By Maria F. Gallo, PhD
Professor, Chair, and Associate Dean of Research, College of Public Health, Division of Epidemiology, The Ohio State University, Columbus
When the first oral contraceptive became available in the United States in 1960, it was approved for use by prescription only. Requiring a prescription creates barriers to access. For example, until recently, those seeking a prescription had to attend an in-person appointment with a qualified provider (physician, nurse practitioner, or physician assistant), and any gaps in their routine visits often would result in lost access to hormonal contraception. Consequently, 29% of adult, reproductive-age women who sought a prescription for hormonal contraception said they had experienced difficulties before in getting or refilling a prescription.1 Access to effective contraception is critical for avoiding unintended pregnancy, which accounts for about 45% of pregnancies overall in the United States.2
In the six decades since the introduction of oral contraception, we gained extensive knowledge about its safety from research studies. (Today, when I search Medline via PubMed, the Medical Subject Heading [MeSH] term “Contraceptives, Oral” produces 35,505 articles; in comparison, the MeSH term for “Metformin,” one of the most widely prescribed drugs worldwide, produces 25,682 articles.) Hormonal contraception has become safer with lower doses of estrogen and new formulations of progestins. As a result, the American College of Obstetricians and Gynecologists (ACOG) and others have argued that short-acting methods of hormonal contraception should be available over the counter to people of any age.3 These methods include oral contraception, vaginal rings, patches, and depot medroxyprogesterone (DMPA). To make this change for a given method, the drug sponsor would need to collect post-marketing data to support the safety of over-the-counter use and then file an application for the method with the U.S. Food and Drug Administration (FDA). To date, this has not been done, and hormonal contraception remains available only by prescription in the United States.
Pharmacy Prescriptions
A stopgap step to increasing access is to expand prescribing authority to pharmacists. Compared to other clinical settings, pharmacies can be easier for people to access, given their wide distribution across the country and their extended hours of operation. Also, pharmacies do not require an appointment, and their setting allows the prescription and method to be obtained in a single visit. Reducing the delay in starting the contraception method is critical for people who are at risk of unintended pregnancy. Starting in 2013, states began to pass legislation to allow pharmacists to prescribe hormonal contraception. Currently, the District of Columbia and the following 16 states have authorized this pharmacy access without requiring a collaborative practice agreement: Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Maryland, Minnesota, Nevada, New Hampshire, New Mexico, Oregon, Utah, Vermont, Virginia, and West Virginia.4 Other states have legislation pending. Advocates hope that pharmacy prescribing of hormonal contraception will follow the example of pharmacy administration of flu vaccines, a practice which initially was approved in individual states before going on to become adopted nationally.
States differ in their rules for pharmacy prescribing of hormonal contraception, the requirements for program certification, and the process for becoming a billable provider. For example, some states do not allow pharmacists to prescribe hormonal contraception to minors (younger than 18 years of age) or allow refills for people who have not seen a physician within a certain timeframe.5 Although all participating states allow pharmacists to prescribe oral contraception and the patch, some do not extend pharmacist authority to include prescriptions for the contraceptive ring and injectable DMPA. States also differ in the duration of the supply that can be prescribed.
Enacting a state law is only a first step in expanding access via pharmacies. Pharmacies then have to enroll in the program. Without widespread participation of pharmacies, access will continue to be an issue, especially among rural and underserved areas. After one year, the fraction of retail pharmacies enrolled has ranged from less than 30% in Utah to 46% in Oregon and 51% in California.6-8 Given that most community pharmacies belong to one of a few large retail chains, gaining the participation of these pharmacy chains is key. After pharmacies enroll in the program, pharmacy staff must be aware of the service, agree to participate, and complete any additional training, which typically includes several hours of continuing education from an accredited training program.9 If not all pharmacists in a given facility agree to participate, people then will need to visit the pharmacy during a time when participating staff is available. Furthermore, the public must know that the option is available to them and want to access contraception through this setting.
