Early medical abortion in Cairns, Queensland: July 2006 – April 2007

Abstract

Mifepristone (RU486), which is used for early medical abortion, can only be obtained in Australia under the Authorised Prescriber legislation (Section 19[5] of the Therapeutic Goods Act 1989 [Cwlth]); two of the authors have permission to obtain, prescribe and administer this drug in Cairns, Queensland. From July 2006 to April 2007, 10 women who fulfilled the Therapeutic Goods Administration (TGA) criteria of “life‐threatening or otherwise serious” indications underwent medical abortion with mifepristone/misoprostol, and 12 women conforming with abortion requirements of Queensland law, but not TGA legislation for mifepristone administration, had medical abortions with the less preferable methotrexate/misoprostol combination. Although it is now more than a year since the cross‐party vote in federal Parliament in February 2006 confirmed wide support for the right of Australian women to a medical abortion, we believe we are at present the only medical practitioners in Australia with permission to use mifepristone. Obtaining Authorised Prescriber status from the TGA is of necessity a complex and protracted process, involving ethics committee approval and auditing, and regular reporting to the TGA. Because of the current restrictions, we believe that women seeking medical abortion in Australia face barriers not experienced by women in other comparable countries, and that drug manufacturing and distributing companies may be discouraged from seeking to market mifepristone in Australia.

Efficacy and safety of mifepristone–buccal misoprostol for early medical abortion in an Australian clinical setting

“…Medical methods for first trimester abortion are safe and effective, with mifepristone in combination with misoprostol the best available regimen for early medical abortion (EMA) . Access to mifepristone, before its registration in Australia, was restricted under the Authorised Prescriber provisions of the Therapeutic Goods Act 1989, limiting its use to a small group of clinicians. In 2012, 200 mg mifepristone, in sequential combination with a prostaglandin analogue, was registered in Australia for the medical termination of a developing intrauterine pregnancy up to 49 days gestation .…”

Abortion pills: under whose control?

“…In Australia there is an Authorised Prescribers scheme, which allows medical practitioners to prescribe medicines not approved for marketing; this scheme is regulated by the Therapeutic Goods Administration (TGA) 21. This bureaucratic approach is far from satisfactory and impedes access to early medical abortion 22. It now appears, however, that a company may be in the process of applying for a licence 23…”

Early medical abortion: legal and medical developments in Australia

“…Consequently, no applications to import and market mifepristone in Australia were made by pharmaceutical companies — presumably because potential sponsors judged it not worth the trouble and expense 23 . This political interference with the risk management role of the TGA led to a de‐facto ban on the use of mifepristone for EMAs, as Australian women were denied the choice of a safe alternative to surgical abortion 24 …”

“…Two gynaecologists, Professor de Costa and Dr Carrette from the Cairns Base Hospital, have documented their experience with an application under the Authorised Prescribers scheme 24 . In December 2005, 2 months before the Harradine Amendment was repealed, and after the Cairns Base Hospital Ethics Committee had granted approval, de Costa and Carrette applied to the TGA for permission to prescribe mifepristone (with misoprostol) to appropriate patients residing in Cairns for induced abortion up to 9 weeks’ gestation.…”

“…

is an urgent need for a more proactive approach from individual doctors, professional bodies and Health Departments, at both state and federal level, to make mifepristone widely used and largely uncontroversial, as it is in other countries 24

…”