Slow entry seen for mifepristone in 2001
Indications point to increased use in 2002
One year after the federal Food and Drug Administration (FDA) issued approval of mifepristone (Mifeprex, manufactured by Danco Laboratories LLC, of New York City), providers have moved cautiously in adding the medical abortion drug regimen to their practices.
A national survey of women’s health care providers by the Menlo Park, CA-based Kaiser Family Foundation (KFF) finds that 6% of gynecologists and 1% of general practice physicians have provided this early nonsurgical abortion option since it became available.1 The FDA issued approval of Mifeprex on Sept. 28, 2000, with drug shipments initiated in November 2000. Danco Laboratories holds an exclusive license from the New York City-based Population Council to manufacture, market, and distribute Mifeprex in the United States.
Gynecologists who perform surgical abortions are more likely to have used mifepristone, KFF survey findings indicate. To place these numbers in context, 27% of gynecologists report having performed surgical abortions within the last five years, including 10% who report doing so "routinely;" 1% of general practice physicians surveyed currently perform surgical abortions, explain KFF officials.2 The national random-sample telephone survey was administered to 790 health care providers, including 595 gynecologists and 195 family practitioners, internists, and general practitioners.
While the numbers may seem small, it is important to remember that it is yet early in the delivery of medical abortion in the United States and that only a relatively small percentage of physicians today perform surgical abortions, notes Tina Hoff, vice president of public health information and partnerships at the foundation.
Facilities that specialize in abortion services performed 70% of all abortions in the United States in 1996, the most recent year for which data are available.2 According to Danco Laboratories statistics, physicians in 45 states and the District of Columbia offer mifepristone to their patients.
However, the number of medical abortion providers may be increasing in 2001. According to the KFF survey results, an additional 16% of gynecologists and 7% of the general practice physicians say they are "likely" to begin offering the drug in 2001.
Education is key
The Washington, DC-based National Abortion Federation (NAF) has made education a priority when it comes to the option of medical abortion. Since January 2000, NAF has educated more than 3,300 professionals in the administration of mifepristone, says Vicki Saporta, NAF executive director.
Provider education has been delivered at regional seminars and national medical meetings, says Saporta. The organization also is customizing inservice training for NAF members who need additional educational opportunities in order to provide the mifepristone regimen.
"We currently have about 200 of our 400 provider members offering mifepristone to women, and more are adding it to their services that they provide on a regular basis," says Saporta.
Educational videotapes, a continuing medical education self-study guide, and an educational CD-ROM are all part of NAF’s efforts to deliver provider education in every desired format. Providers can visit the organization’s web site, www.earlyoptions.org, to order materials and check the schedules for regional training sessions.
NAF has been equally aggressive in providing education on medical abortion to women, both through the earlyoptions.org web site and through a public service advertisement campaign launched in 14 national magazines, which reached some 70% of U.S. women ages 18-49, says Saporta.
A centerpiece of the education program has been NAF’s toll-free hotline [(800) 772-9100], says Saporta. Since the FDA approval, phone lines have been filled with calls about the medical abortion method, she says.
"Now, about 40% of the calls we receive are from women who want more information about medical abortion," states Saporta. "They are very grateful to have a place they can call to get their questions answered and to get referrals to providers of quality care in their area."
Strides are being made
While medical abortion has not yet experienced wide acceptance from American women and their physicians, there has been some steady progress in the past 12 months, says Eric Schaff, MD, professor of family medicine at the University of Rochester (NY).
Newer regimens have become less expensive and simpler without loss of effectiveness, notes Schaff. Recent studies have shown that a 200 mg dosage of mifepristone is as effective as the currently approved 600 mg dosage, which makes the regimen less expensive; the vaginal route of misoprostol allows misoprostol to be taken from one to three days after mifepristone and extends the gestational age up to nine weeks; and misoprostol can be used at home, thereby safely avoiding an additional health care visit.3
Major health insurers, as well as several state Medicaid plans, including New York and Cali-fornia, have added coverage for mifepristone abortion, says Schaff. In addition, more U.S. women are learning about the abortion option through major public educational campaigns, and threats of restrictive legislation have not occurred, he observes.
"As barriers [such as] reimbursement and malpractice are addressed and the costs of the procedure decrease, mifepristone should become a standard option for early abortion, as we have seen in European countries," states Schaff.
References
- Kaiser Family Foundation. 2001 National Survey of Women’s Health Care Providers on Reproductive Health: Views and Practices on Medical Abortion. Menlo Park, CA: September 2001.
- Kaiser Family Foundation. Few offering mifepristone one year after FDA approval; indications that number may increase in next year. Press release. Sept. 24, 2001.
- Newhall EP, Winikoff B. Abortion with mifepristone and misoprostol: Regimens, efficacy, acceptability, and future directions. Am J Obstet Gynecol 2000; 183(2 Suppl):S44-53.
Resources
For more information about Mifeprex, contact the Mifeprex hotline, (877) 432-7596 [(877) 4 Early Option]. Web: www.earlyoptionpill.com.
For more information on medical abortion, contact:
- National Abortion Federation, 1755 Massachusetts Ave. N.W., Suite 600, Washington, DC 20036. Fax: (202) 667-5890. NAF operates a hotline, (800) 772-9100, as well as a web site, www.earlyoptions.org.
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