each question and asked if participants had any ch anges or additions they would like to make to the summary; when changes or additions were made, this information was included. Debriefing between the note-taker and the m oderator occurred directly after each focus group discussion. All data, audiotape, notes, and any other pertinent mate rials collected during focus groups were kept confidential. The materials were stored in locked filing cabinets and no personal identifiers were used. It should be noted that a limitation of the focus groups is that there was a high potential for leading a nd researcher bias since the moderator was also the researcher. In order to reduce this bias, the moderator stayed close to the topical guide created by the panel of experts. In addition, the process of self-reflexivity was performed where the researcher becomes awar e of her own beliefs and how these beliefs may be impacting the inte raction and interpretati on of the research. Pharmacist Questionnaire Target Population & Sampling Frame The third research question, what is the relationship among emergency contraception knowledge, attitude s, subjective norms, percei ved behavioral control, and dispensing practices of Florida pharmacists registered with the Board of Pharmacy, was addressed through a 58-item, mixed-mode (paper or web-based) questionnaire administered to a randomly selected group of Florida pharmacists. This research

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68 question will determine what variables, if any, are predictive of pharmacist emergency contraception dispensing practices. The target population for this research question was all pharmacists in Florida and the sampling frame was all pharmacists register ed with the Florida Board of Pharmacy. Although national organizations such as th e American Pharmaceutical Association (AphA) have an impact on pharmacies and pha rmacists, most pharmacists are regulated more by state law and by their local state Bo ard of Pharmacies. Therefore, although the target population was all pharmacists in the U. S., it is better to perform research on a state-by-state basis because stat e policies and regulations vary from state-to-state. The target sample was 552 Florida pharmacists that were randomly selected from all pharmacists (N= 29,896) registered with th e Florida Board of Pharmacy. The determination of the target sa mple size of pharmacists (N=552 ) for this study is discussed in the power analysis section below. Power Analysis—Sample Size Target sample size (N) is determined by a confluence of factors including the significance criterion ( ), statistical power, and population effect size (ES). In statistical modeling, the relationships between these f our factors are a function of each other (Cohen, 1992). The significance criterion ( ) equals the acknowledge d risk of falsely rejecting the null hypothesis also referre d to as Type I error. Typically is set at .05 and therefore in this study, will set at .05 as well (Cohen, 1992). Statistical power is the probability of reject ing the null hypothesis when it is false. If the null hypothesis is false, fa iling to reject it is an error. This error, failing to reject a false null hypothesis, is referred to as Type II error. The probability of committing a

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69 Type II error ( ) is 1-power. Cohen (1992) recomme nds target power of .80 for general use as a value smaller than .80 represents exce ssive risk of Type II error. Conversely, power larger than .80 would require an N th at would possibly be unattainable given the resources of the res earcher (Cohen, 1992). Population effect size is th e most difficult of all four components to determine. Effect size is the degree to which the null hypot hesis is false. Cohen (1992) has proposed criteria for small, medium, and large effect size values based on a gi ven statistical test. Since the proposed research sought a medium ef fect size and for most of the statistical tests employed in this research, an effect si ze of .30 will be adequate. An effect size of .30 is able to detect an effect that can be visible to the naked eye of an observer (Cohen, 1992). This effect size is ad equate for this research. Given these three pieces of information, =.05, statistical power=.80, and ES=.30, both Cohen’s power tables of N for small, me dium, and large effect sizes as well as a power analysis program (performed in SAS) were employed in order to determine sample size (N). First, it was necessary to determine the correct statistical tests to use. Given the research questions and the leve ls of measurement of the surv ey questions, three statistical tests were identified: Chi-square, significant te sts of a sample r, and logistic regression. Once the statistical tests were defined, the sa mple size required to ge t adequate power for a medium ES could be determined. Each statis tical test yielded a di fferent N and the test with the largest N was chosen as the appropr iate sample size. Please see Table 1 for sample size (N) determined by the sta tistical test with a medium ES.

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70Table 1. Sample Size (N) for Medium ES at Power = .80 for =.05 Test Measure Sample Size (N) Sig r r = .30 n = 85 Chi-square (6df) w = .30 n = 151 Logistic Regression tolerance=.5 n = 331 In order to find the sample size for Chi-s quare and significant tests of a sample r, Cohen’s power tables were employed (1992). Ho wever, in order to determine the sample size required for logistical regression, a pow er analysis was performed in SAS (SAS Institute Inc, Cary, NC). The SAS program code used is a test of a single predictor in a logistic model. Tolerance is the extent to which the predic tor variable is inde pendent of the other predictors. Tolerance set at 1 means that th e predictor is complete ly independent of the other predictor variables and if tolerance is smaller than 1, it means that the predictor variable is related to the other predictors, a nd therefore a larger sample size is needed. Tolerance was tested from 1 to .5. These values are represente d in Table 2 below. Table 2. Sample Size Required for Each Level of Tolerance (1 to .5) in Logistic Regression, =.05. pi OR ToleranceN 0.121166 0.120.9184 0.120.8207 0.120.7237 0.120.6276 0.120.5331 The model was set for power at .80, =.05, and was set for the smallest odds ratio that is cared about finding (OR= 2) if the predictor is unrelated to the other predictors. It is preferred that a tolerance of .5 is unique meaning that ha lf of the variability of each

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71 predictor is independent of th e other predictors. This is why a sample size of 331 was chosen as this sample will maintain enough power to detect any differences. However, in determining any sample size, response rates mu st be taken into consideration. Because there is not a known response rate of pharmaci sts in existing literat ure, an expected response rate was calculated by taking the mean of response rates from the other pharmacist studies discussed in the literatur e review. Borrego et al (2006) had a 40% return rate, Van Riper & Hellerstedt (2005) received a 67% response rate, and Conard et al (2003) had a 75% response rate. Taking the mean of these three studies, a response rate of 60% is expected for this survey which means that a sample of 552 pharmacists will be required. Sampling Plan The power analysis determined that a ta rget sample size of 331 would maintain enough power to detect any differences and a response rate of 60% was established based upon response rates from other studies that surveyed pharmacists. Therefore, it was determined that 552 surveys should be mailed out to procure a sample of 331. The sample was selected through a simple random sampling method. First, information on all pharmacists who were regist ered with the Florida Board of Pharmacy was downloaded from the Department of H ealth webpage (N=29,896) in EXCEL format. Both active and inactive pharmacists living in Florida and outside of Florida were contained in these files. Inactive pharmaci sts as well as pharmacists living outside of Florida were sorted out of the total, le aving 17,310 pharmacists who were active and who lived in Florida. A random number tabl e was employed to generate 552 random numbers from 1 to 17,310. The numbers in a numb er table are listed through a pure random

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72 process which allows any number the equal ch ance of being placed in any position. After the beginning number was selected, th is random sampling technique chose 552 pharmacists as participants for this study. This procedure is described in Neuman (2003) as one way to approximate randomness and thus be able to yield a sample that is representative of the total population. Fina lly, contact information on each of the 552 pharmacists was removed from the larger list and was entered into an additional EXCEL spreadsheet which made up the sample. A sample of 552 pharmacists was randomly selected for participation in this study. Each pharmacist was mailed (a) a pre-notice postcard, (b) an abbreviated informed consent form, (c) a cover letter (d) a questionnaire with an envelope with return postage included, and (e) a thank you/remi nder postcard as suggested to improve response rates by the tailored design met hod (Dillman, 2000). Please see Appendix M for a copy of the pre-notice pos tcard, Appendix N for a copy of an abbreviated informed consent form, Appendix O for a copy of the cover letter, Appendix P for a copy of the questionnaire, and Appendix Q for a c opy of the thank you/reminder postcard. Three separate mailings occurred for this portion of the research study, one for the pre-notice, one for the actual questionnair e, and one for a thank you/reminder mailing with online survey-mode option. Postal addresses of all pha rmacists registered with the Florida Board of Pharmacy were obtained from the Florida Department of Health website. The pre-notice letter was maile d to pharmacists a few days before the questionnaire was mailed. The pre-notice aler ts the pharmacist to be on the look out for an important survey that will be arriving w ithin the near future and indicates that a response would be appreciated. The pre-noti ce should be brief and personalized and is

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73 not meant to provide detail about the study but just to provide no tice of the upcoming request to complete a survey (Dillman, 2000). A few days after the pre-notice was ma iled, another mailing was sent out which will included the informed consent form, cove r letter, paper-based questionnaire, and a return envelope. The return envelope was a ddressed and real stamps were usedinstead of a business reply as using stamps has b een shown to improve study response rates (Dillman, 2000). The cover letter was no longer than one page and included pertinent information about the study. The cover le tter explained why the study is important. Because this survey is a mail survey with fo llow-up internet survey option, a wavier of consent was requested and granted from th e IRB as well as a waiver of written documentation. According to the IRB, a one page document including the basic elements provided in a longer informed consent form is all that is required for a study of this nature. Regardless of whether the study particip ant returned the questionnaire, they received a thank you/reminder postcard approxima tely one week after the delivery of the questionnaire. The main purpose of this postcard is to jog the memories of the individuals and increase the study response ra te (Dillman, 2000). Included in the thank you/reminder postcard was a link to the same survey on-line. Each participant may choose to fill out the paper-based survey th ey received in the second mailing or an online version they received a li nk to in the follow-up post-card Like the Academic Dean survey, the pharmacist web-based survey was held on the USF Ultimate Surveyor program. If pharmacists choose to complete their survey online, the informed consent

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74 form was the same as the paper-based inform ed consent except that participants clicked the check box at the bottom of the screen sign ifying consent to participate in the study. According to Dillman (2000), the type of mixed-mode format where one mode is used at first contact and then another mode is used at fina l contact only to prompt the completion of a survey, will improve coverage and reduce non-response rates. Dillman (2000) notes, “introducing a new mode at this stage of the data collection may allow information to be collected that will improve coverage…it is also likely it improve response rates to the other mode signifi cantly” (p. 222). In addition, potential measurement differences that are found in ot her mixed-mode situations may be avoided by introducing another survey mode this way (Dillman, 2000). This type of mixed-mode survey design was chosen for this study as it improves response rates while limiting measurement di fferences found in other mixed survey modes. It was originally thought desirable to send respondents a choice between a paper and pencil survey and an online version; however in practice th is has not shown to increase response rates (Dillman, 2000). Therefore, the current mixed-mode survey design with the first mode being paper-based and the follow-up or final mode being online was chosen for this research study. Originally, it was thought that a compar ison of critical vari ables to estimate nonrespondent bias could be perfor med. That is, answers from first responders were going to be compared to answers from those who responded after the follow-up post card to measure any differences in the two groups However, due to the low number of responders from the follow-up postcard (n=8), th is type of bias could not be estimated. In an additional attempt to understand the characteristics of non-responders, the Florida

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75 Board of Pharmacy was contacted to see if they collect basic demographic information on Florida pharmacists. However, they do not meaning that the demographic information from the responders cannot be compared to the demographic information of nonresponders and therefore the characteristi cs of the non-responders cannot be known. The pharmacist survey was developed, piloted, and tested for readability, reliability, and validity among a group of pharmacists. The questionnaire inquire about six main variables, (1) level of knowledge about Plan B, (2 ) personal attitudes held about Plan B and about Plan B dispensing, (3) pe rceived social pressures around issues of dispensing, (4) perceived behavior al control over the behavior of dispensing Plan B, (5) intention or likelihood of dispensing Plan B, and (6) emergency contraception dispensing practices. In addition to ques tions that measure these six variables, the instrument will include questions on basic demographics and background such as age, gender, ethnicity, marital status, religious and political party affiliation, t ype of pharmacy, and length of time in practice. Data Collection Instrument Development To guide the questionnaire development and focus group topical guide for this study, interviews were conducted with a panel of experts in which practicing pharmacists were asked general questions about being a pharmacist, thei r schooling and curricula, and their emergency contraception knowledge, at titudes, subjective norms, and perceived behavioral control. Please see Appendix R to review the questions and responses from the expert interviews.

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76 It is from these interviews as well as from the literature review and the theoretical underpinnings of the Theory of Planned Beha vior, that instruments were developed for this study. The literature review in particular brought three im portant studies to light that were influential in the creation of the pharmacist questionnaire. Permission was requested to utilize parts of instruments that were employed in these studies. Questions were selected from these three studies and combined to form one questionnaire however some questions were taken and altered to fit the proposed study. The pharmacist survey instrument was developed from the survey s used in the following three studies: 1) The most influential study in term s of survey development assessed pharmacist knowledge, attitudes, and di spensing practices of emergency contraception among South Dakota pha rmacists. A 14-item survey was mailed to all registered pharmacists (n=810) in South Dakota to assess their attitudes, knowledge, and disp ensing practices of emergency contraception and 62% responded (Van Riper & Hellerstedt, 2005). Many of the practice and workplace as well as knowledge and attitudes questions were taken and adapted from the survey instrument employed in the pharmacist survey. 2) Another U.S.-based study examined emergency contraception knowledge, attitudes, and behaviors among wo men and men ages 18-21 (n=97) attending a university through the use of a 25-item paper-based questionnaire (Corbett, Mitchell, Taylor, & Kemppainen, 2006). Although this questionnaire was read to aid in the development of ideas

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77 for the pharmacist survey, the only ques tions taken from this instrument were the demographic questions. 3) A third study performed a cross-secti onal survey of 96 faculty physicians from four universities to measure prescribing intention of emergency contraception (Sable, Schwartz, Ke lly, Lisbon, & Hall, 2006). Many of the prescribing practice a nd perceived behavioral control questions were taken from the survey instrument, adapted, and employed for use in the pharmacist survey. The pharmacist survey was piloted among a group of pharmacists not eligible for participation in the Florida pharmacist surve y. The Academic Deans survey was piloted among the Academic Dean of the USF College of Public Health as she was not eligible for the pharmacy school curricula review. The feedback from this pilot was helpful in not only adjusting the survey but also for understanding the feasibility of the survey. After reviewing the survey, the Academic Dean of the USF College of Public Health indicated that she would respond to the survey if it had been emailed to her. In order to better understand the feasibility of the Academic Deans su rvey, five Academic Deans were randomly selected and sent an email as king if they would re spond to a three item questionnaire of this nature. The final pharmacist and Academic Dean surveys were developed from the feedback provided through the pilots. Both instruments, the pharmacist questionnaire and the Academic Dean questionnaire, were tested for validity and re liability. The focus group topical guide will be discussed in greater detail later in the pape r. Reliability refers to the dependability or consistency of the instrument and validity imp lies truthfulness and refers to how well the

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78 construct and measure fit toge ther (Neuman, 2003). There ar e three types of reliability that are of concern: stability reliability, representative reliability, and equivalence reliability. Stability reliability is a measure of depe ndability across time. That is, will this instrument yield the same answers over varyi ng time periods? Stability reliability can be measured through a test-retest method where th e instrument is re-administered to the same group of people to see if the same re sults are produced multiple times (Neuman, 2003). Representative reliability is dependability across different groups of individuals. It answers the question; will the instrument yi eld the same answers when administered to different groups? Represen tative reliability can be measured through a subpopulation analysis in which the instrument is measur ed among different groups of people such as people of varying ages, sexes, and ethnicitie s. The instrument is said to have representative reliability if the groups ma intain the same error rate (Neuman, 2003). Equivalence reliability is dependability when multiple indicators are used to measure a construct. It answers the question; does the construct yiel d consistent findings across the various indicators or survey items ? Cronbach’s alpha is a statistical measure that can determine equivalence reliability. Cr onbach’s alpha is a numerical coefficient of reliability ranging from 0 to 1 and the higher the score, the more reliable the scale. A reliability coefficient of .7 is viewed as accep table; however some literature has accepted lower coefficients (Nunnaly, 1978). Not only will the test-retest method, a subpopulation analysis, and Cronbach’s alpha be employed to test for reliability but other ways to increase reliability include: (a)

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79 conceptualizing constructs clearly, (b) em ploying multiple indicators, and (c) running pilot tests (Neuman, 2003). Validity or more specifically, measuremen t validity indicates how conceptual and operational definitions fit with each other. The greater the fit, the more measurement validity is achieved. Validity answers th e question: does the i ndicator measure the construct it is trying to measure? There are tw o types of measurement validity that are of concern for this study: face and construct valid ity. Face validity is a consensus measure of validity which demonstrates that peopl e agree that the indicator measures the construct. Face validity answ ers the question; do people thin k that there is a fit between the definition and the method of measuremen t? Construct validity is employed when measures have multiple indicators. Construct validity answers the question, are the various indicators consistent? Face validity wa s measured through a survey pilot test and construct validity was calculated through factor analysis procedures, all of which will be discussed in the results section below. Measures There are six main constructs measured in the survey of pharmacists, (1) knowledge (2) attitudes, (3) subjective norms, (4) perceived behavioral control, (5) intention to dispense, and (6) dispensing practices. Each of these six constructs is measured by multiple indicators or survey questions. All independent, dependent, and socio-demographic variables, survey questi ons, response options, a nd variable level of measurement are represented in Appendix S. 1) The first construct, knowledge, is measur ed by 10 separate questions and is measured on the nominal level. Knowledge is operationalized through a

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80 comprehension of emergency contraception effectiveness, number of pills dispensed in Plan B packaging, mechan ism of action, and health risks. Individual variables include : # of pills in package, hours of effectiveness, mechanism of action, timing for effec tiveness, comprehension about OTC sales, health risks, birth defects, and abortifacient. 2) The second construct, attitudes, is meas ured by 8 separate questions and is measured at the nominal and ordinal levels. An attitude is defined by Ajzen (1988) as “…a disposition to respond fa vorably or unfavorably to an object, person, institution, or event.” (p. 4). Therefore survey questions about attitudes measure self-reported feelings or beliefs that are positive and negative about emergency contracepti on use and dispensing. Variables include: feelings about benefits and risks, beliefs about maintenance of contraception, feelings about promiscu ity, feelings about prescribing and religion/ethics, feelings a bout repeated use, feelings about comfort level in dispensing, feelings about dispensing to adolescents, feelings about dispensing for clients, beliefs about lifetime use of emergency contraception. 3) The third construct, subjec tive norms, refers to the pe rceived social pressures to perform or not perform a particul ar behavior. Subjective norms are measured through 6 questions that quer y about how the participant perceives what important people think about emer gency contraception dispensing and is measured at the interval level. Variables include: partners/colleagues perception of emergency contraception di spensing, professional organization perception of emergency contracepti on dispensing, boss perception of

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81 emergency contraception dispensing, and close friends and family perception of emergency contraception dispensing. Additionally, two questions were asked regarding their pharmacy culture (i. e. if there is anyone who refuses to dispense the medication at their pharmacy and if there is a policy in place at their pharmacy if someone refuses to dispense Plan B). 4) The fourth construct, perceived behavior al control is measured by 4 questions and refers to how difficult or easy the behavior is to perform and in this case, the behavior is emergency contracepti ve dispensing. Therefore, perceived behavioral control is measured by four que stions that inquire about the ease or difficulty involved in dispensing emergenc y contraception and is measured at the ordinal level. Variables include: perceived ease of counseling clients, perceived ease of dispensing, perceived ease of refuse to dispense, perceived ease of educating clients. 5) The fifth construct, inten tion or likelihood to dispense Plan B, is measured by 8 questions that query pharmacists about their intention to dispense Plan B to varying groups of people. For exampl e, pharmacists answer whether they are likely or unlikely to dispense Plan B to women who are raped, women who have experienced a problem with their birth control method etc. to test for differences in intention to dispense based on the situation of the woman requesting the medication. Intention to dispense is divided by OTC and by prescription to account for any differences. 6) The sixth construct, dispensing practi ces, is measured by 13 questions that query pharmacists about their emergenc y contraception di spensing practices

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82 in general and by prescription and ov er-the-counter to varying groups of people. Variables are measured on both the nominal and ordinal levels and include: pharmacy stock of birth cont rol products, pharmacy dispensing of emergency contraception, ever filled a pr escription, # of prescriptions filled in past 12 months, likelihood of dispensi ng over-the-counter to various groups, and likelihood of dispensi ng by prescription to various groups. However, in the analysis, dispensing practices are onl y measured by two questions that ask pharmacists if they have ever dispense d Plan B by prescription or OTC. In addition to these measures, demographic information such as age, gender, ethnicity, marital status, reli gious and party affiliation, t ype of pharmacy, and length of time in practice will be collected on study par ticipants and these va riables are measured on the nominal, ordinal, and ratio levels. Th e first five constructs knowledge, attitudes, subjective norms, perceived behavioral cont rol, and intention to dispense are the independent variables and disp ensing practices is the depe ndent variable. See Figure 4 below for a graphic representation of thes e variables. This design will aid in understanding which independent variables, if any, predict emergency contraception dispensing practices of pharmacists.

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83 Figure 4: Independent and Dependent Variables Reliability and Validity Measures The pharmacist survey was developed, piloted, and tested for readability, validity, and reliability among a group of pharmacists. After the pilot and te sts, the survey was finalized as a 58 item questionnaire. Validity: Face, Content, and Construct The pharmacist survey was piloted am ong a panel of experts (n=5) including practicing pharmacists, pharmacy faculty, a nd pharmacy students for face and content validity. Participants were asked to rate each question on the instrument as to whether it looks as if it is measuring the designated topic (face validity) and were asked to provide comments on how to fix questions that were given low ratings. In addition, participants were asked if there were important aspects of each question of the designated topic that the instrument was not measuring (content validity). See Appendix T for a sample Knowledge Attitudes Subjective Norms Perceived Behavioral Control Dispensing Practices Independent Variables Dependent Variables Intention to Dispense

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84 review guide that was distributed to measure face and content validity. It was from this pilot among a panel of experts that the pharmacist questionnai re was fully developed (see appendix N for the finalized pharmacist survey). Construct validity of scores was measured by exploratory factor analysis. Survey questions naturally divided into the predefin ed construct areas of knowledge, attitudes, subjective norms, perceived behavioral control, and dispensing practi ces. Factor analysis was conducted separately for each construct area to see if content area questions are only measuring that one factor. Factor anal ysis was performed using SAS statistical packaging (SAS Institute Inc, Cary, NC). Eigenvalues (the proportion of variance determined by each factor) were used to help decide on the number of factors (via the scree plot). In addition, squared multiple co rrelations were used as prior communality estimates, principal factor analysis was used to extract factors, a nd an oblique rotation was employed. A scree test was also used to determine meaningful factors and an item was said to load on a factor if th e pattern coefficient was above .30. Knowledge: The eigenvalues and scree plot suggested that one factor was present among the 10 questions aimed at measuri ng knowledge of emergency contraception (Questions 22-31) as only one factor ma intained an eigenvalue over 1. The factor represented 22.5% of the total it em variance in the set of ques tions. Given the criteria of .30, all variables loaded at .30 or higher ex cept for questions 24 a nd 25 (see Table 3). However, after a closer look at questions 24 and 25 in the survey, it was determined that they would need to stay in the analysis as they measured understanding of the mechanism of action and percentage of ef fectiveness, both of which are critical to knowledge of the medication.

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85Table 3. Factor Pattern matrix for Knowledge Items Item Factor 1 Q22. Number of pills in Plan B package 0.52 Q23. Timing of administration 0.64 Q24. Mechanism of action 0.28 Q25. Percentage of effectiveness 0.20 Q26. Who can sell Plan B to consumers 0.53 Q27. How to sell OTC to women (in advance of need) 0.38 Q28. How to sell OTC to men 0.55 Q29. Plan B can cause birth defects (True/False) 0.50 Q30. Plan B can act as an abortifacient (True/False) 0.58 Q31. The sooner a woman takes Plan B, the more effective it will be (True/False) 0.37 Attitudes: The eigenvalues and scree plot suggested that one factor was present among the 8 questions aimed at measuring attitudes about emergency contraception (Questions 32-39) as only one factor mainta ined an eigenvalue even over 0. The factor represented 86.6% of the total it em variance in the set of ques tions. All items maintained very high loadings on the one factor with the lowest load ing at 0.75 and the highest at 0.99 (see Table 4). Table 4. Factor Pattern matrix for Attitude Items Item Factor 1 Q32. Easy availability of Plan B will di scourage regular contraceptive use 0.99 Q33. Easy availability of Plan B promotes promiscuity 0.89 Q34. I feel uncomfortable dispensing Plan B because of my religious/ethnical beliefs 0.99 Q35. Repeated use of Plan B is wrong 0.81 Q36. I feel comfortable dispensing Plan B to adult women 0.99 Q37. I feel comfortable dispensing Plan B to adolescents (teens <18 yrs old) 0.99 Q38. I feel comfortable dispensing Plan B to men 0.99 Q39. Should Plan B be offered to women who are raped in all hospital emergency rooms, regardle ss of hospital affiliation? 0.75 Subjective Norms: Much like knowledge a nd attitudes, the ei genvalues and scree plot suggested that one factor was presen t among the 4 questions aimed at measuring

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86 subjective norms (Questions 40-43) as only one factor maintained an eigenvalue over 0. The factor represented 78.5% of the total item variance in the set of questions. As demonstrated in Table 5, all items mainta ined very high loadings on the one factor ranging from 0.83 to 0.94. Table 5. Factor Pattern Matrix for Subjective Norm Items Item Factor 1 Q40. My partners/business colleagues think I should dispense Plan B 0.94 Q41. The professional organization I am most active in recommends that I dispense Plan B 0.83 Q42. My supervisor thinks that I should dispense Plan B 0.86 Q43. My close friends and family think I should dispense Plan B 0.91 Perceived Behavioral Control: The eigenvalues and scre e plot suggested that one factor was present among the 4 questions aimed at measuring perceived behavioral control (Questions 46-49) as only one factor maintained an eigenvalue over 0. The factor represented 96.5% of the total it em variance in the set of ques tions. All items maintained very high loadings on the one factor ranging from 0.93 to 1.00 (see Table 6). Table 6. Factor Pattern Matrix for Perceived Behavioral Control Items Item Factor 1 Pattern Loadings Q46. How easy is it for you to counsel clients about Plan B 1.00 Q47. How easy is it for you refuse to dispense Plan B 0.93 Q48. How easy is it for you educate clients about Plan B 1.00 Q49. How easy is it for you dispense Plan B 1.00 Dispensing Practices: Dispensing practices in cludes the two separate constructs of actual dispensing practices and intention to dispense emerge ncy contraception. Actual dispensing practices of emergency contracep tion is measured by two items (Questions 8 and 11). Question 8 asks if a respondent ha s ever filled a prescription of Plan B and question 11 asks if they have ever sold Plan B OTC. Because the variable, actual

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87 dispensing practices, is only measured by two questions, factor analysis does not conceptually make sense. Instead, a cross tabulation, P earson Chi-Square test of association, and Phi coefficient statistic was run to determine the re lationship between the two questions. The Chi-Square test revealed a direct and signifi cant relationship (ChiSquare value 91.33, p<0.001) between the two questions. The Phi coefficient which is the measure of associatio n between the two variable s was significant (Phi=0.585, p<0.0001). These findings provide enough evidence to combine them into one construct measuring actual dispensing practices. As for intention to dispense emergency contraception, the eigenvalues and scree plot suggested that one factor was present among the 8 questions aimed at measuring this construct (Questions 14-21) as only one factor maintained an eigenvalue over 0. The factor represented 80.5% of the total item va riance in the set of questions. All items maintained very high loadings on the one f actor ranging from 0.70 to 1.00 (see Table 7). Table 7. Factor Pattern Matrix for Intention to Dispense Items Item Factor 1 Q14. Likelihood of dispensing OTC to women who have experienced incest or rape 0.73 Q15. Likelihood of dispensing OTC to women who have experienced a problem with their birth control method 0.99 Q16. Likelihood of dispensing OTC to women who request the method after having unprotected sexual intercourse 0.71 Q17. Likelihood of dispensing OTC to a person other than the ultimate consumer of the product such as parents or a boyfriend 0.98 Q18. Likelihood of dispensing by prescription to women who have experienced incest or rape 0.99 Q19. Likelihood of dispensing by prescription to women who have experienced a problem with their birth control method 1.00 Q20. Likelihood of dispensing by pr escription to women who request the method after having unprotected sexual intercourse 1.00 Q21. Likelihood of dispensing by prescription to sexually active teens under age 18 0.70

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88 In summary, exploratory f actor analysis provides evid ence of construct validity of scores for the pharmacist survey. Reliability: Stability and Equivalence Reliability refers to the de pendability or consistency of an instrument and validity implies truthfulness and refers to how we ll the construct and measure fit together (Neuman, 2003). There are two types of reliab ility that are of concern: stability and equivalence reliability. Stability reliability is a measure of depe ndability across time. That is, will this instrument yield the same answers over vary ing time periods? Stability reliability was measured through a test-retest method where th e instrument was re-administered to the same group of people to see if the same re sults were produced multiple times (Neuman, 2003). The pharmacist survey was administer ed online to a group of 18 pharmacists at one point in time and then again about one w eek later. The sample of pharmacists who participated did not practice pharmacy in Florid a, so not to impact study results. Survey data were stored in an EXCEL database and were analyzed using SPSS statistical analysis software (SPSS 16.0, SPSS Inc., Chicago) Percentage agreements and Pearson product-moment correlation coefficients were calculated to measure the relationship between the variables over th e two time periods. Percentage agreements measure the proportion of all occasions at which the vari ables agree across time and are primarily used with nominal level data. A percentage of 80% or higher was deemed as acceptable. Pearson product-moment correlati on coefficients (represented as r ) assess the relationship between variables and range from -1 to zero to +1 and are typically em ployed with rato or interval levels of measurement. A correlati on of -1 demonstrates a perfect negative linear

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89 relationship, 0 means that there is no relations hip, and +1 demonstrates a perfect positive linear relationship between variables. A Pearson correlation of 0.60 or higher was deemed as acceptable. The survey was tested and was found to ha ve acceptable reliabil ity of scores. The results support dependability of scores that w ill be procured from the survey. The results are discussed below and have been cate gorized by survey construct: background characteristics, dispensing practices, knowledge, attitudes, subjective norms, and perceived behavioral control. Background Characteristics. Background characteristics are comprised of 13 variables including gender, ag e, ethnicity, years in practi ce, type of pharmacy, marital status, religion, religiosity, political affiliation, employment status, pharmacy school attended, year of graduation, a nd job title. Percen tage agreement test s were performed on all 13 variables. A Table depicting the result s for the demographic variables is provided below. Table 8. Percentage Agreements for Background Characteristics Variable Percentage Agreement Gender 100% Age 83% Ethnicity 100% Years in practice 83% Type of pharmacy 100% Marital status 100% Religion 94% Religiosity 72% Political affiliation 100% Employment status 100% Pharmacy school attended 94% Year of graduation 100% Job title 94% *Did not meet the 80% cut off value.

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90 All variables except for one (religiosity) met the percentage agreement cut off value of 80%. The percentage agreement for re ligiosity was 72% in that five out of the eighteen participants changed their answer over time. The question on religiosity asked, How would you describe yourself (choose only one) The answer choices were 1) Religious, 2) Spiritual, 3) Religious and spir itual, 4) Undecided, 5) None of the above, and 6) Prefer not to respond. Of the five re spondents that changed their answer from one administration to the other, the first respondent changed their answer from religious to prefer not to respond two participants changed from religious and spiritual to religious one changed from none of the above to religious and spiritual and the last respondent changed from prefer not to respond to none of the above The inconsistency in the answers of these five participants seems to be a result of the personal nature of the question. Dispensing Practices. Dispensing practices is measur ed by 17 questions of which percentage agreements were performed on nine questions and Pears on correlations were performed for the other eight questions. Of th e nine that received percentage agreements, the questions queried about pharmacy st ocking of condoms, spermicide, oral contraceptive pills, stocking of Plan B, dispensing of Plan B and inquired about how many times within the past year that they dispensed it both OTC and by prescription (see questions 5-13 in pharmacist survey Appe ndix N). All nine questions received percentage agreements above the 80% cut off va lue and are therefore reliable. In fact, all but two questions received 100% agreements across the two survey administrations. The two questions that received less than 100% agreements were the open ended questions

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91 querying about how many times they have so ld Plan B OTC and by prescription in the past 12 months and yielded 88% and 83% agreements, respectively. Pearson correlations were run on the eight questions measuring dispensing practices. Specifically, these questions measur e to what extent pharmacists are likely to sell Plan B OTC or dispense Plan B by pres cription to women in varying circumstances such as women who were raped, women who had a problem with their birth control method etc. (see questions 14-21 on the pha rmacist survey Appendix N). These questions employ a 4-point Like rt scale ranging from very unlikely to very likely. Correlations were run for each individual item at time one and time two. In addition, the responses were combined to create a new vari able and the combined variable was run at time one and time two. All individual ques tions received a P earson correlation of r =0.686 or higher, demonstrating a positive rela tionship and all analyses were significant at the p=0.01 level. In a ddition, the combined score for dispensing practices yielded a Pearson correlation coefficient of r =0.820, with significance at the p=0.01 level. Knowledge. Knowledge of emergency contraception is measured by 10 questions querying on the basic pr operties and mechanisms of action of Plan B as well as questions that measure if pharmacists have knowledge around issues of dispensing Plan B OTC (see questions 22-31 in pharmacist surv ey Appendix N). For knowledge, each item was awarded one point if the participant responded correctly and zero if they responded incorrectly. The points were added up for each participant yielding a knowledge score for each participant at time one and time tw o. Then, Pearson correlations were run on these knowledge scores. The Pearson Correlation was r =0.849, demonstrating a positive relationship and was signif icant at the p=0.01 level.

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92 Attitudes. Attitudes is measured by eight questions querying about how pharmacists personally feel about dispen sing and about women using Plan B (see questions 32-39 in pharmacist survey Appendi x N). Seven of the questions are Likert scale questions (questions 3228) and therefore employed Pear son correlations and one of the questions is a nominal level question (question 39) and ther efore a percentage agreement was calculated. Of the seven que stions employing a 4-poi nt Likert scale, responses ranged from completely disagree to co mpletely agree. First scores had to be adjusted such that a higher score demonstrated a more positive attit ude towards Plan B. The response scale for these items was reflecte d. After this process, correlations were run for each individual item at time one and time two. In addition, the responses were combined to create a new variable and the combined variable was run at time one and time two. All individual questions received a Pearson correlation of r =0.727 or higher, demonstrating a positive relationship and all an alyses were significant at the p=0.01 level. In addition, the combined score for atti tudes yielded a high Pearson correlation coefficient of r =0.950, with significance at the p=0.01 level. The one nominal level question received a percentage ag reement of 100% and is reliable. Subjective Norms. The construct subjective norms is measured by six questions pertaining to the way people, groups, and pharmacy policy may be associated with pharmacist dispensing of Plan B (see questions 40-45 in pharmacist survey Appendix N). Pearson correlations were run on four of the questions measured on a 4-point likert scale (interval data) and percentage agreements were calculated for the other two questions that were measured at the nominal level. For th e analysis of the four likert scale questions (questions 40-43), the answers were combined and Pearson correlations were calculated.

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93 The Pearson Correlation was 0.820 and were significant at the p=0.01 level, demonstrating a positive relationship. The two questions that were measured at the nominal level (questions 44-45) maintained 100% agreement between time one and time two. Perceived Behavioral Control. Perceived behavioral cont rol is measured by four questions on a 4-point likert scale depicting how difficult or easy it is to dispense Plan B (see questions 46-49 in pharmacist survey A ppendix N). Questions queried about how difficult or easy it is to counsel and educate c lients, to dispense and refuse to dispense Plan B. Responses to the questions we re added up and Pearson correlations were calculated. The Pearson Correlation was 0.831, demonstrating a positive relationship and all analyses were signifi cant at the p=0.01 level. In summary, the statewide pharmacist survey was found to have stability reliability and thus these results support depe ndability of scores that will be procured from the survey. Equivalence reliability assesses how well variables measure a latent construct. Cronbach’s alpha is a statistical measure that can determine equivalence reliability. This measure is a numerical coefficient of reliab ility ranging from 0 to 1 and the higher the score, the more reliable the scale. A reliabi lity coefficient of .70 is typically viewed as acceptable (Nunnaly, 1978). Reliability anal ysis through Cronbach’s alpha was performed on the four constructs that contained interval and ordinal level data (attitudes, subjective norms, perceived behavioral co ntrol, and dispensing practices) and all coefficients exceeded the acceptable value of .70. In fact, all reliability coefficients exceeded .90. Given that the construct of knowledge is based on nominal level data in

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94 which a composite knowledge score was calcula ted for each individual, it did not make sense to assess scale reliability through Cronbach’s alpha. Instead, the equivalence reliability measure for knowledge will rely on the stability reliability measure and high Pearson correlation that was determined thr ough the test-retest method. However, for the other four constructs, reliability estimates were .98 for a ttitudes, .94 for subjective norms, .99 for perceived behavioral control, and .95 for dispensing practices. Therefore, the variables are measuring each construct and the scale is shown to have equivalence reliability. In sum, reliability tests resu lted in adequate values and the statewide pharmacist survey was found to have st ability and equivale nce reliability. Data Analysis Because the proposed research is em ploying a mixed methods study design, the data analysis for this proposal included both qualitative and quantitative techniques. Although the first main research question, what do the 91 accredited schools of pharmacy in the U.S. teach about emergency contraception is answered through an electronic survey of Deans, the responses from this su rvey only required basi c descriptive statistics (frequencies, mean, median, mode) and cat egorization into typologies. Frequency calculations measure numbers and percentage s of schools that teach about emergency contraception and a typology categorizes a nd quantifies the courses that teach this content. The second major research question, how is emergency contraception course content taught at accredited schools of pharmacy as perceive d by third or fourth year pharmacy students at the four accred ited schools of pharmacy in Florida was explored through focus groups with pharmacy students an d this information required qualitative

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95 analysis techniques. In addition, the third major research question, what is the relationship among emergency contraception knowledge, attitudes, subjective norms, perceived behavioral control, and dispensing pr actices of Florida phar macists registered with the Board of Pharmacy was measured through a surv ey of a random sample of pharmacists and required quantitative analysis t echniques. Therefore, both the qualitative data analysis methods used to analyze th e focus group data and the quantitative data analysis methods used to analyze the pharmacist survey are outlined below. Qualitative Data Analysis Plan Qualitative data includes focus group tran scripts, observation notes, debriefing session notes, particip ant demographic information, and any other pertinent documents. Ethnograph version 5 computer software progr am was used to help with coding, and thematic and content analys is. The reason an ethnogra phic computer program was chosen is because it can handle project data files in multiple forms such as transcripts, field notes, and any other te xt based documents. In a ddition, Ethnograph has a large storage capacity that will be good to use with focus group transcripts. An editing type of qualitativ e analysis was employed where the editor begins with the text and then from this text develops codes, themes, and concepts. Preliminary and thematic analyses were employed to create a range of themes, typologies, propositions and concepts. A coding template was deve loped where categories were created from questions and from the topical guide. Each code was defined in the code book including the parameters involved in assigning the code. Later, the data was checked against the code template to see if it fit. The codes we re adjusted and new codes were added as they emerge.