Patient Acceptability
Eckhaus et al conducted a detailed systematic review of qualitative and quantitative studies on the perspectives of pharmacists and patients regarding pharmacy prescribing of hormonal contraception.10 They found 15 eligible studies. Most studies, though, were small and were not population-based, which limits their generalizability. Also, many studies were conducted before pharmacy prescribing was permitted in their setting. As a result, the findings relate more to hypothetical constructs rather than actual experiences with the practice. Overall, they found that people expressed support for pharmacy prescribing on the grounds that it would be easier to access. The two national surveys found substantial proportions of women were interested in pharmacy prescribing of oral contraception (38%) or hormonal contraception (68%).11,12 Among those not using contraception, 47% of uninsured women and 40% of low-income women reported intent to start use if pharmacy prescribing were to become available. Among those using contraception, 66% expressed a preference for this mode of access. Concerns with pharmacist prescribing included issues related to patient safety, the potential for a decline in completing routine Pap smears, the availability of private space for consultation, the amount of fees charged, and maintaining confidentiality from parents.11,13
Safety
The Direct Access Study conducted among 26 community pharmacists and 214 women in 2003-2004 was a seminal study in demonstrating that pharmacy prescription of hormonal contraception could be safe and acceptable.14 Given that the study procedures included 12 hours of continuing education for the pharmacy participants, this detailed training might be a necessary component for pharmacists to be able to screen and counsel people appropriately on hormonal contraception. Subsequent studies have shown that women who have contraindications to hormonal contraception use (e.g., a history of ischemic heart disease, migraines with aura, and venous thromboembolism) can screen themselves reliably for these conditions using a checklist without the assistance of a physician. Furthermore, as ACOG and others have noted, the increased risk of venous thromboembolism from using combined oral contraception is lower than the increased risk of venous thromboembolism from pregnancy.3 In response to concerns about de-coupling contraception access from attending for routine health examinations, ACOG and the Centers for Disease Control and Prevention also state that pelvic and breast examinations and screening for cervical cancer and sexually transmitted infections are not required for starting hormonal contraception and should not be used to deny access to hormonal contraception.3,15
Insurance
People with private or public insurance can use this to cover their consultation fee when they visit their physician, nurse practitioner, or physician assistant to access contraception. In contrast, few states require insurance to cover pharmacist consultation fees, which were an average of $40 to $45 in Oregon and California.10 Thus, even if someone has insurance that would cover the hormonal contraception itself, they might face financial barriers in obtaining a prescription from a pharmacist. Note that this issue might be less relevant for young people who are on their parent’s or guardian’s insurance and who want to maintain privacy about their contraception use. Paying out of pocket instead of using insurance can be a strategy for maintaining privacy regarding their contraceptive use.
Summary and Recommendations
Until short-acting hormonal contraception is available over the counter, allowing pharmacists to prescribe oral contraception, the patch, ring, and injectable DMPA is important to reduce people’s barriers to starting and continuing effective contraception. Standardized training programs for pharmacists, both board-approved continuing education and pharmacy school-based training, would help ensure the safety and consistency of this practice. Pharmacists should be prepared to refer people who desire long-acting methods (sterilization, intrauterine device, or implant) to an appropriate healthcare provider. Even in these cases, though, people may want to receive a prescription from a pharmacist for a short-acting hormonal method to “bridge” them until they can navigate the process needed to start a long-acting method. Requiring insurance to cover the pharmacy consultation fees likely would reduce barriers to participation both on the part of pharmacies as well as people seeking contraception.
REFERENCES
- Grindlay K, Grossman D. Prescription birth control access among U.S. women at risk of unintended pregnancy. J Womens Health (Larchmt) 2016;25:249-254.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med 2016;374:843-852.
- [No authors listed]. Over-the-counter access to hormonal contraception: ACOG Committee Opinion, Number 788. Obstet Gynecol 2019;134:e96-e105.
- National Alliance of State Pharmacy Associations. Pharmacist prescribing: Hormonal contraceptives. Published April 22, 2021. https://naspa.us/resource/contraceptives/
- Joslin CM, Greenhut S. Birth control in the states: A review of efforts to expand access. R Street Policy Study No. 159. Published November 2018. https://www.rstreet.org/wp-content/uploads/2018/11/Final-159.pdf
- Batra P, Rafie S, Zhang Z, et al. An evaluation of the implementation of pharmacist-prescribed hormonal contraceptives in California. Obstet Gynecol 2018;131:850-855.
- Rodriguez MI, Garg B, Williams SM, et al. Availability of pharmacist prescription of contraception in rural areas of Oregon and New Mexico. Contraception 2020;101:210-212.
- Magnusson BM, Christensen SR, Tanner AB, et al. Accessibility of pharmacist-prescribed contraceptives in Utah. Obstet Gynecol 2021; Nov 4. doi: 10.1097/AOG.0000000000004594. [Online ahead of print].
- Rodriguez MI, McConnell KJ, Swartz J, Edelman AB. Pharmacist prescription of hormonal contraception in Oregon: Baseline knowledge and interest in provision. J Am Pharm Assoc (2003) 2016;56:521-526.
- Eckhaus LM, Ti AJ, Curtis KM, et al. Patient and pharmacist perspectives on pharmacist-prescribed contraception: A systematic review. Contraception 2021;103:66-74.
- Landau SC, Tapias MP, McGhee BT. Birth control within reach: A national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. Contraception 2006;74:463-470.
- Grossman D, Grindlay K, Li R, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception 2013;88:544-552.
- Wilkinson TA, Miller C, Rafie S, et al. Older teen attitudes toward birth control access in pharmacies: A qualitative study. Contraception 2018;97:249-255.
- Gardner JS, Downing DF, Blough D, et al. Pharmacist prescribing of hormonal contraceptives: Results of the Direct Access study. J Am Pharm Assoc (2003) 2008;48:212-226.
- Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep 2016;65:1-103.
