Almost half of pregnancies in the United States each year are unintended; in 2010, these pregnancies cost the U.S. public health system more than $20 billion.1 For an individual woman, an unplanned pregnancy can have profound effects on health, family stability, and household economic well-being. The risk of unintended pregnancy increases with decreasing rates of contraceptive use: in 2009, 41% of unintended pregnancies occurred among women using birth control inconsistently, and 54% occurred among women not using any contraception.1 Many women cite a lack of easy access to contraception as a reason for gaps in use. This is reported disproportionately by low-income and minority women.2
In response, some states have introduced policies expanding access to contraception by expanding health care provider scope of practice. As of this writing, California, Oregon, Colorado, Hawaii, New Mexico, and Maryland have enacted legislation allowing pharmacists to directly prescribe certain hormonal contraceptive methods under a statewide protocol.3–6 In this approach, although hormonal contraceptives are not available “over the counter” in pharmacies, a pharmacist's assessment and order can allow a woman to obtain birth control without a prescription from another health care provider. California's Senate Bill 493, signed into law in October 2013, authorized licensed in-state pharmacists to “furnish self-administered hormonal contraceptives” to all women pursuant to a statewide protocol.7 Regulations specified which hormonal contraceptive methods (ie, pill, patch, vaginal ring, depot injection) could be provided as well as the screening procedures to be used by pharmacists providing these medications, including the administration of a health screening tool and blood pressure measurement. The statewide protocol was finally approved, incorporated into state regulations, and ready for implementation in California pharmacies beginning in April 2016.6,7 The full protocol is provided as Appendix 1, available online at http://links.lww.com/AOG/B80.
The American College of Clinical Pharmacy Women's Health and Practice Research Network supports pharmacist-prescribed hormonal contraceptives with appropriate patient health screenings in place.8 It should be noted that other organizations—including the American College of Obstetricians and Gynecologists—support over-the-counter access to hormonal contraceptives from pharmacies.2 Existing literature supports the rationale behind this expansion in pharmacist scope of practice. Pharmacists are well trained regarding the dosing, side effects, and adverse reactions of hormonal contraceptives; surveys of pharmacists indicate that they are interested in providing contraceptive services to patients.9–12 Surveys of physicians, nurse–midwives, and other midlevel women's health professionals show that they are also in favor of this practice model.13,14 The convenience of nearby pharmacy locations and extended hours may better meet the needs of women seeking contraception than doctors' offices.9,10 Early data also suggest that pharmacist-prescribed hormonal contraceptives are acceptable to women and may promote the use of effective birth control longitudinally. A small prospective study demonstrated women receiving pharmacist-prescribed hormonal contraceptives along with emergency contraception were significantly more likely to report using effective contraception at 8 weeks.15 The receipt of depot contraceptive injections from pharmacists was acceptable to a diverse group of women in two demonstration projects.16,17
This study aimed to evaluate the implementation of pharmacist-prescribed hormonal contraceptives in a probability sample of California retail pharmacies under a statewide protocol.
MATERIALS AND METHODS
This study was a cross-sectional telephone survey of a probability sample of California retail pharmacies performed between December 1, 2016, and April 1, 2017. The study's sample was randomly drawn from the 6,566 retail pharmacies licensed by the California State Board of Pharmacy as of July 1, 2016.18 Sampling was stratified by whether a pharmacy was located in a nonrural or rural county and whether a pharmacy was part of a chain. Nonrural and rural county designations were as defined by the Office of Rural Health Policy's Rural-Urban Commuting Area codes.19 Chain pharmacies were those having four or more licensed retail locations within the state. In preliminary analyses, only 2.4% of California retail pharmacies licensed as of July 1, 2016, were located in rural counties; these pharmacies were thus oversampled to ensure that enough rural pharmacies were available for comparisons. The stratified sampling design is described in Table 1, which shows that rural pharmacies were sampled at a much higher rate (55% vs 6%) than nonrural pharmacies. We hypothesized that this scope of practice change might be implemented more quickly in nonrural pharmacies and in retail pharmacies that were parts of chains. A rural compared with nonrural difference in implementation of pharmacy-accessed birth control services has been previously noted in similar studies of emergency contraception.20 A weighted analysis was planned to acknowledge the stratified sampling.21 A power calculation accounting for sample stratification was performed with the aim of detecting a significant difference in the availability of pharmacist-prescribed hormonal contraceptives (primary outcome) by these two variables. Assuming that survey nonresponse was uninformative in each stratum with a conservative nonresponse rate of up to 50%, a sample size of 480 pharmacies was selected to detect a 20% difference in the primary outcome by whether the pharmacy was located in a rural or nonrural county and had independent or chain status with at least 80% power (for any combination of true proportions).