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96 Open coding, axial coding, and selective coding allowed for data reduction and categorization of data into themes. Open c oding is the first look at the collected data where themes are located and assigned ini tial codes or labels. Open coding brings themes within the data to the surface. Axia l coding is the second look at the data where the researcher already has an organized set of initial codes and focu ses more on the coded themes than on the data. In axial coding, the initial codes are reviewed and examined to establish linkages between themes and raise ne w questions. Selective coding is the last look at the data. With selective coding, the re searcher scans the data and previous codes and looks to compare and contrast cases. Se lective coding is perfor med when all or most of the data is collected. Analytic memos were written and kept th roughout the coding process. Analytic memos are thoughts or ideas written down th roughout the coding process. The memos contain thoughts and reflections about the da ta, coding, and coding process. Each code contained a separate memo discussing the theme. The purpose of an analytic memo is to provide a bridge between the raw data and abstract or theoreti cal thinking. In order to check for coding consistency, trustworthy or consistency checks were performed where the data was reviewed severa l times to ensure consistency of the coding system. In addition, a single coder performe d most of the analys is but another coder analyzed at least 10% of the data to ensu re consistency of the data and inter-rater reliability. The second coder was trained to understand the codebook prior to coding and analysis. The same limitation of having the researcher as the moderator of the focus groups exists in having the researcher anal yze the data for the focus group discussions; however employing two people for qualitative coding limited the researcher bias. After

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97 initial data analysis was performed, the anal ysis moved into an interpretive, theory development, and discussion phase. Researcher Bias Researcher bias exists in any type of research; however researcher behavior can limit the amount of bias that is present. Neuman (2003) identifies six categories of interviewer bias that can be applied to fo cus groups and focus group moderators. The six categories include: 1) errors by the respondent, 2) unintentiona l errors by the interviewer, 3) intentional errors by the interviewer, 4) bias by interviewer’s expectations of respondents, 5) lack of in terviewer probing, and 6) influence on responses due to interviewer behavior. In order to limit these biases, the focu s group moderator became familiar with conducting focus groups and became aware of th e potential biases and methods for bias reduction. The first category of bias as outlined in Neuman (2003), errors by the respondent, includes errors made because of the presence of others such as lying, misunderstanding, or embarrassment. This bias was avoided through the moderator creating an open atmosphere where participan ts felt comfortable sharing their thoughts, feelings, and experiences and where the mode rator was clear in stating the focus group questions and in explaining how the focus group worked. The second category of bias, unintentional errors by the inte rviewer, includes the intervie wer reading questions out of order, mis-recording respondent answers, a nd misreading questions. In order to reduce this bias, the focus group moderator became familiar with conducting focus groups, including becoming familiar w ith the focus group topical gui de and the order of the questions. In addition, the moderator employed a note-taker and a tape recorder to aid in

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98 reducing any unintentiona l error by the moderator. The th ird bias, inten tional errors by the interviewer, includes changing answers on purpose or omitting questions on purpose. In order to minimize this bias, the modera tor stayed close to the focus group topical guide. The fourth bias, bias by interviewer’s e xpectations of respondents, includes the moderator expectations about a respondent’s answer based on appearance or perceived living situation (Neuman, 2003). To reduce this bias, the moderator worked to remain neutral and refrain from making value judgments about the participants. The fifth bias, lack of interviewer probing, was reduced through the moderators understanding how and when to probe properly. In addition, the m oderator developed potential probes to be included in the topical guide, should they be needed. The six and final bias, influence on responses due to interviewer behavior, incl udes changes in respondents answers based on moderators tone, comments, appearance, or r eactions. In order to reduce this bias, the moderator remained neutral a nd open to all responses and av oided passing verbal or nonverbal judgment to the responses given by pa rticipants in the focus group discussions. And last, in order to obtain a greater understanding of res earcher bias in general, a detailed journal of research perceptions, biases, and beliefs was kept throughout the qualitative research process so that potent ial bias could be determined, understood, and reduced. Trustworthiness Trustworthiness in qualitati ve research is much like validity and reliability in quantitative research. According to Li ncoln and Guba (1985), the basic question addressed by trustworthiness is, “How can an inquirer persuade his or her audiences that

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99 the research findings of an inquiry ar e worth paying atte ntion to?” (p. 290). Trustworthiness establishes confidence in the research findings, applicability of findings to other contexts, consistency in findings if research was conducted on similar subjects, and neutrality of the researcher so that th e findings are determined by participants, not by researcher bias (Lincoln & Guba, 1985). Linc oln and Guba (1985) discuss four criteria by which trustworthiness can be operationalized in research: 1) credibility, 2) transferability, 3) dependabil ity, and 4) confirmability. These four criteria were employed in the proposed research and will be discussed in greater detail below. The first criteria, credibility, determines if the data reflects real ity. In qualitative research, the researcher assumes multiple real ities and then attempts to represent them (Hoepfl, 1997). Credibility is met through the richne ss of the information collected and can be measured in a number of ways includ ing triangulation, allowing others to analyze raw data, and member checks. Obtaining a s econd coder aided in es tablishing credibility as well as performing member checks with focus group participants (Lincoln & Guba, 1085). After each focus group, the note taker presented a summary of the main ideas that had been identified in each question and as ked if participants had any changes or additions they would like to make to the summary; when changes or additions were made, this information was included. De briefing between th e note-taker and the moderator occurred directly after each focus group discussi on. These steps aided in increasing the credibilit y of this study. The second criteria, transferability, ex amines whether research findings are applicable to similar situations or in other contexts (Lincoln & Guba, 1985). In order to establish transferability, the proposed rese arch study maintained detailed notes and

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100 journaling. In addition, the re searcher will ensure that the code book, focus group topical guide, and results of the study be made availa ble to the public so that the study may be transferred to varying co ntexts if warranted. The third criteria, dependability, determines if the results stay consistent over time and across varying researchers. Lincoln a nd Guba (1985) propose one method that they term “inquiry audit” (p. 317) where consis tency is met through employing additional researchers that review the process and produc t of the research. Therefore, dependability was met in this study by employing an additional researcher to aid in the process of the research and in the data analysis. An a dditional researcher wa s present throughout the focus group discussions, debriefing sessions, and provided feedback on the focus group topical guide. An additional coder analyzed at least 10% of the data to ensure consistency of the data and inter-rater re liability. The second coder was trained to understand the codebook. The fourth criteria, confirmability, refers to the neutrality of the researcher’s interpretations in qualitative research. Lincoln and Guba (1985) suggest that to meet confirmability, an audit trail must be generated that includes 1) raw data; 2) analysis notes; 3) reconstruction and s ynthesis products; 4) process not es; 5) personal notes; and 6) preliminary developmental informati on (p. 319-320). In order to meet the confirmability criteria, a tape recorder was employed to record the focus groups, field notes were written, a note-tak er was employed, debriefing se ssions I after each focus group, a code book was employed, and detailed not es (journal) of a personal nature were maintained that included ideas, thoughts, biases, motivations, predications, and expectations. These steps discussed above attributed credibil ity, transferability,

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101 dependability, and confirmability to the qualita tive research employed in this study so that the study maintained overall trustworthiness. Quantitative Data Analysis Plan Univariate & Bivariate Analyses Quantitative data analyses were performed primarily using SPSS statistical software (SPSS 16.0, SPSS Inc., Chicago), a lthough SAS statistical software (SAS Institute Inc, Cary, NC) was used in the fact or analysis. First, frequency distributions were performed on all categorical level variab les to determine response distributions and means and standard deviations were calcula ted for all continuous variables. These procedures identified any outliers or non-mean ingful responses that were recoded if necessary. In addition, for continuous va riables, response patterns emerged which sometimes called for collapsing of data based on the distribution. Next, bivariate analysis was performed to test asso ciations between all sociodemographic variables (age, gender, ethnic ity, marital status, religious and party affiliation, type of pharmacy, pharmacy school and year attended, and length of time in practice) and pharmacist dispensing practices. Because the criterion variable, dispensing practices, is measured at both the nominal and ordinal level and the socio-demographic variables are measured on the nominal, ordina l, and ratio levels, three statistical tests were performed to detect bivariate associati ons: Chi-Square tests, Kruskal-Wallis Tests, and Spearman Correlations. A Chi-Square test of independence is th e appropriate statistic to use when both variables are assessed at the nominal level to determine if there is a relationship between the two variables. The Kruskal-Wallis test is appropriate in bivariate analysis with an

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102 ordinal-level criterion variab le and a nominal level pred ictor variable. Spearman correlations are recommended when there is an ordinal-level predic tor variable and an ordinal-level criterion variable This test yields the corr elations between two variables and will determine the strength of the relationship between two variables (Hatcher & Stepanski 1994). Bivariate associations were also be explored between (a) knowledge and dispensing practices, (b) attitudes and disp ensing practices, (c) subjective norms and dispensing practices, (d) percei ved behavioral control and dispensing practices, and (e) intention to dispense and dispensing practices Chi-Square tests and Kruskal-Wallis tests were used to assess the relationships be tween knowledge and dispensing practices, attitudes and dispensing practices, subjectiv e norms and dispensing practices. KruskalWallis tests were used to assess the relations hips between perceived behavioral control and dispensing practices and in tention to dispense and disp ensing practices (Hatcher & Stepanski 1994). Multivariate Analyses Logistic regression mode ls were constructed to discover whether emergency contraception knowledge, attitude s, subjective norms, perceive d behavioral control, and intention to dispense taken t ogether or separate, are predic tive of pharmacis ts’ dispensing practices. The dependent variable, dispen sing practices, was measured by two survey questions and was grouped to create dichotomous yes/no variable. Logistic regression is the a ppropriate statistical test to use when the dependent variable is dichotomous and when there is a single dependent variable with multiple predictor or independent vari ables. In addition, logistic regression should be employed

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103 when the criterion variable is nominal or or dinal and when the predictor variables are at the nominal, interval, or ratio leve l (Hatcher & Stepanski 1994). There are five independent variables, knowledge, attitudes, social norms, perceived behavioral control, and intenti on to dispense. Knowledge consists of 10 questions and is measured at the nominal level. A knowledge score ranging from 1-10 was created for each study participant based on how many questions they get correct. Therefore, knowledge was put into the regr ession model as a continuous variable. Attitude consisted of 8 separate questions and was measured at the nominal and ordinal levels. The 7 ordinal level likert scale quest ions were treated as continuous variables when put into the model. For the other quest ion, it will be collapsed into categories to create a nominal level variable. Subjectiv e norms consisted of 6 questions and were measured at the ordinal and nominal levels. The 4 likert scale questions were treated as continuous variables when put into the mode l and the two nominal level questions were collapsed into categories and run at the nomin al level. Perceived behavioral control consisted of 4 questions and was measured at the ordinal level. Because the 4 questions are likert scale questions, they were treated as continuous variables when put into the model. Intention to dispense Plan B consiste d of 8 likert scale questions measured at the ordinal level and were entered into the model as a continuous variable. In constructing logistical regression m odels, specific steps should be taken. Approximately six models will be created to detect (1) if knowledge is predictive of dispensing practices, (2) if attitudes are pr edictive of dispensi ng practices, (3) if subjective norms are predictive of dispensi ng practices, (4) if perceived behavioral control is predictive of dispensing practices, (5 ) if intention to dispense is predictive of

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104 dispensing practices, and (6) if all variables taken together are predictive of dispensing practices. Also, the socio-demographic variable s were entered into ea ch model to act as control variables. With each model, appr opriate diagnostics were run to test for collinearity. The Wald F statistic is the measure in logistic regression that tests the null hypothesis: that none of the predictor variables are related to the log odds of the criterion variable. In addition, the Wald F will measur e the models’ goodness of fit. In logistic regression, pseudo R-Square is used to measur e the strength of a ssociation between the variables. The significance between know ledge, attitudes, subjective norms, and perceived behavioral control in predicti ng dispensing practices was measured by odds ratios and 95% confidence intervals. A pvalue of less than .05 was employed as a measure at which to rej ect the null hypothesis. Linking Datasets Three different yet intima tely related datasets were produced upon completion of this research. Data was procured from 1) the curriculum review survey, 2) focus group discussions with pharmacy stude nts, and 3) the state-wide pharmacist survey. Taken together, findings demonstrated what is inte nded to be taught to pharmacy students, what is actually being learned by pharmacy st udents, and how practicing pharmacists’ perceptions of emergency contra ception are associated with their dispensing practices. In essence, this research examines bot h the education and practice of pharmacists by following the natural progression of pha rmacists from education to subsequent practice. It examines the emergency contra ception curricula and course content intended to teach future pharmacists, surveys pharmacy students to understand how this course

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105 content translates in to learned knowledge and projected dispensing behavior, and then lastly it surveys the practic ing pharmacists to understand th eir emergency contraception knowledge, attitudes, and actua l dispensing practices. In total, this research study employs a mixed methods design to offer a completed picture of pharmacists and emergency contraception from education to practice.

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106 Chapter Four: Results Introduction Chapter four has been partitioned into three sections based on each research question. Thus, Section 1 discusses the pharm acy school curriculum review and answers research question 1, Section 2 describes th e pharmacy student focus group discussions and answers research question 2, and Section 3 describes the statewide pharmacist survey and answers research question 3. Research Questions Question 1: What do the 91 accredited schools of pharmacy in the U.S. teach about emergency contraception? Question 1a: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are provided in the required courses at the 91 accredited schools of pharmacy in the U.S.? Question 1b: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are provided in the elective courses at the 91 accredited schools of pharmacy in the U.S.? Question 2: How is emergency contraception course content taught at accredited schools of pharmacy, as perceived by fourth year pharmacy students at the four accredited schools of pharmacy in Florida?

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107 Question 2a: What did pharmacy students l earn about emergency contraception in their pharmacy school classes? Question 2b: How was emergency contrace ption taught in their pharmacy school classes? Question 2c: What are the projected emergency contraception dispensing practices of pharmacy students? Question 3: What is the relationship among emergency contraception knowledge, attitudes, subjective norms, perceived behavi oral control, intention to dispense, and dispensing practices of Florida pharmacists registered with the Board of Pharmacy? Question 3a: Is emergency contracepti on knowledge predictive of dispensing practices of Florida pharmacists? Question 3b: Are attitudes about emer gency contraception predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3c: Are subjective norms about emergency contraception (whether important people such as colleagues, s upervisors, corporate headquarters, and peers think they should dispense emergency contraception) predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3d: Is perceived behavioral contro l, the perceived ease or difficulty of dispensing emergency contraception, predic tive of dispensing practices of Florida pharmacists? Question 3e: Is intention to dispense emergency contraception predictive of dispensing practices of Florida pharmacists?

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108 Question 3f: Are emergency contrace ption knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense taken together, predictive of emergency contraception dispensing practices of Florida pharmacists? Section I: Pharmacy School Curricula Review The first research question was addresse d through a web-based survey of Deans of accredited schools of pharmacy in the U.S. As of April 2007, there were 91 accredited schools of pharmacy in the U.S. In this cas e, the target population, the sampling frame, and the sample are the same because the surv ey acts as a census. The Deans of all 91 schools were sent an electronic survey via Ultimate Survey querying them about emergency contraception course content in th eir Pharm. D. programs at their respective institutions. Please see Appendix U for a lis t of the pharmacy schools that received the survey. Because not all schools had Academic Deans, a decision was made to request information from the Deans of all schools. Of the 91 Deans, 47 responded, yielding a 52% response rate. The Dillman Tailored Design Method was employed in data collection which included the following four lett ers: (a) a pre-notice, (b) an abbreviated informed consent form, (c) a cover letter a nd questionnaire, and (d ) a thank you/reminder letter. A fifth letter wa s generated and added to th e study design during the data collection process to act as a second reminder le tter to help yield a higher response rate. This letter was submitted and approved by the IRB prior to use. Please see Appendix V to view this second follow-up letter. The Dean’s survey included only th ree questions with follow-up questions depending on the answer provided. The first two questions asked Deans if they offer

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109 required courses and/or elective courses that provide content on emergency contraception. Content was described as in cluding lectures, course readings, course objectives etc. If they answered that they did include content on emergency contraception, they were asked to include the title of the course and include the syllabi for review. The third and final question asked Deans if they think that pharmacy school curricula in the U.S. should include content mate rial on emergency contraception and to explain their answer. Cont ent was defined as including pharmacology legal and ethical issues and the continual controversy that surrounds emergency contraception. Of the 47 Deans that responded, 87.2% (n=41) reported that they do offer required courses that provide content on emer gency contraception, 8.5% (n=4) reported that they do not, and 4.3% (n=2) said that they were not sure (Table 9). In terms of elective courses, 17% (n=8) report ed that they do offer elective courses that provide content on emergency contraception, 72.3% (n= 34) reported that they do not offer these courses and 10.6% (n=5) said that they we re not sure. All respondents (n=47, 100%) reported that they believe that schools of pharmacy in the U.S. should include content material on emergency cont raception (Table 9). Table 9. Quantitative Results from Dean’s Survey (n=47). Variable Frequency Percent Does school offer required courses that provide content on EC? Yes No Not Sure 41 4 2 87.2% 8.5% 4.3% Does school offer elective courses that provide content on EC? Yes No Not Sure 8 34 5 17.0% 72.3% 10.6% Should pharmacy school curricula include content on EC? Yes No 47 0 100.0% 0.0% EC = emergency contraception

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110 Of the 87.2% (n=41) of Deans that said their schools offer required courses that provide content on emergency contraception, 34 % (n=14) did not list the titles of the courses or attach the syllabi for review when asked. Sixty-five percent (n=27) either listed course titles or provided syllabi for review. Of the 17% (n=8) of schools that reported that they do offer elective courses that provide content on emergency contraception, 50% (n=4) did not list the titles of the courses or attach the syllabi for review. The lists of courses, both required and elective that were said to provide content on emergency contraception have been classi fied into a typology based on the course titles. This typology is found in Table 10 be low and a full list of courses titles is provided in Appendix W. Table 10. A Typology of Required and Elective Courses that Contain Content on Emergency Contraception per the Responses from the Dean’s Survey. Classification of Required Courses Number of courses that fall into category Pharmacotherapy & Therapeutics 17 Pharmacy Ethics 6 Pharmacology 4 Issues in Contemporary Pharmacy Practice 3 Over-the-Counter Medications 2 Women’s Health 2 Self-care 2 Professional Skills Development 1 Early Practice Experience I 1 Classification of Elective Courses Number of courses that fall into category Women’s Health 2 Contraceptive Management 1 Self-care 1 The majority of courses that provide content on emergency contraception are taught in pharmacotherapy a nd therapeutics courses. Specifically, many schools noted that within these pharmacotherapy and therapeu tics courses, this content was taught in the women’s health section. Although it varies from school to school, most students have

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111 taken the pharmacotherapy and therapeutics cour ses listed by their s econd year of study. After pharmacotherapy and therapeutics, sc hools listed that ma terial on emergency contraception was covered in pharmacy ethi cs, pharmacology, issues in contemporary pharmacy practice, over-the-counter medications, women’s health, self-care, professional skills development, and early practice experime nt. One school in particular requires a course called early practice experience and in this course studen ts obtain certification from the state in emergency contraception. Sp ecifically, students l earn about prescriptive authority and are traine d to counsel patients. Among the four schools that listed elective courses that provide content on emergency contraception, content was taught in a women’s health course (n=2), a contraceptive management class (n=1 ), and a self-care class (n=1). Question 1 asked, what do the 91 accredi ted schools of pharmacy in the U.S. teach about emergency contraception? In addition, sub-questions inquired about what objectives, objectives, course assignments, course readings, and lectures concerning emergency contraception are provided in the required and elective courses at the 91 accredited schools of pharmacy in the U.S.? In order to more fully answer research question 1, Deans were asked to submit the sy llabi in which they reported to provide course content on emergency contraception. However, only 10 syllabi were received from seven schools or from 14% of the samp le who reported that they provide course content on emergency contraception in either required or elective classes. Additionally, the syllabi that were received did not provide detailed information on objectives, objectives, course assignments, course r eadings, and lectures concerning emergency

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112 contraception. In fact, only four out of the ten syllabi explicitly mentioned emergency contraception. In order to objectively analyze the sylla bi that were retrieved for emergency contraception course content, a method for cat egorization was devel oped. First, after reviewing course syllabi, th e defined categories for course content provided on the Deans survey, and with the aid of establishe d pedagogy, course content was defined as: course description objectives lectures readings assignments Next, each syllabus was examined based on course content area. Ratings ranged from one to four and each area of course content received an individual rating. The specific definition of each numeric rating is listed below and Table 11 displays these ratings of course content in a comparative format. Rating 1 = No overt mention of emergency contraception in content Rating 2 = The topic listed in the content could lend itself to emergency contraception, but does not specify Rating 3 = The content mentions contracep tion, but not emergency contraception Rating 4 = The content specifically men tions emergency contraception

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113Table 11. Review of Retrieved Syllabi that Re ported to Contain Content Material on Emergency Contraception from the Dean’s Survey. Course Title* Description Objectives Lectures Readings Assignments Contraceptive Management Elective 4 n/a** 4 4 1 Professional Skills Development II Required 2 2 2 2 2 Pharmocotherapy II Required 1 2 3 1 1 Integrated Science & Therapeutics Required 1 1 1 1 1 Women’s Health Some offer required, some elective 3 1 4 3 1 Endocrinology/ Gastroenterology Required 1 3 3 1 1 Pharmacy Practice IV Required 1 1 1 1 1 Pharmacy Ethics Required 2 2 2 n/a 2 Therapeutics I Required 1 4 4 4 1 Reproductive Course Required 4 4 4 4 4 *Courses are listed in no particular order **n/a is listed if the syllabi did not mention the specific content Among all retrieved syllabi which repor ted to include content on emergency contraception, only four of th e ten syllabi overtly mentioned emergency contraception in any of the content areas. Two out of ten syll abi cited contraception in a content area, but not emergency contraception, three out of ten me ntioned a topic area that could lend itself to emergency contraception such as ethics or women’s health, and two out of the ten syllabi retrieved made no overt mention of emergency contraception or contraception, or even contained a topic that could lend itself to a discussion about emergency contraception. In general, there was no part icular patterning or cl ustering of where the content was located or described, howe ver courses that contained emergency

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114 contraception in one content area were more likely to contain it in another content area and vice versa. In addition, although it was not requested th at the schools include a description of where the emergency contraception course cont ent is taught when attaching syllabi, one school did include additional info rmation about how this content is taught in class. This Dean responded that within their course, emergency contraception is used “as an example of one of the many ethical dilemmas that pha rmacists confront and help them construct a thought process on how to deal with the issu es, while respecting the patients’ right and their own values”. This depiction provide s insight into how this content may be addressed in this particular class where students learn to ba lance patient rights and their own values. It would be interesting to fo llow up on this and perhaps observe a pharmacy class to view how this mate rial is actually taught. The third and final question of the Dean ’s survey asked if they believe that pharmacy school curricula in the U.S. should include content on emergency contraception. All respondents sa id yes. They were then aske d to explain their answer in an open-ended format. Of all 47 respondents, 27.7% (n=13) did not answer as to why they thought this content should be include d in pharmacy school curricula, however 72.3% (n=34) did. Through qualitative coding and analysis, five main themes emerged from the open-ended response data. Overall, pharm acy school Deans answ ered that school curricula should include mate rial on emergency contracep tion due to 1) pharmacy practice and training, 2) the role of pharmacists in terms of counseling and education, 3) the controversies that exist about the medicati on 4) the nature of the medication: it is a

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115 drug therapy and, 5) the idea that this curricu la will increase pharmacists’ knowledge for best patient care. These five themes are list ed in order based on the number of times they were mentioned and will be discussed below. Pharmacy Practice/Training The largest grouping of respondents (m entioned 18 times) answered that pharmacy school curricula should include cont ent material on emergency contraception because of issues surrounding pharmacy prac tice and training. Specifically, the Deans expressed that pharmacists will encounter this medication in their practice and therefore pharmacists should have this tr aining so that they can perf orm well in their professional practice. Examples of this sentiment are presented below: Pharmacists need to be trained with resp ect to all prescribed drugs that they may encounter in practice. It is a part of practice and each phar macist should know how to assess the situation and safely us e these products. It is a component of pharmacy practice w ith medical, social, and ethical aspects. It is in within the scope of practice fo r pharmacists especially ones that work in community settings so the pharmacology, dispensing issues and ethics should be discussed. California pharmacists may dispense emergency contraception under a state protocol. Training is essential. Role of Pharmacists: Counseling/education Another major category of response (men tioned 13 times) that emerged from the data was the need for training of pharmaci sts on emergency contraception due to the

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116 perceived counseling and educational role of pharmacists. Specifically, participants responded that pharmacists need to be know ledgeable on emergency contraception in order to provide accurate information to patients and to be able to discuss, counsel, and advise patients on the medication. Some responses are presented here: This subject arises in all Community Pharmacy settings and pharmacists need to be able to intelligently discuss this with patients when questions are asked. It is legal and pharmacies are a fr ont line delivery me thod of EC. Many misperceptions abound about these products and pharmacists should know the facts if their patients ask them questions. Pharmacists serve patient health need s in terms of products and accurate information. This area may be very important for many patients and families. Pharmacists need to be able to give appropriate advice. …Education in this area of pharmaceutical care will enable the pharmacist to be an advisor to the physician and a counselor to the patient. Because pharmacists will encounter this medication in the pharmacies, it is important for them to understand how emer gency contraception works. This will enable them to have an informed con versation with a patient considering emergency contraception. Even if they do not plan to work in a retail setting, they will inevitably be asked questions regarding emergency contraception at some point in their career. Controversy Many respondents alluded to the cont roversy and dilemma that surrounds emergency contraception (mentioned 11 times). Many respondents noted that pharmacy school curricula should include content on emergency contraception despite how controversial the medication may be:

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117 …It is our job as educators to expos e pharmacy students to as much pharmacy knowledge as possible, no matter how controversial. Curricula should include all drug therape utic uses, including mitigation of physiologic conditions, wher e pharmacists play role, no matter how controversial their role and the drug’s use might be. Student pharmacists deserve to have information regarding therape utic indications, legal implications, and discussion of various “opinions” provid ed in their course work. From a pharmacist’s and pharmacology persp ective, it is import ant for students to be aware of the mechanism of ac tion, important counse ling points and the ethical arguments surrounding EC. Some respondents believed that content s hould be taught so that pharmacists understand that emergency contraception is not the same as a medical termination or similarly so that they understand that emer gency contraception’s mechanism of action is comparable to that of hormonal contraception: …Students should be informed about the pr oduct, and most especially, should be informed that it is not the same as mifepristone (RU 486). Pharmacists now are in the position to not only dispense prescriptions for EC, but to also provide it without a prescription to those 18 years and older. Knowledge regarding mechanism of action (especially in regards to the mechanism being the SAME as all hormonal contraception) appropriate use and counseling is essential to the role of a pharmacist… Another pharmacist believed that content s hould be taught so th at pharmacists can have knowledge about the medication shoul d they want to refuse dispensing: …Even if a pharmacist engages the right to refuse dispensing (which I do approve of based on moral or ethical conflict s ) – pharmacists must have appropriate knowledge on why he/she has chosen to re fuse and what his/her obligation is to the patient at that point in time. Additionally, these two res pondents talk about the bala nce that some pharmacists try to keep between professional re sponsibilities and personal beliefs.

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118 This is a medication applicable to a sizabl e portion of the popul ation. It is a very emotional issue as well. Pharmacists MU ST know the information necessary for them to be a reasonable counselor on use and MUST be aware of their professional responsibilities to provide ca re for patients while balancing that with their own personal beliefs. If you ar e a pharmacist, or a pharmacy student you do NOT have any choice. You must know about EC. …Factual information is helpful for the patient regardless of religious beliefs and should be available. Informing people of the correct facts does not mean you are pushing them one way or the other on the issue. Drug Therapy It was mentioned 8 times that emergenc y contraception content should be taught in pharmacy schools because it is a drug thera py and many Deanss said fl atly that it is the duty of pharmacy school curricula to teach a bout all drug therapies. Some respondent comments are below: It’s a drug therapy! Emergency contraception is an OTC product. Schools teach about OTC products… Curricula should include all drug therapeutic uses… It is pharmacological therapy – that’s our job It involves drug therapy Pharmacy schools should educate students on all legal uses of pharmacologic therapy Knowledge for Best Patient Care Lastly, it was mentioned 7 times in th e open-ended responses that curricula should include content on emergency contra ception so that each pharmacist has the knowledge of the medication for best patient care. Same reasons as any therapeutic topic, so pharmacists can provide the best patient care to all patients no matter what the medication is…

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119 Because pharmacists will encounter this medication in the pharmacies, it is important for them to understand how emer gency contraception works. This will enable them to have an informed con versation with a patient considering emergency contraception. Even if they do not plan to work in a retail setting, they will inevitably be asked questions regarding emergency contraception at some point in their career. …(pharmacists) must be aware of their professional respons ibilities to provide care for patients while balancing th at with their own personal beliefs… …Since emergency contraception is a realit y and growing in use, it is critically important that the pharmacist is the drug expert in this area of patient care no different from diabetes or other conditions… On the whole there were sentiments that pharmacists must know correct information about emergency contraception rega rdless of personal or religious beliefs and regardless of the controversial nature of this topic for be st patient care, professional practice, and counseling/education of patients. In addition, given the 52% response rate, it is important to note that we did not hear from 48% of the sample. Therefore, this nonresponsiveness is a limitation in that we ha ve no information from the Deans of these schools and no way to ca pture these responses. Section II: Pharmacy Student Focus Groups The second research question was addr essed through focus groups conducted at all four accredited Schools of Pharmacy in Florida: Florida Agricultural and Mechanical University (FAMU), Nova Southeastern University (NOVA), Palm Beach Atlantic University (PBA), and University of Flor ida (UF). All four schools were contacted regarding participation in the focus groups and letters of support were procured. A topical guide was developed prior to the focus group discussions by the researcher and a panel of experts, which c onsisted of pharmacy faculty, recent pharmacy

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120 school graduates, practicing pharmacists, and a focus group expert (n=8). A preliminary list of topic areas was generate d that began with non-threateni ng issues leading into more specific questions. Through the topical guide development and feedback from the panel, it became clear that there were many close-e nded questions that need ed to be addressed by the focus group participants. Because fo cus group discussions lend themselves to open-ended questions, a paper and pencil surv ey was developed that contained these close-ended questions. This paper and pencil survey was administered to students prior to starting the focus group. See Appendix X for the topical guide and the paper and pencil pre-survey that was administered to st udents. Prior to the actual focus groups, the researcher piloted the focus group session with colleagues. Paper and Pencil Pre-Survey Results In total, 21 third and fourth year Pharm. D. students participated in the focus group discussions (8 from UF, 4 from FAMU, 5 from PBA, 4 from NOVA). The paper and pencil survey consists of 10 questions, five of which are close-ended and five of which are open-ended. All survey data we re entered into a Mi crosoft Office 2003 spreadsheet (Microsoft Corporation, Redmond, Washington). Data from the five closeended questions can be viewed below in Table 12.

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121Table 12. Paper and Pencil Focus Group Su rvey Data: Close-Ended Questions (N=21) Variable N Percent Did you take any classes in your Pharm D program which taught you about EC? Yes No 19 2 90.5% 9.5% Have your pharmacy school classes discussed the new OTC status of EC? Yes No Missing 16 4 1 76.2% 19.0% 4.8% Have your pharmacy school classes discussed the dispensing issues (e.g. pharmacists refusals to dispense) surrounding EC? Yes No Missing 14 6 1 66.7% 28.5% 4.8% Will you dispense EC upon becoming a pharmacist? Yes No Not sure Missing 16 1 3 1 76.1% 4.8% 14.3% 4.8% Are pharmacists well enough informed to confidently dispense EC? Yes No Not sure Missing 9 7 4 1 42.9% 33.3% 19.0% 4.8% Although 90.5% of students responded th at they did learn about emergency contraception in their pharm D classes, still nearly 20% answered either that they would not or that they were not su re about their future dispensi ng of the medication. Similarly, while the majority of students responde d that they did learn about emergency contraception in their classes, over half (52.3 %) of participants were either not sure if pharmacists were well enough informed to disp ense emergency contraception or believed that pharmacists were not well enough informed to confidently dispense the medication. The first open-ended question asked wh ich classes taught about emergency contraception and asked to specif y if the class was required or was offered as an elective. Of the students who responded that their Pharm D program taught about emergency contraception (n=19), nine students said th at a required pharmacotherapy course covered

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122 this material, six students mentioned that a required therapeutics course covered this material, four said that a required ethics course covere d it, and three students each answered that a required medical chemistry c ourse or a required pharmacy care course, or an elective women’s health course covered this material. Lastly, two students each said that a required law course or a required pati ent care management course or a dynamics course covered emergency contraception. All in all, most students responded that they were taught about emergency contraception in a required pharmacotherapy course which substantiated findings from the curriculum review survey. When asked what type of instructional method was used, the majority of students reported class lectures as the most reporte d instructional method, followed by discussion and class readings. One student said that they had a debate fo rmat in a class. The bulk of the students said that they learned the most from a lecture format and one student noted that they learned the most from personal res earch as the professors did not teach them much. Most students stated that there was mo re information that they wished they had learned including OTC laws, the effects of prolonged use, details on side effects, counseling points, contraindictions, time lim its, explanation of how it is not an abortion, the effect of Plan B on an already pregnant female, laws and regulations, adverse effects, interaction with women taking bi rth control at the same time, industry standards/policies, risks associated with repeat use, and ethics. Focus Group Discussion Analysis Focus group research questions aske d about three major topical areas: 1) knowledge about emergency contraception fr om their pharmacy schools classes, 2) teaching instruction on emergency contraceptio n within those classes, and 3) projecting

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123 dispensing practices of emergency c ontraception upon becoming a pharmacist. Therefore, the following analyses were part itioned by topical area. Although responses fell into these three categories, new and une xpected themes emerged from the data. Knowledge. Students were asked both about their specific knowledge of emergency contraception from pharmacy school s classes and were queried about their general knowledge. There was a major disconn ect between what students reported on the quantitative paper and pencil surv ey and what was shared in the focus group discussions. As opposed to what students reported on the paper and pencil survey, the majority of pharmacy students reported that they did not learn about emergency contraception from their pharmacy school classes when queried in the focus group discussions. When pharmacy students were asked where they have gotten information about emergency contraception that they trust, some said th ey received this information from class; however the majority answered from outside so urces such as work, print media, internet, news, and friends. “I would definitely say that the majority of w hat we know is from either from working in retail or other outside sources. Not necessarily from our curriculum.” Of the students that did receive some tr aining in required classes, the majority commented that it was brief: “…I just remember one slide like one bullet point you know during our birth control or female hormone lecture…And they ha ven’t discussed it a lot yet. So…” The most frequently cited answer to where they received information about emergency contraception was work with student’s answering “in the actual workplace” and “from working” When at work, they either read the package insert, asked a pharmacist, read continuing educa tion (CE) credit materials, or a client approached them

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124 with questions about the drug and they had to look up information. Examples of these sentiments are below: “Like she said continuing education is us ually sponsored by drug companies, um they send educational materials to you know where you work, retailer. Also if you’re just working in a pharmacy with your… um with a pharmacist and you dispense it, you don’t know what it is, you ask them”. “Customers coming up too. Say oh what about the morning pill and I’m like huh; It’s prescription and he’s like not anymore.” “Package insert… (another member) Yeah to educate ourselves. (another member) “You know myself. I was like interested in it. So you know reading the thing that comes with it you know.” “…just working experience and having differ ent people coming up and ask us questions about it and you have to go look up” Other outside sources include d friends, a Pharmacy Times article, the internet, and one student mentioned hearing about the firing of pharmacists who did not dispense it in the news: “I kinda just looked it up briefly on the internet; about how it works…” “I personally did some inte rnet research just for a law class that we had. Which was kind of um… you know not a required thing but you know if you don’t know what Plan B is all about then you as a student y ou need to take it upon yourself to find the information. So that kinda, outside the classroom.” “um… another way that I had heard about it was… actually it’s been in the news, I think several times. Where pharmacists were actually um…you know fired from their positions. So that has been kind of a….” “Yeah, uh my friend…And my friend she knows I’m in pharmacy school so, I looked it up for her. So you know I like to … I like to look things up for her and answer any questions, you know. I’m her on call pharmacist. When asked specifically about the knowledge gained about emergency contraception in their pharmacy school classe s, pharmacy students described four major

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125 areas of knowledge: 1) k nowledge about timing and composition, 2) knowledge about mechanism of action, 3) no knowledge, and 4) perceived knowledge of others (see Table 7). The topical area of timing and composition represents whether students understood the correct timing around administra tion of emergency contraception and if they understood its composition. Plan B is hormonal contraception, containing high doses of progestin (levonorgest rel). It is 75%-89% effectiv e in preventing pregnancies when taken within 72 hours (3 days) to 120 hours (5 days ) after sexual intercourse (American Medical Women’s Association (AMWA), 1996; Kaiser Family Foundation, 2000). Although students seemed to have vary ing degrees of understanding of the actual timeframe, the majority of students unders tood that there was a time component to acquiring the medication after unprotected intercourse. As shown in Table 7, some students had more accurate knowledge around timing and composition than others. Knowledge of mechanism of action refers to comprehension of how emergency contraception works in the body. Although th e exact mechanism of action is unknown, it is thought that the medication works through the following three mechanisms, 1) through a delay or inhibition of ovulation, 2) through inhibition of fertilization, and 3) through preventing implantation (American Pharmaceu tical Association special report, 2000). Although students in one of the focus groups seemed to understand the three mechanisms of action of emergency contraception, specific knowledge was not held by the majority of students. In addition, there was some confusi on as to the definition of when life begins. This argument was most thoroughly represente d by a discussion in one of the focus

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126 groups where some students believed that life be gins at implantation and others believed that life begins at fertiliza tion. See the excerpt below: Member 2: But… in order to abort it well fi rst you have to look at the definition of pregnancy. To actually be pr egnant, as a medical definition, there has to be implantation. Is that an agreed statement? Member 1: I disagree. Member 1: I (unclear)… I’ve read a couple of articles that state t hat um…the original term pregnancy was actually um… the egg and a sperm… you know conception… at that point… Member 2: As defined by…? Member 1: and one article said that t hat definition is changing. So I don’t know. Member 4: I don’t think it you know…Webster or whoever medical can tell me where I think contraception begins. So as defined by… per person I would think is un… is sufficient enough for you know… in my opinion. Member 2: Well, what I was looking at when I did my re search… I was looking at the American Medical Association, and where they define medically where pregnancy starts. Cause there’s many times that you have a fe rtilized egg that doesn’t get implanted naturally…so that’s where they have a hard time drawing pregnancy and starting at implantation… at fertiliz ation versus implantation. Member 5: For them as an organizational body… Member 5: But you could take the analogy of a plant seed… does that seed have the capability of growing into a plant? Member 2: Yes. Member 5: And…but in order for it to happe n it must… fall in soil and be watered and somewhat… Member 2: Correct. Member 5: So a lot of things have to happen for the plant to grow, but nevertheless the possibility was there when it was just a seed. For so me people the seed of life is once the sperm enters the egg. It’s all an ethical dilemma. Member 5: Each person has to make their own belief.

