Be prepared for 1999 debut of mifepristone
Is your facility considering the use of mifepristone (RU-486) when it becomes available in the United States? If so, pencil in the end of this year as the target date for adding this form of medical abortion to your services and close the chapter on an announcement that has been some eight years in the making.
"We do expect to make mifepristone available by the end of the year in the U.S.," confirms Heather O’Neill, spokeswoman for the Danco Group in New York City. The firm was granted the U.S. manufacturing license from the Population Council, a nonprofit research group in New York City concerned with reproductive health.
Once the Food and Drug Administration (FDA) signs off on Danco’s manufacturing plans, final approval will be issued, and the drug will be released on the U.S. market.
Danco is working with several women’s health and provider groups in developing provider education, says O’Neill. The company also is garnering input from clinic administrators and counselors to cover all the bases of implementing the mifepristone/misoprostol regimen into current practice.
Mifepristone is an antiprogestin. When used in providing abortion services, it interrupts pregnancy in its early stages by blocking the action of the natural hormone, progesterone. Progesterone prepares the lining of the uterus for a fertilized egg, then maintains the pregnancy. Without the effect of progesterone, the lining of the uterus softens, breaks down, and bleeding begins. Miso prostol is a prostaglandin. When it is used in abortion, the drug causes contractions of the uterus, helping to expel the embryo.1
The FDA has gathered safety and acceptability studies from the large-scale U.S. trial of the mifepristone/misoprostol regimen.2,3 The studies, which included more than 2,000 women enrolled at 17 clinics in 15 states, found the method was safe, effective, and regarded as highly acceptable by patients. (For more information on results of the safety study, see Contraceptive Technology Update, July 1998, p. 87. For more on the acceptability study, see CTU, September 1998, p. 113.)
The U.S. trial called for three clinic visits, beginning with thorough counseling, physical examination, and determination of length of pregnancy. At the first treatment visit, women were instructed to swallow three 200 mg tablets of mifepristone and stay at the clinic 30 minutes for observation. At the second visit, women ingested two 200 mcg of misoprostol and remained at the clinic for four hours. The last visit, scheduled 12 days after the misoprostol visit, served as follow-up to make sure abortion was complete.
Study data suggest that an option of a less medically supervised regimen may be desirable. A study of 166 women who received mifepristone 600 mg orally, and subsequently self-administered 800 mg in the vagina at home two days later, found 90% agreed that home administration of misoprostol was acceptable.4
How can your facility prepare for implementing mifepristone/misoprostol services? Get as much information as possible, asserts Beverly Winikoff, MD, MPH, director of the Population Council’s reproductive health programs. (See box, below right, for the latest on medical abortion, presented at the recent Contraceptive Technology conference.) "People need to understand it, not rely on fiction and mythology," notes Winikoff. "Think through the logistics, depending on how they want to provide the service. That is the critical thing in terms of service position."
With a new service such as mifepristone/misoprostol, time for additional counseling may need to be allotted, according to a survey of surgical abortion providers.5 It is hard to access the amount of time needed for counseling, she says. Both providers and patients are inexperienced when it comes to mifepristone/misoprostol. Once providers integrate information into their practices and become comfortable with the regimen, they will be able to use that experience in talking with women about the method. Women have "street knowledge" when it comes to surgical abortion, but they aren’t as familiar with medical abortion, Winikoff says. Over time, as the method grows, women will come to know more about it.
Before the FDA can give final approval of mifepristone, it must sign off on the manufacturing process and facilities that will be used to make the drug. Danco is working with the federal agency in meeting all requirements to obtain the final approval. Misoprostol already is approved for use in the United States as an ulcer medication.
The situation surrounding the approval of mifepristone is somewhat unique, Winikoff says. Other drugs often have patient demand driving approval, but those who would benefit from mifepristone can’t delay decisions about pregnancy until it is approved. Providers have to be the spokespeople for consumer demand, she says. "If somebody has arthritis, they can say, I’m suffering so much I can’t wait,’ and it creates pressure on the system. It is hard to create pressure on the system with abortion clients because they get their problem solved one way or the other, then they are not waiting for it anymore, because they no longer need an abortion."
1. Ellertson C. Early abortion with mifepristone and misoprostol. Presented at Emory University. Atlanta; February 1997.
2. Spitz IM, Bardin CW, Benton L, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998; 338:1,241-1,247.
3. Winikoff B, Ellertson C, Elul B, et al. Acceptability and feasibility of early pregnancy termination by mifepristone-misoprostol. Arch Fam Med 1998; 7:360-366.
4. Schaff EA, Stadalius LS, Eisinger SH, et al. Vaginal misoprostol administered at home after mifepristone (RU-486) for abortion. J Fam Pract 1997; 44:353-360.
5. Joffe C. Reactions to medical abortions among provid ers of surgical abortion: an early snapshot. Fam Plann Perspect 1999; 31:35-38.
"Providing Medical Abortion Services" was the focus of a half-day preconference session at the recent Contra cep tive Technology seminar in San Francisco and Washington, DC. For cassette recordings of the session, contact:
• Audio Magic, 4457 W. Lake Road, Mayville, NY 14757. Telephone: (800) 679-3646 or (716) 789-3170. The medical abortion services session (461-PC2) is $34.95 (four tapes), plus $7 shipping and handling.