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Future of Emergency Contraception Lies in Pharmacists’ Hands Nicole Monastersky and Sharon Cohen Landau
ABSTRACT Objective: To increase community pharmacists’ awareness about issues related to the provision of emergency contraception (EC) to women by describing pharmacist outreach and training programs and discussing pharmacy access and stocking issues, California’s EC Pharmacy Program, methods for raising pharmacists’ awareness, and professional development opportunities. Summary: EC is both safe and effective in reducing the risk of unintended pregnancy after unprotected intercourse, yet awareness of and demand for the medication has not been high, and it often is not stocked in pharmacies. Various advocacy organizations have engaged in educating the public and physicians about EC, but relatively little attention and few resources have been targeted to ensure that the pharmacy community is aware of and educated about EC. Increased visibility and access to EC in the several states that allow pharmacists to provide EC directly to women have resulted from the active participation and leadership of pharmacists. In these states, women are showing interest in and receptivity to reproductive health services provided by pharmacists. In California, some 3,000 pharmacists statewide have completed training, and in 2004 they provided EC directly to approximately 175,000 women. Pharmacists who provide EC overwhelmingly (91%) report that they do so because they see it as an important community service, and many (57%) recognize the opportunity for professional development. Conclusion: Pharmacists are uniquely positioned to improve access to EC, and leadership within the pharmacy community can facilitate efforts to improve access. Increased education and training of pharmacists about EC—such as continuing education programs available online at www.pharmacyaccess. learnsomething.com—are critical to ensure not only that EC is available in pharmacies but also that pharmacists are engaged in meeting the reproductive health needs of women. Increased access to EC can expand pharmacists’ role in health care provision. State-specific information about EC pharmacy access initiatives is available on the Web at www.GO2EC.org. J Am Pharm Assoc. 2006;46:84–88.
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Received January 19, 2005, and in revised form May 4, 2005. Accepted for publication June 25, 2005. Nicole Monastersky, MPH, is Project Administrator; Sharon Cohen Landau, MPH, is Associate Director, Pharmacy Access Partnership, Public Health Institute, Oakland, Calif. Correspondence: Nicole Monastersky, 614 Grand Avenue, Suite 324, Oakland, CA 94610. Fax: 510-2720285. E-mail:
[email protected] See related articles on pages 12 and 33. Disclosure: The authors are employees of Pharmacy Access Partnership, a center of the nonprofit Public Health Institute. The authors declare no other conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Acknowledgments: To Mackenzie Melton, Belle TaylorMcGhee, and Frances Chung for helpful comments in review of early drafts of the manuscript. Funding: The authors thank the David and Lucille Packard Foundation, and the William and Flora Hewlett Foundation for their support in exploring new options to expand consumer access to contraception. The conclusions and opinions expressed here are those of the authors and not necessarily those of the funders.
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E
mergency contraception (EC), sometimes referred to as the morning-after pill, has a long record of safety and efficacy1 in reducing the risk of unintended pregnancy after unprotected intercourse. Private foundations and reproductive health, grassroots, and advocacy organizations have been pivotal in getting the word out about EC by funding and organizing awareness campaigns. However, limited revenue sources and splintered strategies have left many women uninformed about EC. Not surprisingly, EC has been referred to as the “nation’s best kept secret.” According to a Kaiser Family Foundation (KFF) and Lifetime Television Survey in 2000, only 15% of women in the United States aged 18 and older were aware of this contraceptive option.2 In addition, a 2003 KFF survey of American adolescents found that almost 50% of young people were not aware of a contraceptive method that could be used after sexual intercourse.3 Early outreach efforts have focused mainly on consumers and physicians. Pharmacists have been expected to stock EC, but with the exception of a few states, relatively little focused attention and
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resources have been targeted to ensure the pharmacy community is aware of and educated about EC. Increased education, training, and awareness opportunities for pharmacists about emergency contraception are critical not only to ensure that EC is available in pharmacies, but also that pharmacists are engaged in meeting the reproductive health needs of women and are more widely recognized as important members of the reproductive health care team. Efforts to educate and include the pharmacy community in EC provision in various states are reviewed to illustrate its worth as an investment, leading to increased EC access and setting the foundation for pharmacist and pharmacy involvement in furnishing EC and other hormonal contraceptive methods to women patients. The next step for EC to be widely available and normalized as a known backup method of birth control is recognizing that pharmacists are uniquely positioned to improve access. Leadership within the pharmacy community will help facilitate these efforts.
