Early medical abortion — available and safe

ifepristone, in conjunction with misoprostol, is extremely effective for medical abortion at any gestation and is now widely used throughout much of the world for this purpose.1-3 However, the history of the drug in Australia has been controversial. For 10 years from 1996, it was the object of federal legislation that allowed its use in Australia only with the special permission of the federal Minister for Health. Although this legislation was overturned in parliament in February 2006, mifepristone did not immediately become available in Australia — a drug company must receive approval from the Therapeutic Goods Administration (TGA) to import and market it.4 To date, this has not happened. In December 2005, we applied to the TGA under its Authorised Prescriber (AP) regulations to import and use mifepristone for early medical abortion (EMA) in Cairns. These regulations, which are unrelated to abortion, enable individual medical practitioners to import and use drugs that are recognised and used overseas but are unavailable in Australia. Our application was approved and, in mid 2006, we began using mifepristone in Cairns.4 We asked colleagues to make similar applications. In 2008, three others received AP approval, and the numbers have since increased to around 200 doctors across Australia. Extensive overseas studies have shown mifepristone to be both safe and effective.1-3,5,6 On this basis, we established protocols using mifepristone 200 mg orally and misoprostol 800g vaginally 36–48 hours later. The abortion process, similar to a spontaneous miscarriage, usually takes place within 4–8 hours of misoprostol administration. As we had no facilities in which the process could occur, this took place in the woman’s home. The safety of such arrangements has been well documented in overseas studies; however, it is worth noting that in most countries where EMA using mifepristone–misoprostol has been introduced, this has been initiated in a clinical environment and only later expanded into home abortion services. In the United Kingdom, where mifepristone has been used for 22 years, home abortion is still not widely practised.3,7 We require every woman undergoing EMA in Cairns to have a support person, whom we meet and who stays with her throughout the process. We also have in place robust arrangements for emergency care for those who require it, and ensure that women and their support people are familiar with these arrangements. Routine follow-up takes place between 2 days and 2 weeks after abortion and includes the provision of reliable contraception. Evidence to support antibiotic prophylaxis for medical abortion is level C, as no randomised controlled trial has been conducted. However, we have always prescribed prophylactic antibiotics, including cover for chlamydia, as this is our practice for surgical abortion where there is level A evidence supporting it.3 Our results, and those published by others, show that mifepristone–misoprostol home abortion is safe, effective and acceptable to Australian women.4,8,9 We believe mifepristone can be safely used for EMA by any appropriately trained doctor in Australia, provided there is access to services where spontaneous miscarriage can be safely managed. However, the numbers of cases reported to date have been relatively small. We therefore welcome the report in this issue of the Journal on the outcomes of more than 13 000 EMAs performed in the Marie Stopes International M Caroline M de Costa PhD, FRANZCOG, FRCOG, Professor of Obstetrics and Gynaecology