Emergency contraceptives over the counter

Allowing easy access is important

Requiring an adolescent to consult a clinician before obtaining emergency hormonal contraception is analogous to mandating that she consults a fire station before buying a fire extinguisher for her home. Why does she need supervision to buy several innocuous pills at the drug store when none is necessary to buy pressurized cylinders of chemicals at the hardware store? This double standard in prevention services hurts women, especially adolescents, for whom gaining access to care may often be difficult.

The rate of pregnancy among adolescents is declining across the United States.¹ Nevertheless, it is still higher than in other industrialized nations. Coitus among adolescents is often unanticipated and unprotected. Hence, the easy availability of emergency contraception is important.

Two emergency regimens of hormonal contraception are available in the United States. Both regimens are approved for use up to 72 hours after unprotected coitus. The first to be approved by the Food and Drug Administration was the Yuzpe regimen, which consists of an initial dose of two combination oral contraceptives (0.5 mg levonorgestrel plus 100 μg ethinyl estradiol), followed 12 hours later by two more. The second regimen to be approved was levonorgestrel alone: one 0.75 mg tablet followed 12 hours later by another. In a randomized controlled trial the levonorgestrel regimen prevented about 85% of the pregnancies that would have otherwise occurred in contrast with the Yuzpe regimen which prevented 57%.² The levonorgestrel regimen was also much less likely to cause nausea.

Given this impressive efficacy, why is emergency contraception used so infrequently in the United States? Only 1% of women who might have benefited from emergency contraception in the United States have ever used it.³ In settings as diverse as Scotland and Hong Kong, adolescents know more about emergency contraception and use it more frequently.⁴ The reasons for this disparity are complex but two issues are important: a lack of information and lack of access.⁵ Public service campaigns and pharmaceutical advertisements are beginning to address the lack of information.⁶ Allowing easier access to emergency contraception may not lead directly to greater use, but barriers to access are a hindrance.

In addition, an innovative experiment in Washington state that allows pharmacists to provide emergency contraception⁷ is popular with patients, pharmacists, and physicians. We should now go a step further and eliminate the requirement for the pharmacist as well. For example, the levonorgestrel regimen recently became available over the counter in France (http://www.opr.princeton.edu/ec/cnfrance.htmr).⁸

There are four questions that need to be addressed in considering whether a drug should only be available by prescription: is the condition for which the drug is to be used difficult to diagnose, does the dose need to be tailored to the patient's needs or the virulence of the disease, are the risks and benefits of the treatment finely balanced, and is the drug dangerous (from an overdose or from its potential for addition).⁹

First, in considering emergency regimens of hormonal contraception, no learned intermediary is needed to diagnose a torn condom. Second, the dose is the same for all women with either regimen. Third, rather than being finely tuned, the risk-benefit equation for emergency contraception is weighted heavily in favor of benefit. Although side effects such as nausea and vomiting are common (especially with the Yuzpe regimen), no serious adverse events have been linked to its use, and the benefit of avoiding an unintended pregnancy is a strong argument for providing liberal access. The only contraindication to the use of emergency contraception is an existing pregnancy, although there is no evidence that emergency contraception harms a fetus.¹⁰ Fourth, emergency contraception is safe. The regimens are packaged as single doses, reducing the possibility of an accidental overdose. However, should a woman intentionally take an overdose, vomiting would be the most serious consequence.

Our aim as clinicians should be to maximize the effectiveness of our interventions: for emergency contraception, sooner means better. The longer a woman waits before starting emergency contraception, the less well it works.¹¹ Requests for emergency contraception often arise on weekends when offices are closed.⁵ The costs associated with a visit to a physician or clinic may be prohibitive. Many other factors may deter young women from seeking prescriptions: embarrassment, fear of discovery of sexual activity, and the inability to take time off from school. If emergency contraception were available over the counter in drug stores that are open evenings and weekends, many of these obstacles would be removed.

Like fire extinguishers, emergency contraception may be most useful if stored where the need may arise.¹² This may mean it will be stored in a medicine cabinet, purse, or the glove compartment of a car. A trial in Scotland showed that providing emergency contraception to women in advance does not undermine their ongoing use of their current method.¹³ Similarly, keeping a fire extinguisher in the kitchen is unlikely to lead to risky cooking practices. If women had to go to the hardware store to buy a fire extinguisher after a fire began, its usefulness would be compromised. The same may hold for emergency contraception.¹¹

Most of the popular medicines sold over the counter in the United States were initially available only by prescription.⁹ The transition from being available only by prescription to over the counter sales is a natural evolution for many medicines (for example, cimetidine, miconazole, and ibuprofen).

Critics of deregulation inevitably cite the importance of counseling. Yet what evidence is there that offering counseling with emergency contraception improves outcomes for women? The availability of emergency contraception over the counter could supplement rather than replace the current distribution of other contraceptives.