Division of General Pediatrics & Adolescent Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Heilbrunn Department of Population and Family Health, Mailman School of Public Health, Columbia University, New York, New York.
J Adolesc Health. 2017 Jun;60(6):634-640. doi: 10.1016/j.jadohealth.2016.12.024. Epub 2017 Mar 14.
Oral contraceptives (OCs) are used by millions of women in the U.S. The requirement to obtain OCs by prescription from a clinician may serve as a barrier to contraceptive initiation and continuation for women, in particular adolescents. Over-the-counter (OTC) availability would reduce this barrier and could further reduce unintended pregnancy rates. This review explores the scientific issues and regulatory processes involved in switching OCs to OTC status for minor adolescents. We review: (1) the regulatory criteria for switching a drug to OTC status; (2) risk of pregnancy and safety during use of OCs including combined oral contraceptives and progestin-only pills for adolescents; (3) the ability of adolescents to use OCs consistently and correctly; (4) OTC access to OCs and potential effect on sexual risk behaviors; and (5) the potential for reduced opportunities for clinicians to counsel and provide recommended reproductive health care to adolescents. We find strong scientific rationale for including adolescents in any regulatory change to switch OCs to OTC status. OCs are safe and highly effective among adolescents; contraindications are rarer among adolescents compared to adult women. Ready access to OCs, condoms, and emergency contraception increases their use without increasing sexual risk behaviors.
口服避孕药（OCs）在美国被数百万女性使用。从临床医生那里获得处方 OCs 的要求可能成为女性，特别是青少年开始和继续避孕的障碍。非处方（OTC）可用性将减少这一障碍，并可能进一步降低意外怀孕率。本综述探讨了将 OCs 转换为 OTC 身份的科学问题和监管流程，适用于未成年青少年。我们回顾了：（1）将药物转换为 OTC 身份的监管标准；（2）青少年使用 OCs（包括复方口服避孕药和孕激素仅避孕药）期间怀孕和安全性的风险；（3）青少年持续正确使用 OCs 的能力；（4）OTC 获得 OCs 及其对性行为风险行为的潜在影响；以及（5）减少临床医生向青少年提供咨询和推荐生殖健康护理的机会的潜力。我们发现，将青少年纳入任何监管变更以将 OCs 转换为 OTC 身份具有强有力的科学依据。OCs 在青少年中是安全且非常有效的；与成年女性相比，青少年的禁忌症更为罕见。随时获得 OCs、避孕套和紧急避孕药会增加它们的使用，而不会增加性行为风险行为。