Study staff—representing themselves as young women seeking contraceptives in a “secret shopper” technique—phoned selected pharmacies and spoke to pharmacy staff to assess whether and how pharmacist-prescribed hormonal contraception services were being implemented. The “secret shopper” technique was selected for this study for several reasons. First, knowledge that survey questions were being administered by a researcher could introduce response bias and threaten the validity of results. Second, phone calls from “patients” most closely mirror clinical reality. Third, the “secret shopper” approach has been used successfully in prior contraceptive access studies.22–25 The “secret shopper” presented as a nulliparous 16-year-old girl with health insurance under California's Medi-Cal (Medicaid) program and no medical contraindications to the use of hormonal contraceptive methods. Telephone survey items specifically assessed whether pharmacist-prescribed hormonal contraceptives were provided, whether all four methods were available (ie, pill, patch, vaginal ring, depot injection), what the shopper should do when she arrived at the pharmacy, if she could obtain contraceptives directly from a pharmacist as a minor, and where else she could go if the service was not available at the pharmacy. A standardized script was used to guide discussions with pharmacy staff and pharmacists and all study staff were trained in conducting surveys before collecting data in an attempt to mitigate bias. During this training, calls were made using the script to six nonsample pharmacies to validate the script; no revisions were required as a result of validation. This script is provided in Appendix 2, available online at http://links.lww.com/AOG/B80. Three attempts were made to contact each study pharmacy between 8 am and 8 pm during the business week (Monday through Friday). Responses were entered into a secure computer database.
After inverse probability weights were applied to survey data, estimated proportions with 95% CIs were calculated and reported to describe how many sample pharmacies had implemented pharmacist-prescribed hormonal contraceptives (primary outcome). Similarly, weighted estimated proportions were calculated to describe how many sample pharmacies provided all four allowed contraceptive methods and restricted contraceptive access by patient age. Wald tests were conducted to compare the availability of pharmacist-prescribed hormonal contraceptives between rural and nonrural pharmacies and between chain and independent pharmacies. The threshold for statistical significance in these comparisons was set at a two-sided significance level of .05. Analyses were performed using R.
This study was reviewed by the institutional review board of the School of Medicine at the University of California, Riverside, and was deemed to be non–human subjects research (protocol HS 16-185).
Table 1 describes the probability sample of pharmacies included in the study. The proportion of nonresponding pharmacies (ie, nonworking number or no answer after three telephone attempts) was 4.8% (response rate 95.2%). Table 1 further describes pharmacies that could be reached (n=457). Most retail pharmacies were chain locations (65.4%) and most were located in nonrural communities (85.6%). Rural pharmacies were successfully oversampled per the study's protocol (Table 1). Among responding pharmacies, 376 sites (78.3%) had a pharmacist or staff member available to discuss the topic of pharmacist-prescribed hormonal contraceptives with the study secret shopper. Having staff available to discuss this service did not vary significantly by pharmacy location (P=.29) or type (P=.06). The remaining pharmacies responded that they did not have any staff available to discuss pharmacist-prescribed hormonal contraceptives with the secret shopper.
