EC access initiatives moving forward in U.S.

Plans are on track to seek over-the-counter (OTC) status for the levonorgestrel-only emergency contraceptive pill (ECP) Plan B, with results from a just-published label comprehension study indicating that women can grasp the necessary information for safe and effective use of the drug.1

At Contraceptive Technology Update press time, officials with the Washington, DC-based Women’s Capital Corp. were scheduled to meet with the Food and Drug Administration to review the company’s support material prior to actual filing of the OTC application, reports Sharon Camp, PhD, company president and chief executive officer. If the material is in order, expect the application to be filed in October 2002, she says.

A pharmacokinetic study of adolescent use of Plan B has been completed, with blood sample analysis now under way, says Camp. A safety study of adolescent use is enrolling participants and is expected to finish soon, she notes. A large-scale behavioral study also is under way.

The label study was designed to evaluate women’s comprehension of a prototype OTC package label for an ECP product.

To test the labeling, researchers conducted interviews with 663 women in malls and family planning clinics in eight U.S. cities. To be eligible for the study, women had to be 12-50 years old and able to read English well enough to read an OTC product label.

After looking at the package, women were asked 30 questions that addressed 11 communication objectives about indications, contraindications, instructions, side effects, and management of serious complications. Most questions asked whether use of the product would be appropriate in a described situation, such as the morning after a condom broke during sexual intercourse.

Seven of the 11 communication objectives were each understood by more than 85% of subjects. Most women in the study understood the most important objectives: The product is indicated for prevention of pregnancy after unprotected sex (93%); the first pill should be taken within 72 hours or as soon as possible after intercourse (97%); the product should not be used by women who already are pregnant (98%); and that the product does not prevent sexually transmitted diseases or HIV/AIDS (94%).

Researchers believe the results of the study demonstrate that women should be able to use EC safely and effectively if it were distributed over the counter, says Elizabeth Raymond, MD, MPH, associate medical director of the Biomedical Affairs Division of Family Health International in Research Triangle Park, NC. Raymond served as lead author of the study.

"The fact that so many of our study subjects understood the label is highly significant," she says. "It shows that just by reading the label, women can get the information they need to use the product properly. They don’t need counseling by a clinician."

Researchers recently finished another study in which they evaluated how women actually did use a prototype OTC Plan B product; the results of that study will be available in a few months, states Raymond.

Ads boost awareness

Women in Washington state now enjoy expand-ed access to EC through the 150 pharmacies that participate in the collaborative drug practice program under way in the state. (See "Pharmacists, providers linking to provide emergency contraception," CTU, August 1999, p. 85.) The program allows women to obtain EC through participating pharmacists without an advance prescription.

A 10-week media campaign now running on local radio stations and in area newspapers is reminding women of the pharmacy access program. The campaign should reach more than 5 million sexually active women ages 18-34 who are at risk for an unintended pregnancy, estimate Women’s Capital Corp. officials.

The print ads contain the following message: "Oops’ and Uh-oh.’ Two phrases that should never be uttered in a sexual context. Find out how Plan B, taken within 72 hours of intercourse, can be your backup plan in preventing pregnancy. And find yourself uttering phrases like Phew!’ Accidents happen. That’s why there’s Plan B." Readers are then directed to the product’s web site, www.go2planb.com; and a toll-free telephone hotline, (866) Turn2planB [(866) 887-6275], for more information. The hotline and web site provide full information on EC and a directory of Washington pharmacists who provide it on a walk-in basis. The radio ads convey a similar message about pharmacist availability of Plan B.

Pharmacists who participate in the EC program were alerted about the upcoming campaign so they could stock up on product, display patient brochures, and put up window posters to let women know about EC availability, Camp states.

"Too many women in Washington state still don’t know what Plan B is or where to find it when they need it, and they don’t have a lot of time to find out," says Camp. "We want to help close the information gap so more women can actually get access to Plan B within 72 hours."

Reference

1. Raymond EG, Dalebout SM, Camp SI. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstet Gynecol 2002; 100:342-349.