Advertisement
Review article| Volume 60, ISSUE 6, P634-640, June 2017

Over-the-Counter Access to Oral Contraceptives for Adolescents

      Abstract

      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.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Adolescent Health
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Martinez G.M.
        • Abma J.C.
        Sexual activity, contraceptive use, and childbearing of teenagers aged 15–19 in the United States. NCHS data brief, no 209.
        National Center for Health Statistics, Hyattsville, MD2015
        • Jones J.
        • Mosher W.
        • Daniels K.
        Current Contraceptive Use in the United States, 2006–2010, and changes in patterns of use since 1995. Natl Health Stat Rep; no 60.
        National Center for Health Statistics, Hyattsville, MD2012
        • Grindlay K.
        • Burns B.
        • Grossman D.
        Prescription requirements and over-the-counter access to oral contraceptives: A global review.
        Contraception. 2013; 88: 91-96
        • Lindberg L.
        • Santelli J.
        • Desai S.
        Understanding the decline in adolescent fertility in the United States, 2007–2012.
        J Adolesc Health. 2016; 59: 577-583
        • Santelli J.S.
        • Melnikas A.J.
        Teen fertility in transition: Recent and historic trends in the United States.
        Annu Rev Public Health. 2010; 31: 371-383 4 p following 383
        • Board on Population Health and Public Health Practice
        • Institute of Medicine
        Clinical preventive services for women: Closing the gaps.
        The National Academies Press, Washington, DC2012
        • The Society for Adolescent Health and Medicine and American Academy of Pediatrics
        Confidentiality protections for adolescents and young adults in the health care billing and insurance claims process.
        J Adolesc Health. 2016; 58: 374-377
        • Grossman D.
        • Grindlay K.
        • Li R.
        • et al.
        Interest in over-the-counter access to oral contraceptives among women in the United States.
        Contraception. 2013; 88: 544-552
        • Manski R.
        • Kottke M.
        A survey of teenagers' attitudes toward moving oral contraceptives over the counter.
        Perspect Sex Reprod Health. 2015; 47: 123-129
        • Committee on Adolescence
        Contraception for adolescents.
        Pediatrics. 2014; 134: e1244-e1256
        • Sexual and Reproductive Health Care
        A position paper of the society for adolescent health and medicine.
        J Adolesc Health. 2014; 54: 491-496
        • Committee on Adolescence
        Emergency contraception.
        Pediatrics. 2012; 130: 1174-1182
        • Society for Adolescent Health and Medicine
        Emergency contraception for adolescents and young adults: Guidance for health care professionals.
        J Adolesc Health. 2016; 58: 245-248
        • Committee on Gynecologic Practice
        • American College of Obstetricians and Gynecologists
        Committee opinion no 544: over-the-counter access to oral contraceptives.
        Obstet Gynecol. 2012; 120: 1527-1531
      1. OC OTC Working Group. Available at: http://ocsotc.org/. Accessed October 17, 2016.

        • Juhl R.P.
        Prescription to over-the-counter switch: A regulatory perspective.
        Clin Ther. 1998; 20: C111-C117
      2. S. 650 (108th): Pediatric research equity Act of 2003. 2003 (Available at:) (Accessed October 17, 2016)
      3. Food and Drug Administration, Center for drug evaluation and research. Appl Number:022532sOrig1s000; Summary Review. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf. Accessed October 17, 2016.

      4. Food and Drug Administration, Center for Drug Evaluation and Research. Appl Number: 22–252 Original-1; Summary Review. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022252_Orig-1_SumR.pdf. Accessed October 17, 2016.

