Viewpoints: Should oral contraceptives be sold over-the-counter?

By Daniel Grossman, MD

This debate has many facets, but the salient issues broadly come down to three related questions:

2 Do OCs meet the criteria set by the FDA to qualify for over-the-counter (OTC) status?;

3 Is it likely that OTC availability would improve contraceptive access?

The answers to the first two questions are a resounding yes, while the response to the third is perhaps a bit more tempered and dependent on various outside forces.

Washington, we have a problem

Access to contraception in the United States is already a serious public health issue. What's worse, recent evidence shows that contraceptive non-use and unintended pregnancy rates are rising, especially among poor women and women of color. The National Survey of Family Growth shows that contraceptive non-use among women not seeking pregnancy climbed nationally from 7% in 1995 to 11% in 2002, a period in which disparities based on income and race grew even wider.¹ Given cuts in Title X and other federal funding for family planning services aimed at low-income women, it should come as no surprise that contraceptive use is on the wane. In the face of these alarming statistics, OTC access to effective contraception might improve use and reduce unintended pregnancy rates.

Do oral contraceptives meet the FDA criteria?

The ultimate decision about whether a drug should be made available OTC rests with the Food and Drug Administration (FDA). The federal agency bases its decision about a prescription-to-OTC switch on several criteria regarding a medication's safety, efficacy, and simplicity of use, including whether:

1 the drug is toxic if users overdose;

2 the drug is addictive;

3 users can self-diagnose conditions for appropriate use;

4 users can safely take the medication without a physician's screening;

5 users can take the drug as indicated without a doctor's explanation.

OCs clearly meet the first three criteria: they're very safe, have no potential for overdose or addiction, and women themselves decide if they want to prevent pregnancy, the indication for which OCs are intended. The last two criteria are more complex, however.

OCs are not for everybody

OCs are not appropriate for all women, and clinicians agree that women with certain conditions should not use them. The World Health Organization's (WHO) Medical Eligibility Criteria (MEC) for Contraceptive Use is an evidence-based review of conditions that contraindicate contraceptive methods, which guides clinicians in prescribing family planning.² Of all the conditions listed in the MEC that preclude OC use, only one-the diagnosis of hypertension-is based on a woman's history alone. Even for hypertension, however, the MEC states that in settings where it's not possible to measure blood pressure, this should not be a barrier to providing OCs.

But are women able to self-diagnose these contraindicated conditions? A growing body of evidence suggests they are. Two studies from Mexico, where OCs are available OTC, found that women who obtain their pills without a prescription are no more likely to be contraindicated for use than their counterparts who get them after seeing a clinician.^3,4 A study from Washington state and another from Texas showed that women were able to accurately use a checklist based on the WHO MEC to self-identify contraindications to OCs.^5,6