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127 Member 5: You can defer judgment to you k now bodies such the AMA or other larger institutions but… it’s just a judgment call Member 2: The question we come back to though is whether or not Plan B, is any different than any other birth co ntrol method… Member 2: and chemically it’s not Member 2: So the real question is then, if we have a problem with Plan B, we should really have a problem with every birth c ontrol method out there that’s an oral contraceptive. Because it’s literally the same thing. So t hat’s the problem that… Member 5: That is a logical statement. Member 2: the argument runs into… is that if you’re going to re ject this method, you have to reject something that’s the same th ing. And that’s where our problem lies. As a profession because we’re not being c onsistent. Member 1: I agree. Member 3: Well being that it has three different mec hanisms… again you’d have to go back to where you believe conception starts… so if it’s going to work by thickening the endometrium, and just preventing the egg from meeting the sperm… I personally don’t see why not. But if it’s going to…which I don’t think it’s what you guys (alluded to)… it… it aborting… so once the… the sperm is fertilizing the egg…is it gonna… that’s where I believe conception starts. Is that where, it’s going to work? And if that’s the case, then you’re getting into abortion and being pro-li fe verus pro-choice. But I think you guys said that that’s not how it works.” The topical area of no knowledge encompasses the idea that some students did not learn about emergency contraception in th eir pharmacy school classes and therefore gained no knowledge from this venue. Some students briefly noted that they were being quiet because they did not have knowledge abou t emergency contraception (Table 13). It is important to acknowledge that what is ab sent from discussion is sometimes just as important as what is present. In addition, a few students expressed interest in wanting more information on emergency contrace ption, specifically around the ethics of dispensing.

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128 The theme perceived knowledge of others refers to how the participants described emergency contraception knowledge of othe r pharmacists and the general community. Although students were not questioned about wh at level of knowledge other pharmacists and the community had around emergency contraception, these perceptions were expressed in the discussions and are worth mentioning. Most students remarked that pharmacists do not have knowledge on how it works and perceived that the wider community thinks that it causes an abortion.

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129 Table 13. Major Themes of What Students Learned in their Pharmacy School Classes and Representative Quotes Theme Representative Quote Timing & composition Accurate “...this is not an abortion pill. Th is can only be used within the first 5 days. It can be dispensed two tablets together but all of the research has done one pill and then twelve hours later. It can be, you know, used in this situation. It’s, you know, effectiveness is only 85%” “Like you know I remember learning it’s a high dose of the regular birth control so it’s that’s one thing that always stink in my head” Confusion “You take one, like you take one immediately and you take the other one within 72 hours.” “Twenty-two… within twenty-two hours and then twelve hours later and then that was pretty much it, right?” Mechanism of action “...So we’re not really sure but there’s three or four different ways…we believe it works.” “One of them is in…you know like (another member) was saying, it’s um… a far as just like thickening the endometrial, you know, mucosa so that the um… egg is less uh… less apt to travel um… that’s one of ways that it works; just in the same way as birth control… works.” “Member 1: I remember one line it said this is not an abortifacient. Member 2: I have a question on that.We’re referring to third mechanism of action which states t hat it could or could not effect implantation Member 2: but isn’t that also the same mechanism of action of Ortho Tri-Cyclen? If you look at the mechanism of action…Member 1: It is. Member 2: in Plan B and in Ortho TriCyclen for example, they’re identical.” No knowledge “Member 2: We haven’t had this (have we?). Member 3: Yeah, that’s why I’m kinda quiet…” “I kinda just looked it up briefly on the internet; about how it works..other than that like other than it being brought up in ethics class..about how some pharmacists would dispense it, some others..some err…others don’t. So that’s why I’m like…I’m kinda learning here too” Perceived knowledge of others “The only thing that people have ever heard about emergency contraception is that it aborts a baby.” “One thing that I, I think is important um for mostly for pharmacists cause a lot of the pharmacists that I’ve come across during internships and stuff like that. Th ey don’t, it doesn’t seem like they really get how it works….”

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130 Teaching Instruction. To measure issues around emergency contraception teaching instruction, students were asked about particular methods of teaching instruction on the paper and pencil survey and were asked if they were aware of any position, negative, or even neutral attitudes that they perceived as held about emergency contraception by the instructor. Apart from the survey questions that captured this question discussed earlier, two themes em erged from this questioning, 1) professor attitude and 2) need to e ducate. In terms of the professor attitude when teaching emergency contraception, the majority of students answered that the professor was neutral in their attitude a bout emergency contraception. “ Yeah, I’d pretty much say they were neutral. I mean I didn’t really see any positive or negative thoughts about it when they were teac hing us about it. I mean we touched first of all how it works (unclear) how the medication works and then we discuss it in open group. You know the teacher was neutral he didn ’t, he told us not (unclear) you have to follow the law um that are under that we practice under.” “I think they were very cauti ous because they don’t want to put their biases into it. They’re just supposed to teach us what’s out th ere at this point. And even though we try to bring up… well what about the ethical issu es and stuff they kinda floated over it and didn’t really want to go to far into it.” Although it was more of a minority view, a few students felt that the professor attitude was more negative than positive or neutral: “If anything I felt they erred on the side of against it. Only because of it’s potential for abuse and the side effects and things like that…” Another theme that was mentioned when discussing emergency contraception teaching instruction was the need to educate around emergency contraception. The reason this is included here as this theme was mentioned repeatedly in the discussions around dispensing practices and th erefore it is practical to me ntion here as well. This

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131 theme of duty to educate and counsel was a common theme among all focus group sessions and will be discussed more thoroughly in the next section. “…Basically them (professors) telling us that we need to educate the patient before we give it to them so they are aware of what it’ s actually doing. That it’s not supposed to be a form of regular you know contraception.” Projected Dispensing Practices. Questions around dispen sing practices of pharmacists by far yielded the most discus sion and many non-expected themes emerged from these discussions. Not only were pha rmacy students asked a close-ended question on the paper and pencil survey about wh ether they would dispense emergency contraception in the future, but many ques tions throughout the fo cus group discussions focused on their future dispensing practices. On the paper and pencil survey, almost 20% of the sample responded that they were either not sure or that they definitely would not dispense emergency contraception upon becoming a pharmacist. The focus group discussions uncovered many hes itations in terms of dispensing, where the majority of students said that they would probably dispense, but that they felt hesitancy in doing so. “Yeah, don’t get me wrong I will dispense it but I will feel weird in a way, in the back of my mind.” Hesitancy in dispensing was mainly due to biases held by the study participants. Hesitancy in dispensing was due to many issu es including: hesitancy due to mechanism of action, repeat use, age requirement, due to the situation of a particular woman, due to side effects, and due to belie ving it is wrong (Table 8). An overall theme of judgment emerged from this data. Hesitancy in dispensing or not wanting to dispense due to mechanism of action refers to the idea that pharmacists may not want to dispense emergency contraception

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132 because of not knowing through which mechanism of action that it actually works. One student remarked that if she/he were required to dispense th is medication that it may in fact change her/his career path (see Table 8). These comments points towards the belief that emergency contracepti on is a form of abortion. The most cited reason for being hesitant to dispense emergency contraception came from issues with repeat use Participants thought that repeat use was wrong and was grounds for refusal. They employed wh at they called “professional judgment” to decide whether or not to refuse dispensing of the medication. Part icipants maintained strong judgment against disp ensing to women or men who came in repeatedly for the medication. Following this same idea, many participants were hesitant to dispense due to the teenage use Students seemed to have a problem with teens using this medication and were concerned that someone else would co me in and buy the contraception for teens under 18 years of age. Repeat use by teen agers was also frowned upon. Dispensing also varied based on the situation of the woman For example, students were more likely to have favorable attitudes about dispen sing to women who are raped than to teenagers. In the discussion a bout the situation of the woman, the same bias towards women who use it repeatedly came up. Students were hesitant to dispense emergency contraception OTC due to the perceived side effects of the medication (Tab le 14). Many participants felt that the medication should not have gone OTC due to the perceived side effects and that it should be controlled by physicians. Interestingly, stud ents did not mention wh at particular side

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133 effects the medication caused but were sure that they were going to come out with studies demonstrating these side effects very soon. In addition, a few students did not want to dispense the medication because they believed it was wrong and compared dispensi ng it to being a willing accomplice in a crime: “You do not want to be considered a willing accomplice to something that you feel is wrong.” In contrast to these ideas and responses of not wanting to dispense, many students reported having no problem with dispensi ng emergency contraception. Many had no problem dispensing emergency contraception due to the mechanism of action, meaning if it works the same as oral contra ception and they are willing to dispense that, then they are willing to dispense emergency contraception. In addition, many students that felt that it was not their job as pharmacists to judge or refuse to dispense any medication based on moral or any other judgment. Two st udents noted that dispensing emergency contraception is part of a pharmacists’ job: “I think for any um… any drug, it’s really … If you have religious reasons for not dispensing drugs then why are you a pharmaci st?... Like you know that’s part of the job, right? You do have to give people drugs.”

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134 Table 14. Major Themes of Projected Dispensing Practices and Representative Quotes Theme Representative Quote Hesitancy in dispensing/not wanting to dispense Due to mechanism of action “That’s the problem, we just don’t know… it seems like… we just don’t know how it’s going to work, so…” Moderator: So would you say that you feel more hesitant towards dispensing because not knowing the true mechanism of action? Member 3: “I do.” Member 1: “I definitely do. I feel like I could even change my career path…because of some places require that, then I feel like I couldn’t pursue that career path…” Due to repeat use “I’m a little undecided because um… right now there is no limitation as to you know if person A can come pick it up today and next week come pick it up again or… so I think my limitations are you know like I may consider dispensing it you know if I you know… you know pending when I was in that situation you know and I think… I think I’m okay with it because ultimately I think it’s my goal to be um… to counsel the person and maybe you know… get… give them another perspective. But if it was a situation where I you know was always being confronted with you know maybe the same person or you know I’m in an area where I have to do as often, I don’t know…” “Yeah, I think that’s a little bit despicable, coming every weekend and being like yeah I want my Plan B now.” “if I see the same person coming in… I mean I would say no…as a medical professional you know that is not healthy and I would say absolutely not you need to go see a doctor” Due to teen use “...I will feel uncomfortable in a way. Because you know I see a teenager who’s just doing whatever and having sexual intercourse and not really caring about themselves and this going to be their method, even though you tell them not to. You know I’m married and maybe I’m not taking birth control and something happens… you k now it’s a…it’s a different situation I guess. But I wouldn’t want it to be used as the teenagers, oh it’s okay now don’t protect yourself because you have a birth control pill over the counter. You know so it’s kind of conflicting but by law I would still probably do but just feel a little bit guilty if I see a younger person. Like an 18 year

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135old come in.” “another thing is that would make me hesitant to dispense is the fact that you only have to be 18…” Due to the situation of women “I think, I mean, as a human you would feel different you know if you see an 18 year old girl coming in getting one in comparison to a female who got raped... I mean there’s gonna be a big difference on how you feel about that because I mean if a person was raped then I would definitely you know understand compared to an 18 year old girl who is immature and doesn’t really know all of the consequences…and who will probably do it again… you know there’s a difference. I mean that’s just my personal opinion…there’s a big difference there.” Due to side effects “Well I don’t think it should have been over the counter, due to the fact that it’s a high dose and with high doses you get the most side effect you know. Those are the medications that highly need supervision.” “This way they’re not even going to the doctor to get birth control pills for Pete’s sake…” “I just think that you know there has to be studies that shows over long periods of time how this drug has affect anybody. You know I’m pretty sure… let’s say 5 years down the line from now there’s gonna be a big study saying you know… some kind of something developed…” “It’s gonna go… go back to prescription…” No problem with dispensing Due to mechanism of action “I don’t have a problem with it. I take a look at it. I have no problem dispensing oral contraception…I see it as the same drug… I see it as the same mechanism of action. If I’m willing to fill birth control, I’m willing to fill Plan B.” Because it’s not our job to judge

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136 “It’s not our job to judge. It’s not what we’re here for. I would never apply that to my job.” “...I definitely don’t agree with any pharmacist who refuses to dispense any medication…not just the emergency contraception…but anything based on your own personal beliefs. If you don’t have a medical reason why this person shouldn’t take it, then it’s really not your place...” “My personal belief is that we are…when you inject your own personal belief into a situation such as this which is not of the interest of the patient… we are overstepping our rights pretty much as a pharmacist...we’re supposed to be there to provide medication and information and protect the patient. And by us refusing a product that they’ve already made their mind up that they want and previous ly their doctor has also agreed with that… and provided a prescription for that fact. For us to step in an say no we won’t fill this is… we’re abandoning our patient in a way. That’s how I feel about. “..if they meet all the requirements and I feel that they are safe as a health…from a health perspective, I have no problem dispensing it and I don’t really think of it about if they are too young or a it’s a male picking up or anything like that. Like I… I just don’t personally feel any sort of moral you know thing at all.” There were other major, yet unexpected themes that emerged from the data. These included: 1) duty to counsel, 2) stigma and 3) the argument between professional judgment and mandatory dispensing. In additi on to these themes, participants shared stories of refusal that are included below. The first major yet unexpected theme th at emerged from the discussions around dispensing practices was duty to counsel Most, if not all participants felt that it was their duty to counsel and educate consumers about emergency contraception. This was an interesting finding in that Plan B is no t a pharmacy counseled product (Food and Drug Administration, 2006). Although th e FDA mandates that a h ealthcare professional must be available to answer questions that a consumer may have about Plan B OTC,

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137 counseling for Plan B OTC is not required. The only thing that is required for OTC purchase of Plan B is proof of age 18 or older (Food and Drug Ad ministration, 2006). “They absolutely have to get th e counseling from the pharmaci st, because the technician, a cash register person, whatever… someone who’s standing helping out in the pharmacy, does not understand why it’s im portant to educate the person about this drug...” “I think a little more counseling is needed. At that point you just can’t ask for an ID…ok you’re over 18… there you go. You need to as k a little bit more you know questions; when did you have intercourse and make sure th at it was in the correct time. And that way you’re educating them.” Many study participants explai ned that they felt that it was their duty to educate and counsel consumers on this product due to the OTC status of the drug: “…Now if it would have stayed a prescripti on then you know I know they may deny counseling with me however they went to a physician, they were examined, they obviously were spoken to about the medi cation and if they don’t want to hear my counseling that’s fine… I’m a little more at ease with that. T han in the sense that now it’s over the counter and they just come and buy it and go…” “And me personally, I think it all comes down to like I personally don’t think that that drug should have been placed over the counter just because of the counseling issue.” Other reasons provided for the need to counsel clients on emergency contraception was due to a belief that consum ers are ignorant about their health and that repeat users and teens are irresponsible. Ex amples of the need to counsel due to the ignorance of consumers: “…Take the pill they think it’s taken care of, they could be… three weeks later out at a Dolphins game, tailgating, be drinking most of the morning and ha lf of the afternoon and they’ve damage… they’ve potential ly caused damage to their fetus because they didn’t understand that they needed to follow back up with their doctors…” “I agree with you. Cause some people may not even know what their cycle is and then just probably just wasting their money too and buying some thing that’s not going to work. You know? Some people don’t even think about when they’re really ovulating or what they should look for. So I agree with you on counseling…”

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138 Examples of the belief that education is needed because repeat use and teens are irresponsible are included below: “I think that… the other major thing that c oncerns me with the Plan B, especially going back to the ignorance in a… in women’s health th at a lot of people like to self medicate in this country and they might not seek out getting the Plan A, the regular oral contraceptives, and just util ize the Plan B frequently and there’s not a lot of data on how effective it is if it’s used more frequently; if it becomes le ss effective and I think that’s what the evidence that they’ve been telling us is. That when it’s used more frequently it’s not as effec tive and I… I think when they hav e that over the counter the pharmacist needs to at least tell the… the patient that they need to seek out a good oral contraceptive from that point on.” “… in some instances I believe that you know it’s a reason for young people to have unprotected sex. They feel you know, well I ca n’t get pregnant; you know I can (either) take birth control; I can take emergency contra ception… but their not aware of the other things… the outcomes of it…you know STDs (unclear) for example…I mean I can tell you from experience. I see it everyday at the pharmacy… right here… (unclear) right now we have to have birth control in stock… I mean this we have to have all of (the) at the beginning of the year… birth control… I mean it’s like hot item. Believe it or not those same patients within three months after that has to get prescription for STD. So my thing is yes, you’re not gonna get pregnant but then again you… you are not protecting yourself (about) the other risks. So yeah I me an I think about it but I… well it’s just an excuse for them to go ahead and have unprotected sex… but at the same time you know it’s not my place to say well you can’ t… I cannot dispense it to you.” “… I think that… I had a lady come in w ith her boyfriend, young girl she might have been maybe just 18. I asked her if she needed any counseling. You k now (unclear) wanted to know the side effects on it. And she said no, she just kinda wanted to buy it and run out. I guess cause of being embarrassed or w hatever; so that’s kinda worrisome because you know if they over use that, that could c ause problems for them health-wise. So I think that’s a big issue. I think somehow, it needs to be… counseling has to be a mandatory thing. I think that that … cause they could refuse couns eling but I feel that with that medication, I don’t think that yo u should be allowed to refuse.” Many sentiments such as these below carried a hint of paternalism in the form of counseling despite Plan B not being a counseled product. “… well they chose to get it, I’m not the one who gave them access to it but I can at least tell how to use it right so t hat they don’t harm themselves. Cause by me not giving it to them I’m abiding to my ethical beliefs but th em taking it can harm them more than benefit them if I don’t give them counseling.”

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139 “… I think I’m okay with it because ultimately I think it’s my goal to be um… to counsel the person and maybe you know… get… give them another perspective.” “I think you need to sit and he ar ok this is not a drug that you can use every time...” “… I guess concerned when a male comes in to buy it because we can’ t refuse, if he’s 18, if he shows his ID you know that’s what our discussion was (in lab)… we can’t really refuse him but how do we know he’s not gonna you know… you know worse case scenario… go out and rape somebody and force a 15 year old to take it…” One way to perhaps explain this overw helming need to counsel and educate consumers can be found in par ticipant ideas about pharmacy as a profession. One of the first questions asked in the warm up of the focus group discussions is why students want to be a pharmacist and almost all students responded that they chose to become pharmacists so that they can help and counsel people. “… I enjoy helping people and… my (ideal ) pharmacist is someone who would get out and help the customers.” “I want to become a pharmacist… once again it’s a helping profes sion it gives you the ability to help people in the way that the pharmacist role is going… rather than just standing back behind the counter and filling things out… helping the patients and counseling them and helping them…” “…the counseling piece has always been very important to me and I’ve always kind of felt obligated to do some counseling and inte raction and this gives me an opportunity to do that with more security… this would be something that would give me the opportunity to counsel um… and also give me the opportunity to educate…” The area of stigma took on two forms, one where pa rticipants noted the stigma that consumers feel when coming in and as king for Plan B and two, the overall stigma that participants seemed to have about users of Plan B and around OTC drugs in particular. These quotes embody the noted stigma that consumers may feel when requesting the medication: “Nobody’s happy… nobody’s smiling going… I want my Plan B.”

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140 “They’re usually very quiet about it. They co me in and they’re kinda like do you sell the Plan B? You kinda see them lurking in the aisle before they come up to make sure nobody’s there or if it’s a male pharmaci st, they wait till a fe male at the register.” Upon coming into the focus group, some pa rticipants had a preconceived notion of what kind of person uses Plan B and ther efore already had a stig ma towards the person using the medication. When answering the question, what is the first thing that comes to mind when you hear the term emergency contraception all focus groups said that the first thing that comes to mind is a young girl or te enager trying to fix their mistake or risky sexual behavior. It is possible that this stig ma or notion of a Plan B user may negatively impact access to this medication. Focus group participants mentioned that other stigmas were present for other OTC products such as Su dafed, syringes, and nico tine patches. It is strange that there did not seem to be the same stigma around prescription oral contraceptives even though prescription oral contraceptives and Plan B are compositionally the same. When discussing dispensing practices, data from th e focus group discussions demonstrated a tension between what is called professional judgment and mandatory dispensing Professional judgment is the idea that pharmacists should be able to decide whether or not to dispense medication based on their personal belief s/religion/values and mandatory dispensing is the thought that if you are a pharmacists, you should be required to dispense all approved and legal drugs th at your pharmacy carries. There was much discussion around both sides of this argument in all of the focus groups, however only one excerpt is shown here: “… if it’s religious… if they have a religious belief… I know that they is not supposed to you know take their religion to the workplace but… however as long as they able to refer

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141 the patient you know to where they can get it … I feel like it’s you know it’s their professional judgment and they… th ey don’t want to dispense it…” Member 4: “I don’t…” Member 1: “so I don’t think we can force th em and say hey you have to do this. They are profess… they are professionals and I think their right has to be protected also.” Member 4: “… but a lot of times people use that as an excuse because if you… if it was truly that they didn’t want to dispense it because of their re ligious beliefs…what about all the other medications that… you know what I mean, that fall under that category also… like nobody refuses to dispen se Viagra… nobody refuses to dispense Cialis… nobody refuses to dispense regular birth control… so… then why would your religious beliefs only tell you that you can’t dispense Plan B? Like that doesn’t make any sense.” Member 1: “But the thing is you know…it’s harder like for the older pharmacists… it’s harder for them to accept changes. So you know they still have that old mindset.” Member 4: “They should retire.” Member 3: “I mean I wouldn’t personally refuse anyone, um however I do feel that everyone has their right to believe whatever you believe; but it’s all in how you handle the situation. Ok, if um… if I didn’t want to di spense it and I said to the patient we just don’t have it in stock, let me refer you to blah blah blah. Fine Ok, I can deal with that but… some people are just downright rude and saying I don’t dispen se this drug… you know and just kinda like…right away catch the attitude…and I don’t think that’s appropriate at all. Now if they do you know something like we don’t have it in stock why don’t I refer you to this store. That’s ok ay. I wouldn’t have an issue with that.” Member 3: “If that’s your pe rsonal religious belief, fine I th ink you handled it as best as you could in that case. But if you’re gonna you k now get rude about it… then no…” Member 4: “I think that the issue… that I have with it is like she said… when you’re… when they’re rude… or when they say you know… you shouldn’t take this because I… I’m not giving this to you because I don’t believe in it or you shouldn’t be having unprotected sex or you’re too young to be taking … you know what I’m saying when they say… cause I’ve heard pharmacists say…” Member 4: “Like they won’t just say I can’t di spense this you know whatever. They’ll… they tell the patient… why they th ink they shouldn’t be taking it and that they shouldn’t be taking it and they shouldn’ t be doing this and that’s… I mean that’s not our place to do that.” Member 1: “But I… on the other side… th is is probably gonna be on the side of the pharmacy side. I feel like if we just… if we as … as a professional if we allow you know…

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142 if we allow them to take all of our rights aw ay… you know what ki nd of professional we are? We just gonna be doing whatever we are told to do. You know our profession is not gonna be protected; we not gone have right to do what we feel is right.” Member 4: “But it’s not about… it’s not about your religious beliefs though.Your right is to say… as a pharmacist I have a right to say… you… I’m not gonna dispense this to you because it’s going to cause you to bleed to death… I’m not gonna di spense this to you because I can see that you are addicted to nar cotics… I’m not going to dispense it to you because you’re already taking something that has the same ingredients in it. Not I have a right to tell you that I’m not gonna give it to you because I don’t believe you should be taking it. That’s not…you know what I me an. So I feel like our pr ofessional rights are protected because we do have the authority to say we’re not going to dispense anything to you that is going to endanger your health or your safety.” Member 5: And as far as the patient m ade up their mind or a doctor wrote in on a prescription pad, you’re (uncle ar) saying that a pharmacist is a mere um…vendor um… just there to exchange products and not exchange service. And if the patient made up their mind it doesn’t mean that we should necessarily have to follow whatever they decide. I’ve seen multiple prescriptions that I would not have dispensed on any day of my life… just because it was written on a prescription pad doesn’t mean it was correct. Oh and just because a patient makes up th eir mind doesn’t mean it’s correct…” Lastly, many stories of refusals and pharmacists and pharmacies limiting access to emergency contraception were expressed during the focus groups and will be shared here. Participants noted that they work with pha rmacists who refuse to dispense Plan B. “And regardless of what everyone would like to say about pharmacists don’t pass judgment, there’s a lot of st udents who pass judgment now; which means they are going to be pharmacists who pass judgment. And I’ve worked with pharmacists who refuse to dispense...” “Yeah, I… I personally work in a pharmacy where we had two pharmacists, when it was prescription only, refuse to fill it and… two pharmacists who would. So it was a very interesting cause I was involved in the juggling back and forth be tween…that particular situation.” “… (another) pharmacist that we have, he hides th em… when we get in an order.” All: He hides it? Member 3: Where the heck does he hide it? Member 2: I have no idea. I went to the room the other day and then the pharmacist look for it and I thought he had it…I’m like (are thos e things right there). Cause we made a… we made a bet… a hundred dollars that we can… that we can find (whether) he hides them at. I know he’s not taking it out of the pharmacy…that’s against the law.

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143 He puts them somewhere… he… he makes sure he works on Tuesday night when the order gets in…to make sure he takes them out of those box and puts them somewhere we don’t know” “…(a professor) warned us about there’ s this one student on rotation who got a prescription um for Plan B, um it was CVS in Gainesville and th e pharmacist doesn’t want to fill it but she um, th e student gave it to th eir patient anyway and got into so much trouble. But the pharmacist kind of just blamed it on the stud ent. Well it’s the student’s fault because you’re really not supposed to but um I gue ss the point is like um don’t do anything your like your preceptor wouldn’t do. Just make sure like if your preceptor says no I don’t want to fill it then you don’t give it to the patient…” “It depends on the pharmacist, some pharmacists are totally cool with it but there were pharmacists who would just refuse to give it to their patients.” “(a professor) just warned us like if your preceptor doesn’t feel co mfortable, then don’t do it.” “…I was working with a pharmacist and he me ntioned that he had um you know I’m not against any religion, that he had a Jewish pharma cist who would just not dispense it at all no matter what because he felt that sperm shouldn’t be wasted. So um… it was… he just wouldn’t do it at all…” “I’ve had some pharmacists that won’t sell it to men… also in that same Jewish place... It has to be a female over 18.” Summary In sum, there was a disconnect between what pharmacy students reported on the paper and pencil survey and what was uncovere d in the focus group discussions. On the paper and pencil survey students reported learning about emergency contraception in their pharmacy school classes, however when queried in the focus groups discussions pharmacy students revealed that this learning did not come from their pharmacy school classes but rather from outside sources. Question 2 asked about how emergency c ontraception course content was taught at accredited schools of pharmacy. Accordi ng to the focus group discussions what is taught in pharmacy school classes about emer gency contraception is brief and over half

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144 of the sample felt that pharmacists are not well enough informed to confidently dispense emergency contraception. The majority of participants felt that their professors maintained a neutral attitude in teaching a bout the medication. In addition, participant level of knowledge about emergency cont raception was not specific. Many students entered the focus group with a preconceive d notion about people who use emergency contraception and were hesita nt in dispensing the medicatio n. Many participants held biases or judgments towards emergency contraception users. This stigma may be explained through a belief that pharmacists have a duty to educate and c ounsel clients. It is likely that these beliefs were learned from school. Refusing to dispense emergency contraception is real as noted in many of th eir stories and the arguments for refusing to dispense and for mandatory dispensing were present throughout the focus groups without resolution. Section III: State-Wide Pharmacist Survey The third research question was addre ssed through a state-wide survey of pharmacists. Although 552 surveys were maile d out to pharmacists around the state of Florida, only 146 were returned (138 paper-b ased and 8 online) yielding a 26% response rate. After speaking with committee member s, a second mailing was sent. The second mailing only had one contact point and did not follow Dillman’s method due to budget constraints. Because 185 more surveys were needed at this point, another 712 surveys were sent out to a random sample of pharmacist s and great care was taken to ensure that pharmacists were not double sampled. Of the 712 surveys mailed out in the second mailing, 130 were returned yielding a 18% resp onse rate. However, 30 surveys were either returned by mail or they left message s about how they were retired, sick, or not

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145 currently living in Florida. In total, 1,264 surveys were mailed out, 272 were returned and ~30 were incorrect. Therefore, the fi nal sample size was 272 (which is 82% of the original sample hoped for) with a 22% respons e rate overall. Because the study was not funded and because the research and mailing co sts were out of pocket expenses for the researcher, surveying more pharmacists could not continue and ther efore they desired sample of 331 was not reachable. The follo wing analysis will report on the 272 surveys that were returned. Quantitative Data Analysis: Univariate & Bivariate Analysis Quantitative data analyses were perfor med using SPSS statisti cal software (SPSS 16.0, SPSS Inc., Chicago). Frequency distribut ions were performed on all categorical level variables to determine response distri butions and means and standard deviations were calculated for all continuous variables. These procedures identified any outliers or non-meaningful responses and response patter ns which could call for collapsing of data based on the distribution. All collected and en tered data as well as frequency distribution output data are available on CD. Univariate Analysis. The sample included 272 pharmacists, female (52.6%) and male (47.4%) (Table 15). Age ranged from 25 to 87 and can be equally distributed into thirds with 30.9% under 36 years of age, 34.6% between the ages of 36-50, and 32.7% between the ages of 51-87. The ethnic com position of the sample was primarily White (70.6%), followed by Hispanic (10.7%), Asian (7.4%), Black (6.2%), and Other (3.3%). A little over 67% of pharmacists were married with the remainder single (27.6%) or living with their partner (3.7%). Almost 38% of the sample were Republican, followed by Democrats (25%), Independents (17.3%), a nd none or undecided (15.8 %). In terms of

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146 religion, 67.3% reported some form of Ch ristianity, 8.8% claimed no religion, 7% reported being Jewish, 6.2% reported being Hindu or Buddhist, 1.5% Islamic, and 9.2% did not answer the question. When querie d about religiosity, 47.4% of the pharmacists claimed to be either religious or religious and spiritual, while 25.4% reported to be spiritual only, and 25.4% selected undecided, none of the above, or prefer not to respond. Table 15. Sociodemographics Characteristics of Study Sample (N=272) Variable Total population N (%) Gender Female Male 143 (52.6)* 129 (47.4) Age, years < 36 36-50 51-87 84 (30.9) 94 (34.6) 89 (32.7) Ethnicity White Black Hispanic Asian Other 192 (70.6) 17 (6.2) 29 (10.7) 20 (7.4) 9 (3.3) Marital status Married Living with partner Divorced or separated Widowed Never been married 183 (67.3) 10 (3.7) 28 (10.3) 4 (1.5) 43 (15.8) Political Affiliation Republican Democratic Independent None/undecided Other 103 (37.9) 68 (25.0) 47 (17.3) 43 (15.8) 6 (2.2) Religion Christian Hindu or Buddhist Jewish Islamic None Missing 183 (67.3) 17 (6.2) 19 (7.0) 4 (1.5) 24 (8.8) 25 (9.2) Religiosity Religious Spiritual Religious and Spiritual 43 (15.8) 69 (25.4) 86 (31.6)

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147Undecided None of the above Prefer not to respond 13 (4.8) 35 (12.9) 21 (7.7) *Some percentages do not add to 100 because of rounding or missing data The remainder of the demographic questi ons queried about pharmacists’ current positions and their pharmacy education and training (Table 16). Just over 32% had been practicing pharmacy for 8 years or less, 33.5% had been practicing between 9 and 22 years, and 33.8% had been pr acticing pharmacy between 23 and 55 years. Over half of the sample (51.8%) was employed at a commun ity-chain pharmacy, almost 20% worked at a hospital pharmacy, 15.4% reported working at another type of pharmacy such as home infusion, or mail order, and another 12.9% of pharmacists reported working at a community-independent pharmacy. Just over 58% of the sample said that they were staff pharmacists, 27.6% reported to be pharmacy managers, and 14.3% reported to have a different job title such as clinical pharmacist, pharmacy owner, or medical liaison. Almost 81% of the sample claimed to be employed full-time, 17.3% worked part-time, and a smaller 1.8% were retired. In terms of pharmacy school attendance, the top five schools attended, which represen ted 47.8% of the sample, were University of Florida (24.6%), Nova Southeastern University ( 11.8%), Florida Agricu ltural & Mechanical University (4.4%), Mercer University ( 3.7%), Massachusetts College of Pharmacy (3.3%). Almost a third of the samp le (32.4%) graduated between 1949-1982, 28.7% graduated between 1983-1998, and 34.6% graduated between 1999-2007.

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148Table 16. Demographics on Pharmacy Practice and Training (N=272) Variable Total population N (%) Years in Practice <9 9-22 23+ 88 (32.4)* 91 (33.5) 92 (33.8) Type of Pharmacy where Employed Community—Chain Community—Independent Hospital Other (e. g. Home Infusion, Mail Order) 141 (51.8) 35 (12.9) 54 (19.9) 42 (15.4) Job Title Staff Pharmacist Pharmacy Manager Other (e. g. Clinical Pharmacist) 158 (58.1) 75 (27.6) 39 (14.3) Current Employment Status Full-time Part-time Retired 220 (80.9) 47 (17.3) 5 (1.8) Pharmacy School Attended** University of Florida Nova Southeastern University Florida Agricultural & M echanical University Mercer University Massachusetts College of Pharmacy 67 (24.6) 32 (11.8) 12 (4.4) 10 (3.7) 9 (3.3) Year Graduated 1949-1982 1983-1998 1999-2007 88 (32.4) 78 (28.7) 94 (34.6) *Some percentages do not add to 100 because of rounding or missing data **Only certain data presented for this variable Univariate analysis was performed fo r each independent variable (knowledge, attitudes, subjective norms, and perceived beha vioral control). Knowledge was measured by 10 questions. Higher levels of knowledge were found for comprehension of number of pills in Plan B package, timing of admini stration, percentage of effectiveness, how to sell OTC to men who request it, Plan B and it’s relationship to abortion, and the relationship between timing and Plan B effectiveness. Lower levels of knowledge were found for understanding Plan B’s true mech anism of action, comprehension of who can

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149 sell Plan B to consumers, how to sell OTC to women in advance of need, and the relationship between Plan B and birth defects (Table 17). Table 17. Categorical Cla ssifications for Knowledge Knowledge Items* Total population N (%) Number of pills in Plan B package Correct Incorrect 185 (68.0) 87 (32.0) Timing of administration Correct Incorrect 188 (69.1) 84 (30.9) Mechanism of action Correct Incorrect 120 (44.1) 152 (55.9) Percentage of effectiveness Correct Incorrect 186 (68.4) 86 (31.6) Who can sell Plan B to consumers Correct Incorrect 121 (44.5) 151 (55.5) How to sell OTC to women (in advance of need) Correct Incorrect 61 (22.4) 211 (77.6) How to sell OTC to men Correct Incorrect 183 (67.3) 89 (32.7) Plan B can cause birth defects (True/False) Correct Incorrect 120 (44.1) 152 (55.9) Plan B can act as an abortifacient (True/False) Correct Incorrect 146 (53.7) 126 (46.3) The sooner a woman takes Plan B, the more effective it will be (True/False) Correct Incorrect 248 (91.2) 24 (8.8) *Missing cases are treated as incorrect A composite score was developed from the 10 questions that measured knowledge such that each participant was gi ven a knowledge score, 0 out of 10. The mean, standard deviation, range as well as the distribution of the knowledge composite variable is provided in Table 18. On a scale of 0-10, the mean knowledge score for participants was 5.36, meaning th at the sample had average knowledge across the board.

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150 The knowledge composite score had a normal distribution with a slight left skew meaning that there was a slight skew toward s higher level of knowledge about Plan B in the sample. It was assumed that a pharmacist did not know the answer to a question if they left the question blank. Therefore, an unanswered knowledge question was treated as don’t know. Pharmacists rece ived a 1 if they answered the question correctly and a 0 if they answered the question incorrectly or did not answer the question. There were 47 pharmacists who left 1 or more knowledge que stions blank. Of these 47 pharmacists, 27 only left 1 item blank, 6 left 2 items blank, 3 left 3 items bla nk, 5 left 4 items blank, 5 left 7 items blank, and 1 left all items blank. Table 18. Univariate Statistics for Knowledge Composite Variable, N=272 N (%) Mean (SD) Range Skewness Knowledge Composite Variable 0 1 2 3 4 5 6 7 8 9 10 9 (3.3%) 16 (5.9%) 19 (7.0%) 16 (5.9%) 31 (11.4%) 40 (14.7%) 38 (14.0%) 49 (18.0%) 30 (11.0%) 19 (7.0%) 5 (1.8%) 5.36 (2.46) 0-10 -.381 Table 19 represents the univariate analys is for the items that measured attitudes about Plan B. In general, attitudes about Plan B use and users tended to vary. While over half of the sample (52.9%) disagreed with the statement that easy availability of Plan B would discourage the use of regular contraception, 45.5% either agreed or were not sure. A similar finding was found with the statement easy availability of Plan B promotes promiscuity. While 53.7% of the sa mple disagreed with the statement, the other 44.5% either agreed or were not sure. Over 64% of the sample reported that they

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151 did not feel uncomfortable disp ensing Plan B because of thei r religious/ethnical beliefs, however 33.8% reported that they either did feel uncomfortable due to their religious/ethical beliefs or they didn’t know. A large percentage of the sample felt that repeated use of Plan B is wrong (61%). In terms of comfort with dispensing Plan B to different groups of people, a large propor tion of the sample (66.9%) felt comfortable dispensing to adult women, less felt comfor table dispensing to men (41.5%), and even less felt comfortable dispensing to adolescents (38.6%). This finding is consistent with the dependent variable, dispensing practices wh ich will be discussed below. In addition, the majority of pharmacists (79%) felt that Plan B should be offered to women who are raped in all hospital emergency rooms, regardless of hospital affiliation.

