Abstract
OBJECTIVE: Emergency contraception (EC) is an effective pregnancy prevention strategy. EC is available without a prescription to those aged 17 years or older. The objective of this study was to assess the accuracy of information provided to adolescents and their physicians when they telephone pharmacies to inquire about EC.
METHODS: By using standardized scripts, female callers telephoned 943 pharmacies in 5 US cities posing as 17-year-old adolescents or as physicians calling on behalf of their 17-year-old patients. McNemar tests were used to compare outcomes between adolescent and physician callers.
RESULTS: Seven hundred fifty-nine pharmacies (80%) indicated to adolescent callers, and 766 (81%) to physician callers, that EC was available on the day of the call. However, 145 pharmacies (19%) incorrectly told the adolescent callers that it would be impossible to obtain EC under any circumstances, compared with 23 pharmacies (3%) for physician callers. Pharmacies conveyed the correct age to dispense EC without a prescription in 431 adolescent calls (57%) and 466 physician calls (61%). Compared with physician callers, adolescent callers were put on hold more often (54% vs 26%) and spoke to self-identified pharmacists less often (3% vs 12%, P < .0001). When EC was not available, 36% and 33% of pharmacies called by adolescents and physicians respectively offered no additional suggestions on how to obtain it.
CONCLUSIONS: Most pharmacies report having EC in stock. However, misinformation regarding who can take EC, and at what age it is available without a prescription, is common. Such misinformation may create barriers to timely access.
- EC —
- emergency contraception
- FDA —
- Food and Drug Administration
What’s Known on This Subject:
Emergency contraception is a safe and effective method of pregnancy prevention after unprotected intercourse.
What This Study Adds:
Pharmacies commonly communicate misinformation, both to adolescents and to physicians, concerning who is able to access emergency contraception and through what means.
There are ∼750 000 teenage pregnancies each year in the United States.1 Of these, 85% are unintended.1 It has been estimated that if emergency contraception (EC) were used after every contraception failure, it could prevent half of all unintended pregnancies and 70% of all abortions.2–4 EC is safe; it does not affect an existing pregnancy, slow transport of a fertilized ova, or prevent implantation.4 Thus, in 2009 the US Food and Drug Administration (FDA) made EC (levonorgestrel) available without a prescription to individuals aged 17 years or older; those younger than 17 require a prescription. To obtain EC, consumers must request the medication (which is stocked behind the pharmacy counter) from a pharmacy staff member and present identification to establish their age. Pharmacies are not required to stock EC, and simply stocking it may be insufficient to guarantee timely access.
In 1993, the Institute of Medicine defined “access” as the timely use of health services to achieve the best possible outcomes.5 For EC, the distinction between availability and access is critical because with every 12-hour delay in taking the first EC dose after unprotected intercourse, the odds of pregnancy increase by nearly 50%.6 Therefore, even minor delays in obtaining EC substantially increase the likelihood of pregnancy.
We sought to understand the potential divide between availability of, and access to, EC in 5 major US cities. We conducted scripted phone calls from individuals posing as either adolescents or physicians to every pharmacy in these cities. We used these so-called mystery calls to estimate EC’s availability and to determine who would be told they could or could not obtain EC directly from the pharmacy.
Methods
Design
Every commercial pharmacy in 5 major US cities received 2 telephone calls: 1 from a female caller posing as a 17-year-old adolescent and 1 from a female caller posing as a physician. Callers followed standardized scripts to simulate real-world calls and to uniformly elicit specific information on EC availability and access. The Boston University Medical Center Institutional Review Board deemed this study to be non–human subject research.
Sample
Our sampling frame comprised every pharmacy geographically situated in the counties of Nashville, Tennessee; Philadelphia, Pennsylvania; Cleveland, Ohio; Austin, Texas; and Portland, Oregon. We chose cities in geographically diverse states without special pharmacy access laws that permit trained pharmacists to dispense EC without a prescription to those aged younger than 17 years. Lists of pharmacies were obtained from the boards of pharmacy in each state. Noncommercial pharmacies (eg, prison pharmacies, psychiatric hospitals) were removed from the data set.
Callers
Two female research assistants posed as 17-year-old adolescents who recently had unprotected intercourse; 2 female callers posed as physicians caring for a 17-year-old girl who recently had unprotected intercourse. For pharmacies with automated telephone systems, physician callers, if given the option, selected call prompts designed for clinicians and their offices. All callers used cellular telephones programmed with local area codes.
Every pharmacy was called twice, once by an adolescent caller and once by a physician caller. To maximize the likelihood of obtaining accurate responses, calls were made during weekdays between 9 am and 5 pm local time, when pharmacies would presumably be fully staffed. To avoid 1 call influencing the other, calls were separated by at least 2 weeks, and their order was varied randomly.
