It is now almost five years since the first supplies of mifepristone (RU486) became available to Australian women under the Authorised Prescriber (AP) Scheme of the Therapeutic Goods Administration (TGA), to be used by approved doctors for the purpose of medical abortion.
There are now more than 100 doctors across Australia authorised to prescribe mifepristone, together with the drug misoprostol, for medical abortion. Such abortions may be early (up to nine weeks of pregnancy), in which case the actual abortion process usually takes place in the woman’s home, with an adult support person present, or late, when the process must take place in a hospital setting.
Australian practice has been somewhat different to that in most overseas centres, in that from the start, early abortion has taken place at home, with access to emergency care when needed in hospitals or clinics. Most overseas centres initially provided medical abortion in a clinical setting, later moving to home abortion when staff were more familiar with the procedures involved.
The Australian situation has been due to the unusual way in which the drug was introduced, and continues to be accessed by medical practitioners, under the AP legislation. This legislation allows doctors to import and use in their own practices drugs not available in Australia but licensed and available overseas. While it is anticipated that there may soon be an application by a drug company to market mifepristone nationally approved by the TGA, this has not yet come about.
Meanwhile, there have been three main sources of information about the use of the drug in Australia, the most recent being an article published by two South Australian doctors in the May issue of Australian Family Physician.* In SA clinics and hospitals 1343 tablets of mifepristone were used from early 2009 (when it first became available in SA) to the end of 2010 and 947 of these were used for early medical abortions (up to nine weeks); 75 were used for later abortions (mostly for severe malformations in the fetus) and 321 were used to assist the process of surgical abortion.
The complication rates of early medical abortion in the SA study were low but nevertheless some complications were more common than in some earlier overseas studies. Admission to hospital to undergo a D&C (dilatation and curettage) occurred in slightly more than 5% cases (one woman in 20) and one woman in 200 had a significant haemorrhage (overseas studies have shown 1:500-1:1000 women experiencing this complication.)
As practitioners become more familiar with the methods of medical abortion it is likely that complication rates will fall. Surgical abortion is also recognised as having a small risk of complications similar to those of medical abortion. Certainly, as SA GPs and women became aware of the availability of medical abortion, demand increased — from 276 women in 2009 to 539 in 2010.
At budget estimates hearings of the Senate Community Affairs Committee in June 2010, answers were provided to questions on notice asked by Senator Guy Barnett to the TGA about the use of mifepristone for medical abortion in Australia to that date. The TGA’s reply included the information that to December 31, 2009, a total of 2926 medical abortions using mifepristone and misoprostol had been performed by Australian Authorised Prescribers, including early and late procedures. In that time period there had been significant haemorrhage in seven cases (0.23%); the need for D&C in 84 (2.8%) and ongoing pregnancy requiring surgical abortion in 14 (0.4%).
These figures are well within the parameters found in large overseas studies. Similar findings were noted in a report from Perth’s King Edward Memorial Hospital, of late abortion for severe fetal abnormality, published in the Australian and New Zealand Journal of Obstetrics and Gynaecology in early 2010.
The TGA also reported that while NSW, Victoria, South Australia and the ACT had relatively large numbers of Authorised Prescribers, there were few in Queensland and WA and none in Tasmania or the Northern Territory.
It is highly desirable that the Australian use of mifepristone be carefully scrutinised and that the processes be totally transparent. This certainly appears to be happening, and the results demonstrate that mifepristone used in appropriate clinical circumstances is a safe option for Australian women having to make the often-difficult choice for themselves regarding abortion.
What is now needed is extension of the availability of the drug across all Australian states and territories.
*Mulligan E, Messenger H. Mifepristone in South Australia — the first 1343 tablets. Australian Family Physician; 40 (5); May, 2011: 342-45