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152 Table 19. Categorical Classifications for Attitude Attitude Items* Total population N (%) Easy availability of Plan B will discourage regular contraceptive use Agree Disagree Neither Agree nor Disagree 85 (31.2)** 144 (52.9) 39 (14.3) Easy availability of Plan B promotes promiscuity Agree Disagree Neither Agree nor Disagree 74 (27.2) 146 (53.7) 47 (17.3) I feel uncomfortable dispensing Plan B because of my religious/ethnical beliefs Agree Disagree Neither Agree nor Disagree 59 (21.7) 176 (64.7) 33 (12.1) Repeated use of Plan B is wrong Agree Disagree Neither Agree nor Disagree 166 (61.0) 66 (24.3) 34 (12.5) I feel comfortable dispensing Plan B to adult women Agree Disagree Neither Agree nor Disagree 182 (66.9) 63 (23.2) 23 (8.5) I feel comfortable dispensing Plan B to adolescents (teens <18 yrs old) Agree Disagree Neither Agree nor Disagree 105 (38.6) 133 (48.9) 30 (11.0) I feel comfortable dispensing Plan B to men Agree Disagree Neither Agree nor Disagree 113 (41.5) 117 (43.0) 38 (14.0) Should Plan B be offered to wome n who are raped in all hospital emergency rooms, regardle ss of hospital affiliation? Yes No/Not sure 215 (79.0) 53 (19.5) *The first seven questions were measured on a 5-point Likert scale from completely agree to completely disagree and were collapsed for easier comprehension **Some percentages do not add to 100 because of rounding or missing data A composite score was developed from the 7 questions that measured attitudes. Since the attitude questions were measured on a 5-point Likert sc ale, each respondent received a score from 1-5 for each individua l question and the composite score included a total score for all attitude questions. The at titude composite score ranged 7 to 21 where a

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153 higher score equates to more positive attit udes about Plan B. The mean, standard deviation, and range is provide d in Table 20 for this new co ntinuous variable attitudes about Plan B. On a scale of 7-21, the mean attitude score for participants was 14.87, meaning that the sample had average attitude s across the board. Th e attitude composite score had a normal distribution wi th a slight left skew mean ing that there was a slight skew towards more positive attitude s about Plan B in the sample. Table 20. Univariate Statistics for Attitude Composite Variable Study Sample (N=272) Mean (SD) Range Skewness Attitude Composite Variable 14.87 (3.98) 7-21 -.327 Figure 5 represents the univariate anal ysis of some of the items measuring subjective norms. Overall, the majority of the sample perceived that their partners/business colleagues, pr ofessional organizations that th ey are most active in, their supervisor, and their close friends and family th ink that they should dispense Plan B. In addition, 11.4% of the sample reported that there is someone at their pharmacy who refuses to dispense Plan B, 41.2% reported th at there is no one at their pharmacy who refuses to dispense, 26.7% were not sure, a nd 18.4% of the sample reported that their pharmacy does not carry Plan B (d ata not listed in chart). When asked if there is a policy in place at their pharmacy if someone refuses to dispense Plan B, 29.4% said yes, 24.3% said no, 23.5% were not sure, and 19.1% of th e sample reported that their pharmacy does not carry Plan B (data not listed in chart).

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154 684 15.8 15.8 75 6.6 184 74.3 9.6 16.2 64.4 19.9 158 0 10 20 30 40 50 60 70 80Percent (%) Partners/business colleagues Professional Organization SupervisorClose friends & familyFigure 5. Categorical Classifications for Subjective Norms (whether each group listed thinks they should dispense) Should Dispense Should Not Dispense Missing A composite score was developed from the 4 questions that measured subjective norms such that each participant was given an composite score ranging from 4 to 16. The mean, standard deviation, and range is pr ovided in Table 21 for this new continuous variable subjective norms about Plan B. On a scale of 4-16, the mean subjective norms score for participants was 12.99. The subj ective norms composite score had a normal distribution with a left skew meaning that there was a skew towards pharmacists thinking that influential people think that they should dispense Plan B. Table 21. Univariate Statistics for Subjective Norms Composite Variable Study Sample (N=272) Mean (SD) Range Skewness Subjective Norms Composite Variable 12.99 (2.71) 4-16 -1.115 Figure 6 represents the univariate analys is of the items measuring the construct perceived behavioral control. A large proportion of pharmacists reported that it was easy for them to counsel (69.5%) and educate ( 72.4%) clients about Plan B, while 14.3% and 10.7% felt that it was difficult to counsel a nd educate respectively. In addition, 67.6% of pharmacists reported that it is easy to dispense Plan B and 25.4% reported that it is easy to refuse to dispense the medication.

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155 69514.3 13.6 72.410.7 143 67614 15.8 25.446.7 25 0 10 20 30 40 50 60 70 80Percent (%) Counsel Clients about Plan B Educate Clients about Plan B Dispense Plan B Refuse to Dispense Plan BFi g ure 6. Cate g orical Classifications for Perceived Behavioral Control (How easy is it for you to...) Easy Difficult N/A A composite score was developed from th e 4 questions that measured perceived behavioral control such that each particip ant was given an composite score ranging from 4 to 16. The mean, standard deviation, and range is provided in Table 22 for this new continuous variable perceived be havioral control. On a scale of 4-16, the mean perceived behavioral control score for participants was 12.73. The perceived behavioral control composite score had a normal distribution with a left skew meaning that there was a skew towards pharmacists responding that they have a higher comfort level in dispensing Plan B. Table 22. Univariate Statistics for Perceived Behavioral Control Composite Variable Study Sample (N=272) Mean (SD) Range Skewness Perceived Behavioral Control Composite Variable 12.73 (2.74) 4-16 -.912 Dispensing practices can be divided into two separate measures, 1) self reported dispensing practices of pharmacists (dependent variable) and 2) intention to dispense Plan B. Table 23 and 24 summarize the uni variate analysis for the self-reported dispensing practices including both the freque ncy distribution for the categorical level items and the means, standard deviations, a nd ranges for the continuous level questions.

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156 A similar proportion of pharmacists have ever been asked to fill a prescription of Plan B (55.1%) or sell Plan B OTC (56.6%). Although these propor tions of pharmacists have been asked to dispense Plan B, strange ly, less have actually filled a prescription (47.1%) or sold Plan B OTC (51.8%). Almost 60% of the sample have ever dispensed emergency contraception either by prescrip tion or OTC. In addition, 70.6% of the sample would have the opportunity to come in contact with Plan B at their workplace. Table 23. Categorical Classifications for Dispensing Practices Dispensing Practices Items Total population N (%) Ever been asked to fill a prescription of Plan B Yes No 150 (55.1)* 122 (44.9) Ever personally filled a prescription of Plan B Yes No 128 (47.1) 144 (52.9) Ever been asked to sell Plan B over-the-counter Yes No 154 (56.6) 115 (42.3) Ever personally sold Plan B over-the-counter Yes No 141 (51.8) 128 (46.3) Ever dispensed by prescription OR over-the-counter Yes No 162 (59.6) 105 (38.6) Would you ever have the opportunity at your workplace to come into contact (see, dispense, fill a prescription) with Plan B? Yes No 192 (70.6) 74 (27.2) *Some percentages do not add to 100 because of rounding or missing data Table 24 summarizes the means, standard deviations, and ranges for self-reported dispensing practices by prescription and OTC ove r the past 12 months. When asked how many Plan B prescriptions pharmacists have personally filled in the past 12 months, answers ranged from 0 to 100 with a mean of 2.33 and a standard deviation of 9.29. When asked how many times pharmacists have sold Plan B OTC in the past 12 months, answers ranged from 1 to 200 with a mean of 5.64 and a standard deviation of 16.91.

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157 Table 24. Means, Standard Deviations, and Ranges for Dependent Variable Dispensing Practices Characteristic Mean SD Range Skewness Number of Plan B prescriptions filled in past 12 months 2.33 9.29 0-100 9.169 Number of times sold Plan B overthe-counter in past 12 months 5.64 16.91 0-200 7.466 Table 25 shows the number of times pha rmacists have dispensed emergency contraception in the last 12 months. Over the last year, pharmacists have dispensed emergency contraception OTC more than they have by prescription which may mean that the OTC measure has increased use and access to this medication. Of the pharmacists that reported that they have ev er filled a prescription of Plan B, 60.7% have not filled any prescriptions in the past 12 months, 29.8% ha ve filled 1-5 prescriptions, 7.7% have filled 6-10 prescriptions, 1.1% reported filling be tween 11-50 prescriptions, and 0.7% filled between 51-100 prescriptions. No pharm acist reported filling more than 100 prescriptions of Plan B over the past 12 mont hs. Of the pharmacists that reported that they have ever sold Plan B OTC, 48.5% have not sold emergency contraception OTC over the past 12 months, 29.4% sold 1-5 packages of Plan B, 9.9% sold 6-10 packages, 10.7% reported selling 11-50 packages, 1.1% sold between 51-100 packages, and over 0.4% of pharmacists sold between 101-200 pr escriptions over the past year. No pharmacist reported dispensing more than 200 pr escriptions of Plan B over the past 12 months.

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158 Table 25. Number of Times Pharmacists ha ve Dispensed EC in the Last 12 Months By Prescription N (%) Over-the-counter N (%) 0 165 (60.7) 132 (48.5) 1-5 81 (29.8) 80 (29.4) 6-10 21 (7.7) 27 (9.9) 11-50 3 (1.1) 29 (10.7) 51-100 2 (0.7) 3 (1.1) 101-200 0 (0.0) 1 (0.4) Table 26 summarizes the univariate analysis for intention to dispense. Intention to dispense measures the likelihood or intenti on of dispensing Plan B to varying groups of people and was partitioned into categor ies based on dispensing by prescription or OTC. Intention or likelihood of dispensing Plan B does vary by th e consumer requesting the medication or by the situation of use. Fo r example, when viewing intentions of OTC dispensing of Plan B, a greater percentage of pharmacists reported being likely to dispense to women who have experienced in cest or rape (71%), followed by women who have experienced a problem with their bi rth control method (67.3%), followed by women who request the method after having unprotecte d sexual intercourse ( 66.2%) and last to a person other than the ultimate consumer of the product such as parents or a boyfriend (46.7%). Interestingly, it was almost sp lit half and half in terms of pharmacists likelihood of dispensing OTC to a person other than the ultimate consumer of the product such as parents or a boyfriend. When viewing intention to dispense by pr escription to varying groups of people, pharmacists were most likely to dispense to women who have experienced incest or rape (72.4%), followed by women who request the method after having unprotected sexual intercourse (71%), followed by women who have experienced a problem with their birth control method (68.4%), and la stly to sexually active te ens under age 18 (61.8%).

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159 Interestingly, a greater proportion of pharmacist s were likely to disp ense to all groups by prescription than OTC. It is important to note that some of the items that measure intention to dispense are not real-life examples as pharmacists may ne ver know if a woman is raped or not or if a woman has had unprotected inte rcourse or if her birth control method failed. However, a pharmacist would know if the pe rson requesting Plan B is a t eenager or if it is a person is a male. In addition, it is assumed that the consumer has had some sort of unprotected intercourse if they are reques ting the medication in the first place. That being said, the variable intention to dispense measures hypothetical bias of intention should pharmacists be privy to this information about the consumer.

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160Table 26. Categorical Classifications for Intention to Dispense Intention to Dispense Items Total population N (%) Likelihood of dispensing OTC to women who have experienced incest or rape Likely Unlikely N/A 193 (71.0)* 47 (17.3) 30 (11.0) Likelihood of dispensing OTC to women who have experienced a problem with their birth control method Likely Unlikely N/A 183 (67.3) 60 (22.1) 27 (9.9) Likelihood of dispensing OTC to women who request the method after having unprotected sexual intercourse Likely Unlikely N/A 180 (66.2) 65 (23.9) 24 (8.8) Likelihood of dispensing OTC to a person other than the ultimate consumer of the product such as parents or a boyfriend Likely Unlikely N/A 127 (46.7) 116 (42.6) 28 (10.3) Likelihood of dispensing by prescription to women who have experienced incest or rape Likely Unlikely N/A 197 (72.4) 43 (15.8) 31 (11.4) Likelihood of dispensing by prescription to women who have experienced a problem with their birth control method Likely Unlikely N/A 186 (68.4) 55 (20.2) 30 (11.0) Likelihood of dispensing by prescription to women who request the method after having unprotected sexual intercourse Likely Unlikely N/A 193 (71.0) 51 (18.8) 27 (9.9) Likelihood of dispensing by prescription to sexually active teens under age 18 Likely Unlikely N/A 168 (61.8) 72 (26.5) 30 (11.0) *Some percentages do not add to 100 because of rounding or missing data A composite score was developed from the 8 questions that measured intention to dispense Plan B such that each participant wa s given an intention score ranging from 4 to

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161 16. The mean, standard deviation, and range is provided in Ta ble 27 for this new continuous variable intention to dispense Plan B. On a scale of 4-16, the mean attitude score for participants was 12.70. The intenti on composite score had a normal distribution with a left skew meaning that there was a sk ew towards a greater intention or likelihood to dispense Plan B. Table 27. Univariate Statistics for Intention to Dispense Plan B Composite Variable Study Sample (N=272) Mean (SD) Range Skewness Intention Composite Variable 12.70 (4.12) 4-16 -1.199 Bivariate Analysis. Chi-square tests were used to estimate the associations between sociodemographic variables, demograp hic practice and training variables and the dichotomous dependent variable dispensing practices. Results for socio-demographic variables and dispensing are summarized in Tables 28-30 and results for practice and training variables and dispensing are summarized in Table 31. Overall, gender, ethnicity, political affiliation, religion, and religiosity we re not found to be significantly associated with dispensing of emergency contracepti on. The only socio-demographic variables associated with emergency contraception dispensing was pharmacist age, where younger pharmacists (under 36 years of age) were more likely to have ever dispensed emergency contraception as compared to older pharmaci sts and marital status, where individuals who have never been married and individuals w ho are living with thei r partner were more likely to have ever dispense d emergency contraception.

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162 Table 28. Chi Square Results of Ever Dispensed EC by Sociodemographic Variables Ever Dispensed EC Characteristic % Yes Chi – Square(df) Pattern of Finding (p value) Gender Female 56.7% 1.94(1) Not Significant (p=0.164) Male 65.1% Age, years < 36 74.7% 9.12(2)* Pharmacists under 36 years of age are more likely to have ever dispensed EC (p=0.010) 36-50 53.8% 51-87 56.8% Ethnicity White 59.1% 0.99(4) Not Significant (p=0.911) Black 70.6% Hispanic 62.1% Asian 63.2% Other 66.7% Marital status Married 59.4% 7.85(3)* Individuals who have never been married are more likely to have ever dispensed EC (p=0.049) Living with partner 70.0% Divorced/Separated/Widowed 45.2% Never been married 76.2% Political Affiliation Republican 58.0% 3.92(3) Not Significant (p=0.270) Democratic 56.1% Independent 61.7% None/undecided/other 72.9% Religion Christian 57.0% 6.44(5) Not Significant (p=0.265) Hindu 60.0% Buddhist 100.0% Jewish 68.4% Islamic 50.0% None 66.7% Religiosity Religious 50.0% 6.24(3) Not Significant (p=0.100) Spiritual 71.0% Religious and Spiritual 55.4% Undecided/ None of the above/ Prefer not to respond 63.2% *Indicates statistical significance at p<.05.

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163 Although future analysis will focus only on combined dispensing, Tables 34 and 35 provide a breakdown of socio-demographic variables by prescription and OTC. No socio-demographic variables were found to be associated with dispensing emergency contraception by prescription. For OTC di spensing, pharmacist age was significantly associated with dispensing emergency c ontraception where younger pharmacists (under 36 years old) were more likely to have dispensed emergency contraception OTC as compared to older pharmacists. This findi ng demonstrates that the association with dispensing and age is only significant for di spensing OTC. Marital status was no longer significant for either dispen sing by prescription or OTC.

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164 Table 29. Chi Square Results of Dispensing EC by Prescription by Sociodemographic Variables Ever Dispensed EC by Prescription Characteristic % Yes Chi –Square(df) Pattern of Finding (p value) Gender Female 44.8% 0.64(1) Not Significant (p=0.423) Male 49.6% Age, years < 36 58.3% 5.33(2) Not Significant (p=0.069) 36-50 42.6% 51-87 43.8% Ethnicity White 46.9% 2.78(4) Not Significant (p=0.595) Black 52.9% Hispanic 37.9% Asian 60.0% Other 55.6% Marital status Married 45.4% 3.86(3) Not Significant (p=0.276) Living with partner 50.0% Divorced/Separated/Widowed 40.6% Never been married 60.5% Political Affiliation Republican 40.8% 5.41(3) Not Significant (p=0.144) Democratic 45.6% Independent 51.1% None/undecided/other 60.4% Religion Christian 46.4% 2.61(5) Not Significant (p=0.759) Hindu 60.0% Buddhist 71.4% Jewish 47.4% Islamic 50.0% None 50.0% Religiosity Religious 39.5% 9.98(5) Not Significant (p=0.076) Spiritual 60.9% Religious and Spiritual 40.7% Undecided 46.2% None of the above 54.3% Prefer not to respond 33.3% *Indicates statistical significance at p<.05.

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165 Table 30. Chi Square Results of Dispensing EC OTC by Sociodemographic Variables Ever Dispensed EC OTC Characteristic % Yes Chi –Square(df) Pattern of Finding (p value) Gender Female 49.6% 1.2(1) Not Significant (p=0.273) Male 56.3% Age, years < 36 68.7% 12.26(2)* Pharmacists under 36 years of age were more likely to have ever dispensed EC OTC (p=0.002) 36-50 42.9% 51-87 50.0% Ethnicity White 51.1% 2.11(4) Not Significant (p=0.715) Black 64.7% Hispanic 55.2% Asian 57.9% Other 66.7% Marital status Married 52.8% 5.03(3) Not Significant (p=0.169) Living with partner 70.0% Divorced/Separated/Widowed 38.7% Never been married 61.9% Political Affiliation Republican 47.0% 6.56(3) Not Significant (p=0.087) Democratic 50.0% Independent 55.3% None/undecided/other 68.8% Religion Christian 49.7% 5.08(5) Not Significant (p=0.406) Hindu 50.0% Buddhist 83.3% Jewish 68.4% Islamic 50.0% None 58.3% Religiosity Religious 42.9% 2.94(5) Not Significant (p=0.710) Spiritual 58.0% Religious and Spiritual 51.8% Undecided 53.8% None of the above 58.8% Prefer not to respond 52.4% *Indicates statistical significance at p<.05.

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166 Results for practice and training variable s by dispensing are summarized in Table 31. The number of years a pharmacist is in practice, the type of pharmacy where employed, job title, and current employment stat us all were significantly associated with dispensing emergency contraception. No re lationship was found between dispensing and pharmacy school attended or year of gradua tion. Specifically, pharmacists with fewer years of practice, who were employed at a community-chain pharmacy, and part-time staff pharmacists were more likely to ha ve ever dispensed emergency contraception. These findings stayed consistent when these variables were analyzed separately by prescription and OTC.

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167 Table 31. Chi Square Results of Dispensing EC by Practice and Training Variables Ever Dispensed EC Characteristic % Yes Chi – Square(df) Pattern of Finding (p value) Years in Practice <9 72.4% 9.01(2)* Pharmacists with less years of practice were more likely to have ever dispensed EC (p=0.011) 9-22 59.1% 23+ 50.5% Type of Pharmacy where Employed Community—Chain 87.1% 94.93(3)* Pharmacists employed at a community-chain pharmacy are more likely to have ever dispensed EC (p<0.0001) Community—Independent 54.3% Hospital 26.4% Other (e. g. Home Infusion, Mail Order) 20.0% Job Title Staff Pharmacist 61.7% 16.14(2)* Staff pharmacists are more likely to have ever dispensed EC (p<0.0001) Pharmacy Manager 31.5% Other (e. g. Clinical Pharmacist) 6.8% Current Employment Status Full-time 87.7% 15.74(2)* Full-time pharmacists are more likely to have ever dispensed EC (p<0.0001) Part-time 12.3% Retired 0.0% Pharmacy School Attended** University of Florida 51.1% 78.09(82) Not Significant (p=0.602) Nova Southeastern University 62.5% Florida Agricultural & Mechanical University 83.3% Mercer University 60.0% Massachusetts College of Pharmacy 66.7% Year Graduated 1949-1982 54.0% 3.58(2) Not Significant (p=0.167) 1983-1998 60.0% 1999-2007 67.7% *Indicates statistical significance at p<.05. **Only certain data presented for this variable

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168 Bivariate associations were also expl ored between (a) knowledge and dispensing practices, (b) attitudes and dispensing pract ices, (c) subjective norms and dispensing practices, and (d) perceived behavioral cont rol and dispensing practices. Results are summarized in Tables 37-40. Bivariate analysis was computed for know ledge as an ordinal level variable on a scale of 0-10 with 0 representing low knowledge and 10 representing high knowledge and with knowledge as a categ orical variable with low knowledge representing scores from 0-3, average knowledge for those that answered between 47 knowledge questions correctly, and 8-10 were said to have hi gh knowledge. Kruskal-Wallis analysis of variance was computed for the ordinal level analysis and chi-square analyses were computed for the categorical level knowledge variable. Both categorizations of knowledge yielded significant results wher e knowledge about emergency contraception was found to be significantly related to havi ng ever dispensed it. Similarly significant results were found when dispensing practices were separated by prescription and OTC (Table 32). Table 32. Bivariate Results of Dispensing EC and Knowledge Ever Dispensed EC % Yes Chi – Square(df) Pattern of Finding (p value) Knowledge (ordinal level scale 0-10) n/a 69.48(10)* Significant (p<0.0001) Knowledge (categorical level) Low Knowledge 25.4% 49.58(2)* Significant (p<0.0001) Average Knowledge 64.3% High Knowledge 88.9% *Indicates statistical significance at p<.05. To test the associations between atti tudes about emergency contraception and dispensing practices, Kruskal-Wallis analysis of variance tests were computed for the

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169 ordinal level subjective norm questions and Pearson chi-squares were computed for the one categorical level question (see Table 33). The Kruskal-Wallis test can be used in bivariate analysis with an or dinal-level predictor variable and a nomin al level criterion variable. Table 33 reveals that attitudes a bout emergency contraception are significantly related to whether a pharmacist has ever di spensed emergency contraception, irrespective of whether it was dispensed by prescription or OTC. Because there was one question on the pharmacist survey measuri ng attitudes on a nominal leve l, a chi-square test of association was performed between this que stion and having ever dispended emergency contraception. The question asked if Plan B should be offered to women who are raped in all hospital emergency rooms, regardless of hospital affiliation. Pharmacists’ thoughts about whether Plan B should be offered to women in hospital emergency rooms was found to be significantly related to having ev er dispensed emergency contraception where pharmacists that answered that Plan B should be offered to women who are raped in all hospital emergency rooms were more likely to have ever dispensed emergency contraception than pharmacists who did not think that it should be offered. Table 33. Bivariate Results of Dispensing EC and Attitudes Ever Dispensed EC % Yes Chi – Square(df) Pattern of Finding (p value) Attitude Composite Variable n/a 37.56(14)* Significant (p=0.001) Should Plan B be Offered to Women who are Raped in Hospital Emergency Rooms? Yes No 64.3% 45.3% 6.39(1)* Significant (p=0.011) *Indicates statistical significance at p<.05. To test the associations between subj ective norms and dispensing practices, Kruskal-Wallis analysis of variance tests were computed for the ordinal level subjective

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170 norm questions and Pearson chi-squares were computed for categorical level questions (Table 34). Subjective norms or percei ved social pressures around dispensing of emergency contraception are significantly re lated to having ever dispensed it. In addition, whether there is an employee at their pharmacy who refuses to dispense emergency contraception and whether there is a policy in place at a pharmacists’ workplace if a refusal should occur are both signi ficantly related to having ever dispensed emergency contraception. Specifically, pharm acists were more likely to dispense the medication if there were no employees at their pharmacy who refuses to dispense emergency contraception. In addition, mo re pharmacists were likely to have ever dispensed emergency contraception if ther e was a policy in place should a pharmacist refuse to dispense the medication. Table 34. Bivariate Results of Dispensing EC and Subjective Norms Ever Dispensed EC % Yes Chi – Square(df) Pattern of Finding (p value) Subjective Norms Composite Variable n/a 40.23(10)* Significant (p<0.0001) Employee at Pharmacy who Refuses to Dispense EC Yes No 60.0% 77.1% 3.96(3)* Significant (p=0.046) Policy at Workplace if Refusal Occurs Yes No 88.8% 67.7% 11.85(3)* Significant (p=0.001) *Indicates statistical significance at p<.05. To test associations be tween dispensing emergency contraception and perceived behavioral control (how difficult or easy it is to dispense emergency contraception), Kruskal-Wallis analysis of variance was com puted (Table 35). Perceived behavioral control was significantly related to ever dispensing em ergency contraception. However, when dispensing was separated out, perceive d behavioral control was not found to be

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171 related to dispensing by prescr iption but stayed significant fo r dispensing OTC. It makes some intuitive sense that dispensing OTC w ould be related to pe rceived behavioral control as a pharmacist is more likely to ha ve control dispensing OTC when there is no prescription or patient doctor relationship in the way of dispen sing the medication. Table 35. Bivariate Results of Dispensing EC and Perceived Behavioral Control (PBC) Chi – Square(df) Pattern of Finding (p value) Perceived Behavioral Control (PBC) 23.54(11)* Significant (p=0.015) PBC By Prescription Only 18.34(11) Not Significant (p=0.074) PBC OTC Only 20.76(11)* Significant (p=0.036) *Indicates statistical significance at p<.05. To test associations between intention or likelihood to dispense and dispensing Plan B, Kruskal-Wallis analysis of varian ce was computed (Table 36). Intention to dispense Plan B was found to be signifi cantly related to ever dispensing Plan B by prescription or OTC. Findings stayed significant when individual analysis was performed for dispensing just by prescription or only OTC. Table 36. Bivariate Results of Intention to Dispense and Dispensing EC Chi – Square(df) Pattern of Finding (p value) Ever Dispensed EC by Prescription or OTC 50.49(12)* Significant (p<0.001) *Indicates statistical significance at p<.05. Multivariate Analysis. Question 3: What is the relationship among emergency contraception knowledge, attit udes, subjective norms, per ceived behavioral control, intention to dispense, and disp ensing practices of Florida pharmacists registered with the Board of Pharmacy? Question 3a: Is emergency contracepti on knowledge predictive of dispensing practices of Florida pharmacists?

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172 Question 3b: Are attitudes about emer gency contraception predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3c: Are subjective norms ab out emergency contraception (whether important people such as colleagues, s upervisors, corporate headquarters, and peers think they should dispense emergency contraception) predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3d: Is perceived behavioral contro l, the perceived ease or difficulty of dispensing emergency contraception, predic tive of dispensing practices of Florida pharmacists? Question 3e: Is intention to dispense emergency contraception predictive of dispensing practices of Florida pharmacists? Question 3f: Are emergency contrace ption knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense taken together, predictive of emergency contraception dispensing practices of Florida pharmacists? Six logistic regression mode ls were computed to directly answer the above research questions to detect (1) if knowledge is predictive of dispensing practices, (2) if attitudes are predictive of di spensing practices, (3) if subj ective norms are predictive of dispensing practices, (4) if perceived behavi oral control is pred ictive of dispensing practices, (5) if intention to dispense is pred ictive of dispensing practices, and (6) if all variables taken together are predictive of dispensing practices. The socio-demographic variables identified in Tables 33 and 36 to be statistically significant (p<0.05) (age,

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173 marital status, years in practice, type of pharmacy where employed, job title, and current employment status) acted as control vari ables in each of the regression models. Knowledge and Dispensing Practices: It was hypothesized that pharmacists with high levels of knowledge about emergency contraception would be more likely to dispense it (Table 37). To test this hypothesis, the depe ndent variable was regressed against the continuous variable knowledge (scale 0-10) while controlling for sociodemographic variables. Knowledge was found to be a significant predictor of having ever dispensed emergency contraception. Sp ecifically, for every one point increase in knowledge score, the odds of a pharmacist dispensing emergency contraception were increased by a factor of 1.7 (p< 0.001).

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174 Table 37. Logistic Regression Analysis fo r Knowledge and Dispensing Practices while Controlling for Socio-demographic Variables B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Knowledge .538 .102 27.760 1 p<0.001 1.713 1.402 2.093 Age, years 1.148 2 p<0.563 < 36 (ref group) 36-50 .095 .675 .020 1 p<0.888 1.100 .293 4.131 51-87 .827 .951 .756 1 p<0.385 2.287 .354 14.756 Marital status 7.404 3 p<0.060 Married (ref group) Living with partner .632 1.069 .350 1 p<0.554 1.881 .232 15.281 Divorced/Separated/Widowed -.479 .618 .600 1 p<0.438 .620 .185 2.079 Never been married 1.689 .682 6.139 1 p<0.013 5.414 1.423 20.593 Years in Practice .834 2 p<0.659 <9 (ref group) 9-22 .319 .647 .243 1 p<0.622 1.376 .387 4.890 23+ -.248 .897 .076 1 p<0.782 .780 .135 4.526 Type of Pharmacy Employed* 45.011 3 p<0.001 Community—Chain (ref group) Community—Independent -1.743 .548 10.130 1 p<0.001 .175 .060 .512 Hospital -3.121 .542 33.129 1 p<0.001 .044 .015 .128 Other (e. g. Home Infusion) -3.597 .662 29.555 1 p<0.001 .027 .007 .100 Job Title 4.972 2 p<0.083 Staff Pharmacist (ref group) Pharmacy Manager -1.092 .497 4.836 1 p<0.028 .335 .127 .888 Other (e. g. Clinical Pharmacist) -.144 .645 .050 1 p<0.823 .866 .244 3.067 Current Employment Status* 10.172 2 p<0.006 Full-time (ref group) Part-time -1.750 .549 10.172 1 p<0.001 .174 .059 .509 Retired -20.807 16947 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable

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175 The model was rerun limiting potential conf ounders to those with a p-value of 0.05 and there was a slight decrease in the OR for each level of increased knowledge (Table 38). Pharmacists who have never b een married were more likely to dispense emergency contraception as compared to marri ed individuals. Pharmacists working at a community independent, hospital, or other pharmacy were not as likely to dispense emergency contraception as compared to pharmacists who work at a community chain pharmacy. Pharmacy managers were not as likely to dispense emergency contraception as compared to staff pharmacists and part-tim e pharmacists were not as likely to dispense as compared to pharmacists who were employed full-time.

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176 Table 38. Logistic Regression Analysis fo r Knowledge and Dispensing Practices while Controlling for Marital Status, Type of P harmacy where Employed, Job Title, and Current Employment Status B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Knowledge .519 .096 29.302 1 p<0.001 1.680 1.392 2.027 Marital status 6.795 3 p<0.079 Married (ref group) Living with partner .532 1.069 .248 1 p<0.619 1.702 .210 13.822 Divorced/Separated/Widowed -.375 .572 .430 1 p<0.512 .687 .224 2.108 Never been married 1.445 .613 5.556 1 p<0.018 4.242 1.276 14.107 Type of Pharmacy where Employed* 44.690 3 p<0.001 Community—Chain (ref group) Community—Independent -1.62 .530 9.370 1 p<0.002 .197 .070 .558 Hospital -3.03 .522 33.817 1 p<0.001 .048 .017 .134 Other (e. g. Home Infusion, Mail Order) -3.24 .608 28.443 1 p<0.001 .039 .012 .129 Job Title* 10.630 2 p<0.005 Staff Pharmacist (ref group) Pharmacy Manager -1.63 .502 10.630 1 p<0.001 .195 .073 .521 Other (e. g. Clinical Pharmacist) -20.6 17037.97 .000 1 p<0.999 .000 .000 Current Employment Status 4.508 2 p<0.105 Full-time (ref group) Part-time -.997 .470 4.487 1 p<0.034 .369 .147 .928 Retired -.252 .616 .167 1 p<0.683 .777 .232 2.600 *Indicates statistical significance at p<.05 for the whole group variable Attitudes and Dispensing Practices: It was hypothesized that pharmacists with positive attitudes about emergency contraception w ould be more likely to dispense it. To test this hypothesis, the depe ndent variable was regressed ag ainst the continuous variable attitudes (scale 7-21) and one categoric al level question around attitudes while

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177 controlling for the socio-demographic control va riables (Table 39). Pharmacist attitudes about emergency contraception were found to be a significant predictor of having ever dispensed emergency contraception. Specifica lly, for every one point increase in attitude score, the odds of dispensing increased by 1.2 (p<0.001). The categorical question that measured attitudes that queried about if Plan B should be offered to women who are raped in hospital emergency rooms was not statistically significant.

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178 Table 39. Logistic Regression Analysis for Attit udes and Dispensing Practices while Controlling f or Socio-demographic Variables B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Attitudes .209 .056 14.025 1 p<0.001 1.233 1.105 1.376 Age, years .497 2 p<0.780 < 36 (ref group) 36-50 -.294 .621 .224 1 p<0.636 .745 .221 2.516 51-87 .085 .916 .009 1 p<0.926 1.089 .181 6.553 Marital status 5.353 3 p<0.148 Married (ref group) Living with partner -.657 .944 .485 1 p<0.486 .518 .081 3.297 Divorced/Separated/Widowed -.256 .608 .177 1 p<0.674 .774 .235 2.551 Never been married 1.295 .619 4.370 1 p<0.037 3.651 1.084 12.291 Years in Practice .339 2 p<0.844 <9 (ref group) 9-22 .180 .620 .084 1 p<0.772 1.197 .355 4.038 23+ -.192 .887 .047 1 p<0.829 .825 .145 4.700 Type of Pharmacy where Employed* 57.842 3 p<0.001 Community—Chain (ref group) Community—Independent -1.539 .531 8.399 1 p<0.004 .215 .076 .608 Hospital -3.627 .545 44.253 1 p<0.0001 .027 .009 .077 Other (e. g. Home Infusion) -4.280 .678 39.821 1 p<0.001 .014 .004 .052 Job Title 5.080 2 p<0.079 Staff Pharmacist (ref group) Pharmacy Manager* -1.096 .486 5.077 1 p<0.024 .334 .129 .867 Other (e. g. Clinical Pharmacist) -.340 .573 .352 1 p<0.553 .712 .231 2.189 Current Employment Status* 10.261 2 p<0.006 Full-time (ref group) Part-time -1.767 .552 10.261 1 p<0.001 .171 .058 .504 Retired -21.03 15894.85 .000 1 p<0.999 .000 .000

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179 Should Plan B be Offered to Women who are Raped in Hospital Emergency Rooms? .278 .539 .265 1 p<0.607 1.320 .459 3.800 *Indicates statistical significance at p<.05 for the whole group variable The model was rerun limiting potential conf ounders to those with a p-value of 0.05 and there was no change in the OR for attitudes (Table 40). Much like the knowledge variables, pharmacists who have ne ver been married were more likely to dispense emergency contraception as compar ed to married individuals. Pharmacists working at a community independent, hospital, or other pharmacy were not as likely to dispense emergency contraception as compared to pharmacists who work at a community chain pharmacy. Pharmacy managers were not as likely to dispense emergency contraception as compared to staff pharmacists and part-time pharmacists were not as likely to dispense as compared to ph armacists who were employed full-time.

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180 Table 40. Logistic Regression Analysis for Attit udes and Dispensing Practices while Controlling f or Marital Status, Type of Pharmacy where Employed, Job Title, and Current Employment Status B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Attitudes .208 .051 17.003 1 p<0.001 1.232 1.116 1.360 Marital status 5.981 3 p<0.113 Married (ref group) Living with partner -.596 .932 .409 1 p<0.523 .551 .089 3.423 Divorced/Separated/Widowed -.299 .567 .277 1 p<0.599 .742 .244 2.254 Never been married 1.234 .564 4.783 1 p<0.029 3.435 1.137 10.381 Type of Pharmacy where Employed* 59.698 3 p<0.001 Community—Chain (ref group) Community—Independent -1.43 .511 7.844 1 p<0.005 .239 .088 .651 Hospital -3.49 .514 46.279 1 p<0.001 .030 .011 .083 Other (e. g. Home Infusion, Mail Order) -3.92 .620 40.050 1 p<0.001 .020 .006 .067 Job Title 3.666 2 p<0.160 Staff Pharmacist (ref group) Pharmacy Manager -.861 .452 3.621 1 p<0.057 .423 .174 1.026 Other (e. g. Clinical Pharmacist) -.369 .555 .442 1 p<0.506 .691 .233 2.053 Current Employment Status* 12.514 2 p<0.002 Full-time (ref group) Part-time -1.75 .497 12.514 1 p<0.001 .172 .065 .456 Retired -21.0 16126.07 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable Subjective Norms and Dispensing Practices : It was hypothesized that pharmacists who have influential people in their life who think they should dispense emergency contraception would be more likely to dispense it. To test this hypothesis, the dependent variable was regressed against the continuous variable subjective norms (scale 4-16) and

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181 two categorical level questions around subj ective norms while controlling for the sociodemographic control variables (Table 41). The variable subjective norms was found to be a significant pr edictor of having ever dispen sed emergency contraception. Specifically, for every one point increase in subjective norms or important people thinking they should dispense emergency contraception, the odds of dispensing emergency contraception increased by 1.3 (p<0.018). Neither of the two categorical questions measuring subjectiv e norms was significant. Table 41. Logistic Regression Analysis for S ubjective Norms and Dispensing Practices while Controlling for Socio-demographic Variables B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Subjective Norms Total Score .321 .136 5.580 1 p<0.018 1.379 1.056 1.801 Age, years .936 2 p<0.626 < 36 (ref group) 36-50 -.472 .789 .358 1 p<0.549 .624 .133 2.926 51-87 .251 1.084 .053 1 p<0.817 1.285 .153 10.762 Marital status 4.870 3 p<0.182 Married (ref group) Living with partner .776 1.309 .352 1 p<0.553 2.174 .167 28.280 Divorced/Separated/Widowed 1.733 1.121 2.387 1 p<0.122 5.655 .628 50.923 Never been married 1.715 .938 3.342 1 p<0.068 5.555 .884 34.924 Years in Practice .751 2 p<0.687 <9 (ref group) 9-22 .442 .762 .337 1 p<0.561 1.556 .350 6.923 23+ -.233 1.042 .050 1 p<0.823 .792 .103 6.104 Type of Pharmacy where Employed* 10.449 3 p<0.015 Community—Chain (ref group) Community—Independent -.997 .712 1.957 1 p<0.162 .369 .091 1.491

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182 Hospital -1.90 .758 6.329 1 p<0.012 .148 .034 .656 Other (e. g. Home Infusion, Mail Order) -2.81 1.061 7.020 1 p<0.008 .060 .008 .481 Job Title 2.721 2 p<0.257 Staff Pharmacist (ref group) Pharmacy Manager -1.04 .648 2.575 1 p<0.109 .354 .099 1.259 Other (e. g. Clinical Pharmacist) -.705 .853 .684 1 p<0.408 .494 .093 2.628 Current Employment Status* 7.089 2 p<0.029 Full-time (ref group) Part-time -1.56 .588 7.089 1 p<0.008 .209 .066 .662 Retired -21.0 28301.60 .000 1 p<0.999 .000 .000 Is there anyone in your pharmacy who refuses to dispense EC? -.217 .797 .074 1 p<0.785 .805 .169 3.839 Is there a policy in place at your pharmacy if someone refuses to dispense EC? -.907 .609 2.213 1 p<0.137 .404 .122 1.334 *Indicates statistical significance at p<.05 for the whole group variable The model was rerun limiting potential conf ounders to those with a p-value of 0.05 and there was a very slight decrease in th e OR for subjective norms (Table 42). In addition, pharmacists working at a community independent, hospital, or other pharmacy were not as likely to dispen se emergency contraception as compared to pharmacists who work at a community chain pharmacy. Part -time pharmacists were not as likely to dispense as compared to pharmaci sts who were employed full-time.