Data Collection and Call Scripts
All call scripts (Fig 1; detailed script available on request) were identical, with the exception that the adolescent callers telephoned pharmacies for themselves, and the physician callers telephoned on a patient’s behalf. To keep the calls realistic and avoid revealing the mystery caller, callers were trained to adhere strictly to the script and to avoid obtaining the desired outcome measures by any other means. Scripts were piloted through an iterative process with pharmacies in states not in the sample.
Schematic representation of call script. If, in Step 2, the caller was told that she was unable to access EC because of her age, we considered that answer to be misinformation regarding access without a prescription. The understood age to dispense EC over the counter was not obtained in this situation because of concern that if callers asked this question, it would be perceived by the pharmacy staff as an attempt to obtain information to guarantee access when they presented in-person to the pharmacy.
Each call was divided into 3 successive steps, focusing on EC availability, general access, and over-the-counter access. Each step was introduced by an open-ended probe question, designed to launch a true-to-life dialogue through which each study outcome could be assessed reliably. Depending on how spontaneously revealing the pharmacy staff was, callers probed with more specific queries until each research question was answered. After confirming answers with pharmacy staff, callers recorded all data in standardized abstraction forms.
First, before divulging the patient’s age, callers inquired about same-day availability of EC through an opening probe (Step 1), “Hi, I’m calling to see if I (or my patient) can get emergency contraception today.” For pharmacies that had EC available, callers queried whether a 17-year-old could obtain it by probing (Step 2), “If I am/the patient is 17, is that OK?” Seventeen was chosen to be the caller’s age to reflect FDA regulations. If the caller was told that based on the patient’s age, she could obtain EC, then the age threshold for access without a prescription was specifically queried by asking (Step 3), “My friends said there is an age rule (regarding access without a prescription), do you know what it is?” If the caller was told that she was unable to access EC at all based on her age, we considered that also to be a denial for access without a prescription.
Measures
We examined 3 primary outcomes: (1) same-day availability of EC, (2) whether EC could be accessed by the caller or caller’s patient, and (3) whether the pharmacy representative communicated the correct age at which EC is accessible without a prescription. To characterize the experience of the callers further, we documented whether the caller was placed on hold, who initially fielded the call, whether the call was transferred to a self-identified pharmacist, whether the time frame for taking the medication was communicated spontaneously, and whether the call ended prematurely (eg, hang up or disconnect) before all questions were asked. For pharmacies that did not have EC available on the day of the call, it was noted whether the pharmacy staff member suggested alternative pharmacies to obtain EC or if they offered to order the medication. For those willing to order the medication, we noted how many hours until it would be available for the caller. Finally, to explore other demographic factors associated with access, we merged 2010 estimate census data with pharmacy addresses.
Data Analysis
McNemar tests were used to examine differences in outcomes between the adolescent and physician callers calling the same pharmacy; a paired t-test was used to compare mean hours until the medication would be available. Because we were comparing 2 callers to the same pharmacy, no additional adjustments to the model were made. For pharmacies reporting not to have EC available on the day of the call, we used the χ2 test to compare the proportion of pharmacies that suggested alternatives or offered to order the medication for the caller. All analyses were replicated for each individual city and for independent and chain pharmacies (defined as ≥4 locations). Data were analyzed by using SAS, version 9.1 (SAS Institute, Cary, NC).
Results
Sample
Of the initial sample of 1060 pharmacies, 117 were eliminated because they were noncommercial. Our final sample comprised 943 pharmacies in 5 cities, with Philadelphia contributing the greatest number (358) and Portland the least (102; Table 1). Overall, 687 pharmacies (72.9%) were chains, and 43 (4.6%) were open 24 hours. The average cost of EC was $45 (range $15–$70) for both callers.
Characteristics of Selected Pharmacy Sample (n = 943)
Availability and Access
Across all pharmacies (n = 943), adolescent callers and physician callers elicited similar rates of same-day availability (80% and 81%, respectively, P = .50; Table 2). However, among the adolescent calls, 145 (19%) resulted in the caller being told that she could not obtain EC under any circumstances; in contrast, physicians were given the same misinformation in only 23 calls (3%, P < .0001).
When callers queried the age threshold for access without a prescription to EC, adolescents were given the correct age (17 years) in 431 calls (57%) and physicians in 466 calls (61%, P = .08). In all but 11 calls, the incorrect age was stated as erroneously too high, potentially restricting access. Although in previous work,7 we documented substantial differences in access by neighborhood characteristics, similar differences between adolescent and physician callers persisted across the spectrum of neighborhood income levels. There were also no differences to these overall findings when each city was examined individually and when chain pharmacies were examined separately from independent pharmacies.