Among respondents, 5.1%—22 pharmacies—reported providing pharmacist-prescribed hormonal contraceptives (95% CI 2.9–7.2%). There was no significant difference between the proportions of nonrural pharmacies (5.1%, 95% CI 2.8–7.3%) and rural pharmacies (4.7%, 95% CI 1.6–7.7%) providing pharmacist-prescribed hormonal contraceptives with P=.83 for this comparison. Similarly, there was no significant difference between the weighted proportions of independent pharmacies (6.4%, 95% CI 2.3–10.5%) and chain pharmacies (4.3%, 95% CI 1.8–6.8%; P=.40). These results are depicted in Figure 1.
In cases in which pharmacies responded that they did provide pharmacist-prescribed hormonal contraceptives, study secret shoppers asked questions to describe the service details and the patient experience of obtaining birth control under this new program. These simple descriptive findings are presented in Table 2. Only five pharmacies (22.7% of those providing contraceptives by pharmacists) reported providing all four hormonal methods specified in the protocol. Most pharmacies providing pharmacist-prescribed hormonal contraceptives (n=17 [77.3%]) proactively informed secret shoppers that an assessment of medical history would be required before receiving medications, and 36.4% proactively mentioned blood pressure screening. Half of the pharmacies providing pharmacist-prescribed contraceptives responded that the service was available to a 16-year-old minor (Table 2). Given the small number of pharmacies providing this service in the sample, further bivariate comparisons were not performed within this subgroup. The small subsample of participating pharmacies did not allow for formal statistical inferences regarding the variation in fidelity to the specific procedures outlined in California's protocol regulation.
In the first year after California's statewide protocol availability, a small proportion of California retail pharmacies had implemented pharmacist-prescribed hormonal contraception services. Based on these findings, it is estimated that patients could access pharmacist-prescribed hormonal contraception in relatively few of the more than 6,000 retail pharmacies in California. The decision to implement this practice change did not seem to vary by pharmacy type or rural or nonrural location in this survey. Making additional comparisons within the group of 22 pharmacies in the sample who were providing this service was not possible and would not have been meaningful given the small subsample size.
Our findings differed somewhat from those reported in a recent research letter reporting on a similarly designed telephone survey carried out in California almost concurrently. In the report of this study, which included a larger sample (1,008 responding pharmacies), 11.1% of pharmacies were found to be providing pharmacist-provided hormonal contraceptives (95% CI 9.3–13.2%).26 It is possible that the larger sample size of this study provided a more precise estimate. Additionally, nearly 22% of pharmacies contacted in our sample did not have anyone available to discuss the contraceptive protocol; this may have led to an underestimate in pharmacy participation in our results. The findings of this study were aligned with ours in that there was no significant difference in implementation by urbanity or chain status.26 Also similar was the finding that oral contraceptive pills were referenced by most (77.7%) but not all surveyed pharmacies in this sample.26 This finding of inconsistency in which methods were mentioned may have reflected those methods with which the pharmacy staff member might have been personally most familiar or comfortable with in this “secret shopper” design. However, extrapolations from our study findings regarding the details of protocol implementation (eg, contraceptive types available, whether or not minors were served) must be made with caution given that only 22 pharmacies were providing pharmacist-prescribed services.
The relatively low rates of participation demonstrated in this survey may be attributable to several factors. First, although California's legislation increased the scope of practice of pharmacists to allow for the direct provision of hormonal contraceptives, it did not mandate this service nor did it create additional policies to support the adoption of this practice broadly. For example, California's legislation did not mandate that insurance companies reimburse pharmacists for these clinical services as they reimburse other health care providers. In this scenario, retail pharmacies may not find sufficient economic incentives or patient demand to implement this practice. Chain pharmacies may take time to adopt this practice with protocol development, legal review, and staff training to consider across multiple locations. With more time, it is expected that more pharmacists and pharmacies will participate. This study's finding of a delay or gap in the implementation of a policy related to contraception suggests that a single legislative change might not be enough to effectively and rapidly change practice. In the complex health care delivery system, a constellation of policies better supports such initiatives. Additionally, with our “secret shopper design,” we were not able to capture the multitude of other factors that might have shaped a pharmacy's decision to implement this service, including pharmacist attitudes. These potential drivers of service delivery must be assessed in future studies.
