Pilot Project Examines Feasibility of Over-the-Counter Oral Contraceptives

Laurie Barclay, MD

December 24, 2008

December 24, 2008 — Sparked by an ongoing pilot project in London, the controversy about the pros and cons of making oral contraceptives available over the counter is debated by 2 experts in the December 23 Online First issue of the British Medical Journal.

The pro position is advocated by Daniel Grossman, MD, from Ibis Reproductive Health in San Francisco and the University of California, San Francisco.

"In most countries, women must have a doctor's prescription to obtain oral contraceptives, although many developing countries do not enforce this and pills are effectively available over the counter," Dr. Grossman writes. "Data from the United States suggest that, for at least some women, the prescription requirement represents a barrier to both initiation and continuation of hormonal contraceptives. A US national survey of women in 2004 reported that 41% of women not currently using contraception said they would start using the pill, patch, or vaginal ring if it were available directly in a pharmacy."

For healthy nonsmokers of any age, the risk for cardiovascular death among those who use oral contraceptives is lower than the same risk for carrying a pregnancy to term. To address the question of whether women need to visit a clinician to decide whether oral contraception is an appropriate choice, Dr. Grossman notes that screening for contraindications to oral contraceptive use does not always occur.

In Mexico, oral contraceptives are widely available without a prescription, and women using them without first seeking medical advice were no more likely to have contraindications than those who saw a physician. Two US studies showed that potential oral contraceptive users could identify contraindications to oral contraceptives, except for unrecognized hypertension in older women, using a checklist.

Regarding concerns that women will not use oral contraceptives correctly when they are made available without a prescription, Dr. Grossman points out that little evidence suggests that clinician counseling is useful, and that even when a clinic visit is required, compliance is not perfect. A California study showed that women given 13 pill packs when first starting oral contraceptive use continued it significantly longer and had fewer gaps in use than women given only 1 or 3 packs.

Preventive services, including cervical smear tests or screening for sexually transmitted diseases, are not required before oral contraceptives are prescribed, so Dr. Grossman does not feel that requiring a physician visit before oral contraceptives are prescribed would improve use of these services.

Yet another concern in the United States is the cost to women of obtaining oral contraceptives over the counter, but some states have maintained government funding for over-the-counter emergency contraception for low-income women.

"Making oral contraceptives available without a prescription would not eliminate the option of clinician consultation," Dr. Grossman concludes. "The prescription requirement is an out of date, paternalistic barrier to contraceptive use that is not evidence based. If governments are committed to addressing the challenge of unintended pregnancy — and the related problem of maternal mortality in the developing world, health systems must create mechanisms to allow freer access to hormonal contraception for all women at low or no cost."

Sarah Jarvis, MD, from the Royal College of General Practitioners in London, United Kingdom, counters that the contraceptive pill should not be available without prescription, because she believes it is the wrong approach to reducing unwanted pregnancy. In the United Kingdom, rates of teenage motherhood are 15%, about twice those of Germany, 3-fold those of France, and nearly quadruple those of Sweden.

"The Department of Health Social Exclusion Unit has highlighted complex reasons for the high rates of teenage pregnancy in the UK, including lack of education and mixed messages in the media," Dr. Jarvis writes. "It is contraceptive use, rather than sexual activity, which correlates most closely with rates of unplanned pregnancy. In 2005, the National Institute for Health and Clinical Excellence...highlighted low use of long acting reversible contraception (intrauterine contraceptive devices, intrauterine system, progestogen-only subdermal implants, and progestogen-only injectable contraceptives) compared with user dependent methods such as the contraceptive pill as one of the reasons for high rates of unwanted pregnancy."

Dr. Jarvis notes that availability of the combined oral contraceptive pill without prescription may be safe, but that those using it would not be offered a full range of contraception on every occasion, including long-acting contraceptives that do not require daily compliance and are more reliable in practice.

Compared with other countries, the United Kingdom has less of a problem with access to primary care services. Even though 16- to 19-year-olds are more likely than other groups to use family planning clinics rather than general practitioners to provide contraception, nearly three quarters of teenagers still prefer attending a general practice office for contraceptive services.

According to Dr. Jarvis, there is a great, untapped potential for general practitioners to encourage young women to use long-acting contraceptives.

"The availability of emergency contraception without prescription has done little to change the rate of teenage pregnancies," Dr. Jarvis concludes. "Increased uptake of reliable, non user-dependent methods has to be the key. Rather than making a potentially unreliable method of contraception more easily available, our best avenue for reducing unplanned pregnancies is to encourage general practitioners to help their patients to make the best choices."

Dr. Grossman has disclosed no relevant financial relationships. Dr. Jarvis has received honoraria from Bayer for speaking at symposiums and writing educational articles.

BMJ. Published online December 23, 2008.


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