The Potential Impact of Over-the-Counter Access to Oral Contraceptives to Reduce Unintended Pregnancy.

Over the past five years, several advances have been made in the provision of contraceptive services that have markedly reduced barriers to access. Unquestionably, the most important development is the contraceptive coverage guarantee under the Affordable Care Act, which requires most health insurers to cover all methods approved by the U.S. Food and Drug Administration (FDA) without cost sharing such as copayments or deductibles. In some settings where the cost barrier has been removed and counseling has focused on method effectiveness, the uptake of long-acting reversible contraceptives—including intrauterine devices and implants—has increased significantly.1 However, the next big thing in birth control is already making news before it is even available: over-the-counter (OTC) access to oral contraceptives. Unlike the contentious debate over the availability of OTC emergency contraception, there has been little argument about the safety and effectiveness of OTC daily oral contraceptives. Although this could certainly change as the debate intensifies (particularly concerning adolescent use of OTC pills and insurance coverage), the clear support for OTC access by medical groups such as the American Academy of Family Physicians (AAFP) and the American College of Obstetricians and Gynecologists (ACOG) has helped focus the discussion.2,3 Although there has been significant media coverage about the possibility of OTC oral contraceptives, it will likely be several years before birth control pills are sold on the pharmacy shelf. A company would need to conduct several studies with its specific product, including a label comprehension study showing that consumers understand a simple OTC label and can use the information to determine if the product is right for them, as well as an actual use study demonstrating that they use the product appropriately over time. These studies would then be submitted to the FDA to determine whether the specific pill used in the studies is appropriate for OTC sale. Once these studies begin, the quickest timeline for approval of an OTC product is approximately three years. No pharmaceutical company has publicly acknowledged that it is working toward this goal, but the support of medical groups could be instrumental in motivating a company to move forward. The AAFP and ACOG policy statements supporting OTC oral contraceptives as a way to reduce unintended pregnancy are based on a thorough review of the evidence. Studies have shown that women can accurately use simple checklists to determine if they have contraindications to using hormonal contraception.4 Data also indicate that women obtaining OTC oral contraceptives are significantly more likely to continue use than women obtaining prescriptions at clinics.5 Surveys have found that U.S. women are very interested in using an OTC pill, and about one-third of women using no contraceptive or a method less effective than pills say they would be likely to start using an OTC oral contraceptive if one were available.6 These study results and survey data suggest that making the pill available OTC would improve uptake and continuation of effective contraception, which could help to reduce unintended pregnancy. However, future use of OTC oral contraceptives will be closely linked to price. In one survey, willingness to pay for an OTC pill dropped off precipitously beyond $20 per cycle.6 In a recent cost modeling analysis, researchers found that full insurance coverage of an OTC pill without requiring any outof-pocket expenditure from women would ▲ See related article at http://www.aafp.org/ afp/2015/0501/p625.html. Editorials