This study's findings must be interpreted in the context of its limitations. The secret shopper methodology that we selected for our phone survey did limit the degree to which we could thoroughly assess service provision at sample pharmacies. Although the script (Appendix 2, http://links.lww.com/AOG/B80) included probing and follow-up questions, these could be asked only as a layperson seeking birth control. The use of this methodology also meant that, although all secret shoppers asked to speak to someone knowledgeable about pharmacist-prescribed hormonal contraceptives, some might have spoken to clerks or technicians, whereas others might have been transferred to a pharmacist. Again, this could have introduced variation into study findings. Understanding these risks, we felt that there was still great value in the secret shopper approach, because it best reflected what a woman's true experience would be with respect to seeking these contraceptive services. Another potential limitation of this survey is that it was administered approximately 8–12 months after the contraceptive provisions of Senate Bill 493 were implemented in April 2016. The reality of implementing this type of practice change is that variation in communication regarding new services may persist for some time. Although we had hoped to capture more granular data regarding fidelity to the state protocol (eg, type of contraceptives offered, adherence to medical assessment procedures), we were limited by the small number of sample pharmacies that reported providing the service. This warrants follow-up in future studies once the program has grown throughout the state. Another limitation in our design was the decision to power the study to detect a 20% difference in implementation by the pharmacy characteristics of location and type. This may have been an overestimation and was further affected by the low overall proportion of pharmacies participating in the protocol. For this reason, we might not have detected the urban–rural difference noted in other studies of the implementation of over-the-counter emergency contraception access.20 We also did not sample multiple pharmacies within a given chain; it is possible that even in the setting of corporate policies, individual pharmacy-level factors might affect implementation within retail chains.
These baseline findings at early implementation have implications for California's reproductive care delivery system. It appears that policies widening pharmacist scope of practice to include contraceptive prescription are just one part of a broader legislative strategy that will support access to birth control across the state. State legislators and women's health advocates may next work to develop policies that mandate insurer coverage of these services. We found that rural pharmacies were no more or less likely to implement this service. These pharmacies serve parts of the state where there is a lack of access to other providers of reproductive care. Incentive programs and campaigns could be directed to support rural retail pharmacies seeking to provide these services. These findings may also be useful to community-based advocates; a show of increased consumer demand for these services may be what ultimately drives pharmacy participation in this program. Results may also be instructive or generalizable for other states considering similar legislation given this study's evaluation of a statewide probability sample of retail pharmacies. Again, these states might benefit from considering a package of policies that supports this complex practice change from start to finish. Among other factors, these policies must take into account reimbursement, pharmacist certification and credentialing, and access to this service in remote or rural areas. Other states might also consider evaluating the implementation of similar policies as they evolve over time.
1. Guttmacher Institute. Fact sheet: unintended pregnancy in the United States. Available at: https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states
. Retrieved November 7, 2017.
2. Over-the-counter access to oral contraceptives. Committee Opinion No. 544. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;120:1527–31.
3. Rodriguez MI, Anderson L, Edelman AB. Prescription of hormonal contraception by pharmacists in Oregon: implementation of House Bill 2879. Obstet Gynecol 2016;128:168–70.
4. Yang YT, Kozhimannil KB, Snowden JM. Pharmacist-prescribed birth control in Oregon and other states. JAMA 2016;315:1567–8.
6. California Senate Bill 493. Available at: http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201320140SB493. Retrieved on December 4, 2017.
7. Protocol for pharmacists furnishing self-administered hormonal contraception. California code of regulations. Available at: http://www.pharmacy.ca.gov/laws_regs/1746_1_pt.pdf
. Retrieved December 4, 2017.