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183 Table 42. Logistic Regression Analysis for Subjective Norms and Dispensing Practices while Controlling for Type of Pharmacy where Employed and Current Employment Status B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Subjective Norms Total Score .287 .081 12.658 1 p<0.001 1.332 1.137 1.560 Type of Pharmacy where Employed* 39.024 3 p<0.001 Community—Chain (ref group) Community—Independent -1.11 .559 3.971 1 p<0.046 .329 .110 .982 Hospital -2.66 .502 28.076 1 p<0.001 .070 .026 .187 Other (e. g. Home Infusion, Mail Order) -2.96 .603 24.120 1 p<0.001 .052 .016 .168 Current Employment Status* 9.438 2 p<0.009 Full-time (ref group) Part-time -1.52 .495 9.438 1 p<0.002 .218 .083 .577 Retired -20.3 28378.23 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable Perceived Behavioral Control and Dispen sing Practices: It was hypothesized that pharmacists that find that it is easy to disp ense emergency contraception will be more likely to dispense it. To test this hypothesi s, the dependent variable was regressed against the continuous variable that measured pe rceived behavioral while controlling for the socio-demographic control variables (Table 43). The variable perceived behavioral control was found to be a significant pred ictor of having ever dispensed emergency contraception. Specifically, for every one point increase in perceive d behavioral control or perceived ease in dispensing Plan B, the odds of dispensing it increased by 1.1 (p<0.022).

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184 Table 43. Logistic Regression Analysis for P erceived Behavioral Control (PBC) and Dispensing Practices while Controlling for Socio-demographic Variables B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper PBC Total Score .160 .070 5.212 1 p<0.022 1.173 1.023 1.346 Age, years .098 2 p<0.952 < 36 (ref group) 36-50 -.207 .685 .091 1 p<0.763 .813 .212 3.114 51-87 -.122 .907 .018 1 p<0.893 .885 .150 5.233 Marital status 3.343 3 p<0.342 Married (ref group) Living with partner 1.128 1.275 .782 1 p<0.376 3.089 .254 37.626 Divorced/Separated/Widowed .062 .639 .010 1 p<0.922 1.064 .304 3.723 Never been married 1.066 .636 2.812 1 p<0.094 2.903 .835 10.091 Years in Practice .344 2 p<0.842 <9 (ref group) 9-22 .382 .661 .334 1 p<0.563 1.466 .401 5.354 23+ .382 .875 .190 1 p<0.663 1.464 .263 8.140 Type of Pharmacy Employed* 37.170 3 p<0.001 Community—Chain (ref group) Community—Independent -1.78 .547 10.677 1 p<0.001 .167 .057 .489 Hospital -2.87 .551 27.137 1 p<0.001 .057 .019 .167 Other (e. g. Home Infusion, Mail Order) -3.12 .649 23.223 1 p<0.001 .044 .012 .156 Job Title 5.548 2 p<0.062 Staff Pharmacist (ref group) Pharmacy Manager -1.10 .490 5.105 1 p<0.024 .331 .127 .864 Other (e. g. Clinical Pharmacist) -.805 .585 1.892 1 p<0.169 .447 .142 1.408 Current Employment Status* 9.850 2 p<0.007 Full-time (ref group) Part-time -1.78 .570 9.850 1 p<0.002 .167 .055 .511 Retired -21.3 23058.79 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable

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185 Type of pharmacy where employed, job title and current employment status were the only socio-demographic variables that we re significant and th erefore a logistic regression with only these variab les were computed to find if there were any significant associations present (Table 44). Pharm acists working at a community independent, hospital, or other pharmacy we re not as likely to dispense emergency contraception as compared to pharmacists who work at a community chain pharmacy. Pharmacy managers were not as likely to dispense em ergency contraception as compared to staff pharmacists and part-time pharmacists were not as likely to dispense as compared to pharmacists who were employed full-time. Table 44. Logistic Regression Analysis for P erceived Behavioral Control (PBC) and Dispensing Practices while Controlling for Type of P harmacy where Employed, Job Title, and Current Employment Status B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper PBC Total Score .161 .066 6.017 1 p<0.014 1.175 1.033 1.337 Type of Pharmacy where Employed* 37.918 3 p<0.001 Community—Chain (ref group) Community—Independent -1.70 .519 10.751 1 p<0.001 .182 .066 .504 Hospital -2.79 .524 28.428 1 p<0.001 .061 .022 .171 Other (e. g. Home Infusion) -2.81 .581 23.510 1 p<0.001 .060 .019 .187 Job Title* 6.653 2 p<0.036 Staff Pharmacist (ref group) Pharmacy Manager -1.12 .466 5.774 1 p<0.016 .326 .131 .814 Other -.982 .561 3.061 1 p<0.080 .374 .125 1.125 Current Employment Status* 12.125 2 p<0.002 Full-time (ref group) Part-time -1.87 .537 12.125 1 p<0.001 .154 .054 .442 Retired -21.2 2268 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable

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186 Intention to Dispense and Dispensing Practices: It was hypothesized that pharmacists that have a greater intention to dispense emergency contraception will in fact be more likely to dispense it. To test this hypothesis, the dependent variable was regressed against each of the eight questions th at measured intention to dispense (Table 45). For every one increment increase in intent ion to dispense or likelihood to dispense Plan B, the odds of dispensing increased by 1.2 (p<0.001). Table 45. Logistic Regression Analysis for Intention to Dispense Plan B and Dispensing Practices while Controlling for Socio-demographic Variables B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Intention to Dispense Plan B .249 .053 22.333 1 p<0.001 1.283 1.157 1.423 Age, years .472 2 p<0.790 < 36 (ref group) 36-50 -.248 .705 .124 1 p<0.725 .780 .196 3.108 51-87 .181 .978 .034 1 p<0.853 1.199 .176 8.146 Marital status 4.379 3 p<0.223 Married (ref group) Living with partner -.248 1.028 .058 1 p<0.809 .780 .104 5.845 Divorced/Separated/Widowed -.708 .634 1.244 1 p<0.265 .493 .142 1.708 Never been married 1.037 .651 2.539 1 p<0.111 2.820 .788 10.095 Years in Practice .111 2 p<0.946 <9 (ref group) 9-22 .117 .717 .027 1 p<0.870 1.124 .276 4.584 23+ -.105 .941 .012 1 p<0.911 .900 .143 5.690 Type of Pharmacy where Employed* 43.056 3 p<0.001 Community—Chain (ref group) Community—Independent -1.09 .575 3.604 1 p<0.058 .335 .109 1.036 Hospital -3.28 .576 32.470 1 p<0.001 .037 .012 .116

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187 Other (e. g. Home Infusion, Mail Order) -3.53 .676 27.250 1 p<0.001 .029 .008 .110 Job Title 1.459 2 p<0.482 Staff Pharmacist (ref group) Pharmacy Manager -.440 .508 .750 1 p<0.386 .644 .238 1.743 Other (e. g. Clinical Pharmacist) -.654 .626 1.092 1 p<0.296 .520 .153 1.772 Current Employment Status* 7.586 2 p<0.023 Full-time (ref group) Part-time -1.58 .575 7.586 1 p<0.006 .205 .066 .633 Retired -20.6 18155.73 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable In the analysis between intention to disp ense Plan B and ever dispensing, type of pharmacy where employed and current employ ment status were the only two sociodemographic variables that were significant a nd therefore a logistic regression with only these variables was computed to find if ther e were any significant associations present (Table 46). For intention to dispense Plan B, pharmacists working at a community independent, hospital, or other pharmacy we re not as likely to dispense emergency contraception as compared to pharmacists who work at a community chain pharmacy. In addition, part-time pharmacists were not as likel y to dispense as compared to pharmacists who were employed full-time.

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188 Table 46. Logistic Regression Analysis for Intention to Dispense Plan B and Dispensing Practices while Controlling for Type of P harmacy where Employed and Current Employment Status B S.E. Wald df Sig. OR 95.0% C.I.for OR Lower Upper Intention to Dispense Plan B .251 .049 26.417 1 p<0.001 1.285 1.168 1.414 Type of Pharmacy where Employed* 53.300 3 p<0.001 Community—Chain (ref group) Community—Independent -1.11 .533 4.347 1 p<0.037 .329 .116 .936 Hospital -3.17 .512 38.493 1 p<0.001 .042 .015 .114 Other (e. g. Home Infusion) -3.50 .590 35.254 1 p<0.001 .030 .009 .096 Current Employment Status* 7.563 2 p<0.023 Full-time (ref group) Part-time -1.36 .494 7.563 1 p<0.006 .257 .097 .677 Retired -21.3 17382 .000 1 p<0.999 .000 .000 *Indicates statistical significance at p<.05 for the whole group variable Final Model All variables in model together and disp ensing practices: Even after controlling for all predictor and potentially confounding variables, knowledge, intention or likelihood to dispense Plan B, marital status, type of pharmacy where employed, and employment status still maintained a statistically signifi cant relationship with ever dispensing Plan B (Table 47). Specifically, for every one incr ement increase in knowle dge score, the odds of dispensing increased by 1.7. Likewise, fo r every one unit increase in intention to dispense or likelihood to dispense Plan B, the odds of dispensing increased by 1.1. For marital status, pharmacists who have never been married were more likely to have ever dispensed Plan B as compared to marriage pharmacists. Pharmacists working at a hospital or other type of pharmacy were less likely to have ever dispensed Plan B as

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189 compared to pharmacists working at a co mmunity chain pharmacy and pharmacists working full-time were more likely to have ever dispensed Plan B as compared to pharmacists working part-time. No statis tical significance was found for attitudes, subjective norms, perceived behavioral control, intention to dispense by prescription, age, years in practice, or job title when all the variables were in the model together. Multicollinearity or the linear relations hips between explanatory variables was determined through a tolerance computation (T able 47). Since all tolerances for the predictor variables were high, there is no probl em with multicollineari ty in this study. This finding means that the relationship between the predictor variables and the dependent variable, ever-dispe nsed, are direct and therefor e, strong linear dependencies are not seen among the independent variables. In order to better understand and offer a co mplete picture for the last research question and model, (Question 3f: Are emer gency contraception knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense taken together, predictive of emergency contraception dispensi ng practices of Florid a pharmacists?), it was necessary to take a few components into consideration, 1) th e logistic regression analysis with all variables in the model (Table 47), 2) a goodness of fit test, and 3) a likelihood ratio test. Together, these elements can aid in understandi ng the relative fit of the final model. The Hosmer and Lemeshow goodness of fit test demonstrated a nonsignificant relationship between the pred ictor variables (C hi-square 5.91, p=0.658), which suggests that the variables are fitting the model. In addition, the likelihood ratio test was significant (Chi-square 129.70, p<0.001, also signifying that the variables are fitting the model. These three components suggest that overall the variables are fitting

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190 the model and that all predictor variables take n together are associat ed with dispensing practices of Florida pharmacists. Table 47. Logistic Regression Anal ysis for All Variables in Model Wald Sig. OR 95.0% C.I.for OR Main Research Variables Lower Upper Tolerance Knowledge 13.89 p<0.001 1.745 1.302 2.338 .770 Attitudes 0 p<0.993 0.999 0.837 1.193 .592 Subjective Norms 0.911 p<0.340 1.16 0.855 1.574 .642 Perceived Behavioral Control 0.155 p<0.694 1.039 0.858 1.259 .780 Intention to Dispense Plan B 4.4 p<0.036 1.192 1.012 1.404 .554 Confounders Age, years .323 < 36 (ref group) 0.983 p<0.612 36-50 0.954 p<0.329 2.543 0.391 16.55 51-87 0.637 p<0.425 2.958 0.206 42.393 Marital status 5.181 p<0.159 .885 Married (ref group) Living with partner 0.475 p<0.490 2.767 0.153 49.939 Divorced/Separated/Widow 0.282 p<0.596 1.727 0.229 13.01 Never been married 4.889 p<0.027 10.574 1.307 85.535 Years in Practice 0.294 p<0.863 .318 <9 (ref group) 10-22 0.105 p<0.746 1.35 0.22 8.27 23+ 0.018 p<0.892 0.845 0.075 9.581 Type of Pharmacy where Employed* 12.803 p<0.005 .703 Community—Chain (ref group) Community—Independent 0.997 p<0.318 0.456 0.098 2.129 Hospital 9.313 p<0.002 0.075 0.014 0.395 Other (e. g. Home Infusion) 7.602 p<0.006 0.068 0.01 0.46 Job Title 2.128 p<0.345 .791 Staff Pharmacist (ref group) Pharmacy Manager 1.113 p<0.291 0.491 0.131 1.84 Other (e. g. Clinical Pharmacist) 1.588 p<0.208 0.31 0.05 1.914 Current Employment Status* 6.187 p<0.045 .800 Full-time (ref group) Part-time 6.187 p<0.013 0.17 0.042 0.686 Retired 0 p<1.000 0 0 *Indicates statistical significance at p<.05 for the whole group variable

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191 Table 48. Summary Table of Main Findings Main Variables Crude OR OR for Single Predictor Model* OR with All Predictors in Model* Knowledge 1.57 (1.38, 1.78) 1.68 (1.39, 2.02) 1.74 (1.30, 2.33) Attitudes 1.12 (1.05, 1.19) 1.23 (1.11, 1.36) 0.99 (0.83, 1.19) Subjective Norms 1.42 (1.24, 1.63) 1.33 (1.13, 1.56) 1.16 (0.85, 1.57) Perceived Behavioral Control 1.19 (1.07, 1.32) 1.17 (1.03, 1.33) 1.03 (0.85, 1.25) Intention to Dispense 1.24 (1.15, 1.33) 1.28 (1.16, 1.41) 1.19 (1.01, 1.40) *Model is adjusted for confounders Summary of Results Table 48 provides a summary of the main findings in this study. It includes the crude ORs for each main predictor variable, the ORs for the single predictor model while controlling for confounder variables, and the OR s for the final model with all predictors in the model while controlli ng for confounder variables. In the end, knowledge about emergency contraception was the most important predictor of ever having dispensed emergenc y contraception. After knowledge, intention to dispense was the second most important predictor of having ever dispensed the medication. Although attitudes, subjective norms, and perceived behavioral control were statistically significant in each of their own single predictor models, they failed to reach statistical significance in the full model.

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192 The following confounder variables were c onsistently significant in every single predictor model and the full model: type of pharmacy where employed and current employment status. For type of pharm acy, pharmacists working at a community independent, hospital, or other pharmacy we re not as likely to dispense emergency contraception as compared to pharmacists w ho worked a at community chain pharmacy. For employment status, part-time pharmacists we re not as likely to dispense as compared to pharmacists who were employed full-time. Although marital status was not significant for all models, it was significant for the single predictor models for knowledge a nd attitudes and was also significant in the final model where never married individuals were much more likely to dispense as compared to married individuals. The la st confounding variable job title, was not significant in the full model but was signifi cant for the single predictor models for knowledge, attitudes, and perc eived behavioral control wh ere pharmacy managers were not as likely to dispense emergency contra ception as compared to staff pharmacists. Additional Analyses Table 49. Summary Table of Two Knowledge Items Main Variables Crude OR OR for Single Predictor Model* OR with All Predictors in Model* Plan B can cause birth defects if taken by a pregnant woman 1.76 (1.06, 2.91) 2.25 (1.10, 4.61) 1.44 (0.66, 3.12) Plan B can act as an abortifacient 3.83 (2.28, 6.44) 5.17 (2.47, 10.8) 4.64 (2.15, 10.0) *Model is adjusted for confounders Because discussion in the focus groups centered around two key issues: side effects resulting from plan B and the pot ential for Plan B to induce and abortion,

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193 independent associations were computed for the two knowledge questions addressing these issues: whether or not pharmacists thought that Plan B could cause birth defects if taken by a pregnant woman a nd whether or not they t hought Plan B acted as an abortifacient. Table 49 includes the crude ORs for each item, the ORs for the single predictor model while control ling for confounder variables, a nd the ORs for a model with both items in the model while cont rolling for confounder variables. Understanding that Plan B does not caus e an abortion was the most important predictor of ever having disp ensed it. Although both items we re statistically significant in each of their own single predictor models thinking Plan B causes birth defects failed to reach statistical significance in the full mode l. Since the OR is so high for pharmacists who thought that Plan B can cause an aborti on, this item may be causing much of the association between knowledge and dispensi ng practices which has implications for future research and intervention efforts.

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194 Chapter Five: Discussion and Conclusions Section I: Synthesis of Research Findings Chapter five has been partitioned into th ree distinct sections. Section I provides a synthesis of research findings for each of the three major research questions and methods, key findings and conclusions for the study as a whole, and study limitations and strengths. Section II discusses the holisti c perspective that this study captures and Section III provides broader conclusions and im plications for public health as well as future direction for res earch, policy, and practice. Research Question 1: Pharmacy School Curriculum Review Question 1: What do the 91 accredited schools of pharmacy in the U.S. teach about emergency contraception? Question 1a: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are provided in the required courses at the 91 accredited schools of pharmacy in the U.S.? Question 1b: What objectives, course assi gnments, course readings, and lectures concerning emergency contraception are provided in the elective courses at the 91 accredited schools of pharmacy in the U.S.? The findings from the pharmacy school curr iculum review were as expected in that the majority of accredite d schools of pharmacy in the U. S. reported that they do offer required courses that provide content on emer gency contraception. A much smaller

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195 percentage reported offering elective courses that provide th is content. All (100%) respondents reported that pharmacy schools in the U.S. should include content material on emergency contraception, however not all re spondents reported doing so in their own schools. Participants in the curricula review repor ted that the majority of courses that provide content on emergency contracepti on are taught in pharmacotherapy and therapeutics courses. This finding was subs tantiated by data collected from the focus group discussions. Understanding which cour ses teach emergency contraception content to pharmacy students is important in terms of future educational and intervention efforts. Although the curriculum review survey as ked respondents to attach syllabi that included content on emergency contraception, ma ny did not. Only 10 syllabi (or 14% of the sample) were retrieved across seven school s who reported that they provide course content on emergency contraception in their classes. Even among the limited retrieved syllabi, only four of the ten syllabi overtly mentioned emergency contraception in any of the content areas. In sum, important findings from the pharmacy school curriculum review included the following: 1) that accredited schools of pharmacy in the U.S. report teaching about emergency contraception in their pharmacy school classes, 2) that th is content is taught primarily in required pharmacotherapy and therapeutics courses, and 3) not enough participants included syllabi in the review a nd the information that was detected from the limited course syllabi was not helpful.

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196 Research Question 2: Pharmacy Student Focus Groups Question 2: How is emergency contraception course content taught at accredited schools of pharmacy, as perceived by fourth year pharmacy students at the four accredited schools of pharmacy in Florida? Question 2a: What did pharmacy students l earn about emergency contraception in their pharmacy school classes? Question 2b: How was emergency contrace ption taught in their pharmacy school classes? Question 2c: What are the projected emergency contraception dispensing practices of pharmacy students? The pharmacy student focus groups uncove red rich information on the knowledge pharmacy students reported learning about em ergency contraception from their pharmacy school classes, the teaching instruction from these classes, and the projected future dispensing practices of pharmacy students. Each focus group included an initial paper and pencil survey and a focus group discussion. The paper and pencil survey revealed that although 90.5% of students responded that they did learn about emergency contraception in their pharm D classes, still over half (52.3%) of partic ipants were either not sure or believed that pharmacists were not well enough informed to confidently dispense emergency contraception and nearly 20% answered either th at they would not or that th ey were not sure about their future dispensing of the medication. In a ddition, most students reported that there was more information they wished they had rece ived about emergency contraception. These findings alone demonstrate that what is taugh t in pharmacy school classes is perceived as

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197 insufficient in providing pharmacists with the tools to confidently dispense emergency contraception. The focus group discussions revealed an important discrepancy or disconnect between what students reporte d on their paper and pencil surv ey and what they reported in the focus group discussions. Although the majo rity of students reported that they did learn about emergency contraception in th eir pharmacy school classes on the paper and pencil survey, the focus group discussions rev ealed the exact opposite; that for the most part, students did not learn about emergenc y contraception in their pharmacy school classes. In the focus group discussions, st udents reported that they received information on emergency contraception from outside sources such as work, print media, internet, news, and friends. This discrepancy between what the students reported on the paper and pencil survey and what was reported in the focus group discussions is noteworthy. This finding may be related to social-desirability bi as and will be discussed in detail later in this section. Another important finding from the fo cus group discussions is that specific knowledge was not reported by the majority of the students. Knowledge from pharmacy school classes was disparate and only students in one of the focus groups seemed to understand the three mechanisms of action of emergency contraception. In terms of teaching instruction in pharmacy school classes, most students responded that the professor attitude was ne utral. A neutral at titude seems like the desirable answer yet most likely unachieva ble. Although professors are supposed to maintain a neutral attitude in class, student s may be aware of their professor’s views on a given topic, especially a topic as contr oversial as emergency contraception.

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198 Questions around dispensing pr actices of pharmacists by far yielded the most discussion and many unexpected themes emerge d from these discussions. In terms of emergency contraception dispensing, particip ants held major biases and judgments depending on the situation of the person purch asing the contraception. Participants were hesitant to dispense due to many issues in cluding: hesitancy due to 1) mechanism of action, 2) repeat use, 3) age requirement, 4) the situation of a part icular woman, 5) side effects, and 6) believing it is wrong. These biases could have a direct impact on access to this form of contraception. The focus group discussions revealed tw o other important and surprising findings: 1) that refusals to dispense this medica tion are common and 2) that pharmacists feel a duty to educate about this medication ev en though it is not a pharmacist-counseled product. In the litera ture review, refusals to dispense seemed isolated; however within only four focus groups, unsolicited stories of re fusals were present in each discussion. This finding is alarming and indicates that un covering the true prevalence of refusals is critical. In addition, students reported a strong desire to educate and counsel consumers about emergency contraception even though th ere is no legal need to do so. Future research could focus on whether or not c onsumers want counseling/education from pharmacists if it is not warranted. Also, perh aps there could be an important role for pharmacists in providing accurate informa tion to consumers who request it. In sum, the focus group discussions with pharmacy students were revealing: First, much of what pharmacy students learn about emergency contraception does not come from their pharmacy school classes but come s from outside sources. Second, what is taught in pharmacy school classes about emer gency contraception is brief and over half

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199 of the sample felt that pharmacists are not well enough informed to confidently dispense emergency contraception. Third, student knowledge about emergency contraception was not specific. Fourth, many students entere d the focus group with a preconceived notion about people who use emergency contraceptio n and would hesitate to dispense the medication. Fifth, many participants held biases or judgments towards emergency contraception users which may limit access. Si xth, participants feel a need to counsel consumers about a medication that is not a pharmacy-counseled product. And last, refusing to dispense emergency contraception is real and has the pot ential to limit access to women in need. Research Question 3: StateWide Pharmacist Survey Question 3: What is the relationship among emergency contraception knowledge, attitudes, subjective norms, perceived behavi oral control, intention to dispense, and dispensing practices of Florida pharmacists registered with the Board of Pharmacy? Question 3a: Is emergency contracepti on knowledge predictive of dispensing practices of Florida pharmacists? Question 3b: Are attitudes about emer gency contraception predictive of emergency contraception dispensing pr actices of Florida pharmacists? Question 3c: Are subjective norms ab out emergency contraception (whether important people such as colleagues, s upervisors, corporate headquarters, and peers think they should dispense emergency contraception) predictive of emergency contraception dispensing pr actices of Florida pharmacists?

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200 Question 3d: Is perceived behavioral contro l, the perceived ease or difficulty of dispensing emergency contraception, predic tive of dispensing practices of Florida pharmacists? Question 3e: Is intention to dispense emergency contraception predictive of dispensing practices of Florida pharmacists? Question 3f: Are emergency contrace ption knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense taken together, predictive of emergency contraception dispensing practices of Florida pharmacists? Of all the independent variables, kno wledge about Plan B had the strongest relationship to dispensing Plan B. Speci fically, for every one point increase in knowledge score, the odds of a pharmacist di spensing Plan B were increased by a factor of 1.69 (p<0.001). Pharmacists had low leve ls of knowledge about understanding Plan B’s true mechanism of action, limited awarene ss of who can sell Plan B to consumers and how to sell OTC to women in advance of n eed, and the relationship between Plan B and birth defects. These areas of low knowledge are of concern and s hould be addressed. Pharmacist attitudes about Plan B were found to be a signif icant predictor of having ever dispensed it. Specifically, for every one point increas e in more positive attitudes about Plan B, the odds of disp ensing increased by 1.23 (p<0.001). Although the sample had a slight skew towards more fa vorable attitudes about the medication, many pharmacists felt uncomfortable dispensing to di fferent groups of people. For example, a third of the sample felt uncomfortable dispensing to adult women, 58.5% felt uncomfortable dispensing to men, and 61.4% felt uncomfortable dispensing to

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201 adolescents. The variation in comfort di spensing Plan B based on the person requesting the medication found in the state-wide survey is similar to the hesita ncy in dispensing the medication based on person found in the focus group discussions. The variables subjective norms and perceive d behavioral control were found to be significant predictors of having ever dispensed Plan B (1.33, p<0.001 and 1.17 p<0.014 respectively). Interestingly, pha rmacists were less likely to dispense Plan B when there is an employee at their pharmacy who refuses to dispense it. Additionally, pharmacists were more likely to have ever dispensed Plan B if the pharmacy in which they work had a policy in place regarding what to do if a refusal should occur. These two findings together demonstrate that both policy and pharmacy culture are associated with dispensing practices and potentially access to care. Understanding this has major implications for the development of intervention strategies. Intention or likelihood to di spense Plan B varied by the consumer requesting the medication. For every one increment increase in intention to dispense or likelihood to dispense Plan B, the odds of dispensing increased by 1.28 (p<0.001). In general, a greater percentage of pharm acists reported being likely to dispense to women who have experienced incest or rape, followed by wome n who have experienced a problem with their birth control method, followed by wo men who request the method after having unprotected sexual intercourse followed by dispensing (by prescription) to sexually active teens under age 18, and last to a pers on other than the ultimate consumer of the product such as parents or a boyfriend. In fact almost half of pharm acists reported that they were unlikely to dispense to a person other than the ultimate consumer of the

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202 product such as parents or a boyfriend. This finding is problematic in that any person over 18 can purchase Plan B OTC. Overall, the state-wide pharmacist su rvey was conclusive in finding that knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense are all predictive of dispensing Plan B among Florida pharmacists. Although each single predictor model tells a story, when all variables were in the model together, knowledge about emergency contraception was the most important predictor of ever having dispensed it. After knowledge, inte ntion to dispense was the second most important predictor of having ever disp ensed the medication. Although attitudes, subjective norms, and perceived behavioral c ontrol were statistically significant in each of their own single predictor models, they faile d to reach statistical significance in the full model. Key Findings/Conclusions for Entire Study When viewing the study in totality, there are five main findings that should be highlighted. The first main finding from the st udy as a whole is that there is a disconnect between what pharmacy schools say they are teaching and what pharmacy students report learning in their pharmacy school classes. Ho wever, the true dynamic of this discrepancy is not known. For instance, are pharmacy sc hools teaching the conten t and the students are not retaining the information or are pharmacy schools not effectively teaching the information to students? The second major finding that was found in both the focus groups and the pharmacist survey is that soon-to-be pharm acists and already practicing pharmacists report to be more or less likely to dispense Plan B based on the situation of the person

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203 requesting the medication. This finding demo nstrates that pharmacists are potentially allowing personal values or judgments to gui de their practice through making dispensing decisions based on the consumer purchasing it. These reported biases and the hesitancies in dispensing are troubling. The third important finding that was also mentioned above is that pharmacist knowledge, attitudes, subjective norms, perceived behavioral control, and intention to dispense all are predic tive of having ever dispensed Plan B. Specifically, high levels of knowledge, positive attitudes, an increased pe rception of important people thinking they should dispense, perceived ease of dispensi ng, as well as an in creased likelihood to dispense all increase the odds that a pharmacist has ever dispensed Plan B. However, high levels of knowledge had the greatest odds of ever dispensing Plan B. It is of concern that pharmacists had limited knowledge in some critical areas such as how to dispense Plan B OTC and comprehensi on of its true mechanism of action. Viewing these three findings simultane ously, that low knowledge and decreased intention to dispense (due to the situation of the consumer) of pha rmacists equates to less dispensing, that pharmacy students perception is that they are not learning about the medication in their pharmacy school classes, and that there are major biases and hesitancy about dispensing to varying groups of people, provides evidence of a major problem that has the potential to limit access of emergency contraception to the women who need it. A fourth key finding that should be discusse d is social desirab ility response bias. This type of bias is typically seen when surveys employ threatening or sensitive questions which can lead respondents to change their re sponses to appear socially or politically

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204 correct or more agreeable (Van de Mortel 2008). Social desirability response may be occurring in all three compone nts of this research. For example, in the focus group discussions students responded that they did receive information on emergency contraception in their pharmacy school classe s on the initial paper and pencil survey but then the focus group discussions reveal ed that didn’t learn about emergency contraception from their coursework, but more from outside sources. It is possible that the paper and pencil survey question, did you take any classes in your Pharm D program which taught you about EC? led students to the pick the socially desirable answer but when they started discussing it as a group, it beca me clear that they either did not receive this information or that if they did, it was brief and not comprehensive. Even though the curricula review survey and state-wide pha rmacist surveys were completely anonymous, it is possible that the same bias was occurring in these surveys. For example, perhaps a greater proportion of Dean s responded that they include content on emergency contraception due to the social desirability of the answer thereby infl ating the response. The last key finding concerns not the data but the st udy design, specifically, the importance of the mixed methods study design. In this case, the mixed methods study design strengthened this study in that it allowe d for the most complete analysis of this issue. The quantitative elements captured im portant statistics and the qualitative findings enriched the data by giving voice to the num bers. The study would not have been as powerful without the focus group qualitative data. That is, the finding that pharmacy students are not truly acqui ring information on emergency contraception in their pharmacy school classes would not have come to light. This study demonstrates the need for mixed methods study design in order to fu lly understand the complexity of any issue.

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205 Study Limitations Results from the study should be inte rpreted with caution due to several limitations, the first of which is response ra te. The state-wide pharmacist survey had a low response rate (22%) even after employing the Dillman Tailored Design Method and reviewing response rates from other studies that surveyed pharmacists. No data are available for non-responders and therefore no calculations can be performed to detect non-responder bias. Perhaps incentives provi ded for completing the survey may have increased the response rate, however the st udy was not funded and therefore incentives were not possible. Although there was no problem with the re sponse rate for the pharmacy school curricula review, the lack of syllabi received is a limitation. Only 10 syllabi (14%) were received from seven schools who reported that they provide course content on emergency contraception in their courses. This limite d number of syllabi made it difficult to make generalizations about specific emergency cont raception course content taught in U.S. pharmacy schools. In addition, the syllabi th at were received did not have detailed information on how the emergency contraception course content was presented in class. This finding was unexpected and in or der to fully understand how emergency contraception course content is taught in pha rmacy schools, class observations as well as interviews with professors may be needed. A second limitation in this study is generali zablilty. Specifically, the state-wide pharmacist survey does not procure a nationa l sample and therefor e results cannot be generalized to all pharmacists in the U.S. Likewise, the pharmacy student focus groups

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206 cannot be generalized to all pharmacy students in the U.S. In addition, findings from this research study cannot be generalized to non-English speaking individuals. A third limitation only related to the fo cus group discussions is that cause and effect relationships or statis tical relationships could not be calculated. However, this limitation is true for qualitative research in general and was expected. A fourth limitation is that this study was not able to directly link the curricula review to the schools where the focus groups were conducted. Although this process would have not provided anonymity to the schools, it would have been stronger in demonstr ating relationships between teaching and learning. A fifth limitation is the difficulty in identifying temporal sequence given the cross-sectional nature of this research. For example, although there is a significant relationship between knowledge and em ergency contraception dispensing, does knowledge lead to increased dispensing or doe s increasing dispensing lead to increased knowledge? The same is true for th e other significant relationships. A sixth limitation that was discussed pr eviously is the potential for socialdesirability bias where particip ants may have adjusted their true answer to reflect what they thought was the more social desirable an swer given the potentially sensitive subject matter. A last limitation that parallels social-desirab ility bias is that data collected in this study was self-reported which means that it ma y be prone to some inaccuracy due to inaccurate recall or di scomfort in disclosing personal information. For example, the information received from the pharmacy st udents is based solely on self-reporting, meaning that what pharmacy students report learning about in their classes may not be

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207 reflective of actual classroo m instruction. However, the focus groups provided an accurate picture of what pharmacy students remember learning about emergency contraception and how they remember being taught this information. Study Strengths This study had many strengths and the fi rst of which is its mixed methods study design. Employing mixed methods deeply enrich ed this study and the findings. The big picture or complete perspective could not have been obtained without the focus group discussions as the qualitative da ta is the link to understandin g that there is a disconnect between what pharmacy schools say they are teaching and what pharmacy students report learning. Overall this study was well designe d, informed by theory and literature and produced significant results that can be used to inform research, po licy, and practice. A second strength of this study comes from the study design. For one, the randomization of the state-wide pharmacist study was a strength. Random selection of pharmacists allows for generalization to all Florida pharmacists which provides a piece to the puzzle in terms of understand dispensi ng practices on a national and geographical level. In addition, the curricu lum review study acted as a censu s of all accredited schools of pharmacy in the nation which is useful in that not many studies are able to survey the whole population in their sample. A third strength is the un ique universal pers pective this study provides. Each piece of this research study alone is signi ficant, but together it offers a holistic perspective. This study provides a threepronged holistic view of pharmacy teaching, education, and practice. It is through this perspective th at the whole picture can be captured, providing opportunities for interventio n on multiple levels. It should be noted

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208 that emergency contraception is just one of the many drugs that should be addressed in pharmacy education and training interventions. It is underst ood that this is one of the many competing demands on pharmacy sc hool curricula and practice. A final strength of this study its substa ntial contribution to the literature on pharmacist education, practice, and policy as it is the first known study of its kind. No other study has been so comprehensive in it s comprehension of pha rmacist education and practice. Although Van Riper and Hellerste dt’s (2005) South Dakota study assessed pharmacists’ attitudes, knowledge, and dispen sing practices of emergency contraception, they failed to determine whether pharmacist knowledge and attitudes about emergency contraception predict dispensing practices. The proposed study not only tested these relationships but found statistic al significance which has major implications for policy, education, and practice. Section II: Discussion of Universal Perspective This research offers a unique perspective of three different but related datasets. Taken together, findings demonstrate that teaching may be associated with student learning, which in turn may be associated with dispensing pr actices of pharmacists which inevitably may be associated with access to care. Figure 7 provides a model which can act as a metaphor to describe this process. The model depicts a ga me of pool. In this model, each pool ball represents a key element th at is associated with the other eventually leading to ‘the pocket’ or in this case, lead ing to health access or lack of health access depending on how each cue ball is handled. Ho wever this depiction is telling, in that if all of these elements are not in place, the health access ball may never make the pocket, thereby limiting health access to those who need it. Of course there are other balls that

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209 could be added to this model (e. g. health in surance, poverty etc.); however this study and this model demonstrates how these particular elements are associated with each other to potentially impact health access. It is important to note that interven tion strategies can be applied to any of the pool balls in order to ad dress health access, not just to the teaching ball. Although a multi-pronged approach addressing the pharmacy school curricula, student learning, and pharmacist practice is ideal, an interv ention at any point would be beneficial. This research followed the natural progression of pharmacists from education to subsequent practice. It examined the em ergency contraception curricula and course content intended to teach fu ture pharmacists, surveyed pharmacy students to understand how this course content translates into learned knowledge and projected dispensing behavior, and then lastly it surveyed practicing pharmacists to understand their emergency contraception knowledge, attitudes, and actual dispensing pr actices. In total, this research study employs a mixed methods design to offer a complete picture of pharmacists and emergency contracepti on from education to practice.

