Contraception 75 (2007) 214 – 217
Original research article
Variation in availability of emergency contraception in pharmacies Hannah E. Shactera,*, Rebekah E. Geec,d, Judith A. Longa,b,d a
Philadelphia Veterans Affairs Center for Health Equity Research and Promotion, Philadelphia, PA 19104, USA b Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA c Robert Wood Johnson Foundation Clinical Scholars Program, Philadelphia, PA 19104, USA d Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA Received 30 October 2006; accepted 8 November 2006
Abstract Objective: The availability of emergency contraception (EC) depends on pharmacy stocking practices and pharmacist willingness to dispense the medication. We aimed to describe the availability of EC in areas governed by different state policies regarding pharmacist behavior. Study Design: A telephone survey was conducted between October 1 and December 31, 2005, of every pharmacy listed in the metropolitan areas of Atlanta, Philadelphia and Boston. We asked whether pharmacies could fill a prescription for EC within 24 h and, if not, why not. Results: We interviewed pharmacists at 1085 pharmacies (response rate of 75%). Overall, 23% were unable to fill a prescription for EC within 24 h. The rate of being unable to fill was 35% in Atlanta, 23% in Philadelphia and 4% in Boston (p b .001). Refusal rates were low: 4% overall; 8% in Atlanta; 3% in Philadelphia and 0% in Boston. Conclusions: Variation in state policy predicted the availability of EC. The most common reason for not being able to fill a prescription within 24 h was not having the medication in stock. D 2007 Elsevier Inc. All rights reserved. Keywords: Emergency contraception; Health policy; Women’s health; Pharmacy availability
1. Introduction Emergency contraception (EC), formulated as two 750 Ag of levonorgestrel and marketed in the United States as Plan B, reduces the risk of pregnancy after unprotected intercourse [1,2]. Use of EC can reduce the probability of pregnancy by 95% when taken within 24 h of unprotected intercourse but has often been underutilized [1,2]. Timely access to EC is therefore critical for clinical effectiveness [3,4]. There are several barriers to EC access. The American College of Obstetrics & Gynecology states that Plan B does not terminate a pregnancy but rather prohibits implantation [5,6]; however, Plan B is often confused with the abortifacient RU-486 (Mifeprex) [7]. This has led to confusion among providers and patients regarding the purpose and mechanism of action of the drug. Many women simply do not know that there is a postcoital method available to prevent pregnancy [8]. Further,
4 Corresponding author. Philadelphia, PA 19104, USA. E-mail address:
[email protected] (H.E. Shacter). 0010-7824/$ – see front matter D 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2006.11.005
women face barriers in obtaining the medication when pharmacies do not stock EC or pharmacists actively refuse to dispense the medication [7–9]. In an effort to improve access to EC, the United States Food and Drug Administration (FDA) recently made the decision to allow pharmacists to dispense EC without a physician’s prescription to women aged z 18 years. This decision greatly improves the ability of women to obtain EC during the timeframe when it is effective. However, the FDA decision has no bearing on the behavior of pharmacists or the stocking practices of pharmacies. Whereas, previously, both doctors and pharmacists were involved in the chain of access, now, only pharmacists regulate access to EC. It is therefore increasingly important to understand the factors that influence the availability of EC in pharmacies. Availability of EC in pharmacies is dictated by two primary factors. First, the pharmacy must have the medication in stock or be able to order it in a timely manner. Second, the pharmacist at the store must be willing to fill the prescription and order the medication if needed. The right of pharmacists to refuse to fill prescriptions based on moral or ethical grounds has been heavily debated, and
H.E. Shacter et al. / Contraception 75 (2007) 214 – 217
