Companies commit to emergency contraception — Have you?
Plan B expands access, Gynétics’ progestin-only ECP seeks approval
Good news on the emergency contraception (EC) front: A nationwide commercial launch is on the way for the first levonorges trel pill, approval is pending on a second progestin-only product, and solid research shows that women who use emergency contraception do not intend to substitute it for regular pregnancy prevention methods.
Despite this positive news, family planning experts maintain that the awareness level of EC is still too low among patients and providers. At least one manufacturer has expressed willingness to spend $40 million to $50 million to raise awareness of EC among patients to the 50% level. Providers will need to up their efforts to expand knowledge of EC, once dubbed "the nation’s best-kept secret."1
"During the first year on the market, promotion of Preven caused awareness of emergency contraception to increase from 11% to 15%," says Sherry Bump, executive director of marketing for Gynétics in Belle Mead, NJ, the first company to launch a dedicated EC pill in the United States. "While this is an improvement, still far too many women are ignorant about emergency contraception — that pregnancy can be averted after sex, how EC works, and when EC should be used for greatest efficacy."
It will take $40 million to $60 million to move women’s awareness levels from 15% to 50%, says Bump. Gynétics is willing to commit that level of funding to reach its audience with a mix of public relations and advertising messages. The company has enlisted the help of MTV’s "Loveline" co-host Drew Pinsky to speak with the media and the public on the importance of emergency contraception.
"As we enter the new millennium, we will be reaching out to women through radio and television ads," says Bump.
Every effort needs to be directed to women to increase their knowledge and understanding of EC, she says. "Women have a tremendous need for EC, but they do not know solutions exist to prevent pregnancy after sex. Given that lack of knowledge, growth, acceptance, and usage will be slow."
Look for new ECP
Gynétics expects to file a new drug application with the U.S. Food and Drug Administra tion (FDA) for a levonorgestrel ECP by the close of 1999, with an anticipated approval in the second half of 2000, Bump reports. The company’s first product, Preven, is stocked in nine out of the 10 top retail drug chains, which account for 75% of all prescription volume in the country.
(The top chains include Albertson’s-American Stores of Boise, ID; CVS Corp. of Woonsocket, RI; Eckerd Corp. of Largo, FL; Kmart Corp. of Troy, MI; Kroger Co. of Cincinnati; Longs Drug Stores Corp. of Walnut Creek, CA; Medicine Shoppe International of St. Louis; Rite Aid Corp. of Camp Hill, PA; and Walgreen Co. of Deer field, IL.) Wal-Mart of Bentonville, AR, continues its decision not to carry Preven. It is a decision Wal-Mart says was based on a variety of business considerations and not intended as a moral statement or judgment about the drug.2
"Initially, Gynétics’ goal was to achieve dis tribution in six of the top 10 chains," Bump explains. "While we would like 10 out of 10 chains stocked, we are very pleased with this high level of distribution."
The lowdown on Plan B
There seems to be a considerable amount of misinformation circulating about the current and future product availability of Plan B, the new progestin-only ECP from Women’s Capital Corp. of Bellevue, WA, according to Sharon Camp, PhD, company president.
[Plan B, which is packaged with two 0.75 mg levonorgestrel tablets, received FDA approval in July. See Contraceptive Technology Update, September 1999, p. 108, for additional information on Plan B.]
"Some people seem to be under the impression that there will be a gap in supply," reports Camp. "We definitely do not anticipate any such problem, despite some initial expiration dating issues."
The product now in distribution will expire at the end of January. The company intends to begin distributing the new drug product in January (it will expire in June) and has made a commitment to replace any expired product with the new product at no cost by means of a credit against new orders, Camp explains. The company encourages clinics to order what they believe they will need through January but not to order excessive amounts.
Women’s Capital Corp. submitted additional information on the expiration dating issue to the FDA in October, along with a request for expedited review of the new data, Camp announces. "At the time of the national commercial launch next year, Plan B is expected to have an expiration date comparable to that for similar products, but a final decision on the new expiration dating may not be made by the FDA for several months," she says.
Other rumors erroneously have Plan B distribution restricted to Planned Parenthood clinics, Washington state, or to clinical trial sites, says Camp. Following its FDA approval, Women’s Capital Corp. began distribution to health care providers who were able to dispense the drug directly from their clinics or offices, she explains. Plan B is now available in hundreds of clinics across the country, she says.
The product is not available through retail pharmacies, except in western Washington state, where pharmacists are dispensing emergency contraception under collaborative drug therapy agreements with local physicians and nurse practitioners. Women’s Capital Corp. is testing a variety of marketing strategies in that area to ensure the success of the commercial launch in 2000, says Camp.
"Meanwhile, we have made an effort to concentrate supplies of Plan B in the health facilities currently providing the bulk of emergency contraception," she notes. "Our marketing efforts have focused on Planned Parenthood affiliates, Title X family planning clinics, campus health centers, and providers listed on the Emergency Contraception Hotline and Web site."
[The hotline number is (888) not-2-late. For information on the Web site, see resource box, below right.]
However, any provider who can dispense Plan B directly to clients may order the product by calling the company at (800) 330-1271, stresses Camp. Preferential pricing is available to qualified nonprofit providers. Introductory pricing has ended, and a new price schedule will be announced shortly.
Women will use EC, study shows
A great deal of education is needed for both providers and patients to get EC into the mainstream, says Marie Harvey, DrPH, director of research at the Center for the Study of Women in Society at the University of Oregon in Eugene.
"It is clearly a lot of education for both women and providers to know that it is available and be able to request it and for providers to be able to offer it," Harvey explains. "I really hope that providers will start giving it to women who are using contraception as a backup method, just to have it available in case something goes wrong."
When emergency contraception is made available, women will use it, according to a recently-published acceptability study. A survey of 235 women’s experiences with EC pills at 13 Kaiser Permanente medical offices in San Diego, the study shows that participants:
• were overwhelmingly accepting of the method — 91% were satisfied with EC pills, and 97% said they would recommend them to family and friends;
• found them easy to use — 99.6% reported no problems in usage;
• did not intend to substitute the method for regular contraception — 97% said they would use EC pills for emergencies only,3 thus dispelling fears that women would forego use of ongoing contraception.
Seventy percent of the women who participated in the study were using a contraceptive method when they requested EC pills. When asked about the situation that led to unprotected intercourse, nearly one-half indicated it had been a condom failure.
Harvey, lead author of the study, says, "I’m a person who is concerned about women’s reproductive health in general; while I want to prevent unintended pregnancy, I also want to prevent the spread of sexually transmitted diseases [STDs] and HIV. The important thing is to make sure as we counsel women about ECPs is to let them know that because they were unable to protect themselves against pregnancy, they also were unable to protect themselves against STDs and HIV."
References
1. Hatcher RA, Trussell J, Stewart F, et al. Emergency Contraception: The Nation’s Best-Kept Secret. Atlanta: Bridging the Gap Communications; 1995.
2. Wal-Mart. Wal-Mart’s Statement Concerning Preven. Bentonville, AR; July 21, 1999.
3. Harvey SM, Beckman LJ, Sherman C, et al. Women’s experience and satisfaction with emergency contraception. Fam Plann Perspect 1999; 31.
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