Pharmacy Access AT A GLANCE Synopsis: Pharmacists are key players in providing access to emergency contraception (EC) but have generally not been the focus of information campaigns developed by reproductive health advocates. Because demand for EC has been low, these products are often not stocked in pharmacies. Increased awareness of the contraceptive backup option on the part of women will increase demand and open the door for pharmacists to expand their practices to include the delivery of additional reproductive health services. Education and training of pharmacists in EC are necessary to prepare them to answer patient questions and provide counseling. Analysis: Pharmacy Access Partnership, a Californiabased center of the nonprofit Public Health Institute, played a pivotal role in enabling women in California to have direct access to EC at pharmacies without first visiting a clinic or physician. In 2002, California became the first state in the United States to pass legislation specifically to increase women’s access to EC in pharmacies. Many media reports, as well as Hepler’s viewpoint in the July/August 2005 issue of JAPhA, have addressed the controversy surrounding conscientious refusals by pharmacists to dispense contraceptive medications. These authors broaden the view by presenting California’s and other states’ experiences and highlighting the efforts of many pharmacists to increase women’s access to EC, promote reproductive health, and reduce the incidence of unintended pregnancy.
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Stocking EC has been the primary expectation held of pharmacists. While this seems reasonable to consumers and advocacy groups, pharmacists’ and pharmacies’ experiences make stocking EC a sometimes less than clear-cut and attractive practice. Limited consumer and provider awareness of EC historically has resulted in minimal prescription orders for these products. With thousands of Food and Drug Administration (FDA)approved drugs available, pharmacies have to be selective about which ones to stock; in most pharmacies, those decisions are driven largely by demand. Pharmacies may choose not to stock EC simply because demand is low. Findings in several states exemplify this lack of consumer demand. Planned Parenthood of Connecticut and NARAL ProChoice Connecticut conducted an informal statewide survey of pharmacists’ knowledge and attitudes in summer 2003 and found that 20% of pharmacists did not carry a dedicated product because of little demand.4 That same year, NARAL Pro-Choice Colorado conducted an informal survey of 350 independent, grocery, and chain community pharmacies throughout the state and found that 41% did not readily stock EC, usually because of lack of demand or education about EC.5 Eve Espey, MD, with the University of New Mexico, led a study in March 2003 in which two research assistants visited each of the pharmacies in Albuquerque twice, and asked for either Preven (levonorgestrel and ethinyl estradiol—Duramed Labs, a subsidiary of Barr Pharmaceuticals, Inc.) or Plan B (levonorgestrel—Duramed Labs, a subsidiary of Barr Pharmaceuticals, Inc.) on alternate visits. Only 20% of the approximately 90 pharmacies in Albuquerque carried either dedicated EC product. Again, the primary reason for not stocking was lack of demand.6 Pharmacists practicing in independent community pharmacy settings have been trailblazers in providing increased access to EC. Journal of the American Pharmacists Association
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They usually have more flexibility in deciding to stock EC than colleagues in corporate chain environments. Moreover, they have been first to get involved in providing direct pharmacy access to EC in states that permit it, often setting the stage and modeling a world of possibility and acceptability. They are to be commended for their enterprising public health spirit. Despite differences in flexibility, the need to promote awareness about EC transcends all types of pharmacy settings. Considering the finding that limited awareness about EC translates to limited availability of the product, more education and information is clearly needed. Lack of knowledge is perpetuated as pharmacists do not receive requests for EC and simultaneously are not targeted in outreach activities. In addition to issues around demand and inventory space constraints, pharmacists have reportedly not stocked EC because of moral or religious objections. Recently, the issue of conscience clauses—in which some pharmacists have cited moral objections to filling EC prescriptions— has received substantial national media attention7 and was the subject of an editorial in this journal.8 Despite the rash of interest paid to pharmacists refusing to fill EC prescriptions, the more often untold story is that the pharmacy community in many states is actively engaged in making EC available, demonstrating leadership in providing increased access to EC. Washington State, the first state in the nation to permit pharmacist-based prescribing of EC in pharmacies, did not need to make regulatory or statutory changes to allow pharmacists to initiate EC protocols. Thanks to burgeoning education and training opportunities in several states throughout the country, and the efforts of Pharmacy Access Partnership