laws vary across states [10–14]. The American Pharmaceutical Association states that bthe individual pharmacist [has a] right to exercise conscientious refusal [13].Q Such Conscience clauses provide a framework for individual pharmacists to refuse to fill prescriptions for EC [8,10,11]. Currently, there is no federal policy regulating the availability of EC. However, many states have policies regarding pharmacist refusals. Four states (Arkansas, Georgia, Missouri and South Dakota) allow pharmacists to refuse to fill prescriptions based on personal moral objections, and two states require pharmacists to fill EC prescriptions (Massachusetts and Illinois) [15,16]. The effect of state pharmacist refusal policies on EC availability has not previously been studied. The objective of this study was to determine the availability of EC in three major US metropolitan areas in states with differing policies regarding pharmacist refusals. We hypothesized that a state policy that allows pharmacists to refuse to fill EC would be associated with lower pharmacy availability and that a state policy that prohibits pharmacist refusals would be associated with higher pharmacy availability. 2. Materials and methods We surveyed pharmacies in three metropolitan areas: Boston, MA; Philadelphia, PA and Atlanta, GA. We chose these locations given the variation in state policy on pharmacist refusals. In Massachusetts (Boston), pharmacists are required to fill all valid prescriptions for EC. In Georgia (Atlanta), pharmacists are legally allowed to refuse to fill prescriptions for EC based on moral or religious beliefs. Pennsylvania (Philadelphia) has no policy regarding pharmacist refusals [17]. At the time of the study, a prescription was needed in each of these locations. We used Dex Online, a service of the Yellow Pages, to identify every pharmacy in each city (n =1701). We excluded 256 listings because they were either not publicly accessible pharmacies or the telephone number was incorrect, leaving 1445 eligible pharmacies for inclusion. We attempted to contact each pharmacy a maximum of three times by telephone, at varying hours, and successfully contacted 1085 pharmacies for an overall response rate of 75%. Calls were made between October 10 and December 31, 2005, 7 days a week between the hours of 8 am and 8 pm. To assess the availability of EC, the script, which was approved by the institutional review board (IRB) of the University of Pennsylvania, was written to closely approximate the experience a woman would have when calling a pharmacy to obtain EC. We asked pharmacists whether a patient with a prescription would be able to obtain the medication within 24 h, the marker we chose for timely access. For pharmacies unable to fill a prescription within 24 h, we differentiated between those who were willing to fill it but were not able to do so in that time frame because of not having EC in stock, and those where pharmacists refused to dispense the medication. All pharmacists were
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asked whether their store had a company policy in regards to filling prescriptions for EC. In order to more closely approximate a woman’s experience at that pharmacy, all pharmacists were also asked how they believed other pharmacists in the store would handle the prescription. However, for the purposes of our study, pharmacies were classified according to the answer provided by the pharmacist who responded to the survey. We also collected information about the pharmacies, including the size of each chain and characteristics of the area surrounding the pharmacy. Pharmacies were categorized as large ( z 20 pharmacies within one city), medium (5–19 pharmacies) or small/independent (four or less pharmacies). Information from the 2000 Census was used to evaluate ZIP-code level data including self-identified race and ethnicity and percentage of the population below the federal poverty level. Within each ZIP code, we also calculated the percentage of 2004 federal contributions that went to Democratic candidates. Our primary outcomes were the overall rate of pharmacies unable to dispense EC within 24 h, refusal rates and notcarried rates. The bunable to dispenseQ rate was defined as the pharmacist stating that the medication could not be provided