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Get ready for increased interest in emergency contraception as the first progestin-only dedicated emergency contraceptive pill (ECP) enters the U.S. market. With Food and Drug Administra tion (FDA) approval now in hand, the Women’s Capital Corp. of Seattle is moving ahead with shipments of Plan B, its levonorgestrel-only product.
Providers have been looking forward to the U.S. introduction of a progestin-only product since an international study showed the levonorgestrel-only method was more effective and resulted in fewer side effects than the combination regimen now in use.1 (Read more about the study results in the November 1998 issue of Contraceptive Technology Update, p. 143.)
Awareness of ECPs has grown following the 1998 U.S. market introduction of the Preven Emergency Contraceptive Kit. Marketed by Gynétics of Belle Mead, NJ. Preven was the first dedicated ECP product to be released in the United States. (See CTU, November 1998, p. 141, for further coverage of Preven’s introduction.)
Women’s Capital Corp. is taking a different marketing and distribution approach to emergency contraception than Gynétics, which also is developing a progestin-only product. (For more on the progestin-only products, see CTU, March 1999, p. 28.)
Company president Sharon Camp, PhD, says Women’s Capital Corp. plans to market and distribute Plan B to those facilities and providers who prescribe and dispense on-site. The 1999 CTU Contraception Survey shows that the number of these providers is growing: Three-quarters of survey respondents report their facilities prescribe emergency contraceptive pills (ECPs) on site and provide them at any time, up from 62% in 1998. (See chart, above.)
"We are an outgrowth of a private/public consortium, so we have a very strong public-sector focus," she says of the initial move not to market to retail pharmacies. "Our focus is on existing ECP providers/dispensers, such as Planned Parent hood affiliates, major Title X programs, and college/university student health centers."
By keeping its focus on such facilities, Women’s Capital Corp. sees Plan B’s chief competitors as those oral contraceptives (OCs) now determined by the FDA to be safe and effective for emergency contraception use. The challenge for Plan B is to be competitively priced because many facilities get bulk discount rates for OCs, says Camp.
1999 CTU survey results show that family planners are using Preven and the OCs approved by the FDA for ECP use. Lo-Ovral, a 30 mcg pill from Wyeth-Ayerst of Philadelphia, was the OC most frequently named for use as an ECP by survey respondents. Providers also used two Wyeth-Ayerst products: Nordette, a 30-mcg pill, and Ovral, a 50-mcg OC; and the Preven kit.
Preven has just received FDA approval of revised product labeling, says Sherry Bump, Gynétics executive director of marketing. The labeling change, which eliminates the "Black Box Warning" from the package, represents a reduction in the weight of the warnings of potential serious side effects. Black Box Warnings are used by the FDA to highlight areas of concern regarding side effects for which the FDA requires special note.
"This change puts the benefits and risks of emergency contraception in perspective," says Bump. "Additionally, removal of the Black Box Warning eliminates substantial restrictions on the company’s ability to communicate directly to the consumer and to the medical professional."
This decision should help to accelerate the process of building awareness of emergency contraception and its availability in the United States, she notes.
More women are getting the message about emergency contraception, report participants in the 1999 CTU Contraception Survey. "We are listed on the [Emergency Contraception] Web site for ECPs," says Lois Wessel, FNP, director of primary care at Washington (DC) Free Clinic. "We started last fall, and our number has increased." (The resource listing at left explains how your facility can be listed on the Web site.)
The number of women seeking ECPs also has increased at Beaverhead Family Planning Clinic in Dillon, MT, says Patricia Carrick, FNP-C, clinic coordinator. "We try to give information on ECPs to all patients who are on oral contraceptives, using condoms, or using no method," she says.
1. Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998; 352:428-433.