"Actual use" study of emergency contraceptive pills provided in a simulated over-the-counter manner

To evaluate use of an emergency contraceptive pill product dispensed under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events.

The study was conducted at family planning clinics and pharmacies in the United States. During enrollment, these facilities did not provide unsolicited counseling about or evaluations for emergency contraceptive pills. Women who requested emergency contraception were asked to examine a package that was modified for over-the-counter use. A package (levonorgestrel, two 0.75-mg tablets) was provided to each woman who met study criteria and indicated that she wished to receive one. Each subject paid the amount normally charged by the facility for emergency contraceptive pills. Subjects were contacted 1 and 4 weeks later and asked about use of the product, side effects, and pregnancy.

Of 665 women screened for the study, 585 received at least one package, and 540 reported having used the product. Of classifiable first uses, 1.3% (97.5% confidence interval [CI] 0.5%, 3%) were contraindicated and 28% (97.5% CI 23%, 32%) were incorrect by strict primary definitions of these inappropriate use patterns, based on the label instructions. Only 6.6% (97.5% CI 4.3%, 9.5%) of classifiable first uses were incorrect by a reasonable alternate definition. Ten subjects received the product more than once, and ten were found to be pregnant during the study. The pattern of adverse events was consistent with findings of previous studies.

Most women used emergency contraceptive pills appropriately without provider evaluation and counseling.