within 24 h for any reason. The brefusalQ rate was defined as the percentage of pharmacies where the pharmacist was not willing to provide the medication in any time frame, while the bnot carriedQ rate was defined as the percent of pharmacists willing to provide the medication but unable to do so within 24 h. Secondary analyses investigated the effect of pharmacy chain size (large, medium, small), and ZIP-code level characteristics on the ability or willingness to provide Plan B. The entire study was approved by the IRB of The University of Pennsylvania. We used m2 tests to compare rates and considered p b.05 to be significant. In the analysis of pharmacies that did not carry EC versus refused to dispense the medication, four pharmacies were excluded because the pharmacists responding to the survey were unclear. In the model evaluating pharmacies able to dispense vs. pharmacies unable to dispense, we used multivariate logistic regression. In the model focusing on pharmacies not carrying vs. pharmacies able to dispense and pharmacy refusals vs. pharmacies able to dispense, we used multinomial logit regression. All analyses employed SAS version 8.0 (SAS Institute Inc, Cary, NC, USA). Table 1 Rates of pharmacies unable to dispense EC within 24 h Location
n
Unable to dispense [n (%)]
Willing to dispense but EC not carried [n (%)]
Refusal to dispense [n (%)]
Overall Boston Philadelphia Atlanta
1085 268 427 390
247 11 99 137
197 11 84 102
46 0 12 34
(23) (4) (23) (35)
(18) (4) (20) (26)
(4) (0) (3) (9)
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H.E. Shacter et al. / Contraception 75 (2007) 214 – 217 Table 3 Adjusted odds of pharmacies unable to dispense EC within 24 h
3. Results The overall rate of pharmacies unable to dispense the medication within 24 h was 23% (Atlanta, 35%; Philadelphia, 23%; Boston, 4%) (Table 1). All pairwise comparisons were statistically different from each other (p b.001). Not being able to dispense the medication within 24 h was primarily driven by not carrying EC. However, we encountered many pharmacists who refused to provide the medication. Among all pharmacies, the rate of pharmacist refusals was 4%: 8% in Atlanta, 3% in Philadelphia and 0% in Boston (all pairwise comparisons were pb .01). Rates of pharmacies unable to dispense EC within 24 h were 19% overall, 25% in Atlanta, 12% in Philadelphia and 0% in Boston (m2 p =.02 for comparison between Atlanta and Philadelphia). Stable comparisons with Boston could not be made because nearly all Boston pharmacies were able to dispense EC within 24 h. Overall, large chains were more likely to be able to provide the medication within 24 h (Table 2). The rates of being unable to provide EC were 17% for large chains, 45% for medium chains and 32% for small chains (all pairwise m2 comparisons p values b .05). Table 3 presents the adjusted odds of not being able to dispense, not carrying and refusing relative to being able to dispense, stratified by city and chain size. The odds ratios (ORs) for being unable to dispense vs. being able to dispense were significantly different for all cities and chain sizes: Using the rate in Boston as the referent rate, the OR for Philadelphia was 7.48, 95% confidence interval (CI) =3.90– 14.34, and for Atlanta, it was 12.69, 95% CI = 6.66 24.19. Using the rate in large chains as the referent rate, the OR for medium chains was 3.81, 95% CI = 2.28– 6.37; for small chains, it was 2.36; 95% CI =1.65 –3.36. The ORs for not carrying vs. able to dispense were also significant for all variables: Philadelphia OR = 6.11, 95% CI = 5.46 – 6.76; Atlanta OR = 9.53, 95% CI = 8.88 – 10.17; medium chain Table 2 Rates of pharmacies unable to dispense EC within 24 h by chain size Pharmacies
n
Unable to dispense [n (%)]
Overall total Largea Mediumb Smallc Boston total Large Medium Small Philadelphia total Large Medium Small Atlanta total Large Medium Small
1085 784 82 219 268 200 19 49 427 311 14 102 390 317 49 68
246 137 38 71 11 3 5 3 99 61 3 35 137 74 30 33
a b c
(23) (27) (46) (32) (4) (2) (26) (6) (23) (20) (21) (34) (35) (23) (61) (49)
Chains with z 20 stores within the city. Chains with 5 to 20 stores within the city. Chains with four or fewer stores within the city.
