Over-the-counter access for the Pill?
While the majority of respondents to the 2001 Contraceptive Technology Update Contracep-tion Survey say they are not in favor of changing the prescription-only status of oral contraceptives (OCs), the number of those who support such a switch rose almost 10% from 2000 poll results, the largest jump in five years.
A total of 62.9% of responses to the 2001 survey were opposed to moving OCs to over-the-counter (OTC) status, with 37.1% registering in favor of such action. (See chart on over-the-counter status for OCs, below.) In 2000, 28% said they were for switching OCs from a prescription-only status, which was virtually unchanged from the 1996 survey’s 27% figure.
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Low-dose combined oral contraceptives are safe and effective, says Jeffrey Maurus, MD, medical director of the Rock Island (IL) County Health Department. With proper education, OTC status would increase contraception and prevent unplanned pregnancy, he says.
Deb Lowry, CNM, quality management coordinator at Planned Parenthood of Santa Barbara, Ventura and San Luis Obispo counties in Santa Barbara, CA, says, "I think OTC OCs make sense; the possibility of adverse events is so low. I think people can be trusted to make their own decisions, given good informed consent information in the packaging."
However, clinicians such as Sharyn Ginsberg, RNP, CNM, nurse practitioner at Kaiser Perma-nente Medical Group in Walnut Creek, CA, continue to ask questions about the safety of moving pills into direct access.
"I do think that women should be examined and have the opportunity to review safe-sex issues and medical history," notes Ginsberg. "Perhaps this can be done initially, and then [give access] over the counter."
If not OCs, then ECPs?
Moving a drug from prescription-only to OTC is usually instituted by a manufacturer with an application to the Food and Drug Administration (FDA). While proponents of OTC access for OCs were able to voice their support during a July 2000 FDA hearing on the general issue of OTC access, no company has yet come forth to apply for such a switch.
Such is not the case with emergency contraceptive pills (ECPs), however. Women’s Capital Corp. of Bellevue, WA, which markets the levonorgestrel-only ECP Plan B, is moving forward with its FDA application for OTC status, reports Sharon Camp, PhD, company president. (See further information on the move to take ECPs over the counter in the May 2001 issue of CTU, p. 52.)
For the FDA to consider a drug’s move to OTC status, two studies must be performed: a label comprehension study and an actual use study. Women’s Health Corp. began in-depth interviews in April 2001 for the labeling study and is conducting further consumer interviews, says Camp. Analysis of data, which will be performed by Family Health International in Research Triangle Park, NC, will begin shortly, she notes.
The actual use study, which will take place at Planned Parenthood clinics and pharmacies participating in EC access, is scheduled to begin later this summer, says Camp. The Buffet Foundation of Omaha, NE, and the John Merck Fund of Boston are providing partial support for the two required studies, she adds.
Another larger study of 3,000 women has just begun at University of California at San Francisco that compares clinic access to nonprescription pharmacy access or advanced provision of three packets of Plan B, says Camp. This study, supported by the Wallace Alexander Gerbode Foundation in San Francisco and the Compton and Hewlett foundations, both in Menlo Park, CA, will supplement Women’s Capital Corp.’s actual-use study, explains Camp. It will provide more data on the impact of easier EC availability on pregnancy, risk taking, patterns of regular contraceptive use, sexually transmitted disease risk, and other issues. The studies should be completed by the end of 2001, states Camp.
When the studies are completed, Women’s Capital Corp. will submit the application to the FDA, says Camp. With its application, the company also plans to include extensive post-marketing data from Europe on "behind-the-counter" (access controlled by pharmacists) and OTC sales, as well as data from various ECP pharmacy access projects in the United States and Canada.
"All in all, we should have lots of data to address any concerns that may arise about the safety and efficacy of OTC sales of Plan B and about the way women are likely to use the OTC product," says Camp.
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