Published data seem to support OTC access.
Data support over-the-counter (OTC) access for teens and adult women seeking oral contraceptive, according to a literature review published recently in the Journal of Adolescent Health.
The review, led by Krishna Upadhya, MD, MPH and her colleagues at Johns Hopkins University School of Medicine comes as reproductive health service providers and federal policymakers continue to debate moving oral contraceptives to OTC status, particularly for teenagers. Additionally, a partnership between HRA Pharma and Ibis Reproductive Health to begin an application for an OTC oral contraceptive to the FDA was recently announced.
Under FDA laws and regulations, prescription drugs should only be switched to OTC status if they are safe for self-administration, effective when self-administered, treat a condition or address a concern that is self-diagnosable, and can carry labels that are easily understood and tailored for self-administration.
In their review, the researchers noted that medical conditions that could increase the risk of serious side effects among pill users are rare among teens. The reviewers also note that the risk of blood clots that can cause serious complications like heart attacks and stroke are up to 4 times greater during pregnancy than with use of combined oral contraceptives.
The research also note in the study that data on adolescent development suggest that most teens have the reasoning skills to make informed decisions about oral contraceptives. Because the use of oral contraceptives is a daily behavior not tied to specific or imminent sexual or emotional pressures — as is the case with condom use — teens may actually be more likely to use them consistently.
The team reviewed the impact of FDA action in 2012 making the hormonal emergency contraceptive marketed as “Plan B” available OTC for teens. Upadhya and colleagues found that teen use of Plan B increased from 8% in 2002 to 22% in 2011 to 2013. Increased use after reduced restrictions demonstrated a need for improved access for teens, not increased sexual behaviors, posture the researchers, who assume the same if oral contraceptives were to gain OTC status.
Finally, the researchers considered the potential of OTC status to negatively impact clinicians’ opportunities to counsel teens and provide additional sexual and reproductive health care. The team found that the percentage of teens who get recommended annual preventive visits is already low. According to one study of 14- to 17-year-olds from 2000 to 2004, only 38% received the recommended annual visit, and of those who did receive a visit, only 40% reported having private discussions with their clinician. Upadhya says the results suggest that providing alternative access points outside of clinics, when possible, is critical to ensuring that all teens in need can use effective contraceptives.
Upadhya KK, Santelli JS, Raine-Bennett TR, Kottke MJ, Grossman D. Over-the-Counter Access to Oral Contraceptives for Adolescents. J Adolesc Health. 2017; doi: 10.1016/j.jadohealth.2016.12.024