Pharmacies
Odds of being unablea vs. ableb
Odds of not Odds of carryingc vs. able refusald vs. able
OR (95% CI)
OR (95% CI)
City Boston 1.0 Philadelphia 7.48 Atlanta 12.69 Chain size Large 1.0 Medium 3.81 Small 2.36
OR (95% CI)
e 1.0 (3.90 – 14.34) 6.11 (5.46 – 6.76) e (6.66 – 24.19) 9.53 (8.88 – 10.17) e
1.0 1.0 (2.28 – 6.37) 1.96 (1.35 – 2.58) 60.19 (59.04 – 61.34) (1.65 – 3.36) 1.60 (1.20 – 1.99) 28.66 (27.58 – 29.75)
a
Pharmacy is unable to dispense EC within 24 h. Pharmacy is able to dispense EC within 24 h. c Pharmacist is willing to dispense EC but cannot do so within 24 h because the medication is not in stock. d Pharmacist is not willing to dispense EC. e Odds ratio incalculable since the refusal rate in Boston (the reference city) was zero. b
OR = 1.96, 95% CI =1.35 – 2.58 and small chains/independent pharmacies OR = 1.60, 95% CI =1.20 –1.99. Because there were no refusals in Boston, we could not calculate the odds of refusal versus being able to dispense using Boston as a reference group. However, the odds of refusal versus able to dispense were statistically significant by size with large chains as a referent rate: medium chain OR = 60.19, 95% CI = 59.04 – 61.34; small chains/independent pharmacies OR = 28.66, 95% CI= 27.58 29.75. Of pharmacists who stated that they were able to provide EC within 24 h, 94% thought that other pharmacists in the pharmacy would also dispense the medication. Two percent stated that other pharmacists would refuse, and 4% were not sure what other pharmacists would do. Of pharmacists who said they were willing to provide the medication but did not carry EC, 92% thought that the other pharmacists in their pharmacy would also be willing to provide the medication, 3% thought that other pharmacists would refuse even if the pharmacy did carry EC and 5% were not sure what the other pharmacists would do. Of pharmacists who refused to provide the medication, 4% thought that the other pharmacists in the pharmacy would be willing to provide it, 92% thought that other pharmacists would also refuse and 4% were not sure what other pharmacists would do. An analysis of ZIP-code level data showed that neither self-identified race nor ethnicity, nor percentage of residents below poverty line in stores’ respective ZIP codes predicted EC availability. Further, the share of 2004 campaign contributions to Democratic candidates by ZIP code was not associated with availability of EC in local pharmacies. 4. Discussion This study demonstrates high rates of pharmacies unable to dispense EC within 24 h in Atlanta and Philadelphia: one in three pharmacies in Atlanta and almost one in four in Philadelphia. There was a high level of availability in Boston
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where refusals are illegal. Atlanta, with a policy allowing pharmacists to refuse to fill prescriptions for EC, had the lowest level of EC availability. Surprisingly, Philadelphia, lacking a state policy affecting either pharmacists or patients, had a high rate of pharmacies being unable to provide EC within 24 h, more similar to Atlanta than Boston. One might expect high availability of EC in Philadelphia, similar to Boston: both cities are strongly Democratic and generally supportive of bpro-choiceQ political candidates [17]. However, the availability of EC in Philadelphia pharmacies was nearly as limited as in Atlanta, where pharmacist refusals are protected. Although many factors may affect availability of EC, the similarity in results between Philadelphia and Atlanta suggests that the policy in Atlanta allowing pharmacist refusals does not restrict access to EC so much as the policy in Massachusetts improves availability. Furthermore, an analysis of ZIP-code level demographics and political data showed that these factors do not contribute to the availability of EC, implying that state policy is a primary factor in determining availability. The most common reason for not being able to provide EC within 24 h was not having the medication in stock. This obstruction of access can be seen as a more passive means of refusal in the majority of cases. While willing to order and dispense the medication, pharmacists were unable to do so in a timely manner. This delay in provision can have similar effects on patients seeking EC as an outright refusal. The rate of