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210 Figure 7. Pharmacist and EC Access Model 8 7Health AccessTeachingStudent LearningPharmacist PracticeEach pool ball impacts one another to inevitably affect health access. Section III: Broader Implications for Public Health and Future Direction Broader Implications for Public Health Although this study is concerned with one health access issue and one group of health service providers, it has broader implications for public health as a whole as well as other areas and health service professiona ls. That is, education and training may be associated with clinical practice for any h ealth profession, for nurses, doctors, social workers and the list goes on. The importanc e of effective teaching, translating to efficient learning and informed practice and polic y is important. As demonstrated in this study, the best intention of pharmacy school teaching does not lead to best practice. Practicing professionals shoul d be trained to meet the needs of the public. Access to health care should not be mitigated by personal beliefs and lack of knowledge. Personal perspective and beliefs sh ould not drive clinical practice, science

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211 should drive clinical practice. Specifically concerning is the lack of awareness around how to dispense Plan B OTC where 77.6% of pharmacists did not understand how to dispense Plan B OTC to women and 55.5% di d not know who at the pharmacy could sell Plan B to consumers. Also concerning was the lack of knowledge about Plan B in general where 55.9% did not understand th e correct mechanism of action, 55.9% incorrectly reported that Plan B can cause bi rth defects and just over 46% reported that Plan B can cause an abortion. Another broad implication of this research concerns the idea of bias and issues of self-report data. There are va rying levels of bias to be aware of when researching a controversial topic such as this one. This study uncovered th ree potentially varying levels of bias, 1) professor bias, 2) student bias, and 3) pharmacist bias. The professor bias can present itself in a few ways. For one, the professor may re port that they teach certain content but they really do not cover it. Secondly, a professor may teach content but insert their biases in the content such that the true co ntent is not taught correctly. Student bias may occur when a student may incorrectly report that she/he did not receive the information in class. Alternately, a stude nt may come to class with a pre-set view or bias about the medication that is different fr om the teachers’ view. Pharmacist bias may be such that a pharmacist may have a bi as towards a medication that no amount of training will change. In addi tion, a pharmacist may skim important material just enough to answer the questions in hi s/her continuing education course s so that they never gain new knowledge. These types of bias are not only present for this particular issue and this particular health profession but may be present with other health fields and topics as well.

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212 Also, limited knowledge about other drugs may be associated with health across many varying professions. Future Direction. Results from this study have imp lications for future research, policy, and practice. Figure 6 can be used as a model to guide this discussion around the overall conceptual model and pot ential areas for intervention. Research. There is a need to better understa nd what is being taught to pharmacy students in terms of emergency contraception course content. Th e curriculum review survey did not fully capture what is being taught to students due to the low number of syllabi provided by pharmacy schools. Ho wever, even after reviewing the limited number of syllabi that were collected, pert inent information on course content could not be obtained. Therefore, more informa tion could potentially be gathered through interviewing professors to determine what content is presented in class and perhaps observing some pharmacotherapy courses where the content is said to be taught to better understand the dissemination of this content. In addition, because the majority of re spondents from the curriculum survey reported that they are teaching about emergency contraception, schools should review their course outline to ensure that what they think is being taught within their courses is actually being taught. Schools could look to see if there is a disparity between formal objectives a nd what is being taught in class. It would also be helpful to track the numb er of actual refusals that are taking place at our local pharmacies or develop a ‘turn-it-in’ hotline or webpage where consumers can report refusals that occu r. This way, the magnitude of this problem could be captured.

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213 One main element missing in this study is the voice of the consumer. How do consumers feel about pharmacists and Plan B dispensing? Do consumers want to be counseled? Do consumers feel that pharmacists should assume their perceived role of the counselor/educator? Does fear of pharmacist bias and stigma impact consumer Plan B seeking behaviors? It would be interesting to either conduct a consumer study or even link results from a consumer study with the results from this study to make appropriate inferen ces. A study aimed at understanding the role of pharmacists from both the pract itioner and consumer perspective may provide additional insights. It would also be interesting to review the stories of refusal from the pharmacy student focus groups and laye r these stories with the pha rmacist professional code of ethics. This may demonstrate how polic y is translated (or not translated) into practice. Another potential research avenue would be to compare knowledge, attitudes, and dispensing practices of Plan B with a nother OTC medication that does not have the same moral implications to see if th ere are any differences or similarities. Policy. There are also implications for pha rmacy policy. This study uncovered some important information regarding the way that pharmacy culture and policy are associated with practice. Pharmacists th at worked at a pharmacy with an existing policy regarding refusals of emergency cont raception were more likely to have ever dispensed the medication and a pharmacist who worked at a pharmacy where a colleague refuses to dispense the medicati on was less likely to have ever dispensed Plan B. Since policy is associated with pr actice, a next step w ould be to contact the

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214 American Pharmacists Association (AphA ), the American Medical Association (AMA), and the American College of Obst etricians and Gynecologists (ACOG) and work together to ensure that all pharmaci es create policies regarding dispensing Plan B and that there is protocol in place should pharmacists refuse to dispense a medication. Practice. There are also implications for bette r teaching. For example, it would be helpful to bring together pharmacy school faculty and students to create a teaching module that will be most effective in teaching students about emergency contraception. This module could then be tested and implemented in pharmacy school classrooms. Employing students in th e development of this module along with faculty may ensure effective teaching by the professor and efficient learning and retention of material by the student. If it worked and wa s evaluated, this type of module development and curriculum enhan cement could be used by a variety of controversial topics in science. In terms of reaching already practicing pharmacists, better continuing education credit opportunities to learn about this material would be helpful, although there is already an informative and well-written one available through Postgraduate Healthcare Education, LLC which is accredited to provide continuing pharmacy education by the Accredita tion Council for Pharmacy Education. Ensuring that pharmacists are picking this particular CEU or a comparable one would be helpful. Also, developing a training that can be pr ovided to already practicing pharmacists would be useful. This trai ning could focus on the deficiencies in knowledge found in this study, increasing pha rmacist comfort level in dispensing

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215 to varying groups of people, along with a discussion of unfair and unjust bias placed on a consumer and how this bias might limit access to those in need. Requiring that pharmacists go through th is training is essential. Dissemination. The findings from this study will be widely disseminated. In terms of education, providing findings to the accredited schools of pharmacy in the U.S. will increase awareness about the disparity between teaching and student learning. Pharmacy schools may use the resu lts to enhance alrea dy existing curricula or develop new curricula for students. These findings will also be disseminated to pertinent organizations such as national and state pharmacy associations and other like minded organizations in the field such as the American Medical Association. The findings can then be used to support and implement new policy that will increase access to this medication. Lastly, this resear ch and its effective use of the Theory of Planned Behavior can be added to the knowledge on the use of this theoretical framework.

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216 Figure 8. Emergency Contraception Health Access Model Effective Teaching Skills Efficient Learning Health Access Informed Practice Training Policy Change -Pharmacy -Government -Prof. Orgs Curriculum Enhancement Preconceived Bias In sum, this study uncovered a disconnect between pharmacist education and practice. It also uncovered important findings regarding pharmacist biases which are associated with dispensing and inevitably health access. Research from this study suggested that knowledge, att itudes, social norms, perceive d ease with dispensing, and dispensing intention are associated with dispensing and access to care. Figure 8 pictorially demonstrates that effective teachi ng may be associated with efficient learning, which creates informed practice, which may be associated to health access. Preconceived bias or beliefs should also be considered in the model. Additiona lly, there are potential areas for intervention at each stage. This study was well designed, informed by theory and literature and produced impor tant results that can be used to inform future research, policy, and practice.

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217 References Abbott, J., Feldhaus, K. M., Houry D., & Lowenstein, S. R. (2004). Emergency contraception: What do our patients know? Annals of Emergency Medicine, 43 376-381. Aiken, A. M., Gold, M. A. & Parker, A. M. (2005). Changes in young women’s awareness, attitudes, and perceived ba rriers to using emergency contraception. Journal of Pediatric and Adolescent Gynecology, 18 25-32. Ajzen, I. (1985). From intentions to actions: A theory of planned behavior. In J. Kuhl and J. Backmann (Eds.), Action-control: From cognition to behavior (pp. 11-39). Heidelberg: Springer. Ajzen, I. (1988). Attitudes, personality and behavior Chicago, IL: The Dorsey Press. Ajzen, I. & Fishbein, M. (1980). Understanding attitudes and pr edicting social behavior Englewood-Cliffs, NJ: Prentice-Hall. Ajzen, I. & Madden, T. J. (1986). Predicti on of goal-directed behavior: Attitudes, intentions, and perceive d behavioral control. Journal of Experimental Social Psychology, 22 453-74. Alan Guttmacher Inst itute (AGI). (2006). State policies in brief, emergency contraception. Retrieved August 18, 2006, from http://www.guttmacher.org/stat ecenter/spibs/ spib_EC.pdf American College of Obstetrician s and Gynecologists (ACOG). (2003). ACOG news release. Emergency contraception: Works up to 120 hours and in different combinations Retrieved June 10, 2006, from http://www .acog.org/from_home/publications/p ress_releases/nr 05-31-03-5.cfm. American College of Obstetrician s and Gynecologists (ACOG). (2001). Statement of the American College of Obstetricians and Gynecologists Supporting the Availability of Over-the-Counter Emergency Contraception Retrieved October 1, 2001, from http://www.acog.org/from_home/publicati ons/press_releases/n r02-14-01.htm. American Medical Association (AMA). (2002). H-75.985 Access to emergency contraception. Retrieved October 21, 2003, from http://www .ama-assn.org/

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221 Free Dictionary (n. d.). Retrieved August 8, 2006 from http://medicaldictionary.thefreedictionary.com Fuentes EC & Azize-Vargas Y. (2007). Know ledge, attitudes and prac tices in a group of pharmacists in Puerto Rico rega rding emergency contraception. Puerto Rico Health Science Journal, 26 191-197. Galson, S. (2004, May 6). Food and Drug Administration (F DA) CDER Plan B NA letter NDA 21-045/S-011 Retrieved June 1, 2004, from www.fda .gov/cder/drug/infopage/p lanB/planB_NALetter.pdf Gardner, J. S., Hutchings, J., Fuller, T. S., & Downing, D. (2001). Increasing access to emergency contraception through community pharmacies: lessons from Washington State. Family Planning Perspectives, 33 (4), 172-175. Gold, M., Schein, A., & Coupey, S. M. ( 1997). Emergency contraception: A national survey of adolescent health experts. Family Planning Perspectives, 29 15-24. Golden, N. H., Sigel, W. M., Fisher, M., Schneider, M., Quijano, E., Suss, A., at al. (2001). Emergency contraception: Pediat ricians’ knowledge, attitudes, and opinions. Pediatrics, 107 (2), 287-292. Grimes, D. (2002). Switching emergency c ontraception to over-the-counter status. The New England Journal of Medicine, 347, 846-849. Grimes, D. A., & Raymond, E. G. (2002). Emergency Contraception. Annals of Internal Medicine, 137, E180-E189. Harper, C. C. & Ellertson, C. E. (1995). The emergency contraceptive pill: A survey of knowledge and attitudes among stude nts at Princeton university. American Journal of Obstetrics and Gynecology, 173 (5), 1438-45. Hatcher, L., & Stepanski, E. (1994). A Step-by-Step Approach to Using the SAS System for Univariate and Multivariate Statistics. Cary, N.C.: SAS Institute. Hellerstedt, W. L., Pirie, P. L., Lando, H. A., Curry, S. J., McBride, C. M., Grothaus, L. C., et al. (1998). Differences in precon ceptional and prenatal behaviors in women with intended and unintended pregnancies. American Journal of Public Health, 88, 663-666. Henderson, C. (2000). Emergency Contraception Update. Pregnancy Prevention for Youth Network, 3, 1-2. Henshaw, S. Unintended Pregnancy in the United States. (1998). Family Planning Perspectives, 30, 24-29.

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223 Nguyen, L., Bianchi-Demicheli, F., & Ludi cke, F. (2003). Wome n’s knowledge and opinions of emergency contraception. International Journal of Gynaecology and Obstetrics, 82 229-230. Nunnaly, J. (1978). Psychometric theory. New York: McGraw-Hill. Onwuhafua, P. I., Kantiok, C., Olafimiha n, O., & Shittu, O. S. (2005). Knowledge, attitude and practice of family pla nning amongst community health extension workers in Kaduna State, Nigeria. Journal of Obstetrics and Gynaecology, 25 (5), 494-9. Orr, S. T., Miller C. A., James, S. S., & Babones, S. (2000). Unintended pregnancy and preterm birth. Pediatric and Perinatal Epidemiology, 14, 309-313. Ottesen, D., Narring, F., Renteria, S. C ., & Michaud, P. A. (2002). Emergency contraception among teenagers in Switzer land: A cross-secti onal survey on the sexuality of 16to 20year-olds. Journal of Adolescent Health, 31 (1), 101-110. Planned Parenthood (n. d.). Emergency contraception. Retrieved August 12, 2006, from http://www .plannedparenthood.org/pp2/portal/ Population Reference Bureau (n. d.). Glossary of population terms Retrieved August 12, 2006, from http://www .prb.org/ Princeton University & Re productive Health Professiona ls, Not2Late.com. (2006). The emergency contraception website Retrieved August 18, 2006, from http://ec .princeton.edu/ Reuters. Pharmacist refuses pill for victim. (2004, February 11). Chicago Tribune P. C7. Romo, L. F., Berenson, A. B. & Wu, Z. H. (2004). The role of misconceptions on Latino women’s acceptance of emergency contraceptive pills. Contraception, 69 227235. Sable, M. R., Schwartz, L. R., Kelly, P. J ., Lisbon, E., & Hall, M. A. (2006). Using the Theory of Reasoned Action to Explai n Physician Intention to prescribe emergency contraception. Perspectives on Sexual and Reproductive Health, 38 (1), 20-27. Santelli, J., Rochat, R., Hatfield-Timajchy, K., G ilbert, B. C., Curtis, K., Cabral, R., et al. (2003). The measurement and m eaning of unintended pregnancy. Perspectives on Sexual and Reproductive Health, 35 (2), 1-8.

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224 Schifter, D. B. & Ajzen, I. (1985). Intenti on, perceived control, and weight loss: An application of the theory of planned behavior. Journal of Personality and Social Psychology, 49 843-51. Sevil, U., Yanikkerem, E., & Hatipoglu, S. (2006). A survey of knowledge, attitudes and practices relating to emergency contr aception among health workers in Manisa, Turkey. Midwifery, 22 (1), 66-77. Sheehan, K. (2001). E-mail survey response rates: A review. Journal of ComputerMediated Communication, 6 (2), 1-20. Sills, M. R., Chamberlain, J. M., & Teac h, S. J. (2000). The associations among pediatricians’ knowledge, attitudes, and practices regarding emergency contraception. Pediatrics, 104 954-956. Tanne, J. H. (2005). Emergency contraception is under attack by U.S. pharmacists. British Medical Journal, 330 (7498), 983. Tripathi, R, Rathore, A. M., & Sachde va, J. (2003). Emergency contraception: knowledge, attitude and practices among hea lth care providers in North India. Journal of Obstetrics and Gynaecology Research, 29 142-146. Trussell, J., Duran, V., Shochet, T., & Moore, K. (2000). Access to emergency contraception. Obstetrics and Gynecology, 95, 267-70. Trussell, J., Stewart, F., Guest, F., & Hatc her, R. A. (1992). Em ergency contraceptive pills: A simple proposal to reduce unintended pregnancies. Family Planning Perspectives, 24, 269-73. U.S. Department of Health a nd Human Services (DHHS). (2000) Healthy People 2010 (conference ed, 2 vols). Washington, DC Retrieved September 22, 2003, from http://www.healthypeople.gov/doc ument/Word/Volume1/09Family.doc Uzuner, A., Unalan, P., Akman, M., Cifcili, S., Tuncer, I., Coban, E., et al. (2005). Providers’ knowledge of, at titude to and practice of emergency contraception. European Journal of Contracepti on Reproductive Health Care, 10 (1), 43-50. Van Look, P. F. A. & Stewart, F. (1998). Emer gency contraception. In R. R. Hatcher, J. Trussell, & F. Stewart (Eds.), Contraceptive Technology (17th ed., pp. 277-296). 17th ed. New York, NY: Ardent Media. Van de Mortel, T. (2008). Faking it: social desirability response bias in self-report research, Australian Journal of Advanced Nursing, 25 (8), 40-48.

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225 Van Riper, K. K. & Hellerstedt, W. L. (2005). Emergency contraceptive pills: Dispensing practices, knowledge and attitude s of South Dakota pharmacists. Perspectives on Sexual and Reproductive Health, 37 (1), 19-24. Vasilakis, C., Jick, S. S., & Jick, H. (1999). The risk of venous thromoembolism in users of postcoital contraceptive pills. Contraception, 59 79-83. Wallace, J. L., Wu, J., Weinstein, J., Go renflo, D. W., & Fetters, M. D. (2004). Emergency contraception: Knowledge and attitudes of family medicine providers. Family Medicine, 36 (6), 417-422. Wal-Mart news release. Re trieved March 3, 2006, from http://walmartstores.com/GlobalWMS toresWeb/navigate.do?catg=512&contId=6 075 Webb, A. & Morris, J. (1993). Practice of pos tcoital contraception—the results of a national survey. The British Journal of Family Planning, 18 113-118. Wells, E. S., Hutchings, J., Gardner, J. S., Winkl er, J. L., Fuller, T. S., Downing, D., et al. (1998). Using pharmacies in Washington State to expand access to emergency contraception. Family Planning Perspectives, 30 288-90. Word Reference (n. d.). English Dictionary. Retrieved August, 8th, 2006, from http://www.wordreference.com

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226 Appendices

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227 Appendix A. Table 50: Oral contraceptives that can be used for emer gency contraception in the United Statesa Brand Company Pills per Doseb Ethinyl Estradiol per Dose (g) Levonorgestrel per Dose (mg)c Progestin-only pills: Take 1 dosebPlan B Barr/Duramed 2 white pills 0 0.75 Ovrette Wyeth-Ayerst 40 yellow pills 0 0.75 Combined progestin and estrogen pills: take 2 doses, 12 hours apart Alesse Wyeth-Ayerst 5 pink pills 100 0.50 Aviane Barr/Duramed 5 orange pills 100 0.50 Cryselle Barr/Duramed 4 white pills 120 0.60 Enpresse Barr/Duramed 4 orange pills 120 0.50 Lessina Barr/Duramed 5 pink pills 100 0.50 Levlen Berlex 4 light-orange pills 120 0.60 Levlite Berlex 5 pink pills 100 0.50 Levora Watson 4 white pills 120 0.60 Lo/Ovral Wyeth-Ayerst 4 white pills 120 0.60 LowOgestrel Watson 4 white pills 120 0.60 Lutera Watson 5 white pills 100 0.50 Ogestrel Watson 2 white pills 100 0.50 Ovral Wyeth-Ayerst 2 white pills 100 0.50 Nordette Wyeth-Ayerst 4 light-orange pills 120 0.60

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228 Appendix A (Continued) Portia Barr/Duramed 4 pink pills 120 0.60 Seasonale Barr/Duramed 4 pink pills 120 0.60 Seasonique Barr/Duramed 4 light-bluegreen pills 120 0.60 Tri-Levlen Berlex 4 yellow pills 120 0.50 Triphasil Wyeth-Ayerst 4 yellow pills 120 0.50 Trivora Watson 4 pink pills 120 0.50 *Source: Princeton University and The A ssociation of Reproductive Health Professionals: Not2late.com, The Emergency Contraception Website.

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229 Appendix B. Package Insert for Plan B and RU-486

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FDA approves EC OTC for women 18 & over Preven, the 1st dedicated product for EC was created Petition filed in support of OTC EC FDA panel supports OTC access of EC FDA struck down recommend ation from its committee 1960s 1996 1997 1998 1999 2001 2003 2004 2006 FDA approves 6 brands of OCs to be used as EC Nat’l campaign created by Princeton Univ. & RHTP Advent of BC pill. Packs of pills cut up to be used as EC Washington State begins CDTA program with pharmacists Plan B, the 2nd dedicated product for EC was created 2n d petition filed in support of OTC EC Makers of Plan B submit new application for OTC EC for women 16 yrs. & older 236 Appendix C. Figure 9. History of Emergency Contraception

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Appendix D Table 51. Emergency contraception studies in a comparative context: Client knowledge & attitude studies Author Study Description Major Findings Abbott et al (2004) Survey (self-administered paper-based) of 158 women at an inner-city ED in the US 77% of women had heard of EC, although only half of those knew how to use it. Of those who had heard of it, 26% were not aware of the correct timing, 24% were not aware that it was available in the U.S., and 45% were not aware that a prescription was required for use. 51% of women reported that they would think about using EC if they needed it; however 17% reported moral or religious objections to its use Aiken et al (2005) Survey (interview) of 133 women in 1996 and 139 women in 2002 from a hospital-based clinic and drug treatment center in the US Between 1996 and 2002, the percentage of clients who had ever heard of EC grew from 44% in 1996 to 73% in 2002 and comprehension of timing for use also increased from 20% in 1996 to 51% in 2002. Over half of women thought that there may be a future need to use EC and of these, 95% reported that they would use it if needed Aziken et al (2003) Survey (self-administered paper-based) of 880 female students attending a University in Nigeria 58% of students were familiar with EC but only 18% knew the 72 hour protocol for use and 49% believed that the pills needed to be taken within 24 hours of unprotected intercourse Babaee et al (2003) Survey (interview) of 250 married women (ages 1548) in a health center in Iran 8% of women knew about EC and 77% of women reported that they would be willing to use it in the future Chuang & Freund (2005) Survey (self-administered paper-based) of 188 women (ages 18-44) in a Boston neighborhood in the US 82% of women in a Boston community had heard of EC but only about half of those women knew how it worked Corbett et al (2005) Survey (25-item selfadministered paper-based questionnaire) of 97 college students between 18-21 years old in the US Almost half of participants thought that EC was the same as RU-486 and of women who reported to be less likely to choose EC, 100% said that they would feel judged or embarrassed if they had to ask for it Harper & Ellertson (1995) Survey (telephone) of 550 undergraduate and graduate students in the US 52% of respondents did not know the difference between EC and RU-486. Democrats and people who reported to be not religious had more favorable attitudes towards EC than Republicans or highly religious individuals. As knowledge about EC went up, so did the positive attitudes about EC. Jackson et al (2000) Survey (self-administered paper-based) of 371 postpartum women from an inner-city public hospital in the US 36% of women had heard of EC and only 7% understood the appropriate timing for use. Two-thirds of these women reported a willingness to use EC in the future Larsson et al (2004) Survey (mail questionnaire) of 800 women attending a family planning clinic in Sweden 98% of women were aware of EC but 38% were not aware its effectiveness when taken on the first day and 59% were not aware its effectiveness when taken on the third day. 90% agreed that access to EC is positive 237

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240 Mathew & Urquhart (2005) Survey (self-administered paper-based) of 78 women attending an abortion clinic in the UK 78% of women were familiar with EC and 90% of women said they would consider using EC in the future Nguyen et al (2003) Survey (self-administered paper-based) of 365 women who requested EC in Switzerland Knowledge of EC was satisfactory but 42% thought it had to be taken within 24 hours of unprotected intercourse and 13% thought that EC was 100% effective in preventing pregnancy Ottesen et al (2002) Nationally representative population-based study (n=4283) in Switzerland surveying (computerized questionnaire) 16to 20year-olds 89% of sexually active girls and 75% of sexually active boys had heard of EC Romo et al (2004) Survey (self-administered paper-based) of 297 Latina women ages 18-43 from a clinic in the US 17% of Spanish-speaking women and 41% of English-speaking Latina women had heard of EC and 25% believed that EC would end an existing pregnancy. Only half of the women who have heard of EC said that they would be willing to use it in the future and those who did not comprehend the action of EC were even less likel y to say that they would use it in the future Tripathi et al (2003) Survey (self-administered paper-based questionnaire) of 500 patients seeking abortion services and 110 college students in India none of the clients surveyed were familiar w/ EC EC, Emergency contraception; ED, Emergency department Appendix D (Continued)

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241 Appendix E Table 52. Emergency contraception studies in a comparative context: Provider knowledge, attitudes, & practice. Author Study Description Major Findings Beckman et al (2001) Survey (self-administered paper-based) of 102 providers (physicians, registered nurse practitioners, certified nurse midwives, & physician assistants) in the U.S. At baseline, one-third of the sample did not know the correct timing for EC & only 7% of providers reported prescribing EC once a month. At followup, knowledge about EC & prescribing frequency of EC significantly increa sed. However, providers still had limited knowledge side effects and modes of action. Attitudes about EC showed little change. Chuan et al (2004) Survey (mail survey) of 282 providers (OB-GYN, family practitioners, & general internists) in the U.S. 94% of Ob-gins, 76% of family practitioners, & 63% of general internists ever prescribed EC. Being female was a positive predictor & being Catholic was a negative pr edictor for prescribing EC. 75% of the physicians reported infrequent prescribing of EC (less than five times a year), regardless of their specialty Delbanco et al (1998) Survey (telephone) of 754 women's health professionals (Ob-gyn, family physicians, nurse practitioners, & physician assistants) Although the number of physicians that prescribed EC once in the last year increased, very few commonly prescribe EC, regardless of specialty. Gold et al (1997) Survey (interview) of 167 physicians with expertise in adolescent health in the U.S. Attitude variables are predictors of failure to prescribe EC. Golden et al (2001) Survey (mail survey) of 233 Pediatricians in the U.S. 72.9% of respondents coul d not identify the FDA approved methods for EC and roughly 72% could not identify the correct timing for the drug. 68% of respondents felt uncomfortable prescribing EC, 17% did not prescribe due to perceived teratogenic effects & 12% did not prescribe due to moral or religious reasons. 22% agreed that EC provision encourages adolescent risk taking behavior & 52.4% said they would place restrictions on how many times they would dispense the drug to a patient. Onwuhafu a et al (2005) Survey (self-administered paper-based) of 232 community health extension workers in Nigeria EC was not known about Sable et al (2006) Survey (paper-based) of 96 faculty physicians from one Southern & three Midwestern Universities 42% intended to prescribe EC for teens but 6577% intended for other specified groups. High intention to prescribe wa s significantly associated with positive attitudes but knowledge was not. Sevil et al (2006) Survey (interviews & paperbased questionnaire) of 72 providers (general practitioners, nurses, & midwives) in Turkey Almost 1 in 10 providers were unfamiliar with the words ‘emergency contraception’

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242 Sills et al (2000) Survey (mail survey) of 121 Pediatricians in the U.S. All but 1 doctor had heard of EC but about half did not know the timing of EC or that it was FDA approved. Knowledge, not attitudes, are significant predictors of EC prescribing. Tripathi et al (2003) Survey (self-administered paper-based) of 405 health care workers in India 84% of gynecologists & 41% of general practitioners were vaguely familiar with EC though of those who had knowledge, most were unsure of how to prescribe it. 51% of gynecologists & 17% of practitioners reported ever prescribing it Uzuner et al (2005) Survey (interviews) of 180 family planning providers in Turkey Only half of providers knew the correct timing and dose interval of EC. 39.4% of respondents believed that EC causes abortion, 31.1% thought that it was harmful for the fetus, 78.9% incorrectly thought that pill use may increase unprotected intercourse & that use will lead to men giving up on condom use (75%). Wallace et al (2004) Survey (self-administered paper-based) of 78 providers (family physicians and nurse providers) 96% reported that they were knowledgeable on the indications & 78% reported that they understood the protocols for prescribing EC although knowledge inaccuracies were found between perceived and actual knowledge. 44% inaccurately thought that EC was an abortifacient. 90% thought that EC was an appropriate topic of discussion at women’s exams and felt that the benefits of EC outweighed the risks. 59% of providers said they would restrict how many times they prescribed EC, 14% thought that EC use would discourage regular contraceptive use, 16% were uncomfortable prescribing EC for religious or ethical reasons, & 7% said that they would not prescribe it under any circumstances Webb et al (1993) National study of British health authorities The majority of physician s surveyed report that they prescribe EC a few times per week. 74% reported that they have prescribed EC in the past, with an average of 3.2 ti mes in the past year EC, Emergency contraception; ED, Emergency dep artment; FDA, Food and Drug Administration OB-GYN, Obstetricians/gynecologists Appendix E (Continued)

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243 Appendix F. Table 53. Emergency contraception studies in a comparative context: Pharmacists' knowledge, attitudes, and dispensing practices. Author Study Description Major Findings Aneblo m et al (2003) Survey (mail-based) of pharmacy staff (n=237) & nursemidwives (n=163) in Sweden Both study groups had positive attitudes towards EC and towards the OTC administration of EC; however nurse midwives demonstrated more favorable attitudes than the pharmacist group. In addition, verbal information and counseling to clients on issues of EC was more commonly reported by the nurse-midwife group than by the pharmacist group and both groups reported that they wanted more collaboration between health care providers. Bennett et al (2003) Survey (employed mystery callers) of 315 pharmacists in the U.S. Knowledge about & access to EC was limited. 30% of pharmacists did not provide t he correct timing required for EC administration: 23% thought it needed to be taken within 24 hours & 7% thought it needed to be taken within 48 hours. Also, 13% of the pharmacists said that EC would cause an abortion. 65% (n=201) of phar macists reported that they would not be able to fill a prescription of EC that day. Borrego et al (2006) Survey (mail-based) of 523 pharmacists in the U.S. Pharmacists from New Mexico had positive attitudes and beliefs about prescribing EC but their knowledge was average. 40% of the sample had an interest in becoming certified to prescribe EC in their state-approved prescribing training program. Of those pharmacists would wanted to be certified, they were more likely to be male, non-Hispanic, non-Christian, to report liberal or moderate political views, and to say that they had employer approval, time, and privacy at their pharmacy to prescribe EC. Conard at al (2003) Survey (mail-based) of 948 pharmacists in the U.S. 48% of the pharmacists surveyed did not dispense EC. Pharmacists under 45 years of age were more likely to report dispensing EC; however no differences were found for sex. Of the 59% of pharmacists who have dispensed EC to adolescents, 83% said that they felt uncomfortable doing so. There were no differences in feelings of comfort based on age or sex. Draut (1999) Survey (telephone) of 100 pharmacists in the U.S. Only 3 out of 100 pharmacist s surveyed provided correct information about EC and 38 (38%) pharmacists did not know it was available in the U.S. Van Riper et al (2005) Survey (mail-based) of 501 pharmacists in the U.S. Only 54% of pharmacists worked in pharmacies that carried EC. Of those, 67% had dispensed EC in 2003 but 24% reported that they were not comfortable providing counseling about the medication. 37% were unaware that the medication is similar in its mechanism to oral contraceptives, 74% either incorrectly agreed or were uncertain about whether EC causes birth defects when administered to pregnant women & 85% of respondents either incorrectly agreed or were uncertain about whether repeated use of EC poses health risks. Only 5% of the sample correctly answered all five of the knowledge questions on the survey. EC, Emergency contraception

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244 Appendix G. Pre-notice to Academic Deans* Date: To: JaneDoe@mail.edu From: Alice Richman arichman@hsc.usf.edu Subject: Academic Dean Survey Hello and greetings. As part of my dissert ation research, I am interested in learning about the teaching of emergency contracepti on in our pharmacy school classrooms. I am committed to identifying which classes, if any, within pharmacy school curricula provides instruction on emergency contraception. This information is being sought as we currently have little information on what classe s cover this information or the extent of this instruction. In order to reach these ai ms, I am asking you to help me gather this information. Within the next couple of days you will be receiving a brief three question survey from the University of South Florida from this same email address. We would greatly appreciate if you could take a few moments to complete it. By doing so you will help ensure that we have the best information pos sible. Please be assu red that your answers are confidential and only gr oup data will be reported. If you have questions, feel free to contact Ali ce Richman or Ellen Daley at the University of South Florida at the contact information provided below. Thank you in advance for your cooperation. Sincerely, Alice R. Richman Ellen Daley, Ph.D. USF College of Public Health USF College of Public Health Phone: (813) 732-1903 Phone: (814) 974-8518 Email: arichman@hsc.usf.edu Email: edaley@hsc.usf.edu *The template for this letter was taken from Dillman (2000).

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245 Appendix H. Academic Dean Informed Consent Form Researchers at the University of South Fl orida (USF) study many t opics. We want to learn about the instruction of emergenc y contraception in our pharmacy school classrooms. Title of research study: The Role of Pharmacists and Emergency Contraception: An Assessment of Pharmacy School Curricula in the U.S. and the Knowledge, Attitudes, and Dispensing Practices of Florida Pharmacists. Person in charge of study: Alice R. Richman Study staff who can act on behalf of the person in charge: Dr. Ellen Daley Where the study will be done: In Florida The purpose of this study is to review pharm acy school curricula in the U.S. for course content related to emergency contraception. All Academic Deans from the 91 accredited school of pharmacy in the U.S. will be sent a three question web-based survey that will ask questions about their program curricula. In addition, Academic Deans will be asked to provide course syllab i where applicable. During this study, you will be asked to complete a three question survey pertaining to the curricula and course content concerning em ergency contraception at your institution. You may also be asked to provide electronic co pies of course syllabi. The survey should not take more than 10 minutes to complete. If you decide not to take part in this study, that is okay. It will not cost you anything to take part in the study. Although there will not be any immediate benefit to you, your pa rticipation in this study will be helpful in understanding pharmacy school curricula and course conten t related to emergency contraception and will advance the state of knowledge in this area. Your participation is greatly appreciated. There are no known risks to those who take part in this study. We may publish what we find out from this study. If we do, we will not use your name or anything else that woul d let people know who you are. If you have any questions about this study, ca ll Alice Richman at (813) 732-1903 or Ellen Daley at (813) 974-8518. If you have questi ons about your rights as a person who is taking part in a study, call USF Res earch Compliance at (813) 974-5638.

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246 Appendix I. Academic Dean Cover Letter & SurveyCurricula Review Date: To: JaneDoe@mail.edu From: Alice Richman arichman@hsc.usf.edu Subject: Academic Dean Survey Below you will find the brief three question survey on how emergency contraception is being taught at pharmacy schools in the U.S. which Alice Richman notified you about via email a few days ago. We found that there is limited information on the current instruction on emergency contraception at pharmacy schools, and thus we are asking for your help via this brief survey. Please take a few minutes to answer the following questions. Your answers will be kept confidential and data will only be reported in aggregate form. Definition of Emergency Contraception : Emergency contraception is a type of hormonal contraception, containing high doses of estr ogen and progestin or progestin only. This medication is 75%-89% effective in preventi ng pregnancies when taken within 120 hours after sexual intercourse. 1) Does your School of Pharmacy offer required courses that provide content on emergency contraception? Content can incl ude lectures, course readings, course objectives etc.. No _____ Not sure _____ Yes _____ If you answered Yes, please li st the titles of courses and attach syllabi or link to syllabi: __________________ __________________ __________________ 2) Does your School of Pharmacy offer elective classes that provide content on emergency contraception? Content can incl ude lectures, course readings, course objectives etc.. No _____

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247 Appendix I (Continued) Not sure _____ Yes _____ If you answered Yes, please li st the titles of courses and attach syllabi or link to syllabi: __________________ __________________ __________________ 3) In your opinion, do you believe that School of Pharmacy curricula in the U.S. should include content material on emergency contraception (including pharmacology, legal and ethical issues, and the continual controversy that surrounds the medication)? Yes Please explain No Please explain Important : If you answered yes to either question 1 or 2, w ould you kindly attach an electronic copy of the course syllabi listed to this email and forward them to Alice Richman at arichman@hsc.usf.edu If you do not have an electronic copy of the syllabi of your courses, please tell me from where I may procure the syllabi (e.g., from a specific web site, URL). Thank you for your time and attention. All identifying information will be kept confidential. If you have questions about the study or would like a copy of the studys findings, please cont act Alice Richman at arichman@hsc.usf.edu or call (813) 732-1903.

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248 Appendix J. Thank you/Reminder Email to Academic Deans* Date: To: JaneDoe@mail.edu From: Alice Richman arichman@hsc.usf.edu Subject: Academic Dean Survey About a week ago we sent you a survey via email. We are asking Academic Deans of the schools of pharmacy in the U.S. about the curricula that addr esses instruction on emergency contraception. As of today, we have not received a completed survey from you. I realize that we all have busy schedules, however we have contacted you and others now in hopes of obtaining the insight s that only Academic Deans, like yourself, can provide. As we mentione d before, answers are confidential and will be combined with others before disseminating the results. In case the previous questionnaire has been deleted from your email account, we have included it again and hope you will respond. Should you have any questions or concerns, f eel free to contact me (Alice Richman) or Ellen Daley at the contact information pr ovided below. Thank you for your cooperation. Alice R. Richman Ellen Daley, Ph.D. USF College of Public Health USF College of Public Health Phone: (813) 732-1903 Phone: (814) 974-8518 Email: arichman@hsc.usf.edu Email: edaley@hsc.usf.edu (Link to Survey Inserted Here) *The template for this letter was taken from Dillman (2000).

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249 Appendix K: Sample Recruitment Flyer Are you a 3rd or 4th year Pharm D. student in Pharmacy School? Then we need YOU to be part of a focus group of 3rd & 4th year Pharm D. students @ the University of Florida. Who is eligible? 3rd or 4th year Pharm D. students. English speaking individuals. What will I have to do? Participate in a focus group discussion with 7 other students. Discuss your perceptions of emergency contraception course instruction and projected dispensing practices. How much time will this take? Participation will take approximately 1 hour. Do I get anything for my time? Students will receive a $10 gift certificate to Starbucks. Help add to the scientific body of knowledge. When will the group meet? Wednesday, August 29th at 10am Room 115A. How can I sign up? E-mail Alice Richman at arichman@health.usf.edu or call at (813) 732-1903.

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250 Appendix L. Focus Group Informed Consent Form Informed Consent for an Adult Social and Behavi oral Sciences University of South Florida Information for People Who Take Part in Research Studies Researchers at the University of South Fl orida (USF) study many t opics. We want to learn more about pharmacy students’ percep tion of emergency contraception course content taught at accredited schools of pharmacy. To do this, we need the help of people who agree to take part in a research study. Title of research study: The Relationship among Emergency Contraception Knowledge, Attitudes, and Dispensing Practices of Florida Pharmacists and Pharmacy School Curricula in the U.S. Person in charge of study: Alice R. Richman Study staff who can act on behalf of the person in charge: Dr. Ellen Daley Where the study will be done: Focus groups will be held at all four accredited Schools of Pharmacy in Florida: Florida Agricu ltural and Mechanical University, Nova Southeastern University, Palm Beach Atlant ic University, and University of Florida Should you take part in this study? This form tells you about this research study. You can decide if you want to take part in it. You do not have to take part. Reading this form can help you decide. Before you decide: Read this form. Talk about this study with the person in char ge of the study or the person explaining the study. You can have someone with you when you talk about the study. Find out what the study is about. You can ask questions: You may have questions this form does not answer. If you do, ask the person in charge of the study or study staff as you go along. You don’t have to guess at things you don’t understand. Ask the people doing the study to explain things in a way you can understand. After you read this form, you can: Take your time to think about it. Have a friend or family member read it. Talk it over with someone you trust.

