Mifepristone for early medical abortion: experiences in France, Great Britain and Sweden - Special Report

Perspectives on Sexual and Reproductive Health, May-June, 2002 by Rachel K. Jones, Stanley K. Henshaw

In September 2000, the Food and Drug Administration (FDA) approved mifepristone (also known by the trade name Mifeprex or its original French name, RU-486) for use along with a prostaglandin for ending pregnancies up to 49 days from the onset of a woman's last menstrual period. The FDA-approved protocol involves the administration of 600 mg of mifepristone followed two days later by 400 mg of oral misoprostol administered at a medical facility. Many abortion providers soon adopted the method, at least on a trial basis, but it is not universally available. As of early 2002, two-thirds of providers belonging to the National Abortion Federation (NAF) were offering the method to eligible patients. (1) NAF members perform about half of all abortions in the United States; they include the majority of Planned Parenthood Federation of America facilities that provide abortions. The brief U.S. experience with mifepristone leaves many questions unanswered about its ultimate level of acceptance: How many abortion providers and physicians who have not previously offered abortion services will provide medical abortions using mifepristone? What proportion of abortion patients will choose medical abortion? How will the availability of mifepristone affect the overall abortion rate?

Other questions concern the appropriate protocols that most providers in the United States will ultimately use for early medical abortion involving mifepristone. Experience in other countries indicates that protocols can vary in mifepristone dosage, the gestational limits that determine whether women are eligible for the method and whether the prostaglandin used to stimulate uterine contractions is administered at a medical facility or at a woman's home.

The experience of European countries can shed light on these issues. Mifepristone is approved for use in most of Europe, * and three countries have had a decade or more of experience with its use: France, Great Britain ([dagger]) and Sweden. In this report, we synthesize information from national abortion statistics, professional guidelines and interviews with experts in these three countries to describe levels of mifepristone use for early medical abortion, ([double dagger]) practice protocols and factors that have affected mifepristone's acceptance. We also discuss the implications of these experiences for acceptance and use of mifepristone for early medical abortion in the United States.

PROTOCOLS FOR EARLY MEDICAL ABORTION

Though reference to mifepristone as the "abortion pill" makes early medical abortion sound like a simple procedure, it actually involves the administration of two drugs on separate days, a span of several days before the abortion occurs and up to 2-3 weeks of bleeding and spotting. Both in the United States and in Europe, protocols can vary according to whether providers use registered regimens (those formally approved by a country's regulatory authority) or alternate regimens, developed to improve effectiveness and efficiency, and to minimize side effects.

Registered Regimens

Registered regimens largely reflect the state of research at the time the drug was approved for use--1988 in France (although the regimen was changed in 1992), 1991 in Great Britain and 1992 in Sweden. France, Great Britain and Sweden have similar registered regimens for early medical abortion. Their protocols involve administration of 600 mg of mifepristone (three 200 mg pills) to a woman at a licensed medical facility. Mifepristone, an antiprogestin, prevents the lining of the uterus from holding onto the fertilized egg, which leads to embryonic demise. Two days later, the woman returns to the facility, where she takes a prostaglandin, which stimulates uterine contractions that expel the products of conception. The approved regimens in Great Britain and Sweden provide that the prostaglandin gemeprost be administered vaginally. In France, the prostaglandin--either misoprostol or gemeprost--may be administered orally or vaginally. Women in these countries also must remain at the facility until they expel the products of conception or, if they are not expelled, for a minimum of three hours after the prostaglandin is administered. (2) The protocols call for a follow-up visit 1-2 weeks later to confirm that the pregnancy has been terminated and that the woman has had no complications.

One important variation in the registered protocols is the eligibility period. Mifepristone is approved for early abortion up to 49 days from the onset of the last menstrual period in France and up to 63 days in Great Britain and Sweden. However, because medical abortions at 50-63 days from the onset of the last menstrual period can be less effective and more painful than those performed earlier, physicians in Great Britain (3) and Sweden (4) recommend mifepristone predominantly for abortions earlier than 49 and 56 days, respectively. Some providers in these two countries discourage or do not provide medical abortion at 50-63 days' gestation.