outright refusals was highest in Atlanta where refusals were legal and nonexistent in Boston where refusals were illegal. Philadelphia fell between the two extremes. In 25% of Atlanta pharmacies unable to dispense EC within 24 h, the reason given was refusal to provide the medication. In Philadelphia, this number was 12%; in Boston, 0%. Pharmacist refusals were two times as likely to be the cause of unavailability in Atlanta as in Philadelphia, supporting the premise that the Georgia policy may enable Atlanta pharmacists to feel more comfortable with refusals. This study has limitations. We studied only three US eastern cities, and our results may not be generalizable to other parts of the country. Despite a strong response rate, we cannot characterize nonrespondent pharmacies, which might behave differently from our participants. In addition, all pharmacists knew they were responding to a survey; thus, we may have received responses deemed socially acceptable, so that true refusal and not carried rates may be higher. This is supported by a study on the availability of EC in Pennsylvania, suggesting that the actual availability of EC in this state may be lower than the rate reported to us by pharmacists [7]. The strength of this study is that it showed that not carrying EC serves as the most common barrier to pharmacy access. Also, in controlling for neighborhood demographics
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and political contributions, this study shows a strong link between state policy and pharmacy availability. In addition, there was one caller to all the sites, using a uniform script. The sample size is large, and we were able to contact 75% of our targets. Our results indicate that EC availability is limited as a result of pharmacies not having the medication in stock. Further, availability is strongly predicted by state policies governing pharmacist refusal. Therefore, in order to ensure that women have timely access to EC, policies aimed at guaranteeing access should require that pharmacies stock as well as dispense the medication. References [1] Task Force on Postovulatory Methods of Fertility Regulation. Lancet 1998;352:428 – 33. [2] Weismiller D. Emergency contraception. Am Acad Fam Phys 2004;70:707 – 14. [3] Glasier A, Wood A. Drug therapy. N Engl J Med 1997;337:1058 – 64. [4] Piaggio G, Von Hartzen H, Grimes DA, Van Look PFA. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 1999;353:271. [5] ACOG statement of contraceptive methods. 1998. http://www. acog.org/departments/dept_notice.cfm?recno = 15&bulletin = 1326 [accessed August 17, 2006]. [6] ACOG practice bulletin #69. Emergency contraception December 2005. [7] Bennett W, Petraitis C, D’Anella A, Marcella S. Pharmacists’ knowledge and the difficulty of obtaining emergency contraception. Contraception 2003;68:261 – 7. [8] Karasz A, Kirchen NT, Gold M. The visit before the morning after: barriers to prescribing emergency contraception. Ann Fam Med 2;4;345–50. [9] Espey E, Ogburn T, Howard D, Qualls C, Ogburn J. Emergency contraception: pharmacy access in Albuquerque, New Mexico. Obstet Gynecol 2003;102:918 – 21. [10] Cantor J, Baum K. The limits of conscientious objection — may pharmacists refuse to fill prescriptions for emergency contraception? N Engl J Med 2004;351:2008 – 12. [11] Manasse H. Conscientious objection and the pharmacist. Science 2005;308:1558 – 9. [12] Charo R. The celestial fire of conscience — refusing to deliver medical care. N Engl J Med 2005;352:2471 – 3. [13] Dailard C. Beyond the issue of pharmacist refusals: pharmacies that won’t sell emergency contraception. The Guttmacher report on public policy. http://www.guttmacher.org/pubs/tgr/08/3/gr080310.html [accessed November 22, 2005]. [14] Greenberger M, Vogelstein R. Pharmacist refusals: a threat to women’s health. Science 2005;308:1557 – 8. [15] Guttmacher Institute. State policies in brief: emergency contraception. http://www.guttmacher.org/statecenter/spibs/index.html [accessed November 22, 2005]. [16] Blagojevich R. EC gets Green Light in Illinois. Contemp Sex 2005;39:9. [17] Planned Parenthood Federation of America. Summary of state actions related to pharmacy refusals at. http://www.plannedparenthood.org/ pp2/portal/files/portal/media/factsreports/fact-050418-pharmacistrefusals.xml [accessed November 22, 2005].