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

Jennifer McIntosh, Pharm.D., M.H.S.; Sally Rafie, Pharm.D.; Mitzi Wasik, Pharm.D.; Sarah McBane, Pharm.D.; Nicole M. Lodise, Pharm.D.; Shareen Y. El-Ibiary, Pharm.D.; Alicia Forinash, Pharm.D.; Marlowe Djuric Kachlic, Pharm.D.; Emily Rowe, Pharm.D.; Kathy Besinque, Pharm.D., M.S.Ed., FASHP

Disclosures

Pharmacotherapy. 2011;31(4):424-437. 

In This Article

Abstract and Introduction

Abstract

Addressing the issue of unintended pregnancy is a national priority. One proposed strategy to reduce unintended pregnancy is to improve access to oral contraceptives by changing them to over-the-counter (OTC) status. Existing data indicate that oral contraceptives meet safety criteria required of OTC products. Available literature demonstrates that women can self-screen for contraindications to oral contraceptives and can do this as well as clinicians, and experience with OTC emergency contraception suggests that OTC oral contraceptives would not increase sexual risk-taking behavior. Women support OTC access to oral contraceptives, but express an interest in accessing pharmacist counseling. On the basis of these data, the Women's Health Practice and Research Network of the American College of Clinical Pharmacy supports changing oral contraceptives to OTC status under two conditions: that they are sold where a pharmacist is on duty and that there are mechanisms in place to cover OTC contraceptives through Medicaid. Future research should address the issues of out-of-pocket costs to individuals, label-comprehension studies, and models for pharmacist reimbursement for time spent counseling on contraception.

Introduction

Preventing unintended pregnancy continues to be a major public health focus in the United States, where almost half of all pregnancies are unintended.[1] Unintended pregnancies are associated with poor health outcomes for infants and mothers and have negative social and economic implications for society as a whole. Women experiencing an unintended pregnancy are less likely to seek prenatal care in the first trimester, more likely to drink alcohol and smoke during pregnancy, less likely to breastfeed, and more likely to experience depression.[2,3] Children born to women who did not intend to become pregnant are more likely to be low birth weight and small for gestational age, are at an increased risk for child abuse, and have fewer developmental resources available such as positive interaction with their mothers or opportunities for skill development.[2–4] Unintended pregnancy is also expensive, with direct medical costs estimated to be $5 billion in 2002.[5] Teen pregnancies, of which 81% are unintended, cost tax payers $9.1 billion in direct and indirect costs.[6]

Addressing unintended pregnancy is a national priority. Healthy People 2010 set the benchmark that 70% of all pregnancies in the United States would be planned by 2010 and cites increasing contraception use as one strategy to achieve this goal.[7] In their 2009 report on priorities for comparative research, the Institute of Medicine specifically called for the evaluation of "innovative strategies for preventing unintended pregnancies," including "over-the-counter (OTC) access to oral contraceptives or other hormonal methods."[8]

The call for OTC availability of oral contraceptives is not new; as early as 1993, the United States Food and Drug Administration (FDA) scheduled a meeting of the Fertility and Maternal Health Drugs Advisory Committee to address the question. The meeting was canceled and never rescheduled, partly due to opposition from organizations such as Public Citizen, the National Women's Health Network, and some physicians and other family planning providers.[9] Levonorgestrel (Plan B; Duramed Pharmaceuticals, Cincinnati, OH) was approved for emergency contraception in 2006, making it the first hormonal contraceptive with OTC availability.[10] With the success of the prescription-to-OTC switch of levonorgestrel and the new recognition by the Institute of Medicine, advocates are once more evaluating the possibility of changing traditional oral contraceptives (including combined estrogen-progestin and progestin only) to OTC status. (The FDA approved ulipristal acetate, a progestin agonist-antagonist, as a prescription-only emergency contraceptive in August 2010 after approval by the European Medicines Agency in March 2009.[11,12] Because of the recent approval of ulipristal and its limited postmarketing surveillance data, this article pertains only to estrogen-progestin and progestinonly oral contraceptives.)

The pharmacy community has remained relatively quiet throughout the oral contraceptive prescription-to-OTC debate, despite pharmacists playing an increasing role in improving access to contraception and other public health initiatives.[13–15] As pharmacists expand their clinical role in women's health, it is important for pharmacists to contribute to policy debates affecting access to contraception. Pharmacists bring a unique perspective to the OTC debate with their understanding of access to contraception in the community setting and their role in counseling and educating consumers about both prescription and nonprescription contraceptives. In this article, we review the regulatory requirements around OTC approval, examine the safety data on direct access to oral contraceptives, discuss policy implications of a prescription-to- OTC switch, and provide policy recommendations on changing oral contraceptives to OTC status.

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