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251 Appendix L (Continued) It’s up to you. If you choose to be in the study, then you can sign the form. If you do not want to take part in this study, do not sign the form. Why is this research being done? The purpose of this study is to find out wh at and how emergency contraception course content is taught at accredited schools of pharm acy as perceived by third or fourth year pharmacy students. In reaching this aim, you are being asked to participate in an hour long focus group where you will be asked questions about the pharmacy school instruction and course content related to emergency contraception. The focus group discussions will be tape recorded but no identi fying information will be used or linked to the study results. Why are you being asked to take part? We are asking you to take part in this study b ecause you are a third or fourth year Pharm. D. student enrolled at an accredited school of pharmacy. We want to find out more about what type of emergency contraception in struction you were taught in your pharmacy school classes. How long will you be asked to stay in the study? You will be asked to spend about 1.5 hours in this study. The focus group itself will run about one hour. The other thirty minutes wi ll be spent at the beginning of the focus group acquainting each other and explaining th e process of the focus group discussion. How often will you need to come for study visits? A study visit is one you have with the person in charge of the study or study staff. You will need to come for one study visit in all and that is today for the focus group discussion. Questions will be asked pertaining to course instruction on emergency contraception in your pharmacy school classes such as any lectures, course assignments, and discussions that you may have had in class. Questions will inquire about what you learned, what and how you were taught, and questions will al so ask about your projected dispensing practices and perceptions of emergency contraception. What other choices do you have if you decide not to take part? If you decide not to take part in this study, that is okay. There are no other choices, such as becoming involved in another focus group, that are offered by this study. How do you get started? If you decide to take part in this study, you will need to sign this consent form. After consenting, you will be able to participate in the focus group.

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252 Appendix L (Continued) What will happen during this study? During the study, you will be asked questions pe rtaining to your course instruction at your institution in a group setting. Here is what you will need to do during this study In order to take part in the study, all you have to do is participate in the group discussion that will last about an hour. Will you be paid for taking part in this study? We will pay you for the time you volunteer in this st udy in the form of a $10 gift card to Starbucks. You will be given the gift card pr ior to your participation in the focus group. What will it cost you to take part in this study? It will not cost you anything to take part in the study. What are the potential benefits if you take part in this study? Although there will not be any immediate benefit to you, your participation in this study will be helpful in understanding pharmacy school curricula and course content related to emergency contraception and will advance the state of knowledge in this area. Your participation is greatly appreciated. What are the risks if you take part in this study? There are no known risks to those who take part in this study. What will we do to keep your study records private? Federal law requires us to k eep your study records private. All identifying information will be kept confidential and will not be disse minated with the research findings. Your name or school affiliation will not be used or linked to the study results. However, certain people may need to see your study r ecords. By law, anyone who looks at your records must keep them confidential. The only people who will be allowed to see these records are: The study staff. People who make sure that we are doing the study in the right way. They also make sure that we protect your rights and safety: o The USF Institutional Review Board (IRB) o The United States Department of Health and Human Services (DHHS) We may publish what we find out from this study. If we do, we will not use your name or anything else that woul d let people know who you are.

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253 Appendix L (Continued) What happens if you decide not to take part in this study? You should only take part in this st udy if you want to take part. If you decide not to take part: You won’t be in trouble or lose any rights you normally have. What if you join the study and then later decide you want to stop? If you decide you want to stop taking part in the study, tell the study staff as soon as you can. We will tell you how to stop safely. We will tell you if there are any dangers if you stop suddenly. Are there reasons we might take you out of the study later on? Even if you want to stay in the study, there may be reasons we will need to take you out of it. You may be taken out of this study: If we find out it is not safe for you to stay in the study. For example, your health may get worse. If you act in an inappropriate manner in the focus group discussions. You can get the answers to your questions. If you have any questions about this study, call Alice Richman at (813) 732-1903. If you have questions about your rights as a person who is taking pa rt in a study, call USF Research Compliance at (813) 974-5638. Consent to Take Part in this Research Study It’s up to you. You can decide if you want to take part in this study. I freely give my consent to take part in this study. I understand that this is research. I have received a copy of this consent form. ________________________ ________________________ ___________ Signature Printed Name Date of Person taking part in study of Person taking part in study Statement of Person Obtaining Informed Consent I have carefully explained to the person taki ng part in the study what he or she can expect. The person who is giving consent to take part in this study Understands the langu age that is used. Reads well enough to understand this form. Or is able to hear and understand

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254 Appendix L (Continued) when the form is read to him or her. Does not have any problems that could ma ke it hard to understand what it means to take part in this study. Is not taking drugs that make it hard to understand what is being explained. To the best of my knowledge, when this pe rson signs this form, he or she understands: What the study is about. What needs to be done. What the potential benefits might be. What the known risks might be. That taking part in the study is voluntary. ________________________ _____________________________ __________ Signature of Investigator Printe d Name of Investigator Date or authorized research investigator designated by the Principal Investigator

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255 Appendix M. Final Pharmacist Pre-Notice Letter* Date Inside Address A few days from now you will receive in the mail a request to fill out a brief questionnaire for an importan t research project being c onducted by the University of South Florida. It concerns the perceptions and experiences of pharmacists in rela tion to dispensing the medication emergency contraception. I am writing in advance because we have found many people like to know ahead of time that they will be contacted. The study is an important one that will help add to the body of knowledge on pharmacists and dispensing prac tices. The study is also anonymous as your name, pharmacy, or affiliations will be ke pt confidential and will not be linked to the study results. Thank you for your time and consideration. It ’s only with the generous help of people like you that our research can be successful. Sincerely, Alice R. Richman University of South Florida College of Public Health *The template for this letter was taken from Dillman (2000).

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256 Appendix N. Final Pharmacist Informed Consent Form Researchers at the University of South Flor ida (USF) study many topi cs. In this study, we want to learn more about pharmacists’ pe rceptions and experien ces and how they may or may not impact emergency c ontraception dispensing practices. Title of research study: The Role of Pharmacists and Emergency Contraception: An Assessment of Pharmacy School Curricula in the U.S. and the Knowledge, Attitudes, and Dispensing Practices of Florida Pharmacists. Person in charge of study: Alice R. Richman, MPH, Ph.D. Candidate Study staff who can act on behalf of the person in charge: Ellen Daley, Ph.D., MPH Where the study will be done: In the State of Florida The purpose of this study is to understand pharmacists’ perceptions and experiences surrounding emergency contraception and to understand how these perceptions are related to dispensing practices. This study involves sending a questionnaire to pharmacists registered with the Florida Board of Pharmacy. Questions on the survey inquire about issues of perceptions about emergency contraception and your dispensing practices of the medication. Questions also request some demographic information; however any identifying information including your name or pharmacy will be kept confidential and all data will be de-identified meaning it will be rendered anonymous and will not be linked to the study results. The survey should take you about 10 minutes to complete. You may decline to take part in this study. You will neither be compensated nor have to pay anything to participate in this study. Although your partic ipation will not accrue any immediate benefit to you, your pa rticipation in this study will be helpful in understanding pharmacists’ perceptions and dispensing pract ices related to emer gency contraception and will advance the state of knowledge in th is area. Your participation is greatly appreciated. There are no known risks to those who take part in this study. We may publish the results and findings from this study. If we do, we will not use your name or anything else that w ould let people kno w who you are. Authorized research personnel, employees of the Department of Health and Human Services, and the USF Institutional Review Boar d and its staff, and any other individuals acting on behalf of USF, ma y inspect the records from this research project. If you have any questions about this study, call Alice R. Richman at (813) 732-1903 or Ellen Daley at (813) 974-8518. If you have questions about your rights as a person who is taking pa rt in a study, call USF Office of Research Comp liance at (813) 974-5638. Thank you so much for your time and participation.

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257 Appendix O. Final Cover Letter to Pharmacists* Inside Address I am writing to ask your help in a study of pharmacists being conducted by researchers from the University of South Florida (U SF). This study aims to understand Florida pharmacists’ perceptions of emergency c ontraception and their dispensing practices. It’s my understanding that you are a pharmacist practicing in Florida. We are contacting a random sample of pharmacists in Florida and are requesting that they help us by completing a brief questionnaire on their per ceptions and dispensing practices concerning emergency contraception. Results from the survey will be used to understand pharmacists’ perceptions and dispensing practices related to emergency c ontraception and will advance the state of knowledge in this area. Your part icipation is greatly appreciated. Your answers are completely anonymous a nd no identifying information about you will be collected. This survey is voluntary. However, you can help us very much by taking a few minutes to share your perceptions a bout emergency contraception with us. There is a paper survey attached in this pa cket for you to fill out and return in the enclosed and stamped envelope. If you have any questions or comments about this study, we would be happy to talk with you. Feel free to call Alice R. Richman at (813) 732-1903 or contact via email at arichman@health.usf.edu Thank you very much for helping with this important study. Sincerely, Alice R. Richman University of South Florida *The template for this letter was taken from Dillman (2000).

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258 Appendix P. Final Pharmacist Survey Thank you for taking the time to complete this survey. Your opinions and responses are important to us. All responses will rem ain anonymous. Please complete this survey and return it in the enclosed self-addressed and stamped envelope. In order to complete this survey, please circle the number that corresponds to the answer you choose or if there is no numb er listed, please write in your answer. First, I’d like to ask you some quest ions about your practice and workplace. 1. How many years have you been a pr acticing registered pharmacist? ____ year/years 2. The type of pharmacy where you work coul d be best described as (if you have more than one job, please ci rcle the number that corre sponds to your primary type of pharmacy) ____ 1 Community -Chain ____ 2 Community -Independent ____ 3 Hospital ____ 4 Government (e.g., US Public Health Service, military) ____ 5 Indian Health Service ____ 6 Not currently work ing in a pharmacy ____ 7 Other: Please specify _______________________ 3. What is your job title? ____ 1 Staff Pharmacist ____ 2 Pharmacy Manager ____ 3 Other: Please specify _______________________ 4. What is your current employment status? ____ 1 Full-time ____ 2 Part-time ____ 3 Retired 5. Does your pharmacy stock any of the following products? Condoms ____1 Yes ____0 No Spermicide ____1 Yes ____0 No Oral contraceptive pills ____1 Yes ____0 No 6. Does your pharmacy stock Plan B? ____ 1 Yes ____ 0 No

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259 Appendix P (Continued) 7. Have you ever been asked to fill a prescription of Plan B? ____ 1 Yes ____ 0 No 8. Have you personally ever filled a prescription of Plan B? ____ 1 Yes ____ 0 No (skip to question #10) 9. Approximately how many Plan B prescriptio ns have you personally filled in the past 12 months? ____________ 10. Have you ever been asked to sell Plan B over-the-counter ? ____ 1 Yes ____ 0 No 11. Have you personally ever sold Plan B over-the-counter ? ____ 1 Yes ____ 0 No (skip to question #13) 12. Approximately how many times have you sold Plan B over-the-counter in the past 12 months? ____________ 13. Would you ever have the opportunity at your workplace to come in contact (sell, dispense, fill a prescription) of Plan B? ____ 1 Yes ____ 0 No Next, I would like to ask you about your intention to dispense Plan B to each of the following groups. Please check the box that co rresponds to the answer you choose. To what extent are you likely to sell Plan B over-the-counter to… Very Unlikely Somewhat Unlikely Somewhat Likely Very Likely N/A 14. Women who have experienced incest or rape. 15. Women who have experienced a problem with their birth control method. 16. Women who request the method after having unprotected sexual intercourse. 17. A person other than the ultimate consumer of the product such as parents or a boyfriend.

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260 Appendix P (Continued) To what extent are you likely to dispense Plan B by prescription to… Very Unlikely Somewhat Unlikely Somewhat Likely Very Likely N/A 18. Women who have experienced incest or rape. 19. Women who have experienced a problem with their birth control method. 20. Women who request the method after having unprotected sexual intercourse. 21. Sexually active teens under age 18. Now I’d like to ask you some questions about what you generally know about Plan B. Please answer these questions to the best of your ability without looking up the answer. 22. How many pills are in a Plan B package? ____ 1 One ____ 2 Two ____ 3 Three ____ 4 Four ____ 5 Five ____ 6 Six ____ 7 Twelve ____ 8 Not Sure 23. According to the Plan B label, Plan B is effective if taken within how many hours of unprotected intercourse? ____ 1 Up to 12 hours ____ 2 Up to 24 hours ____ 3 Up to 36 hours ____ 4 Up to 72 hours ____ 5 Not Sure 24. Plan B prevents pregnancy via wh ich of the following mechanisms? ____ 1 Inhibition or delay in ovulation ____ 2 Disruption of an implanted embryo ____ 3 Changes in the endometr ial lining of the uterus ____ 4 All of the above ____ 5 Not sure

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261 Appendix P (Continued) 25. According to the Plan B label, what pe rcentage of the time does Plan B prevent pregnancy if used properly? ____ 1 <25% ____ 2 25%-49% ____ 3 50%-74% ____ 4 75%-89% ____ 5 >89% 26. Sales of Plan B to eligible consumers may be made by: ____ 1 Pharmacists only ____ 2 Pharmacists or pharmacy technicians only ____ 3 Any member of the pharmacy staff working behind the pharmacy counter, as long as a pharmacist is on duty ____ 4 Sales clerks, but only if a pharmacist is not on duty 27. A woman asking to buy Plan B in advance of need: ____ 1 Must wait for a contraceptive emergency before buying it ____ 2 Should be advised to take a pregnancy test before taking it ____ 3 May purchase more than one package ____ 4 Can only make a purchase if she is using it for herself 28. When selling Plan B without a prescription to a man, pharmacists: ____ 1 Need to see proof that he is at least 18 years of age ____ 2 Must limit sales to one package ____ 3 Must ask for the name of the person who will be taking the product ____ 4 Are violating the law Do you think the following statements are true or false? 29. Plan B can cause birth defects if taken by a pregnant woman. ____ 1 True ____ 2 False ____ 3 Not sure 30. Plan B can act as an abortifacient. ____ 1 True ____ 2 False ____ 3 Not sure 31. The sooner a woman takes Plan B, the more effective it will be. ____ 1 True ____ 2 False ____ 3 Not sure

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262 Appendix P (Continued) The next few questions will ask you about how you personally feel about Plan B. Please check the box that corresponds to the answer you choose. Completely Disagree Somewhat Disagree Neither Agree nor Disagree Somewhat Agree Completely Agree 32. Easy availability of Plan B will discourage regular contraceptive use. 33. Easy availability of Plan B promotes promiscuity. 34. I feel uncomfortable dispensing Plan B because of my religious/ethical beliefs. 35. Repeated use of Plan B is wrong. 36. I feel comfortable dispensing Plan B to adult women. 37. I feel comfortable dispensing Plan B to adolescents (teens <18 years old). 38. I feel comfortable dispensing Plan B to men. 39. Should Plan B be offered to women w ho are raped in all hospital emergency rooms, regardless of hospital affiliation? ____ 1 Yes ____ 2 No ____ 3 Not sure

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263 Appendix P (Continued) The next questions will ask you about your perceptions of what other people think. The people and groups listed below may be influ ential in your dispensing decision-making. Please indicate (by checking the box) how you think the following consider Plan B dispensing practices, either by prescription or over-the-counter. Definitely Should Not Probably Should Not Probably Should Definitely Should 40. My partners/business colleagues think that I _________ dispense Plan B. 41. The professional organization I am most active in recommends that I dispense Plan B. 42. My supervisor thinks that I dispense Plan B. 43. In general, my close friends and family think that I_________ dispense Plan B. 44. Is there anyone in your pharmacy w ho refuses to dispense Plan B? ____ 1 Yes ____ 2 No ____ 3 Not sure ____ 4 My pharmacy does not carry Plan B 45. Is there a policy in place at your pharmacy if someone refuses to dispense Plan B? ____ 1 Yes ____ 2 No ____ 3 Not sure ____ 4 My pharmacy does not carry Plan B Some pharmacists may feel that where they work a ffects their dispensing pr actices of Plan B. The following questions will ask you about y our comfort level in dispensing Plan B.

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264 Appendix P (Continued) How easy is it for you to… Very Difficult Somewhat Difficult Somewhat Easy Very Easy N/A 46. Counsel clients about Plan B. 47. Refuse to dispense Plan B. 48. Educate clients about Plan B. 49. Dispense Plan B. The last group of questions will as k some basic questions about you. 50. What is your gender? ____ 1 Female ____ 2 Male 51. How old are you? ____________ 52. What pharmacy school did you graduate from? ________________________ 53. What year did you graduate from pharmacy school? ____________ 54. How would you describe your self (choose only one)? ____ 1 Religious ____ 2 Spiritual ____ 3 Religious and Spiritual ____ 4 Undecided ____ 5 None of the above ____ 6 Prefer not to respond 55. Which religious group do you most closel y identify with (choose only one)? ____ 1 Roman Catholic ____ 2 Baptist ____ 3 Methodist ____ 4 Episcopalian ____ 5 Lutheran ____ 6 Quaker ____ 7 Presbyterian ____ 8 Assembly of God ____ 9 Hindu ____ 10 Buddhist

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265 Appendix P (Continued) ____ 11 Jewish ____ 12 Islamic ____ 13 Mormon ____ 14 Non-Denominational ____ 15 None ____ 16 Prefer not to respond ____ 17 Other please specify (___________________) 56. What is your race/ethnicity (choose all that apply)? ____ 1 Caucasian ____ 2 African American ____ 3 Hispanic ____ 4 Asian ____ 5 Other please specify (___________________) 57. What is your current marital status? ____ 1 Married ____ 2 Living with a partner ____ 3 Divorced ____ 4 Separated ____ 5 Widowed ____ 6 Never been married 58. What is your political affiliation? ____ 1 Republican ____ 2Democratic ____ 3 Independent ____ 4 Green Party ____ 5 None/Undecided ____ 6 Other please specify (___________________)

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266 Appendix Q. Pharmacist Thank you/Reminder Postcard* Date Last week, a questionnaire seeking your pe rceptions about emergency contraception was mailed to you. Your name was randomly drawn from a list of all pharmacists registered with the Florida Board of Pharmacy. If you have already completed and returned the questionnaire to us, please accept our sincere thanks. If not, please do so today. We are especially grateful for your help because it is only by asking people like you to share your thoughts and experiences that we can understand pharmacists’ perceptions and practices concerning emergency contraception in the state of Florida. If you did not receive a questionnaire, or if it was misplaced, pl ease call Alice R. Richman (813) 732-1903 and we will get anothe r one in the mail to you today. Also, you are welcome to go online at www.ultimatesurveyor.com and complete the survey there. Alice R. Richman University of South Florida *The template for this letter was taken from Dillman (2000).

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267 Appendix R. Panel of Experts Q&A Questions for Pharmacist Panel of Experts Combined Interview Responses 1) Male ( blue ) 2) Male ( purple ), 3) Female ( green ) Male works at a CVS in Boston, MA Male who works at Walgreens in Lakeland, Florida Female works at Kaiser and formally worked with Kroger (Kings Super) Date: May 26, 2006 General Questions: 1. Is there a National professi onal society or association that impacts/establishes policy re: pharmacist practices? #1: The American Pharmaceutical Association (APhA) has a big impact politically as they work at the national level but most pharmacies are regulated by their local state Board of Pharmacies. In fact, pharmacies in general are regulated more by state law then from national policy. #2: There are national pharmacy organizations but pharmacist procedures come from the State Board. Each state has its own Bo ard of Pharmacy. First there are federal laws created and then each state makes sure the laws are followed. #3 No, there isn’t one large association that impacts policy but there is APha. Female thought that the employer can influence polic y over anyone else (over both the state and the national authorities) Knowledge Questions: 2. When you were in school, what courses taught you the pharmacology of basic pharmaceuticals? What courses taug ht you about ethics and legality? #1: Male didn’t exactly remember wh ich courses taught hi m basic pharmacology because he’s been practicing pharmacy since 1975 but he remembers biology, chemistry, and biochemistry as the courses that covered this material. Also he thinks that now pharmacy students get this info rmation from courses on biotheraputics and pharmacology. Male remembers taking a pharm acy law class that taught him about pharmacy ethics and legality but now he thi nks Pharmacy schools o ffer ethics classes.

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268 Appendix R (Continued) #2: Pharmacotherapy covered the pharmacology of basic pha rmaceuticals and he took 2 semesters of pharmacy law that taught ethi cs and legality. He also mentioned that information on ethics was worked in to case studies and group assignments from other classes. He did not take an ethics course. Pharmacotherapy: teaches which drugs cure which disease Medical Chemistry: teaches how drugs work chemically Pharmacology: teaches how drugs work in body #3: Pharmacology taught her the basic pharmacology of pharmaceuticals and she’s had no formal ethics class though she thinks that in her pharmacy management class, they may have discussed ethics. She did ta ke pharmacy law that discussed dispensing issues. She was in school 20 years ago so she thought it was a little difficult to remember. As I also plan to do a curriculum review of the accredited schools of pharmacy in the U.S., what courses should I be looki ng for that teach the pharmacology or mechanism of EC and what courses may teach the ethics or lega lity of dispensing or not dispensing a medication? #1: Male has been out of school for t oo long to answer this question. #2: The pharmacology or mechanism of EC was taught in pharmacotherapy and ethics or legality of dispensing was learned in law class (when it’s okay not to fill) but Male said that ethics were applied thr oughout curriculum and he did not have an ethics class. #3: She thinks that pharmacology is the cour se that will teach the mechanism of EC and pharmacy law may teach the ethics or le gality of dispensing EC. When she went to school, she was just taught about disp ensing; now students learn a lot more. 3. How do pharmacists acquire the required CEUs? How many are needed per year? #1: Male is a pharmacist in Boston, Massac husetts, and he needs 15 per year. And 5 of those 15 credits must be live and 2 must be about pharmacy law. Most CEUs are good for 2 credits (2 hours) and he can do them on the internet by reading an article and answering questions or can attend conferences for example. He receives mailings for different programs offering CEUs and he can find out about CEUs from Journals. He has noticed that there ar e a lot on EC dispensing, especi ally since Massachusetts is about to have Collaborative Drug Therapy Agreements (CDTA) where a pharmacist will be able to counsel and prescribe EC at a pharmacy in conjunction with a physician. He mentioned one CEU course on EC dispensing training offered through Northeastern University : www.ace.neu.edu/rxce/index.php

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269 Appendix R (Continued) #2: Regular pharmacists need 12 hours/year in Florida. A consulting pharmacist, like a pharmacist who works in a nursing home checking charts of patients, needs 24 hours/year. 5 credits must be live, 2 credits must involve AI DS or terminal illnesses, and 1 credit must involve medication errors. Pharmacists can find CEUs online, from the Hills County Pharmacy Association Office. Also, national organizations have m eetings twice per year and he can get all live credits for a 2 year period completed in one conference. (Random note: pharmacists call CEUs, CEs.) #3: Pharmacists in Colorado need 12 CEUs per year and these contact hours can be procured however they want. Colorado doesnt differ between live and not live. She procures her CEUs from a J ournal she prescribes to called Pharmacist Letter It comes out monthly and covers all sorts of issu es and then she takes the quiz at the end and gets her CEU credits. The remainder of her CEUs comes internally from Kaiser. Here is the information for CEUs for Fl orida Pharmacists as found on the Florida Board of Pharmacy Florida De partment of Health website http://www.doh.state.fl.us/mqa/pharmacy/phceu.html Pharmacist: 30 hours of CE per bie nnium (two year licensure period) ten (10) hours must be live, one (1) hour HIV/AIDS, and 2 hours Pharmaceutical Education on medication errors per biennium (maybe counted toward required CE hours). 4. What are the typical journals that pharm acists read? In your opinion, do they tend to read practice or professional journals? Or is there even a distinction made? a. What kinds of issues are out there being circulated in the field, for example are there a lot of reproductive, contraception, or reproductive pharmaceutical related articles? #1: Typical Journals include Application of Clinical Pharmacy, Pharmacy Times, or American Druggists. There is no real distinction made between practice or professional journals and there are not a lo t of reproductive or contraception related articles out there. He guesses that th e amount of reproductive related articles is within the accepted percentage for the Journals He also noted that he doesnt read a lot of Journals and if he does, its for CEU credits. #2: Male says that some pharmacists read the same main medical journals as we do such as New England Journal of Medicine, AGHP, and American Pharmacist Association. He says that these Journals are more research based. Then there are other Journals such as Pharmacy Today a nd Drug Topics that keep pharmacists up-todate on new drugs and medications He says that these Journals are sent to Walgreens for free.

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270 Appendix R (Continued) In terms of reproductive related articles in J ournals he said that whatever is typically in the news is also in the Journals. He remembers seeing a lot of EC related articles when it almost went OTC in the general news. #3: Pharmacists typically read Pharmacy Times or the Journal put out by APha. Pharmacists read both practice and professi onal journals and she doesn’t think that there is a distinction made between the two. Female doesn’t think that there are a lo t of reproductive pharmaceutical related articles out there and since we last spoke sh e’s kept her eye out for articles on EC and hasn’t noticed any. 5. How do pharmacists get information on cha nges to contraception (for example the upcoming change of birth control pills) ? How do pharmacists find out about all new medications? #1: Surprisingly, no one ever really tells pharmacists about changes to medication. He will typically notice a change on a prescription a doctor writes and then if he doesn’t recognize the prescrip tion or drug he will sometimes tries to self educate through looking medication up. Some drug sa lespeople do come by the store but he doesn’t usually talk to them because they are just pushing their drug. Sometimes, CVS will send a corporate letter saying wh at new drugs they will be carrying. #2: Both changes to medication and ne w medications are found out through the following avenues: i. Package inserts on the new drugs when they arrive at the store ii. Drug companies will send information to pharmacists iii. Magazines will talk about new magazines iv. CEUs may come out on the particular drug or topic #3: Pharmacists get information on changes to contraception from the following mechanisms: Reading Journals See new prescription that was written See it through practice When she worked with Kroger, she f ound out about new medications through drug reps and Journals but now that she works for Kaiser it’s a closed formulary so no reps are allowed. Attitude Questions: 6. Is there a National policy or c ode of ethics for pharmacist?

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271 Appendix R (Continued) #1: He thinks that there is something lik e the Hippocratic Oath for pharmacists but doesn’t know for sure. He recommends that we search for a code of ethics by state because everything is deferred to the state le vel. He also thinks that CVS has its own code of ethics and he’s going to search for it and send it to me if he can find it. #2: Yes, there is a code of ethics for pharmacists (he’s goi ng to see if he can find it). It’s given to pharmacy students when they start the program and when they graduate. #3: Yes, they say it when students graduate from pharmacy school (she’s going to try and find it and get back to me). 7. How would you say an individual’s moral or ethical beliefs would impact their professional practice as a pharmacist? #1: Male thinks that it’s de pendent on where you live. He noted that Boston is very open and liberal and he doesn’t think that professional opin ion affects practice. He talked about women getting repeat prescrip tions of EC and how that bothered him a little bit but he never has changed his dispensing practices At the same time, he also said that there are some people who will not dispense birth control pills or EC. (These seem to be conflicti ng statements that on the one ha nd he says that he doesn’t think beliefs impact practi ce but then on the other hand he has heard of people who will not dispense BCPs). #2: Male thinks that BC and EC are the only times that moral or ethical beliefs would impact professional practice but he also me ntioned that there is sometimes an issue with pain killers/relievers and cancer patie nts but not as much as with BC and EC. He has never known anyone who refused to fill prescriptions but he has heard of it a lot around Lakeland. He knows of one Publix in Lakeland doesn’t stock EC because the pharmacist will not fill EC. So, Publix then sends these customers to Walgreens to fill the prescription. Becau se his store has 24 hour access, they have 3 pharmacists around and available so if one person will not fill it, someone else will. #3: Female thinks that an individual’s mo ral or ethical beliefs are impacting practice more than it use to, that is, you are more like ly to see refusal to fill now then before. She said that it use to be that you got a pr escription and you filled it. Now a pharmacist has the option to refuse ba sed on ethical, moral, or drug based (contraindications) reasons. Kaiser has no policy or record and no sugge sted policy but Kroger did have a policy that was not accessible to the public. The policy was that if you refuse to fill a prescription, it’s your responsibility to find someone who would fill it, either within

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272 Appendix R (Continued) your own pharmacy or some other nearby pha rmacy. So, for example, Walmart (who up until recently did not carry EC) would call Kroger with a client asking to fill EC. She herself has never known anyone to refuse but has heard about it. Dispensing Practice Questions: 8. What are the general policies on dispen sing at pharmacies? Is the policy corporate or state-driven? Is it accessible to the public? #1: There is no general policy on dispensing at CVS. Dispensing hasn’t been a real issue or problem so there’s been no polic y created BUT there has been a suggested method of handling a situation where a pharmacists is uncomfortable filling a prescription for religious or moral re asons. CVS suggested that if you’re uncomfortable filling a prescription (for relig ious or moral reasons ), you first see if someone else is available to fill it (For Male at his CVS, there’s only 1 pharmacist on duty at any given time so there wouldn’t be a nyone to fill it). Then, if there’s no one else to fill it, you give the cl ient directions to another CV S store where they will fill it. This is the suggested guideline by CV S as they sent a letter around, but no formal policy has been set yet. He also noted that policy is corporate dr iven and is not accessible to the public. This is very interesting to me, that they suggest wome n to go to another pharmacy. How would this policy be affective in rural areas? #2: There are no policies on dispensing at Walgreens though he feels that Walgreens would not be happy if you refuse to fill a pr escription especially after hearing about how pharmacies were sued for it. If the pharmacy doesn’t stock it, then they send women to another store that does. Male told me that he doesn’t agree with EC unless in cases of rape. He thinks that his store gets about 1 or 2 pres criptions of EC per month. #3: There are no real policies created until there’s a problem. No company policy at Kaiser but at Kroger there was one. If there is a policy, it’ s corporate and not accessible to the public. 9. How do you think corporate policy affects personal behavior? #1: Male believes that corporate policy would be a VERY STRONG motivator that affects personal behavior and he noted that you can not buck the system very long until you will get thrown out.

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273 Appendix R (Continued) #2: He thinks that fear of losing your job does have a large affect on personal behavior and he also thinks that if there were no cons equences that more people would refuse to fill it. #3: She thinks that corp orate policy does affect personal behavior by making pharmacists aware of the need to take care of the client regardless of personal beliefs. 10. What is the recourse or ramifications if you refuse to fill a prescription for a client? In your opinion, why would a pharmacist not want to fill a prescription? #1: If you refuse to fill a prescription, you n eed to find another person or pharmacy to fill it. If Males opinion, a pharmacist may not want to fill a prescription based on: Religious Beliefs Moral Beliefs Political Beliefs #2: Male thinks that if you refuse to fill a prescription for a client that it would depend on the situation but he thinks that you may lose your job over it. He heard that Eckerd fired someone fo r not filling a prescription. In his opinion, a pharmacist would not fill a prescription due to religious or moral reasons. Also, if the patient is currently taking one drug and the prescription is for another drug that could harm the patient if these drugs were taken together, that is another reason for refusal (har m to the patient or contrai ndications). An example of this is that he’s refused Viagra to some one before b/c the combination of his two medications is known to be lethal. #3: She thinks that refusing to fill pres criptions may be breaking state law and may result in a termination of your job but she doesn’t know. A pharmacist may not want to fill a prescr iption based on moral or pro-life beliefs. 11. Are all OTC medications placed differently in a pharmacy? Meaning, are all OTC medications placed in front the c ounter or are some placed behind the counter. If some are placed in front and some behind, what distinguishes these differences? #1: The only OTC medications required to be behind the counter are tobacco and Sudafed. However, some medications are placed behind the counter because they are worth a lot of money and people try to steal them. For example, powdered baby formula and crest white strips are held behi nd the counter because of their high ticket

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274 Appendix R (Continued) value and because they will walk right out the door if not held behind the counter. Male believes if EC ever went OTC that it would be held behind the counter as well. #2: In the past, all OTC medications were pl aced in front of the counter but now they have to keep Sudafed behind the counter. They also place home drug tests behind the counter because people were stealing them. #3: Sudafed is the OTC drug required to be behind the counter but sometimes high priced items such as nicoderm and diabetic supplies will be be hind the counter. She also thinks that if EC with OTC, that it would be held behind th e counter b/c it would be in little packages that would be easy to steal. Final Questions: 12. In the survey of pharmacists, we will need to ask questions about knowledge, attitudes, and dispensing pract ices of EC. Can you help think of ways to ask these questions most effectively to pharmacists (have some examples ready to help prompt ideas including existing questions on these variables as well as factors such as age of recipient, repetition of filling prescription, and OTC status)? #1: Male said that he would be willing to edit some questions on the survey after we put it together and provide s uggestions if the questions don ’t seem to ask what we think they’re asking. #2: Male mentioned that he is willing to help with the survey development when we have some questions for him to look at. He also mentioned, like Male, that if he saw a woman using EC repeatedly, he may choose to talk to her or to contact her doctor to have him/her talk to the patient. He also noted that there may have been negative attitudes towards HIV/AIDS patients thinking that they were promiscuous or dirty because they had HIV/AIDS but he said th at think negative thinking was cleared up. His email address is: buie933@hotmail.com #3: If there are what a pharmacist perceives to be too many refills, some pharmacists personally call the doctor to make sure th at’s what they meant to write on the prescription. Also if a pharmacist notices that a woman is getting EC twice/month, she has called her doctor and spoken to the doctor before. (I think Female was telling me that she herself has called a doctor before to qu estion why a women has been using EC repeatedly—this finding was in the ot her interviews and is interesting)

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275 Appendix R (Continued) 13. Is it possible that I call you or email you a couple more questions in a few weeks if I need to? #1: Yes, Male is more than willing for me to call him with questions anytime. #2: Yes. #3: Yes. She’s very intere sted in seeing the survey. 14. Do you have any questions for me? #1: No. #2: No. #3: No. Other: #1: He noted that pharmacy is very regulated by drug companies and corporations. Noted that they don’t have acces s to the internet at work because they run a very tight system (Condour System) There are 5,000 CVS stores Additional website to check out: CVS.net (find CVS learn net) for good pharmacy information 6 of the top 18 drugs filled are birth control pills Most prescriptions for EC are filled on Monday and Tuesday (right after the weekend). He fills around 5 on Monday and 2-3 on Tuesday. #2: Male Graduated in 2001 but then chose to do a 1-year residency to become more specialized in community pharmacy. He received his education from University of Florida (one of th e 4 accredited Schools of Pharmacy in Florida).