      5. Time for Plan B.
        Nature. 2013; 496: 138
        • Trussell J.
        Contraceptive Efficacy.
        in: Hatcher R.A. Trussel J. Nelson A.L. Contraceptive Technology. 20th ed. Ardent Media, New York, NY2011: 777-861
        • Ranjit N.
        • Bankole A.
        • Darroch J.E.
        • Singh S.
        Contraceptive failure in the first two years of use: Differences across socioeconomic subgroups.
        Fam Plann Perspect. 2001; 33: 19-27
        • Sheth A.
        • Jain U.
        • Sharma S.
        • et al.
        A randomized, double-blind study of two combined and two progestogen-only oral contraceptives.
        Contraception. 1982; 25: 243-252
        • Grimes D.A.
        • Lopez L.M.
        • O'Brien P.A.
        • Raymond E.G.
        Progestin-only pills for contraception.
        Cochrane Database Syst Rev. 2013; : CD007541
        • Curtis K.M.
        • Tepper N.K.
        • Jatlaoui T.C.
        • et al.
        U.S. Medical eligibility criteria for contraceptive use, 2016.
        MMWR Recomm Rep. 2016; 65 (Available at:) (Accessed October 17, 2016): 1-104
        • Grossman D.
        • Fernandez L.
        • Hopkins K.
        • et al.
        Accuracy of self-screening for contraindications to combined oral contraceptive use.
        Obstet Gynecol. 2008; 112: 572-578
        • Williams R.
        • Hensel D.
        • Lehmann A.
        • et al.
        Adolescent self-screening for contraindications to combined oral contraceptive pills.
        Contraception. 2015; 92: 380
        • Piaget J.
        Science of education and the psychology of the child.
        Penguin Books, New York1971
        • Weithorn L.A.
        Children's capacities to decide about participation in research.
        IRB. 1983; 5: 1-5
        • Smith A.R.
        • Chein J.
        • Steinberg L.
        Impact of socio-emotional context, brain development, and pubertal maturation on adolescent risk-taking.
        Horm Behav. 2013; 64: 323-332
        • Kost K.
        • Singh S.
        • Vaughan B.
        • et al.
        Estimates of contraceptive failure from the 2002 national survey of family Growth.
        Contraception. 2008; 77: 10-21
        • Winner B.
        • Peipert J.F.
        • Zhao Q.
        • et al.
        Effectiveness of long-acting reversible contraception.
        N Engl J Med. 2012; 366: 1998-2007
        • Hall K.S.
        • White K.O.
        • Reame N.
        • Westhoff C.
        Studying the use of oral contraception: A review of measurement approaches.
        J Womens Health (Larchmt). 2010; 19: 2203-2210
        • Pittman M.E.
        • Secura G.M.
        • Allsworth J.E.
        • et al.
        Understanding prescription adherence: Pharmacy claims data from the contraceptive choice project.
        Contraception. 2011; 83: 340-345
        • Moreau C.
        • Bouyer J.
        • Gilbert F.
        • et al.
        Social, demographic and situational characteristics associated with inconsistent use of oral contraceptives: Evidence from France.
        Perspect Sex Reprod Health. 2006; 38: 190-196
        • Kennedy C.
        • O'Reilly K.
        • Medley A.
        • Sweat M.
        The impact of HIV treatment on risk behaviour in developing countries: A systematic review.
        AIDS Care. 2007; 19: 707-720
        • Kirby D.
        Emerging answers 2007.
        National Campaign to Prevent Teen Pregnancy, Washington, D.C2007
        • Meyer J.L.
        • Gold M.A.
        • Haggerty C.L.
        Advance provision of emergency contraception among adolescent and young adult women: A systematic review of literature.
        J Pediatr Adolesc Gynecol. 2011; 24: 2-9
        • Polis C.B.
        • Schaffer K.
        • Blanchard K.
        • et al.
        Advance provision of emergency contraception for pregnancy prevention: A meta-analysis.
        Obstet Gynecol. 2007; 110: 1379-1388
        • Eisenberg D.L.
        • Allsworth J.E.
        • Zhao Q.
        • Peipert J.F.
        Correlates of dual-method contraceptive use: An analysis of the National Survey of Family Growth (2006-2008).
        Infect Dis Obstet Gynecol. 2012; 2012: 717163
        • Ott M.A.
        • Adler N.E.
        • Millstein S.G.
        • et al.
        The trade-off between hormonal contraceptives and condoms among adolescents.
        Perspect Sex Reprod Health. 2002; 34: 6-14
        • American Academy of Pediatrics Committee on Practice and Ambulatory Medicine and Bright Futures steering committee
        Recommendations for preventive pediatric health care.
        Pediatrics. 2007; 120: 1376
        • Irwin Jr., C.E.
        • Adams S.H.
        • Park M.J.
        • Newacheck P.W.
        Preventive care for adolescents: Few get visits and fewer get services.
        Pediatrics. 2009; 123: e565-e572
        • Lewis F.M.
        • Dittus P.
        • Salmon M.E.
        • Nsuami M.J.
        School-based sexually transmitted disease screening: Review and programmatic guidance.
        Sex Transm Dis. 2016; 43: S18-S27
        • American College of Obstetricians and Gynecologists Committee on Gynecologic Practice
        • Long-Acting Reversible Contraception Working Group
        ACOG Committee Opinion no. 450: Increasing use of contraceptive implants and intrauterine devices to reduce unintended pregnancy.
        Obstet Gynecol. 2009; 114: 1434-1438