8. McIntosh J, Rafie S, Wasik M, McBane S, Lodise NM, El-Ibiary SY, et al. Changing oral contraceptives from prescription to over-the-counter status: an opinion statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy. Pharmacotherapy 2011;31:424–37.
9. Cook EA, Farris KB, Chrischilles E, Aquilino M. Relationship between availability of contraceptive products and pharmacists as information sources. J Am Pharm Assoc (2003) 2012;52:342–8.
10. Picardo C. Pharmacist-administered depot medroxyprogesterone acetate. Contraception 2006;73:559–61.
11. Gardner JS, Miller L, Downing D, Le S, Blough D, Shotorbani S. Pharmacist prescribing of hormonal contraceptives: results of the direct access study. J Am Pharm Assoc (2003) 2008;48:212–21.
12. Landau S, Besinque K, Chung F, Dries-Daffner I, Maderas NM, McGhee BT, et al. Pharmacist interest in and attitudes toward direct pharmacy access to hormonal contraception in the United States. J Am Pharm Assoc (2003) 2009;49:43–50.
13. Rafie S, Haycock M, Rafie S, Yen S, Harper CC. Direct pharmacy access to hormonal contraception: California physician and advanced practice clinician views. Contraception 2012;86:687–93.
14. Vu K, Rafie S, Gridlay K, Gutierrez H, Grossman D. Pharmacist intentions to prescribe hormonal contraception following new legislative authority in California. J Pharm Pract 2017 Jan 1. [epub ahead of print].
15. Michie L, Cameron ST, Glasier A, Greed E. Contraceptive use among women presenting to pharmacies for emergency contraception: an opportunity for intervention. J Fam Plann Reprod Health Care 2014;40:190–5.
16. Monastersky Maderas NJ, Landau SC. Pharmacy and clinic partnerships to expand access to injectable contraception. J Am Pharm Assoc. 2007;47(4):527–31.
17. Picardo C, Ferreri S. Pharmacist-administered subcutaneous depot medroxyprogesterone acetate: a pilot randomized controlled trial. Contraception 2010;82:160–7.
18. California Department of Consumer Affairs. California State Board of Pharmacy. Available at: http://www.pharmacy.ca.gov/
. Retrieved July 1, 2016.
19. Office of Rural Health Policy, the Department of Agriculture's Economic Research Service and the University of Washington Rural Health Research Center. Rural-urban commuting area codes. Available at: https://catalog.data.gov/dataset/rural-urban-commuting-area-codes
. Retrieved December 4, 2017.
20. Sampson O, Navarro SK, Khan A, Hearst N, Raine TR, Gold M, et al. Barriers to adolescents' getting emergency contraception through pharmacy access in California: differences by language and region. Perspect Sex Reprod Health 2009;41:110–8.
21. Scheaffer RL, Mendenhall W, Ott RL. Elementary survey sampling. 6th ed. Belmont (CA): Duxbury; 2006.
22. Bigbee JL, Abood R, Landau SC, Madera NM, Foster DG, Ravnan S. Pharmacy access to emergency contraception in rural and frontier communities. J Rural Health 2007;23:294–8.
23. Gee RE, Schacter HE, Kaufman EJ, Long JA. Behind-the-counter status and availability of emergency contraception. Am J Obstet Gynecol 2008;199:478.e1–5.
24. Bullock H, Steele S, Kurata N, Tschann M, Elia J, Kaneshiro B, et al. Pharmacy access to ulipristal acetate in Hawaii: is a prescription enough? Contraception 2016;93:452–4.
25. French AC, Kaunitz AM. Pharmacy access to emergency hormonal contraception in Jacksonville, FL: a secret shopper survey. Contraception 2007;75:126–30.
26. Gomez AM. Availability of pharmacist-prescribed contraception in California, 2017. JAMA 2017;318:2253–4.