in California, eight states (Washington, California, Alaska, New Mexico, Hawaii, Maine, New Hampshire, and Massachusetts) allow pharmacists to provide EC directly to patients without an advance prescription. In each of these states, the pharmacy community has been actively involved. Changes at the state level allowing pharmacists to provide EC directly to women has further created the visibility necessary to endorse pharmacists’ education and awareness about EC, thus improving access. Efforts to expand pharmacists’ role in the provision of EC and other hormonal birth control methods come at a time when women themselves are showing interest and receptivity to more directly accessible reproductive health services at the pharmacy. In a 2004 national random digit-dial survey, two thirds (63%) of women across all demographic categories said they would use pharmacy access for hormonal contraception, including pills, patches, rings, and EC. Moreover, 4 in 10 women (41%) not using any method of birth control said they would begin a hormonal method if pharmacy access were available. If EC were available at the pharmacy without an advance prescription, 55% of women said they would be more likely to use it.9 The majority of women recognized pharmacies’ convenient hours and locations as important advantages. These findings represent compelling reasons to further explore pharmacy access to hormonal contraception and to consider investing in building the capacity of pharmacists and pharmacies to enhance women’s access to their contraceptive method of choice without compromising their care. 86
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Engaging the Pharmacy Community The above surveys demonstrate that women are expecting more from the pharmacy than just stocking EC. As women search for more effective and convenient methods of contraception, providers of reproductive health services and supplies—including pharmacists—must be prepared and educated on how to meet increased demand. The unique and pivotal position held by pharmacists allows for continued leadership in meeting the needs of women and families in their communities. Pharmacists, who recognize EC as an important birth control method in preventing unintended pregnancy, view their timely provision of EC as an essential public service. In a 2002 survey of 235 EC pharmacists conducted by Pharmacy Access Partnership, the overwhelming majority (91%) cited as their main reason for providing EC services was that this is an important community service. More than one half of pharmacists (57%) also recognized the opportunity for professional development and a motivation to get involved in delivering EC services (Pharmacy Access Partnership, unpublished data, 2002). While a growing number of pharmacists have become familiar with EC and understand the importance of increased availability in the pharmacy, some still do not recognize the benefits of ensuring and improving access. Myriad tactics have been attempted to ensure that pharmacies stock EC, but without appropriate education, the pharmacist may be less likely to be engaged. For example, in 2003, the New York City Council passed a measure requiring pharmacies not stocking EC to post a sign in the window indicating the lack of availability; pharmacies failing to post the signs were subject to a $700 fine.10 Additional educational information was not offered to pharmacists as part of the new requirement. Yet to provide responsible and informed service, pharmacists must be provided educational opportunities and become comfortable with EC before dispensing. The response from a spokesperson for New York City’s Department of Consumer Affairs offers a more effective and reasonable perspective: “…educating comes before issuing violations to small businesses.”10 To that end, various forums have facilitated the inclusion of the pharmacy community in campaigns to increase access to EC. Training sessions and meetings have been an important way to personally engage the pharmacist community and connect with the advocacy community concerned about reproductive health access to advance EC issues. In April 2003, Pharmacy Access Partnership brought together pharmacy stakeholders representing nine states and provinces from across the United States and Canada to share information, lessons learned, and develop strategies to improve access to EC in pharmacies. When the next such meeting convened in May 2004, representatives from 17 states and provinces participated and showed an active interest in the role pharmacists and pharmacies can play in making EC accessible. In 2005, legislation was introduced in 10 states (Illinois, Kentucky, Massachusetts, Maryland, New Hampshire, www.japha.org
