By Nancy Pitsenbarger
*Pitsenbarger is a Maternal and Child Health MPH student at the University of Minnesota.
In July 2009, the Food and Drug Administration (FDA) expanded over-the-counter (OTC) access to emergency contraception (EC) for individuals aged 17 and older. In December of 2011, the FDA was poised to expand OTC access to EC to youth of all ages, but Kathleen Sebelius, Secretary of the Department of Health and Human Services (DHHS), blocked the decision before it could go into effect. Secretary Sebelius explained in a public statement that her decision was due to insufficient evidence: “The data provided as part of the actual use study and the label comprehension study are not sufficient to support making [EC] available to all girls 16 and younger…” (DHHS, 2011). Reproductive and sexual health professionals argued that this unprecedented move by Secretary Sebelius was based on politics, and that existing research and surveillance data supported the need for OTC to EC for youth under age 17.
In response to Secretary Sebelius’ call for additional evidence, Raine et al. (2012) conducted an actual use study, in consultation with the FDA, which simulated OTC access to EC for girls aged 17 and younger. They found that 92% of girls aged 13 – 17 appropriately decided whether or not to use EC without any counseling from clinic staff; of those who appropriately decided to use EC, 89% had never before used the medication (Raine et al., 2012). These findings suggest that young girls are capable of using EC correctly in an OTC setting. In a related study, Cremer et al. (2010) analyzed EC label comprehension among girls aged 12 – 17 and found that they “…understood the concepts necessary for safe and effective use as well as the adults [in a comparable study]” (pg. 843).
Despite the actual use and label comprehension studies described above, the need for OTC access to EC for youth under age 17 has been clearly documented by surveillance data. In 2006, 79% of pregnancies among girls aged 15 – 17, and 98% of pregnancies among girls younger than age 15, were unintended (Finer & Zolna, 2011). A recent report by the Center for Disease Control and Prevention (2012) found that approximately 47% of high school students are sexually experienced; of those, only 6% report having had sex prior to age 13. The report also found that 34% of high school students were currently sexually active; of those, 61% reported using a condom, and 23% of females reported using a hormonal method of contraception, at last intercourse (CDC, 2012).
The fact that the majority of sexually active youth are protecting themselves against pregnancy is encouraging, but using behavioral methods of contraception consistently and correctly can be challenging (Trussell, 2011). Emergency contraception is meant to be used as a “back-up method” in instances of contraceptive failure and after sexual encounters in which no contraception was used. Given that 13% of sexually active high school students did not use any contraception at last intercourse, and that 33% of 9th graders (most of whom are age 15) report being sexually experienced (CDC, 2012), expanding OTC access to EC for youth under age 17 would enable young people to more effectively protect themselves against pregnancy.
Emergency contraception is 89% effective in preventing pregnancy if taken within three days of unprotected intercourse; it can be taken within five days, but efficacy starts to decline after 72 hours (Piaggio et al., 2011). Adolescents may be more strongly affected by this time limit than persons aged 18 and older, especially when a prescription for EC is required. For example, an individual under age 17 attempting to obtain EC by prescription would have to overcome certain barriers, such as: scheduling a timely appointment with a doctor, securing transportation to-and-from the clinic (and perhaps to-and-from the pharmacy), and securing funds to pay for the medication…all within 72 hours of unprotected intercourse in order to maximize the medication’s effectiveness. Many family planning clinics dispense EC immediately after prescribing it, and often at a discounted price, which helps to increase access for youth. Making EC available to youth of all ages without a prescription would not remove all of these barriers, but it would help to eliminate a few.
Whether EC should be made available to youth without a prescription has been an on-going debate in the US since the 1990s and it may take a couple more years before the issue is resolved. In the meantime, clinicians should provide youth under age 17 with advance prescriptions for EC as a way to increase the likelihood that young people will have ready-access to the medication should they need it (Upadhya, 2012). Additionally, a sustained effort to increase the amount of EC counseling that youth receive, which is one of the strongest predictors of whether the medication is used (Kavanaugh, 2011), would help to increase access to EC while the OTC policy continues to be debated.
A public policy that provides youth with OTC access to EC regardless of age is supported by both surveillance and research data regarding adolescent sexual activity, contraceptive use, and pregnancy. The FDA should also support it. In recent years, young people are waiting longer to become sexually active and when they do they are more likely to use contraception. A policy that continues to restrict EC access for youth, at the same time that youth are more actively trying to protect themselves from pregnancy, undermines the safe decisions made by the majority of sexually active young people. Emergency contraception is very effective at preventing pregnancy and making access difficult for those who need it most is unacceptable. If EC were made available to youth of all ages without a prescription, young people would still have barriers to overcome in order to access this medication, but politics would no longer be one of them.
Centers for Disease Control and Prevention (2012). Youth Risk Behavioral Surveillance – 2011. Morbidity and Mortality Weekly Report, 61(SS-4).
Cremer, M. et al. (2010). Adolescent comprehension of emergency contraception in New York City. Obstetrics & Gynecology, 113(4), 840-844.
Department of Health and Human Services (2011). News Release: A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius. Retrieved February 9, 2013 from http://www.hhs.gov/news/press/2011pres/12/20111207a.html
Finer, L. B. & Zolna, M. R. (2011). Unintended pregnancy in the United States: Incidence and disparities, 2006. Contraception, 84(5), 478-485.
Kavanaugh, M. L., Williams, S. L., & Schwarz, E. B. (2011). Emergency contraception use and counseling after changes in United States prescription status. Fertility and Sterility, 95(8), 2578-2581.
Piaggio, G., Kapp, N., & von Hertzen H. (2011). Effect on pregnancy rates of the delay in the administration of levonorgestrel for emergency contraception: a combined analysis of four WHO trials. Contraception, 84(1), 35-39.
Raine, T. R. et al. (2012). An Over-the-Counter Simulation Study of a Single-Tablet Emergency Contraceptive in Young Females. Obstetrics & Gynecology, 119(4), 772-779.
Trussell, J. (2011). Contraceptive failure in the United States. Contraception, 83, 397-404.
Upadhya, K. K. et al. (2012). Committee on Adolescence Policy Statement: Emergency Contraception. Pediatrics, 130(6), 1174-1182.