Edward C. Geehr, M.D., Lifescript Chief Medical Officer
Last week, the American College of Obstetricians and Gynecologists (ACOG) recommended that birth control pills be available to women over-the-counter (OTC), without prescription. The committee felt that OTC oral contraceptives would improve access and result in fewer unintended pregnancies.
But the recommendation is not without controversy. And the Food and Drug Administration (FDA) would have to approve any such change, which could take years.
The rate of unwanted pregnancy has changed very little over the past 20 years, accounting for about 50% of all pregnancies. The cost of these pregnancies to taxpayers is estimated at $11.1 billion annually. According to the Institute of Medicine, women with unintended pregnancy are less likely to obtain prenatal care or breastfeed.
According to ACOG, several factors contribute to the high rate of unintended pregnancy, but the key issues are access and cost.
Some women find that prescriptions are a barrier to access, even though many organizations offer free or reduced-price access to family planning services. Others lack insurance coverage and can?t afford the cost of some oral contraceptives (OC).
To date, there has been no U.S. study on the effect of OTC access on reduction in unintended pregnancy. There have been a few studies in other countries on the use of OTC OC, such as Mexico, Jamaica and Thailand. But none examined the effect on rate of unintended pregnancy. And there is no long-term data on adverse health consequences for OTC users, according to ACOG.
Over-the-counter OC helps to solve the access problem, but doesn?t address the cost issue. According to one study published in the journal Contraception, the average price per pill pack was $16, which, for some lower income women, is beyond their budget. Paradoxically, some women could be adversely affected by the shift to OTC OC.
Under the Affordable Healthcare Act (AHA), all prescription contraceptives must be provided by new private health plans at no cost to enrollees. However, the move to OTC status would leave the cost uncovered under the AHA, shifting the entire cost burden to the consumer. Medicaid programs aren?t subject to the same guidelines, so co-pays would still apply.
And for those with health savings accounts, under AHA, all OTC medications will require a prescription in order to allow the use of pre-tax dollars for payment. So if OC become an OTC item, a prescription would be required anyway in order to use dollars from a health savings account, which, of course, would defeat the purpose of offering OTC access.
Conversion to OTC status under current FDA regulations would require that each manufacturer apply for exemption for their particular brand of oral contraceptive. The FDA has indicated they would meet with any company that requests such an exemption, but none have stepped forward yet. It could take years for the FDA to rule on such requests, possibly requiring additional safety studies.
Access and cost issues aside, some doctors are very concerned that the health risks of OC may be too great to safely offer the medication OTC, and requires further study before making the change.
So what are the health risks associated with OC? The primary concern is the increased tendency to form blood clots, which can result in fatal pulmonary embolism. Birth-control pills slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors.
Generally accepted contraindications to OC include pre-existing cardiovascular disease, women with a familial tendency to form blood clots, women with severe obesity and/or high cholesterol, heavy smokers and smokers over age 40, liver disease, breast cancer, some types of diabetes, and high blood pressure.
Manufacturers could be exposed to additional product liability risk by offering their oral contraceptives OTC. Prescription OC increases the likelihood that patients will be properly screened for important contraindications and be advised of the risks. Offering OTC access means that patients would need to self-police and be aware of all the medical issues surrounding oral contraceptives. Those who are ill-informed or ignore the written contraindications could end up suing the manufacturers for any adverse health effects.
With these concerns in mind, many physicians question the wisdom of offering such medications OTC and placing the entire screening burden on women consumers. Safety studies of OTC access would go a long way to assuring physicians and the public that consumers can and will educate themselves and use OTC OC appropriately.
Do you think OTC oral contraceptives are a good idea??
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