OTC Oral Contraceptive May Break More Precedent Than Expected

OTC Guide2023 OTC Guide

As patient access, public health advocates flex their muscles to reduce barriers to care, products, will that continue to translate in marketplace?

Oral contraceptives are used mainly to prevent unintended pregnancies, which represented 45% of all pregnancies as of 2011, according to CDC data.

Girl buying contraceptive pills in a pharmacy | Image Credit: Antonioguillem - stock.adobe.com

Antonioguillem - stock.adobe.com

Although contraceptives are nothing new in pharmacy aisles, a medication meant to be used consistently for decades by many patients without need for diagnosis or identification of an underlying condition would be a new addition to the OTC repertoire. Many investigators say accessible, affordable, and reliable contraceptives are nearly as important to society’s economic and medical well-being as having clean water and vaccinations.

Traits That Translate to Other Classes, Conditions

Chronically used medications are quite rare in the OTC arena, although a great deal of off-label use is widely known and largely ignored for some classes, such as proton pump inhibitors and second-generation antihistamines.

OTC oral contraceptives could “pierce the veil” and demonstrate that such a medication labeled for yearslong use can be available to the masses without significant untoward effects, or not, depending on approvals and findings. If they are found to be effective and safe as OTCs after months or years of widespread use, what are the arguments against the use of classes such as statins, once diagnosed? Or even β-blockers? Do not forget that insulin is one of the most dangerous drug products on the market if used incorrectly, yet access is critical, so policy allows for OTC classification. Adverse effects? Please. At one point, federal agencies argued that diphenhydramine was worthy of OTC status, but access to loratadine without a physician’s signature would send legions of children to the emergency department.

Would an OTC Contraceptive Air or Hinder Pharmacist Prescribing of Other Oral Contracepties?

The same constituencies advocating for OTC oral contraceptives are largely those seeking pharmacist prescribing of oral contraceptives to increase access, save for adding pharmacist advocacy groups on the latter effort. Just as some states are making headway with pharmacist prescribing of oral contraceptives, here comes the first of what could be many OTC oral contraceptive applications to the FDA. Will patients see retail locations (truck stops?) as places to get OTC oral contraceptives, or will they see pharmacies as destinations for contraceptive care, with patients falling outside protocol being referred to experts? And would the latter eventuality foretell the future of pharmacy practice generally?

FDA Approval Process Could Result in 2 Tiers of OTCS

If there are 2 tiers of oral contraceptives (OTC and prescription only), as is the case with injectable antidiabetic medications (insulins against newer insulins and agents), what are the implications for public policy regarding insurance coverage and coverage for assessments performed by a pharmacist? Would health plans cover assessments for initiating a prescription-only oral contraceptive but not assessments that result in a recommendation of an OTC oral contraceptive? Do we do the same for physician assessments during visits? We all know the answer.

Never a dull moment in the OTC space. We hope you enjoy the 2023 OTC Guide.

About The Author

Troy Trygstad, PharmD, PhD, MBA, is the executive director of CPESN USA, a clinically integrated network of more than 3500 participating pharmacies.


Unintended pregnancy. CDC. March 27, 2023. Accessed May 23, 2023. https://www.cdc.gov/reproductivehealth/contraception/unintendedpregnancy/index.htm

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