December 2015

Over-the-counter access to oral contraceptives

Grossman D. Over-the-counter access to oral contraceptives. Obstetrics and Gynecology Clinics of North America. 2015 Dec; 42(4):619-29.

Unintended pregnancy in the United States has remained persistently high over the past two decades, accounting for about half of all pregnancies. A variety of factors contribute to nonuse of contraception, gaps in use, and early discontinuation, all of  which put women at risk of unintended pregnancy. For some women, side effects, both experienced and feared, lead them to not use or stop using a method, whereas others just do not like the available methods. But other women report difficulties accessing contraception, including challenges getting a prescription or a method and problems paying for a method. In one study exploring gaps in use, 40% reported problems accessing or using methods. In another study from a nationally representative sample, 30% of women who had ever tried to obtain a prescription for hormonal contraception reported difficulties obtaining the prescription or refills. The high cost of contraception has recently been addressed by the contraceptive coverage guarantee under the Affordable Care Act, which mandates that most private insurances cover methods approved by the Food and Drug Administration (FDA) without cost sharing, such as copayments or deductibles.4 But the prescription requirement may be another barrier to use that is no longer medically necessary, and removing this obstacle could be an additional strategy to reduce unintended pregnancy. 

At first glance, it seems likely that oral contraceptives (OCs) meet the FDA’s criteria to be made available without a prescription. OCs have no significant toxicity if overdosed, and they are not addictive. Women themselves determine if they are at risk of unintended pregnancy, essentially self-diagnosing the condition for appropriate use of the product. The FDA will also want to see that women can safely take the medication without a clinician’s screening, and take the medication as indicated over time without a clinician’s explanation. This article reviews the evidence indicating whether OCs meet these criteria, and women’s interest in an over-the-counter (OTC) pill and several policy issues related to a change in status for OCs.