Safety implications of transferring the oral contraceptive from prescription-only to over-the-counter status


The idea of making oral contraceptives available without prescription has a long history, and has been recently revived in the US and the UK. High dose oral contraceptives have generally been replaced by low dose formulations and, subsequently, most cardiovascular risks have been reduced and a protection against ovarian and uterine cancers has been consistently demonstrated. Oral contraceptive compliance, however, continues to be a problem, but there is no reason to assume that wise practice would be any more or less if oral contraceptives were available over-the-counter (OTC). Some countries have introduced alternatives to prescription-only oral contraceptives, whereby nurses, midwives, social workers and/or pharmacists are incorporated into the distribution process. This article concludes that the balance of risks and benefits is in favour of OTC access for oral contraceptives.

PIP: US and UK Family planning providers have revived the debate of whether or not to make oral contraceptives (OCs) available over-the-counter. Decreased hormone doses in OCs have reduced most cardiovascular risk and protect against ovarian and uterine cancers. An advantage of progestogen-only pills is that they can be used safely by smokers and breast-feeding women. In the US, an OC prescription provides many women from minority groups and single mothers who receive OCs from family planning programs with their only access to health care. Since the cost of an OC prescription is so high, women receiving subsidized OCs tend not to switch to other methods. User compliance remains a problem even with prescription. One study found a failure rate of up to 11% for OC users younger than 18. Poor user compliance would as likely be a problem if OCs were available over-the-counter. Two public health specialists with the University of California, Berkeley, echo the recommendation that emergency contraception (2 high-dose OC pills initially followed by 2 more pills 12 hours later) should be available without prescription, which can be managed separately from the routine use of OCs. Pharmacists could be trained to explain OCs, discuss possible contraindications, and provide reference materials to potential OC users. Nurses, midwives, or social workers could be responsible for OC prescription. In the UK, nurses can already prescribe drugs more complicated and potentially dangerous than OCs. Making OCs available over-the-counter could improve women’s health, make OCs more easily available, free some professional and financial resources that might then focus on other areas (e.g., diagnosis and treatment of sexually transmitted diseases in the young), and boost confidence of OC users. If OCs are on the shelf next to aspirin and antihistamines, they will be perceived, as they well should be, as a well-tolerated, easy-to-use medicine.

Published in Drug Safety Journal, 12 1995, 13(6):333-7

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Malcolm Potts
Colleen Denny
Publication date: 
March 19, 1995
Publication type: 
Journal Article