New Review Makes the Case for OTC Oral Contraceptives

The scientific and regulatory issues involved in switching to OTC status was assessed by the researchers
The scientific and regulatory issues involved in switching to OTC status was assessed by the researchers

A new review published in the Journal of Adolescent Health highlights evidence that supports an Rx-to-OTC switch for oral contraceptives, allowing for easier access to these drugs for both adults and teens.

In this study, Krishna Upadhya, MD, MPH, assistant professor of pediatrics at the Johns Hopkins University School of Medicine, and her colleagues reviewed the scientific and regulatory issues involved in switching oral contraceptives to OTC status and also looked at data related to the safety and effectiveness of these drugs in teens, specifically, the risk of pregnancy associated with typical use, the ability of adolescents to use oral contraceptives correctly and consistently, the potential impact of OTC access on sexual behaviors, and the potential for reduced opportunities for clinicians to counsel patients and provide recommended reproductive healthcare.

In order for the Food and Drug Administration (FDA) to switch the regulatory status of medications, the drug would need to be considered safe, with labeling that could easily be understood for self-administration. The researchers found that among teens, the incidence of medical conditions that may increase the risk of serious side effects with oral contraceptives appears low. With regards to their ability to use oral contraceptives consistently and correctly, the studies showed that most teens had the reasoning skills to make informed decisions. In addition, studies comparing the contraceptive failure rate in teens versus young women showed no significant differences. In one study, where adolescents were asked questions about correct oral contraceptive use, 90% answered the questions correctly. 

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In 2012, the FDA approved the OTC availability of Plan B for teens which led to an increase in the use of the hormonal emergency contraceptive (8% in 2002 vs. 22% in 2011–2013). This increase, the researchers believe, demonstrates the need for improved contraceptive access for teens, rather than an increase in sexual behaviors; a similar increase in use would likely occur if oral contraceptives were to gain OTC status.

Lastly, the researchers looked at what impact the OTC switch would have on clinicians' opportunities to counsel adolescents and provide additional sexual and reproductive healthcare. A study which assessed healthcare usage in patients between 14- and 17-years of age showed that only 38% of teens received the recommended annual visit, and of those patients, only 40% reported having private discussions with their clinician. The researchers pointed out that this finding indicates the importance of having contraceptive options for teens outside of clinician visits, however the team stressed that more efforts should be put forth to increase contraceptive visits with clinicians.

"Oral contraceptives are popular, safe and effective methods of pregnancy prevention for women and teens. Our review emphasizes that any future over-the-counter pill has the potential to benefit teens, and there is no scientific rationale to restrict access based on age," concluded Upadhya.

For more information visit jahonline.org.