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New Jersey, New York, Oregon, Texas, and Vermont) seeking to allow pharmacy access to EC. New Hampshire and Massachusetts were both successful in passing EC pharmacy access laws. In New York State, the bill passed both the Senate and the House but was vetoed by the governor. Providing online resources has also been useful in building support from stakeholders—including pharmacists—across the country. In September 2003, Pharmacy Access Partnership launched www.GO2EC.org to keep national audiences informed about EC and pharmacy access on a state-by-state basis. The site has been well received, with approximately 10,000 unique visits in its first year and now averaging 4,500 hits per month. Other mechanisms can be employed to raise visibility in the pharmacy community and increase access to EC. Specifically, conducting a survey of pharmacists, simply asking whether they stock the product, is an effective educational and mobilizing tool. However, surveys regarding knowledge about and attitudes toward EC often have been conducted by organizations outside the pharmacy community. Most state level or regional pharmacist surveys and follow-up work have been carried out by reproductive or public health advocacy organizations. For example, NARAL ProChoice Colorado surveyed hundreds of pharmacies in fall 2003 to create Emergency Contraception: The Pharmacy Referral Guide for Colorado, a bilingual resource that features more than 200 pharmacies across the state that stock and dispense EC. The Wyoming Health Council collaborated with NARAL Pro-Choice Wyoming to survey most of the state’s 139 pharmacies to determine whether they provide EC with a prescription. In March 2005, a coalition of more than 150 women’s health and medical organizations held events across 35 states to promote timely access to EC as part of the fourth annual Back Up Your Birth Control day of action. The year’s strategic focus was on the pharmacist’s role in providing access to EC. Activists in 11 states and Washington, D.C., surveyed and/or visited local pharmacies and distributed nearly 20,000 pharmacist education cards on EC. In addition to advocacy organizations’ surveys and mobilizing efforts, pharmacist associations and schools of pharmacy have many opportunities to survey and mobilize their own membership and community to better understand their own EC access issues. State or regional pharmacy associations can play a larger role by introducing resolutions about pharmacy access to EC at their state’s delegates meetings and reach out to members on their Web sites, in newsletters, through mailings, and via surveys. From surveying state pharmacy associations in the past, we learned that EC is often not a high priority issue for them. Understandably, pharmacy associations have a multitude of important issues to address. Focus on EC, however, may be a topic that propels pharmacists closer to the clinical scope of services and professional development for which they often express interest in having a greater role. EC offers the rare opportunity for increased patient interaction as well as for payment from consumers for consultative services. The American Pharmacists Association (APhA) has taken a lead in offering educational and training programs on EC to pharVol. 46, No. 1
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macist members. In March 2004, at its annual conference, APhA not only sponsored education and training on the clinical aspects of EC, but also provided a special session on pharmaceutical care models in EC that focused on state-level strategies the pharmacy community can use to increase access to EC.
Effective State Model In California, the investment in educating and training pharmacists about EC and facilitating an opportunity to play a bigger role in EC provision through collaborative protocols has been fruitful. In the last 4 years, more than 3,000 pharmacists have completed training and provide EC directly to patients in approximately 1,200 pharmacies statewide (Pharmacy Access Partnership, unpublished data, 2004). These independent and chain community pharmacies are located in 49 of the state’s 58 counties. The growing number of access points to EC is testament to the number of women able to get EC. The Pharmacy Access Partnership study found that in 2004, approximately 175,000 women obtained EC in California pharmacies without an advance prescription through the EC Pharmacy Program.11
Beyond EC Pharmacist participation in California’s EC Pharmacy Program has also opened the door to interest and involvement in delivering other reproductive health services. Not only are pharmacists interested in promoting their EC services using signage and informational brochures, they have welcomed the prospect of increasing educational opportunities and promoting sexual health in general. Select chain and independent EC pharmacies in California are currently promoting family planning supplies through increased and improved signage, shelf talkers, and bag stuffers. They are also providing educational materials about condoms, sexually transmitted infections, and sexual health and wellbeing in designated family planning sections of the pharmacy. Pharmacists are expanding their clinical services as well. Through active involvement with the EC Pharmacy Program, dedicated pharmacists sought out additional opportunities to increase access to reproductive health services. Over the past 2 years, pharmacists in California have been offering reinjections of medroxyprogesterone acetate (Depo-Provera—Pfizer) to patients of collaborating clinics and medical offices. Participating pharmacists receive specialized training in contraceptive management and injection technique. Select pharmacists completed a training and educational curriculum to provide Depo-Provera birth control shots to patients of local community clinics in the pharmacy.