Among pharmacies that did not have EC available on the day the call was made, 54% of them for adolescents and 56% of them for physicians either spontaneously offered to order the medication or were able to order it on request (P = .68). The average pharmacy-estimated time until the medication would be available was 45 hours (range 19–168) for adolescents and 39 hours (range 3–144) for physicians, (P < .0001). When EC was not available, 67 pharmacies (36% of those without same-day EC availability) called by the adolescent and 58 pharmacies (33% of those without same-day EC availability) called by the physician (P = .47) did not provide any option to obtain EC by the end of the call.
Characteristics of Call
During the calls, adolescent callers were placed on hold more often than physician callers, (54% vs 26%, P < .0001) (Table 3). Adolescents were also less likely than physicians to talk to a self-identified pharmacist (3% vs 12%, P < .0001) and more likely to talk to a staff member who did not identify himself or herself (95% vs 84%, P < .0001). However, when physicians spoke to a pharmacist (n = 183), correct information regarding over-the-counter EC access was conveyed no more frequently than when they spoke with a nonpharmacist (15.3% vs 15.1%, P = .97). Because adolescents spoke with a pharmacist so rarely, sources of correct versus incorrect information could not be determined.
Availability and Access Differences Between Adolescent and Physician Callersa
Differences Between Adolescent and Physician Calls
Discussion
Our data demonstrate that when 17-year-old mystery callers telephone pharmacies, nearly 20% are told that they cannot obtain EC under any circumstances, but when callers posing as physicians telephone pharmacies on behalf of 17-year-old patients, this misinformation is conveyed in only 3% of cases. Furthermore, almost half of all pharmacies communicate incorrect age guidelines to both adolescents and physicians for EC nonprescription access. In trying to obtain this information, adolescents are put on hold twice as often as physicians and frequently end up speaking with a pharmacy staff member who does not identify himself or herself.
Numerous research reports exist that use mystery callers or shoppers to illicit information regarding EC from pharmacies.8–14 However, the only study we could find that examined adolescents’ access to EC8 specifically among pharmacies that were designated as having special pharmacy access programs designed to empower pharmacists to prescriptive authority for EC. We took a different approach and examined pharmacies representative of those in the 41 states without pharmacy access laws, the laws of which automatically default to nationwide FDA regulations.
In 2009, the FDA made EC available to individuals aged 17 years or older without a prescription, and in December 2011, the US Secretary of Health and Human Services overruled the FDA Center for Drug Evaluation and Research’s recommendation to remove EC prescription requirements for all, regardless of age.15,16 Ensuing debates in the lay press have focused on EC’s safety, its effectiveness, the time-sensitive nature of its use, and the maturity level of its would-be consumers.17–20 Largely absent from this debate, however, has been a discussion of the barriers that adolescents (either themselves or via their health care providers) face in accessing EC under the current federal regulations. From our study, it appears that 1 in 5 adolescents who phone pharmacies looking for EC are told they cannot obtain it under any circumstances and that nearly half of all adolescents and physicians are told an erroneously high age for EC access without a prescription. Such misinformation poses a potentially substantial barrier to access. Furthermore, only 5% of pharmacies called in our study sample were open 24 hours, which is an additional barrier to access.
There are several limitations of our study. First, calls were made only during the week and during normal business hours. We thus cannot comment on how evening or weekend calls would have been answered when calls to pharmacies regarding EC may be more common. Because calls to the same pharmacy were separated in time and we did not uniformly ask the identity of the pharmacy staff member (we considered it an unnatural question, unlikely to be asked in a real-world call by an adolescent), we cannot comment on the direct source of misinformation. In addition, our study assessed telephoning a pharmacy and thus does not necessarily reflect in-person inquiries. Lastly, we chose the age of our callers to reflect current FDA regulations; thus, we cannot comment definitively on what adolescents of other ages would have been told. However, we specifically queried the pharmacy staff member on the legal age for access without a prescription, allowing us to obtain estimates of misinformation applicable to would-be EC consumers of all ages.
These limitations withstanding, we believe that our study demonstrates that despite attempts to improve access to EC by lowering the age at which a prescription is required to 17, there still appears to be substantial access barriers for adolescents, largely based on misinformation. Given the recent FDA decision not to change the prescription age requirements for EC, it appears from our study results that additional education regarding the current rules around EC dispensing is needed for pharmacy staff, adolescents, and physicians attempting to obtain this medication.
Footnotes
- Accepted January 23, 2012.
- Address correspondence to Tracey A. Wilkinson, MD, MPH, Fellow, Division of General Pediatrics, Boston University School of Medicine, Boston Medical Center, 88 East Newton St, Vose Hall, 3rd Floor, Boston, MA 02118. E-mail: tracey.wilkinson{at}bmc.org
All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; to drafting the article or revising it critically for important intellectual content; and all authors provided final approval of the version to be published.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: This study was made possible by a grant from The Joel and Barbara Alpert Endowment for the Children of the City and Boston University School of Medicine.
References
- Copyright © 2012 by the American Academy of Pediatrics