An OTC Oral Contraceptive Is Approved. Will It Be a Trendsetter or a Unique Case?

FDA Approves First OTC Oral Contraceptive

Last month, the FDA approved Opill (Perrigo Company, Inc) as the first daily oral contraceptive for use in the United States without a prescription.¹ The progestin-only pill, sometimes referred to as the minipill, contains norgestrel as its sole active ingredient and is considered greater than 90% effective when used as directed. In the filing with the FDA, the manufacturer reported only 14 pregnancies among the 955 participants in 1 of the submitted studies, with an adherence rate also greater than 90%.²

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Meanwhile Many States Have Approved or Are Condisering Pharmacist-Prescribed Oral Contraceptives

At least 24 states have laws and policies in place to allow pharmacists to prescribe an array of oral contraceptives.³ These policies give pharmacists varying levels of autonomy, from state statute or statewide protocol to collaborative practice agreements (CPAs), which can offer more formal and direct supervision, depending on the CPA requirements in that state. Over the past few years, more states have adopted policies friendly to the pharmacist-as-prescriber, and states that already have some form of prescriber status for oral contraceptives have tended to become less restrictive and require less supervision over time.

Will Patients Shift From Office Visits to OTC Use?

As we near 2024, when OTC Opill is scheduled to become available, the effect on provider and retail access points is unknown. The extent to which new user populations, such as the young and underserved, access oral contraceptives for the first time because they are OTC is likely to be the subject of a lot of inquiry and analysis. Researchers will surely also examine the effects of moving the site of care from a clinic to a pharmacy, or even a gas station or vending machine. For existing users of oral contraceptives, it seems less likely that large-scale switching to the minipill will occur. The norgestrel single-active-ingredient option has been on the market for 50 years and performed well for millions of women over that time,¹ yet an array of oral contraceptives and a growing number of other methods and contraceptives have come to the market during that same period of time. Will some existing patients switch? Will they do so without consulting a health care provider? Will new patients start with this option as a “fail first”? How do they know if it has failed, and are they connected to a health care provider? All of these questions remain to be answered, but one thing is for certain: Pharmacies must work to build assessment and counseling services tailored to address these questions, and to help patients understand the array of options.

Building Consultative and Assessment Services in the Pharmacy

Some pharmacies have built clinics of their own within the pharmacy to offer consultations, which may now include recommendation for the OTC contraception option. A few (too few) states require that pharmacists get reimbursed for these services, and some pharmacies offer the service with cash payments. Will this new option increase the demand for these pharmacist-provided consultation and prescribing services, as we saw with vaccines and testing during the COVID-19 pandemic? Or will OTC availability lessen the perceived need to talk to a physician, nurse practitioner, physician assistant, pharmacist, or other prescriber?

Cost, Access, Misuse Were All Considerations in OTC Approval

Nearly all involved in the process of approval, from the data scientists reviewing the supporting studies to the advocacy groups and health care provider associations, agree there is some risk associated with allowing this new OTC product to come to market, and they will all likely be considering combination products soon. However, the experts are also nearly universal in their belief that the benefits far outweigh the risks. Two of the many reasons for vocal support are that almost half of the 6.1 million pregnancies in the United States each year are unintended, and lack of access is a major issue.

Why Do Experts in Public Health Keep Overlooking the "Third Door" Option?

Some seasoned pharmacists remember a time when some products, like cough medicine, were available without a prescription but could only be found in the pharmacy. The pandemic confirmed that community pharmacies are the now-undisputed champions of convenient access to safe and effective protocol-based assessment, as well as ordering and administering treatments and diagnostics for products and conditions where evidence-based protocols are possible. Policymakers should greatly expand access via pharmacists and pharmacies and take advantage of the well-qualified and well-placed health care professionals in more than 60,000 locations across the country. Additionally, legislators should build more protocol-driven services into pharmacies, such as prescribing of oral contraceptives, vaccinations, and test-to-treat.

Missed Opportunities in Contraceptive Care

With the coming option of OTC oral contraceptives, more states should consider following the likes of Hawaii, Oregon, Washington, and California and promote broad-based, protocol-driven care with reimbursement. This allows the pharmacy to be an initial point of care for patients seeking prescription or nonprescription contraception who would otherwise not seek or access care, while also taking advantage of screening and referral opportunities for patient populations and consumers who tend to maintain high rates of screening gaps.

About the Author

Troy Trygstad, PharmD, PhD, MBA, is executive director of CPESN USA, a clinically integrated network of more than 3500 participating pharmacies. He received his doctor of pharmacy and master in business administration degrees from Drake University and a doctorate in pharmaceutical outcomes and policy from the University of North Carolina.

References

1. FDA approves first nonprescription daily oral contraceptive. News release. FDA. July 13, 2023. Accessed July 17, 2023. https://www.fda.gov/newsevents/press-announcements/fda-approves-first-nonprescription-dailyoral-contraceptive
2. Belluck P. FDA approves first US over-the-counter birth control pill. New York Times. July 13, 2023. Accessed July 17, 2023. https://www.nytimes.com/2023/07/13/health/otc-birth-control-pill.html
3. Jones KB. Advancing contraception access in states through expanded pharmacist prescribing. Center for American Progress. January 31, 2023. Accessed July 17, 2023. https://www.americanprogress.org/article/advancing-contraception-access-in-states-through-expanded-pharmacistprescribing/