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On 30 August 2012, the Therapeutic Goods Administration (TGA) announced registration in Australia of the drugs mifepristone (Mifepristone Linepharma) and misoprostol (GyMiso) for the purpose of early medical abortion (EMA) up to 49 days of pregnancy.
Mifepristone is also registered for “pretreatment” when using prostaglandin analogues for the termination of pregnancy for medical reasons “beyond the first trimester”. The TGA website lists Marie Stopes International Australia (MSIA) as the sponsor of the drugs. This organisation will now have full control of which Australian medical practitioners are able to prescribe them.
This is welcome news and we congratulate MSIA and the French pharmaceutical company Linepharma, who invested enormous amounts of time and money into this venture. While there has been a steady increase in the numbers of Australian doctors able to prescribe mifepristone under the TGA’s Authorised Prescriber legislation, this was essentially a cumbersome stop-gap measure. Full TGA registration has the potential to make mifepristone accessible to all Australian women faced with the decision about abortion.
However, some questions have yet to be answered. Approval is only for EMA at less than 7 weeks’ gestation, and for later abortion “after the first trimester”. Strongly worded product information reinforces these time frames. But many Australian women request abortion at 7–9 weeks, a gestation at which mifepristone/misoprostol has been widely and safely used overseas (and, until now, in Australia).
Furthermore, GyMiso is registered only for oral use, not vaginal, even though vaginal administration is also common practice here and overseas. While using drugs for “off-label” indications is accepted medical practice in Australia, it is not clear that this is going to be appropriate with these products, nor what the medicolegal implications might be for off-label use.
We do not know yet what the drugs will cost. Financial accessibility to medical abortion is as important as geographical and social accessibility. To date in our Authorised Prescriber practice of EMA, we have paid NZ$60 per tablet of mifepristone to the not-for-profit New Zealand company Istar, who in turn obtain the drug from commercial European suppliers. We would hope that the price from MSIA would not be too dissimilar. While an intention to apply for PBS listing has been expressed, this may be some time coming — one need only note that tibolone, another drug of proven benefit to women’s health, still does not have PBS listing.
Mandatory follow-up of women prescribed mifepristone for EMA is described in the drug’s product information, as is the stipulation that “the patient should be informed not to travel far away from the prescribing centre as long as complete expulsion has not been recorded”. It is unclear how these requirements will be enforced, given that home abortion has become overwhelmingly the practice in Australia, and given the significant rates of failure of follow-up reported in a recent Australian study.
The need for careful follow-up arises because a small percentage of women will have a continuing pregnancy despite what can be quite significant vaginal bleeding. If they fail to present for follow-up, the pregnancy may remain undetected until after the first trimester, making surgical abortion more difficult to access, and more risky for the woman.
Lastly, it must be said that the arrangements for distribution of the drugs are unusual. There are close links between the MSIA abortion provider “Dr Marie”, currently charging quite substantial fees for EMA in clinics across Australia, and MS Health, the MSIA subsidiary company who will control which Australian doctors will be able to prescribe the drug. Currently such potential prescribers are listed as Fellows and Diplomates of RANZCOG and doctors who undertake an online education program “freely provided” through MS Health.
This may indeed prove a very effective way of ensuring safe EMA for all Australian women. But it is one that should, and no doubt will, be subject to close scrutiny in the coming months. We wish MSIA every success in achieving an outcome acceptable to all stakeholders.
Professor Caroline de Costa is professor of obstetrics and gynaecology at James Cook University School of Medicine, Queensland. Dr Michael Carrette is a Cairns-based gynaecologist.
Posted 10 September 2012