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Conclusion Efforts have been made by reproductive health, advocacy, and pharmacy groups to educate patients, medical providers, and, in some instances, pharmacists about EC. But for EC to be widely known as the safe and effective backup birth control method to prevent pregnancy after sexual intercourse, and for pharmacists to be comfortable in providing an informed and valuable service, unified strategies for increasing educational opportunities about EC for pharmacists are essential. Pharmacists can continue to take a leadership role in promoting EC and their own accessibility as a professional resource for information. In addition to stocking the product, pharmacists can participate in training programs, community outreach activities, conferences, legislative advocacy, and partnerships with other health care professionals to improve awareness and access. Considering pharmacists’ changing role in the pharmacy, promoting increased access to EC is not only logical and important in meeting the contraceptive needs of their patients, it may also make sense from a business perspective. Building the capacity of pharmacists while increasing the visibility of EC will contribute to the greater awareness and understanding that women can do something after unprotected intercourse to prevent an unintended pregnancy. Pharmacies are an ideal point of access to EC, with easy accessibility and open hours on evenings, weekends, and holidays. Pharmacists who are knowledgeable about EC are resourceful and educated members of the health care team available to increase access and effectively negate the reference to EC as the “nation’s best kept secret.” An estimated 1.3 million unintended pregnancies could be avoided annually with pharmacy access to EC.9 Pharmacists who are informed and educated about this method of birth control are not only more likely to stock EC, but are able to answer questions and provide appropriate information to women. FDA has reviewed
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the application to make EC available OTC for women aged 16 and older. Regardless of what FDA decides about nonprescription sales of Plan B, pharmacists remain key players in EC by providing access to needed products and by serving as professional and knowledgeable resources. Now more than ever is the time for pharmacists to reach out and take advantage of educational opportunities about EC.
References 1. Turner A, Ellertson C. How safe is emergency contraception? Drug Safety. 2002;25:695–706. 2. Kaiser Family Foundation and Lifetime Television. Vital Signs Index No.2, Emergency contraception (selected findings). Accessed at www.kff.org/womenshealth/upload/13433_1.pdf, December 7, 2004. 3. Hoff T, Greene L, Davis J. The Henry J. Kaiser Family Foundation. National survey of adolescents and young adults: sexual health knowledge, attitudes and experiences. Accessed at www.kff.org/youthhivstds/upload/14269_1.pdf, December 7, 2004. 4. Pharmacy Access Partnership. Connecticut State profile. Accessed at www.go2ec.org/ProfileConnecticut.htm, December 7, 2004. 5. NARAL Pro-Choice Colorado. Emergency contraception: the pharmacy referral guide for Colorado. Accessed at www.prochoicecolorado. org/s06healthcare/ecpharmacy.shtml, January 6, 2005. 6. Pharmacy Access Partnership. New Mexico State profile. Accessed at www.go2ec.org/ProfileNewMexico.htm, January 6, 2005. 7. Pharmacy Access Partnership. State profiles. Accessed at www.go2ec.org/StateProfiles.htm, December 7, 2004. 8. Hepler CD. Balancing pharmacists’ conscientious objections with their duty to serve [viewpoint]. J Am Pharm Assoc. 2005;45:434–6. 9. Pharmacy Access Partnership. Birth control within reach, a national survey on women’s attitudes and interest in pharmacy access to hormonal contraception. June 2004. Accessed at www.pharmacyaccess.org/ pdfs/ExecutiveSummary.pdf, January 6, 2005. 10. Kaiser Family Foundation. New York City pharmacies that do not provide EC fail to post required signs, city council study says. Daily Reproductive Health Report. February 10, 2004. Accessed at www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=2&DR_ID=2 2118, December 13, 2004. 11. Greene DF, Landau SC, Monastersky N, et al. Pharmacy access to emergency contraception in California. Persp Sexual Reprod Health. In press.
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