An OTC Birth Control Pill Could Become a Reality
Sally Rafie, PharmD, BCPS, APh, NCMP is a pharmacist specialist at the University of California San Diego (UCSD) Health and an assistant clinical professor at the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences. She started the Birth Control Pharmacist project (www.birthcontrolpharmacist.com) to help educate pharmacists and other health care professionals about family planning topics such as hormonal contraception, emergency contraception, and youth-friendly pharmacy services. Her advocacy efforts support widespread access to reproductive health services and products, particularly in pharmacies.
HRA Pharma has partnered with Ibis Reproductive Health to conduct research and submit a new drug application for an OTC progestin-only pill to the FDA.
An over-the-counter (OTC) birth control pill is finally on the horizon. HRA Pharma, a French pharmaceutical company, has recently formed a partnership with the nonprofit research organization Ibis Reproductive Health to conduct the research needed to prepare and submit a new drug application for an OTC progestin-only pill to the FDA. While the approval may be several years away, at least we are on the way. More than 70% of women support OTC access to birth control.1
This is an exciting prospect that could make birth control pills more widely available and easier for people to access and use. Ultimately, it may make a dent in our high rate of unintended pregnancies (45% of all pregnancies in the United States.). 2
All birth control pills — combined and progestin-only – are currently available by prescription only. Some states, such as California and Oregon, have enacted state laws allowing pharmacists to prescribe hormonal birth control. The more resources and options people have to obtain their birth control, the more likely they are to use it to effectively control if and when they have a pregnancy.
The birth control options currently available OTC are spermicides, condoms, and levonorgestrel emergency contraception. Progestin-only pills are much more effective at preventing pregnancy than any of these other methods. The pill—including progestin-only and combined—is one of the most effective birth control methods available. Both pill types are about 99% effective when used exactly as directed and 91% effective with typical use.3 Progestin- only pills have about the same effectiveness as combination estrogen and progestin pills, rings, and patches.
While combined hormonal birth control pills are generally more popular, the estrogen component results in some serious contraindications and precautions.3 Women with high blood pressure, migraines with aura, and other medical conditions should be avoiding estrogen. On the other hand, the progestin-only pill does not have the same concerns and can be safely used by most women. An OTC progestin-only pill is expected to follow in the footsteps of levonorgestrel — a progestin-only emergency contraceptive pill.
Many professional medical associations have expressed support for OTC birth control pills, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, and the American College of Clinical Pharmacy Women’s Health Practice and Research Network.4-7 It’s even a bipartisan issue, although there are disagreements on who should pay for an OTC birth control pill among different political parties.
Pharmacists and other providers have expressed concerns about expanding access to birth control and how that might impact other necessary health services.8,9 We must trust women to continue to seek and obtain related preventive health care and health maintenance from their primary care physicians, obstetricians/gynecologists, or other health care providers. There is no evidence to suggest that birth control pills should be held hostage to make women go to the doctor. Pap smears and other preventive health care procedures are important, and access to birth control pills is important, but the 2 are independents and do not need to be linked. 3
- Grossman D, Grindlay K, Li R, Potter JE, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013;88(4):544-52.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008—2011. N Engl J Med. 2016; 374(9): 843-52
- US Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, 2016. MMWR. 2016;65(4):1-66.
- American Academy of Family Physicians (AAFP) Resolution No 501: Endorse access without age restriction to over-the-counter oral contraceptive pills. April 2016.
- American College of Obstetricians and Gynecologists Committee Opinion No 615: Access to contraception. Obstetrics and Gynecology. 2015; 125(1):250—5.
- American Medical Association Resolution D-75.995 (Sub. Res. 507, A-13): Over-the-counter access to oral contraceptives. American Medical Association. 2013.
- McIntosh J, Rafie S, Wasik M, McBane S, Lodise NM, El-Ibiary SY, et al. Changing oral contraceptives from prescription to over-the-counter status: An opinion statement of the Women’s Health Practice and Research Network of the American College of Clinical Pharmacy. Pharmacotherapy. 2011;31(4):424-37.
- Rafie S, Kelly S, Gray EK, et al. Provider opinions regarding expanding access to hormonal contraception in pharmacies. Womens Health Issues. 2016;26(2):153-60.
- Rafie S, Haycock M, Rafie S, Yen S, Harper CC. Direct pharmacy access to hormonal contraception: California physician and advanced practice clinician views. Contraception. 2012;86(6):687-93.