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276 Appendix S. (p. 276-284) Table 54. Description of Survey Variables Model Item (Question) Responses Level of Measurement I. Background Variables Gender What is your gender? Female/Male Nominal Age How old are you? List age Ratio Ethnicity What is your race/ethnicity (choose all that apply)? ____ 1 Caucasian ____ 2 African American ____ 3 Hispanic ____ 4 Asian ____ 5 Other please specify (___________________) Nominal Years in Practice How many years have you been a practicing registered pharmacist? list # of years Ratio Type of Pharmacy The type of pharmacy where you work could be best described as (if you have more than one job, please circle the number that corresponds to your primary type of pharmacy) ____ 1 Community -Chain ____ 2 Community -Independent ____ 3 Hospital ____ 4 Government (e.g., US Public Health Service, military) ____ 5 Indian Health Service ____ 6 Not currently working in a pharmacy ____ 7 Other: Please specify Nominal

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277 Marital Status What is your current marital status? ____ 1 Married ____ 2 Living with a partner ____ 3 Divorced ____ 4 Separated ____ 5 Widowed ____ 6 Never been married Nominal Religion Which religious group do you most closely identify with (choose only one)? ____ 1 Roman Catholic ____ 2 Baptist ____ 3 Methodist ____ 4 Episcopalian ____ 5 Lutheran ____ 6 Quaker ____ 7 Presbyterian ____ 8 Assembly of God ____ 9 Hindu ____ 10 Buddhist ____ 11 Jewish ____ 12 Islamic ____ 13 Mormon ____ 14 NonDenominational ____ 15 None ____ 16 Other please specify ( ) Nominal Religiosity How would you describe yourself (choose only one)? ____ 1 Religious ____ 2 Spiritual ____ 3 Religious and Spiritual ____ 4 Undecided ____ 5 None of the above 6 Prefer not to respond Nominal Political Affiliation What is your political affiliation? ____ 1 Republican ____ 2Democratic ____ 3 Independent ____ 4 Green Party ____ 5 None/Undecided ___ 6 Other please specify ( ) Nominal Employment Status What is your current employment status? ____ 1 Full-time ____ 2 Part-time ____ 3 Retired Nominal

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278 Pharmacy School Attended What pharmacy school did you graduate from? Open-ended Nominal Year of Graduation What year did you graduate from pharmacy school? List year Ratio Job Title What is your job title? ____ 1 Staff Pharmacist ____ 2 Pharmacy Manager ____ 3 Other: Please specify _______________________ Nominal II. Dispensing Practices Does your pharmacy stock any of the following products? Condoms Spermicide Oral contraceptive pills Yes/No Nominal Does your pharmacy stock Plan B? Yes/No Nominal Have you personally ever filled a prescription of Plan B? Yes/No Nominal Have you ever been asked to fill a prescription of Plan B? Yes/No Nominal Approximately how many Plan B prescriptions have you personally filled in the past 12 Open-ended Ratio

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279 months? Have you ever been asked to sell Plan B over-the-counter ? Yes/No Nominal Have you personally ever sold Plan B over-the-counter ? Yes/No Nominal Approximately how many times have you sold Plan B over-thecounter in the past 12 months? Open-ended Ratio Would you ever have the opportunity at your workplace to come in contact (sell, dispense, fill a prescription) of Plan B? Yes/No Nominal III. Intention to Dispense Plan B To what extent are you likely to sell Plan B over-the-counter to… 4-point Likert Scale, with 1 = Very Unlikely, 2= Somewhat Unlikely, 3= Somewhat Likely, 4= Very Likely, 5=N/A Women who have experienced incest or rape. Women who have experienced a problem with their birth control method. Women who request the method after having unprotected sexual intercourse. A person other than the ultimate consumer of the product such as parents or a boyfriend. Ordina/Interval

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280 To what extent are you likely to dispense Plan B by prescription to 4-point Likert Scale, with 1 = Very Unlikely, 2= Somewhat Unlikely, 3= Somewhat Likely, 4= Very Likely, 5=N/A Women who have experienced incest or rape. Women who have experienced a problem with their birth control method. Women who request the method after having unprotected sexual intercourse. Sexually active teens under age 18. Ordinal/Interval IV. Knowledge How many pills are in a Plan B package? ____ 1 One ____ 2 Two ____ 3 Three ____ 4 Four ____ 5 Five ____ 6 Six ____ 7 Twelve 8 Not Sure Nominal According to the Plan B label, Plan B is effective if taken within how many hours of unprotected intercourse? ____ 1 Up to 12 hours ____ 2 Up to 24 hours ____ 3 Up to 36 hours ____ 4 Up to 72 hours ____ 5 Not Sure Nominal Plan B prevents pregnancy via which of the following mechanisms? ____ 1 Inhibition or delay in ovulation ____ 2 Disruption of an implanted embryo ____ 3 Changes in the endometrial lining of the uterus ____ 4 All of the above 5 Not sure

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281 Sales of Plan B to eligible consumers may be made by: ____ 1 Pharmacists only ____ 2 Pharmacists or pharmacy technicians only ____ 3 Any member of the pharmacy staff working behind the pharmacy counter, as long as a pharmacist is on duty ____ 4 Sales clerks, but only if a pharmacist is not on duty Nominal According to the Plan B label, what percentage of the time does Plan B prevent pregnancy if used properly? ____ 1 <25% ____ 2 25%-49% ____ 3 50%-74% ____ 4 75%-89% ____ 5 >89% Nominal A woman asking to buy Plan B in advance of need: ____ 1 Must wait for a contraceptive emergency before buying it ____ 2 Should be advised to take a pregnancy test before taking it ____ 3 May purchase more than one package ____ 4 Can only make a purchase if she is using it for herself Nominal When selling Plan B without a prescription to a man, pharmacists: ____ 1 Need to see proof that he is at least 18 years of age ____ 2 Must limit sales to one package ____ 3 Must ask for the name of the person who will be taking the product 4 Are violating the law Nominal

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282 Do you think the following statements are true or false? True False Not Sure Emergency contraceptive pills cause birth defects if taken by a pregnant woman. Emergency contraception can act as an abortifacient. The sooner a woman takes emergency contraception, the more effective it will be. Nominal V. Attitudes The next few questions will ask you about how you personally feel about emergency contraception. Please check the box that corresponds to the answer you choose. 5-point Likert Scale, with 1 = Completely Disagree, 2= Somewhat Disagree, 3= Neither Agree nor Disagree, 4= Somewhat Agree, 5= Completely Agree --Easy availability of emergency contraception will discourage regular contraceptive use. --Easy availability of emergency contraception promotes promiscuity. --I feel uncomfortable dispensing Plan B because of my religious/ethical beliefs. --Repeated use of emergency contraception is wrong. --I feel comfortable dispensing Plan B to adult women. --I feel comfortable dispensing Plan B to adolescents (teens <18 years old). --I feel comfortable dispensing Plan B to men. Ordinal/Interval Should emergency contraception be offered to women who are raped in all hospital rooms, regardless of hospital affiliation? ____ 1 Yes ____ 2 No ____ 3 Not sure Nominal VI. Subjective Norms

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283 The next questions will ask you about your perceptions of what other people think. The people and groups listed below may be influential in your dispensing decision-making. Please indicate (by checking the box) how you think the following consider emergency contraception dispensing practices, either by prescription or over-the-counter. 5-point Likert scale 1=Definitely should not, 2=Probably should not, 3= Probably should, 4=Definitely should) 59. My partners/business colleagues think that I dispense Plan B. 60. The professional organization I am most active in recommends that I dispense Plan B. 61. My supervisor thinks that I_________ dispense Plan B. 62. In general, my close friends and family think that I_________ dispense Plan B. Ordinal/Interval Is there anyone in your pharmacy who refuses to dispense Plan B? ____ 1 Yes ____ 2 No ____ 3 Not sure ____ 4 My pharmacy does not carry Plan B Is there a policy in place at your pharmacy if someone refuses to dispense Plan B? ____ 1 Yes ____ 2 No ____ 3 Not sure ____ 4 My pharmacy does not carry Plan B VII. Perceived Behavioral Control

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284 Some pharmacists may feel that where they work effects their dispensing practices of Plan B. The following questions will ask you about your comfort level in dispensing Plan B. How easy is it for you to… 4-point Likert scale with N/A option 1=Very Difficult, 2= Somewhat Difficult, 3= Somewhat Easy, 4= Somewhat Easy, 5= N/A Counsel clients about Plan B. Refuse to dispense Plan B. Educate clients about Plan B. Dispense Plan B. Ordinal/Interval

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285 Appendix T Focus Group Topical Guide 1) Introduction Good morning, evening, afternoon and welcome to our session. Thank you for taking the time to join our discussion. Your assist ance is important; the ideas you share today will help us understand the perceptions about emergency contraception among pharmacy students. My name is Alice Richman and assisting me today is Lisa Nugent. 2) Purpose I am a doctoral student at the University of South Florida and I am conducting research on pharmacists and access to emergency contr aception. I am trying to understand what pharmacy students learn about emergency contraception in their pharmacy school classes. We are interested in all of your thoughts and comments. There are no right or wrong answers but rather differing point s of view. Please feel free to share your point of view even if it differs from what others have said. Before we begin, let me remind you of some groundrules… 3) Procedure & Ground Rules Group discussion – so don’t wait to be called on, but please speak one at a time so I can get your opinions on the tape. Audiotape: we’re tape recording the sessi on b/c we don’t want to miss any of your comments. Although we may use your first names in the discussion, no names will be attached to comments. You may be assured of complete confidentiality. No right or wrong answers: want both positive and negative comments Please feel free to disagree with each other, respectfully of course, and ask the group questions. If you have to use the bathroom, please f eel free to get up at any time during our discussion. About 1 hour 4) Questions Opening Question Tell us your first name and why you wa nt to be a pharmacist? (5 min)

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286 Appendix T (Continued) Introductory Question: When I say emergency contraception which is also sometimes referred to as the morning after pill, what is the firs t thing that comes to your mind? Warm up: What have you learned about emergency contr aception that you thi nk is important for people to know? Probe Questions: What is it? How does it work? Who should use it? When should people take it? Mechanism of action? Purpose? Warm up: Where have you gotten information this information? Probe Questions: could be a range of pe ople and places: in school, from pharmacy practice experience, pharmacy representati ves, magazines, from friends, teachers, parents? Where else have you learned about it? Key Question: Thinking back to the courses you have ta ken in your Pharm D program, what do you remember learning about emergency contraception? Things I am looking for: Ti ming of administration? Mec hanism of action? Purpose? Elective or required? Key Question: Think back to any instruction you recei ved on emergency contraception in your pharmacy school classes. Were you aware of any attitudes toward s the medication by the instructor? Positive/negative/neutral Key Question: How do you feel about dispensi ng emergency contraception? Probe Questions: There are a number of circ umstances where EC is thought to be controversial: feelings about dispensing to adolescents, rape victims, women whose birth control fails, women who use it repeatedly.

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287 Appendix T (Continued) Key Question: Do you feel any differently about dispensing emergency contraception than you do dispensing any other medications? Probe Question if they feel negatively: Wher e do your feelings about dispensing come from? Key Question: The Food and Drugs Administration (FDA) recently approved for emergency contraception to be administered over-the -counter to women 18 years of age and over in the U.S. What do you think about this decision? Key Question: Does that (OTC status) cha nge your views about it? Key Question: Some pharmacists have refused to dispense emergency contraception. How do you feel about this? Key Question: Should moral or religious views guide disp ensing of pharmaceutical products? What about dispensing of emergency contraception? Recap Brief summary of key issues. How well does that description capture what we have talked about? Have we missed anything? Any other comments?

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288 Appendix T (Continued) Initial Paper & Pencil Survey for Focus Groups 1. Did you take any classes in your Ph arm D program which taught you about emergency contraception? (please check a box) Yes No (skip to question 9) Not sure (skip to question 9) 2. Which classes taught you about emergency contraception? (please list below) Please also check the box if these classes we re required or offered as an elective. required elective required elective required elective 3. In your estimation, how much time woul d you say was spent on learning about emergency contraception in a given class? 4. What types of instructional methods were used to teach you about emergency contraception in your pharmacy school cla sses? (e. g. lectures course readings, power point discussions, vide os, course discussions) 5. Of the instructional methods that taug ht you about emergency contraception in your pharmacy school classes, which met hod/s did you learn the most from and why?

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289 6. Was there any information concerning emergency contraception that you wished you had learned or had more detailed instruction on? 7. Have your pharmacy school classes discu ssed the new over-the-counter status of emergency contraception? Yes No Not sure 8. Have your pharmacy school classes disc ussed the dispensing issues (e. g. pharmacists refusals to dispense) surrounding emergency contraception? Yes No Not sure 9. Do you think you will dispense emergency contraception upon becoming a pharmacist? Yes No Not sure 10. Do you think pharmacists are well enough informed to confidently dispense emergency contraception? Yes No Not sure Thank you for completing this survey!!

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290 Appendix U (p. 290-293) List of 91 pharmacy schools t hat received Dean’s survey* Alabama Auburn University Harrison School of Pharmacy 2316 Walker Building Auburn AL 36849 334-844-8348 Samford University McWhorter School of Pharmacy 800 Lakeshore Drive Birmingham, AL 35229 205-726-2820 Arizona The University of Arizona College of Pharmacy 1295 N. Martin Avenue PO Box 210202 Tucson, AZ 85721 520-626-1427 Midwestern University College of Pharmacy Glendale 19555 North 59th Avenue Glendale, AZ 85308 623-572-3500 Arkansas University of Arkansas for Medical Sciences College of Pharmacy 4301 West Markham #522 Little Rock, AR 72205 501-686-5557 KentuckyUniversity of Kentucky College of Pharmacy 725 Rose Street Pharmacy Building Lexington, KY 40536-0082 859-257-2736 Louisiana The University of Louisiana at Monroe College of Pharmacy 700 University Avenue Monroe, LA 71209 318-342-1600 Xavier University of Louisiana College of Pharmacy 1 Drexel Drive New Orleans, LA 70125 504-520-7500 Maryland University of Maryland School of Pharmacy 20 North Pine Street Baltimore, MD 21201 410-706-7651 Massachusetts Massachusetts College of Pharmacy and Health Scien School of Pharmacy-Boston 179 Longwood Avenue Boston, MA 02115-5896 617-732-2781 The University of Toledo College of Pharmacy 2801 West Bancroft Street Mail Stop #608 Toledo, OH 43606 419-530-1904 Oklahoma University of Oklahoma College of Pharmacy PO Box 26901 Oklahoma City, OK 73190 405-271-6485 Southwestern Oklahoma State University College of Pharmacy 100 Campus Drive Weatherford, OK 73096 580-774-3760 Oregon Oregon State University College of Pharmacy 203 Pharmacy Building Corvallis, OR 97331 541-737-3424 Pennsylvania Duquesne University Mylan School of Pharmacy 306 Bayer Learning Center Pittsburgh, PA 15282 412-396-6380 Lake Erie College of Osteopathic Medicine LECOM School of Pharmacy 1858 West Grandview

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291California University of California, San Diego Skaggs School of Pharmacy & Pharmaceutical Science 9500 Gilman Drive, MC 0657 La Jolla, CA 92093-0657 858-822-4900 University of California at San Francisco School of Pharmacy 521 Parnassus Avenue Clincial Sciences, Room C156 San Francisco, CA 94143 415-476-2733 Loma Linda University School of Pharmacy West Hall 11262 Campus Street Loma Linda, CA 92350 909-558-1300 University of the Pacific Thomas J. Long School of Pharmacy & Health Science 3601 Pacific Avenue Stockton, CA 95211 209-946-2561 University of Southern California School of Pharmacy 1985 Zonal Avenue Los Angeles, CA 900899121 323-442-1369 Touro University-California School of Pharmacy 1310 Johnson Lane, Mare Massachusetts College of Pharmacy and Health Scien School of PharmacyWorcester 19 Foster Street Worcester, MA 01608 508-890-8855 Northeastern University Bouve College of Health Sciences, School of Pharma 360 Huntington Avenue 206 Mugar Hall Boston, MA 02115 617-373-3380 Michigan Ferris State University College of Pharmacy 220 Ferris Drive Big Rapids, MI 49307 231-591-2254 The University of Michigan College of Pharmacy 428 Church Street Ann Arbor, MI 48109 734-764-7312 Wayne State University Eugene Applebaum College of Pharmacy and Health Sc 259 Mack Avenue Detroit, MI 48201 313-577-1574 Minnesota University of Minnesota College of Pharmacy 5-130 Weaver-Densford Hall 308 Harvard Street SE Minneapolis, MN 55455 Boulevard Erie, PA 16509-1025 814-866-6641 University of the Sciences in Philadelphia Philadelphia College of Pharmacy 600 South 43rd Street Philadelphia, PA 19104 215-596-8870 University of Pittsburgh School of Pharmacy 1104 Salk Hall 3501 Terrace Street Pittsburgh, PA 15261 412-624-2400 Temple University of the Commonwealth of Higher Ed School of Pharmacy 3307 North Broad Street Philadelphia, PA 19140 215-707-4990 Wilkes University Nesbitt School of Pharmacy 84 West South Street Wilkes-Barre, PA 18766 570-408-4280 Puerto Rico University of Puerto Rico School of Pharmacy PO Box 365067 San Juan, PR 00936 787-758-2525 Rhode Island University of Rhode Island College of Pharmacy 41 Lower College Road

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292 Island Vallejo, CA 94592 707-638-5200 Western University of Health Sciences College of Pharmacy College Plaza, 309 East Second Street Pomona, CA 91766 909-469-5214 Colorado University of Colorado at Denver & Health Sciences School of Pharmacy C238 4200 East Ninth Avenue Denver, CO 80262 303-315-5055 Connecticut The University of Connecticut School of Pharmacy 69 North Eagleville Road Unit 3092 Storrs, CT 06269 860-486-2129 District of Columbia Howard University School of Pharmacy College of Pharmacy, Nursing & AHS 2300 4th Street NW Washington, DC 20059 202-806-5431 Florida University of Florida 612-624-1900 Mississippi The University of Mississippi School of Pharmacy Thad Cochran Research Center Room 1026, PO Box 1848 University, MS 38677 662-915-7265 Missouri University of Missouri Kansas City School of Pharmacy 5005 Rockhill Road Kansas City, MO 64110 816-235-1609 St. Louis College of Pharmacy 4588 Parkview Place St. Louis, MO 63110 314-367-8700 Montana The University of Montana Skaggs School of Pharmacy 32 Campus Drive #1512 Missoula, MT 59812 406-243-4621 Nebraska Creighton University School of Pharmacy and Health Professions 2500 California Plaza Omaha, NE 68178 402-280-2950 Fogarty Hall Kingston, RI 02881 401-874-2614 South Carolina South Carolina College of Pharmacy MUSC Campus 280 Calhoun Street, PO Box 250141 Charleston, SC 29425-2301 843-792-8450 South Carolina College of Pharmacy USC Campus Columbia, SC 29208 803-777-4151 South Dakota South Dakota State University College of Pharmacy Pharmacy Building Room 125 Box 2202C Brookings, SD 57007 605-688-6197 Tennessee University of Tennessee College of Pharmacy 847 Monroe Avenue, Suite 226 Memphis, TN 38163 901-448-6036 Texas University of Houston College of Pharmacy 141 Science & Research 2

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293 College of Pharmacy PO Box 100484, JHMHC 101 South Newell Drive, #4334 Gainesville, FL 32611 352-273-6601 Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences 333 New Pharmacy Building Tallahassee, FL 32307-3800 850-599-3301 Nova Southeastern University College of Pharmacy Health Professions Division 3200 South University Drive Fort Lauderdale, FL 33328 954-262-1300 Palm Beach Atlantic University School of Pharmacy 901 South Flagler Drive West Palm Beach, FL 33416 561-803-2700 Georgia The University of Georgia College of Pharmacy Green Street Athens, GA 30602 706-542-1911 Mercer University College of Pharmacy and Health Sciences 3001 Mercer University University of Nebraska College of Pharmacy 986000 Nebraska Medical Center Omaha, NE 68198 402-559-4333 Nevada University of Southern Nevada College of Pharmacy 11 Sunset Way Henderson, NV 89014 702-990-4433 New Jersey Rutgers, the State University of New Jersey Ernest Mario School of Pharmacy 160 Frelinghuysen Road Piscataway, NJ 08854-8020 732-445-2675 New Mexico University of New Mexico College of Pharmacy MSC09 5360 1 University of New Mexico Albuquerque, NM 87131 505-272-3241 New York University at Buffalo School of Pharmacy and Pharmaceutical Sciences 126 Cooke Hall Box 601200 Buffalo, NY 14260-1200 716-645-2823 Building Houston, TX 77204 713-743-1300 The University of Texas at Austin College of Pharmacy 1 University Station A1900 Austin, TX 78712 512-471-3718 Texas Southern University College of Pharmacy and Health Sciences 3100 Cleburne Houston, TX 77004 713-313-7559 Texas Tech University Health Sciences Center School of Pharmacy 1300 S. Coulter Street Amarillo, TX 79106 806-354-5463 Utah University of Utah College of Pharmacy 30 South 2000 East Room 201 Salt Lake City, UT 84112 801-581-6731 Virginia Hampton University School of Pharmacy Kittrell Hall Hampton, VA 23668 757-727-5071 Shenandoah University Bernard J. Dunn School of Pharmacy

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294 Drive Atlanta, GA 30341 678-547-6304 South University School of Pharmacy 709 Mall Boulevard Savannah, GA 31406 912-201-8120 Idaho Idaho State University College of Pharmacy Stop 8288 921 S. 8th Avenue Pocatello, ID 83209 208-282-2175 Illinois University of Illinois at Chicago College of Pharmacy (M/C 874) 833 South Wood Street Suite 145 Chicago, IL 60612 312-996-7240 Midwestern University Chicago College of Pharmacy 555 31st Street Downers Grove, IL 60515 630-971-6417 Southern Illinois University Edwardsville School of Pharmacy 200 University Park Drive Campus Box 2000 Edwardsville, IL 62026 618-650-5150 Long Island University Arnold & Marie Schwartz College of Pharmacy and He 75 DeKalb Avenue Brooklyn, NY 11201 718-488-1234 St. John's University College of Pharmacy and Allied Health Professions 8000 Utopia Parkway Jamaica, NY 11439 718-990-1415 Union University Albany College of Pharmacy 106 New Scotland Avenue Albany, NY 12208 518-694-7200 North Carolina Campbell University School of Pharmacy PO Box 1090 205 Day Dorm Road, Room 101 Buies Creek, NC 27506 910-893-1685 University of North Carolina School of Pharmacy Beard Hall, CB#7360 Chapel Hill, NC 27599 919-966-1121 Wingate University School of Pharmacy Campus Box 3087 Wingate, NC 28174 704-233-8331 North Dakota North Dakota State 1775 N. Sector Court Winchester, VA 22601 540-665-1282 Virginia Commonwealth University School of Pharmacy MCV Campus Box 980581 410 North 12th Street Richmond, VA 23298 804-828-3006 Washington University of Washington School of Pharmacy H-364 Health Science Building Box 357631 Seattle, WA 98195 206-543-2030 Washington State University College of Pharmacy PO Box 646510 105 Wegner Hall Pullman, WA 99164 509-335-5901 West Virginia West Virginia University School of Pharmacy Room 1136 HSN, Health Science Center PO Box 9500 Morgantown, WV 26506 304-293-5101 Wisconsin University of Wisconsin Madison School of Pharmacy 777 Highland Avenue

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295Indiana Butler University College of Pharmacy and Health Sciences 4600 Sunset Avenue Indianapolis, IN 46208 317-940-9322 Purdue University School of Pharmacy and Pharmaceutical Sciences Heine Pharmacy Building 575 Stadium Mall Drive West Lafayette, IN 47907 765-494-1368 Iowa Drake University College of Pharmacy and Health Sciences 2507 University Avenue Des Moines, IA 50311 515-271-2172 The University of Iowa College of Pharmacy 115 South Grand Avenue Iowa City, IA 52242 319-335-8794 Kansas University of Kansas School of Pharmacy 1251 Wescoe Hall Drive Malott Hall #2056 Lawrence, KS 66045-7582 785-864-3591 University College of Pharmacy, Nursing, and Allied Sciences 123 Sudro Hall 1401 Albrecht Boulevard Fargo, ND 58105 701-231-6469 Ohio University of Cincinnati James L. Winkle College of Pharmacy 3225 Eden Avenue PO Box 670004 Cincinnati, OH 45267-0004 513-558-3784 Ohio Northern University College of Pharmacy 525 South Main Ada, OH 45810 419-772-2275 The Ohio State University College of Pharmacy 217 Parks Hall 500 West 12th Avenue Columbus, OH 43210 614-688-4756 Madison, WI 53705-2222 608-262-1416 Wyoming University of Wyoming School of Pharmacy Department 3375 1000 E. University Avenue Laramie, WY 82071 307-766-6120 *List of pharmacy schools taken from American A ssociation of Colleges of Pharmacy (AACP) website www.aacp.org The listing includes colleges and schools of pharmacy whose professional degree programs have been granted full or ca ndidate accredited status by the Accreditation Council for Pharmacy Education (ACPE) and whose requests for memb ership have been approved by the AACP House of Delegates.

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296 Appendix V Second follow-up letter to Deans About two weeks ago we sent you a survey via email. We are asking Deans of the schools of pharmacy in the U.S. about the curricula that addr esses instruction on emergency contraception. As of today, we have not received a complete d survey from you. I realize that we all have busy schedules; however we are hoping for at least a 50% respons e rate on this brief 3-question survey. As we mentioned before, answers are confidential and will be combined with others before disseminating the results. In case the pr evious questionnaire has been deleted from your email account, we have included it again and hope you will respond. Should you have any questions or concerns, f eel free to contact me (Alice Richman) or Ellen Daley at the contact information pr ovided below. Thank you for your cooperation. Alice R. Richman Ellen Daley, Ph.D. USF College of Public Health USF College of Public Health Phone: (813) 732-1903 Phone: (814) 974-8518 Email: arichman@health.usf.edu Email: edaley@health.usf.edu (Link to Survey Inserted Here)

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297 Appendix W (p. 297-298) List of course titles containing em ergency contraception course content Questions on Deans Survey : You answered yes that your School does offer required courses that provide content on emergency contraception. Would you please lis t the titles of these courses in the box below. You answered yes that your School does offer elective courses that provide content on emergency contraception. Would you please lis t the titles of these courses in the box below Answers provided for required courses that contain emer gency contraception content: Women's Health (a combination course with Men's Health). 1) Pharmacologic Basis of Therapeutics III : The endocrinology section of this basic science course includes a lect ure that addresses the mechan ism of action of emergency contraceptives, the period of time during whic h they can be effectively used, and their side effects. 2) Early Practice Experience I: As part of this early clinical c ourse, the students obtain certification from the State in emergency cont raception. They lear n about prescriptive authority, and are trained to counsel patients appropriately. Professional Skills Development II Health Assessment and Pharmacotherapy II Integrated Science and Therapeutics II. It 's part of a 2-hr co ntraception lecture. Therapeutics Women's Health Syllabi not available at this time. PHA 5930--Issues in Contemporary Pharmacy Practice. Clinical Therapeutics IPDM (Integrated Pharmacology & Disease Management III Endocrinology/Gast roenterology Princles of Pharmacotherapy 1: Se lfcare and Alternative Medicine Princles of Pharmacothera py 8: Special Populations Ethics and Professional Responsibility Pharmacotherapy II Pharmacy Ethics It is in one of our Pharmacotherapy courses It is contained within a pa thophysiology and therapeutics co urse that has a section on women's health. The syllabus only states th at the topic of contra ception is covered. see printed out syllabus -reproductive health course. There are a couple of lectures in Pharmacy 505 which is a pharmacy practice course titled Pharmaceutical Care and a case discus sion in pharmacy 514 Pharmacy Ethics. Pharmacotherapy 4: contemporary topics 2hours, 5th year spring semester class

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298 Phrm 6206 includes endocrine and reproductive medicine. Material Covered in Over-the-Counter Medicat ions Course under OTC Contraception. Not specifically mentioned in the syllabus. Integrated Sequence 4 To the best of my knowledge, I believe we are teaching this in these courses. PHA 551 Endocrine Disorders PHA 502 Pharmacy Law and Ethics PHA 566 Women's Health Therapeutics I It is taught in our Self Care course in th e lecture covering the pr evention of unintended pregnancy. I apologize for not bei ng able to attach the syllabus. In PHR 920 (Communication and Behavior in Pharmacy Practice) from a social behavioral aspect, in PHR 930 (Legal, Ethi cal and Access Issues in Pharmacay), in PHR 933 (Pharmacological Basis for Therap eutics: Endocrine Systems) from a pharmacologic perspective and in PHR 946 (Advanced Pharmacotherapy I) in the block on "women's health" from a pharmacol ogical and therapeutic perspective. The course syllabi are not very desc riptive of the topics they only indicate "contraception" or "Plan B". Integrated Therapeutics III Course and Laborat ory offers review of material regarding emergency contraception. It may also be di scussed in the mandatory Healthcare Ethics class. PHP 414 Therapeutic Core /Endocrinology/Women's Health PHP 518 Self Care 1 PHP 519 Elective Self Care 2 Pathophysiciology and Therapeutics III under Women's Health NonPrescriptions Drug Products under contraception Possibly in phamacology, not sure I know we teach this but I dont know specifics on courses since several have changed recently. Topic is covered in our PharmacotherapyDisease State management course. The topic is not listed in the syllabusit is discu ssed as part of the contraception discussion Answers provided for elective courses that contain emer gency contraception content: Overview of Contraceptive Management; I' ll send the syllabus via email attachment "Women's Health" Women's Health PHP 519 Self Care 2

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299 Appendix X (p. 299-313) Panel of Experts Interview Guide for Re view of Pharmacists’ Questionnaire You are being asked to be part of a speci al panel of experts that will review a questionnaire to make sure it is valid. Th e survey you are reviewing will be administered to Florida pharmacists and it is designed to measure emergency contraception knowledge, attitudes, and dispensing pract ices of pharmacists who practice in the state of Florida. Your honest input and feedback is essential to producing a valid instrument and I want to personally thank you for your participation. This review will inquire about five six main topics: (1) level of knowledge about emergency contraception, (2) personal attitudes held about emer gency contraception and about emergency contraception dispensing, (3) perceived social pressures around issues of dispensing, (4) perceived behavioral control over the behavior of dispensing emergency contraception, (5) emergency contraception dispensing practices and (6) basic demographics and background questions. Directions : First, rate each question on the instrume nt according to the extent to which you think it looks as if it is measuring the designated topic (i.e., face validity), with 1 = this item does not look as if it has anything to do with measuring the topi c, and 7 = this item looks very much as if it is on-target with measuring the topic. Please explain your ratings that are below 5, that is, items that you do not think look as if they are measuring the designated topic. What would you do, if anything, to fix them? Second, are there important aspects of the designated topic that the instrument is not measuring (i.e., content validity)?

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300 Topic 1: Knowledge about Emergency Contraception Rating 1 2 3 4 5 6 7 Explain ratings <5, what would you do to fix them? Q1: How many pills are dispensed in Plan B packaging? ____ Q2: Emergency contraception or Plan B is effective if taken with in how many hours of unprotected intercourse? ____ 1 Up to 24 hours ____ 2 Up to 36 hours ____ 3 Up to 72 hours ____ 4 Up to 120 hours ____ 5 Not Sure Q3: The mechanism of action of emergency contraception is most similar to (please choose one): ____ 1 Spermicides ____ 2 Oral Contraceptives ____ 3 Mifepristone (RU-486) ____ 4 Not Sure Q4: If used properly, emergency contraception or Plan B prevents pregnancy what percentage of the time? ____ 1 <25% ____ 2 25%-49% ____ 3 50%-74% ____ 4 75%-89% ____ 5 >89% Q5: To what extent do you think the following statements are true or false? Repeated use of emergency contraceptive pills can pose health risks. ____ 1 True ____ 2 False Q6: To what extent do you think the following statements are true or false? Emergency contraceptive pills cause birth defects if taken by a pregnant woman. 1 True

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301 ____ 2 False Q7: To what extent do you think the following statements are true or false? Emergency contraception can act as an abortifacient. ____ 1 True ____ 2 False Q8: To what extent do you think the following statements are true or false? The sooner a woman takes emergency contraception, the more effective it will be. ____ 1 True ____ 2 False Q9: To what extent do you think the following statements are true or false? Plan B is the same as the abortion pill (RU-486). ____ 1 True ____ 2 False Q10: To what extent do you think the following statements are true or false? Emergency contraception can protect against HIV and other sexually transmitted infections (STIs). ____ 1 True ____ 2 False Are there important aspects of the topic emergency contraception knowledge that the instrument is not measuring (i.e ., content validity)?

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302 Topic 2: Attitudes about Emergency Contraception Rating 1 2 3 4 5 6 7 Explain ratings <5, what would you do to fix them? Q1: ____ I feel the benefits of emergency contraception outweigh the risks. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q2: ____ Emergency contraception will discourage regular contraceptive use. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q3: ____ Emergency contraception will promote promiscuity. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q4: ____ I feel uncomfortable prescribing emergency contraception for religious/ethical reasons. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q5: ____ Repeated use of emergency contraception by adolescents is wrong. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q6: I feel comfortable dispensing

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303 emergency contraception to women. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q7: ____ I feel comfortable dispensing emergency contraception to adolescents. 1=Completely Disagree 2=Somewhat Disagree 3=Not sure 4=Somewhat Agree 5=Completely Agree Q8: In general, I think that dispensing emergency contraception for clients is… ____ 1 Good ____ 2 Positive ____ 3 Beneficial ____ 4 Harmful ____ 5 Negative ____ 6 Bad Q9: What is the maximum number of times emergency contraception should be given to one individual woman over her lifetime? ____ 1 0 times ____ 2 1 time ____ 3 2-5 times ____ 4 6-10 times ____ 5 10+ times ____ 6 Not sure Are there important aspects of the to pic emergency contraception attitudes that the instrument is not measuring (i.e ., content validity)?

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304 Topic 3: Emergency Contraception Dispensing Practices (includes both intention to dispense and actual dispensing practices) Rating 1 2 3 4 5 6 7 Explain ratings <5, what would you do to fix them? Q1: Does your pharmacy dispense any forms of emergency contraception (e. g. Plan B)? ____ 1 Yes ____ 2 No Q2: Have you ever been asked to fill a prescription of emergency contraception? ____ 1 Yes ____ 2 No Q3: Have you personally ever filled a prescription of emergency contraception? ____ 1 Yes ____ 2 No Q4: Approximately how many emergency contraceptive pill pr escriptions have you personally filled in the past 12 months? ____________ Q5: Have you ever been asked to dispense emergency contraception over-the-counter? ____ 1 Yes ____ 2 No Q6: Have you personally ever dispensed emergency contraception over-the-counter? ____ 1 Yes ____ 2 No Q7: Approximately how many times have you dispensed emergency contraceptive pills over-the-counter in the past 12 months? ____________ Q8: To what extent are you likely to dispense emergency contraception over-the-counter to… Women who have experi enced incest or rape 1=Very Unlikely

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305 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q9: To what extent are you likely to dispense emergency contraception over-the-counter to… Women who have expe rienced a problem with their birth control method 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q10: To what extent are you likely to dispense emergency contraception over-thecounter to… Sexually active 18, 19, and 20 year olds 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q11: To what extent are you likely to dispense emergency contraception over-thecounter to… Women who request th e method after having unprotected sexual intercourse 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q12: To what extent are you likely to dispense emergency contraception over-thecounter to… Men requesting emergency contraception

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306 over-the-counter for their partner 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q13: To what extent are you likely to dispense emergency contraception by prescription to… Women who have experi enced incest or rape 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q14: To what extent are you likely to dispense emergency contraception by prescription to… Women who have expe rienced a problem with their birth control method 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q15: To what extent are you likely to dispense emergency contraception by prescription to… Sexually active teens under age 18 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Q16: To what extent are you likely to dispense emergency contraception by prescription to…

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307 Women who request th e method after having unprotected sexual intercourse 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely 5=Very Likely Are there important aspects of the topic emergency contraception dispensing practices that the instrument is not measuring (i.e., content validity)? Topic 4: Perceived Social Pressures Concerning Dispensing Practices of Emergency Contraception Rating 1 2 3 4 5 6 7 Explain ratings <5, what would you do to fix them? Q1: My partners/colleagues think that I _________ dispense emergency contraception. 1=Definitely Should Not 2=Probably Should Not 3=Neutral 4=Probably Should 5=Definitely Should Q2: My professional organization recommends that I_________ dispense emergency contraception. 1=Definitely Should Not 2=Probably Should Not 3=Neutral 4=Probably Should 5=Definitely Should Q3: My boss thinks that I dispense emergency contraception. 1=Definitely Should Not 2=Probably Should Not 3=Neutral 4=Probably Should 5=Definitely Should

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308 Q4: My corporation or pharmacy thinks that I dispense emergency contraception. 1=Definitely Should Not 2=Probably Should Not 3=Neutral 4=Probably Should 5=Definitely Should Q5: In general, most people or groups that are important to me think that I dispense emergency contraception. 1=Definitely Should Not 2=Probably Should Not 3=Neutral 4=Probably Should 5=Definitely Should Q6: My clients or customers thinks that I_________ dispense emergency contraception. 1=Definitely Should Not 2=Probably Should Not 3=Neutral 4=Probably Should 5=Definitely Should Are there important aspects of the topic per ceived social pressures concerning dispensing practices of emergency contraception that the instrument is not measuring (i.e., content validity)? Topic 5: Perceived Ease or Difficulty (comfort level) with Dispensing Emergency Contraception Rating 1 2 3 4 5 6 7 Explain ratings <5, what would you do to fix them? Q1: How easy would it be for you to ____ Counsel clients about emergency contraception 1=Very Difficult 2=Difficult 3=Not sure

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309 4=Easy 5=Very Easy Q2: How easy would it be for you to… ____ Dispense emergency contraception 1=Very Difficult 2=Difficult 3=Not sure 4=Easy 5=Very Easy Q3: How easy would it be for you to… ____ Refuse to dispense emergency contraception 1=Very Difficult 2=Difficult 3=Not sure 4=Easy 5=Very Easy Q4: How easy would it be for you to… ____ Educate clients about emergency contraception 1=Very Difficult 2=Difficult 3=Not sure 4=Easy 5=Very Easy Q5: How comfortable are you talking about emergency contraception with customers? 1=Very Uncomfortable 2=Somewhat Uncomfortable 3=Somewhat Comfortable 4=Very Comfortable Are there important aspects of the topic percei ved ease or difficulty (comfort level) with dispensing emergency contraception that the instrument is not measuring (i.e., content validity)?

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310 Note: This last section titled Demographic & Background Questions is a little different as each topic is listed for each question in blue. Topic 6: Demographic & Background Questions Rating 1 2 3 4 5 6 7 Explain ratings <5, what would you do to fix them? Topic Measuring: Years in Practice Q1: How many years have you been in practice (registered as a pharmacist)? ____ year/years Topic Measuring: Type of Pharmacy Q2: The type of pharmacy where you work could be best described as (if you have more than one job, please circle the nu mber that corresponds to your primary type of pharmacy) ____ 1 Retail ____ 2 Independent ____ 3 Chain ____ 4 Hospital ____ 5 Nuclear ____ 6 Government ____ 7 VA ____ 8 Academia ____ 9 HIS ____ 10 Home Infusion ____ 11 Other: Please specify _______________________ Topic Measuring: Employment Status Q3: What is your curren t employment status? ____ 1 Full-time ____ 2 Part-time ____ 3 Retired Topic Measuring: Pharmacy Availability of Birth Control Products Q4: Does your pharmacy carry any of the following birth control products? Condoms 1 Yes 0 No

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311 Spermicide ____1 Yes ____0 No Oral contraceptive pills ____1 Yes ____0 No Topic Measuring: Gender Q5: What is your gender? ____ 1 Female ____ 2 Male Topic Measuring: Age Q6: How old are you? ____________ Topic Measuring: School of Attendance Q7: Where did you go to school to become a pharmacist? ________________________ Topic Measuring: Year of Graduation Q8: What year did you graduate school to become a pharmacist? ____________ Topic Measuring: Religion Q9: If you had to choose only one, which would it be? ____ 1 Religious ____ 2 Spiritual ____ 3 Religious and Spiritual ____ 4 Undecided ____ 5 None of the above ____ 6 Not religious or Spiritual Topic Measuring: Re ligious Identity Q10: If you had to choose one, which religious group do you most clos ely identify with? ____ 1 Roman Catholic ____ 2 Baptist ____ 3 Methodist 4 Episcopalian

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312 ____ 5 Lutheran ____ 6 Quaker ____ 7 Presbyterian ____ 8 Assembly of God ____ 9 Hindu ____ 10 Buddhist ____ 11 Jewish ____ 12 Islamic ____ 13 Mormon ____ 14 Neo-Pagan/Wicca ____ 15 Non-Denominational ____ 16 Not Religious ____ 17 Other Topic Measuring: Ethnicity Q11: What is your ethnicity? ____ 1 Caucasian ____ 2 African American ____ 3 Hispanic ____ 4 Asian ____ 5 Multi-Racial ____ 6 Other please specify (___________________) Topic Measuring: Marital Status Q12: What is your marital status? ____ 1 Married ____ 2 Living with a partner ____ 3 Divorced ____ 4 Separated ____ 5 Widowed ____ 6 Never been married Topic Measuring: Ethnicity Q13: To what extent are you likely to dispense emergency contraception by prescription to… Women who have experi enced incest or rape 1=Very Unlikely 2=Unlikely 3=Not sure 4=Likely

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313 5=Very Likely Topic Measuring: Po litical Affiliation Q14: What is your political affiliation? ____ 1 Republican ____ 2Democratic ____ 3 Independent ____ 4 None/Undecided Are there important aspects of the questions asked in this la st section titled Demographic & Background Questions that the instrument is not meas uring (i.e., content validity)? Thank you for your time. Please save your answers and follow the directions outlined in the email provided.

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About the Author Alice Richman received a Bachelor’s Degree in English Literature with a minor in Women’s Studies from North Ca rolina State University in 1999 and a Master’s Degree in Public Health with a concentration in Matern al and Child Health from Boston University in 2003. Following the completion of her MPH, she began the Ph.D. program at the University of South Florida College of Public Health in 2003. Over the last eight years, Ms. Richman ha s worked in a variety of public health settings with diverse communities, providing bot h face-to-face client contact as well as being involved in policy, pl anning, research, and training. She has been engaged in a variety of research projects, taught several publ ic health courses at a variety universities, has both independently written and co-a uthored and published her work, and has disseminated findings at regional and nati onal conferences. Af ter graduation, Ms. Richman will begin a two-year post doctoral fellowship at the University of North Carolina at Chapel Hill Sc hool of Public Health.