Professor Caroline de Costa, from the James Cook University School of Medicine, and Dr Michael Carrette were the first clinicians in Australia to prescribe RU486, having pioneered the Authorised Prescriber approach. Below they provide insight into the implications of last week’s important decision to recommend PBS listing for RU486.
The decision, announced last Friday by the Pharmaceutical Benefits Advisory Committee (PBAC), to recommend that mifepristone (RU486) be listed on the PBS, is an important step towards national accessibility of the drug.
Accessibility, affordability, safety and choice for all Australian women are the goals we, along with many others, have been working towards since we made our first application to import mifepristone to the Therapeutic Goods Administration (TGA) in late 2005, when the Harradine amendment was still in force.
However, while congratulations are certainly in order, above all to Marie Stopes International Australia (MSIA), who guided the application through the PBAC, there are still some obstacles to overcome.
The PBAC has recommended that mifepristone gain an authority-required listing for termination of pregnancy up to 49 days (7 weeks) gestation. The current TGA licence for MS Health (the MSIA-associated company that gained marketing approval for the drug in August 2012) also specifies an upper limit of 49 days in the first three months of pregnancy (although also permitting the use of the drug after three months in hospital practice).
Currently MS Health maintains a register of doctors who may prescribe mifepristone – this includes specialist gynaecologists, all doctors who previously had the Authorised Prescriber approval of the TGA, and doctors who have successfully completed an online educational program provided by MS Health. Presumably doctors in these categories would also be those who would be able to obtain the authority to prescribe mifepristone on the PBS.
The cost of mifepristone once on the PBS would be $12 for concession card holders (this includes both mifepristone and the drug misoprostol, used with mifepristone) and $72 for general patients (the current non-PBS price of a single tablet of mifepristone is $308).
However, mifepristone is widely recognised, overseas and in recent practice in Australia, as appropriate for early medical abortion up to 63 days (9 weeks) gestation, and in Australia the majority of early abortion requests are for gestations later than 49 days. Those of us who have prescribed mifepristone as Authorised Prescribers of the TGA for the last six years have safely used the drug in the first 63 days of pregnancy, but use is now restricted to the first 49 days – for no obvious compelling reason.
While some practitioners have suggested that it would be possible to use the drug “off-label” between 49 and 63 days– that is, outside the regulations but within the boundaries of normal practice – it is not clear what the practical and medico-legal implications would be of using an authority-required drug in this manner. (A doctor prescribing an authority-required drug must confirm the indications and obtain approval from the Commonwealth Department of Health and Ageing if the drug is to be supplied on the PBS.)
The current regulations of the TGA require that doctors not registered to prescribe mifepristone complete the MS Health online program, which in our experience takes several hours, possibly a time challenge for a busy GP. In addition, the drug is currently available only in pharmacies who register with MS Health. A GP or other doctor can therefore only prescribe mifepristone for a woman who can access a registered pharmacy.
Pharmacies must already have an account with Symbion, MS Health’s one chosen distributor, or must open an account. There is likely to be reluctance by some pharmacies (and possibly by Symbion) to open an account for just the occasional order. It is to be hoped that with the PBS listing will come a decision that the drug, like all other PBS listed drugs, must be available in all Australian pharmacies.
As the drug becomes available nationally, it is also important that there is public awareness of the major differences between Australia and those countries, especially the United Kingdom and other European countries, which have provided guidelines for safe practice of early medical abortion.
Since we first began providing early medical abortions at home in Cairns in 2006, this has become by far the most common way in which the procedure has been carried out in Australia. This is not the case in Europe, where after two or three decades most early medical abortion still takes place in clinics.
Moreover, in European countries there is usually an integrated system of abortion care and emergency care that women can access in the event of a problem with a home medical abortion; women can easily receive appropriate and non-judgmental care in these health systems. In Australia most early abortion takes place in the private sector (apart from services in South Australia) but women are often dependent on public sector care if a problem arises (which may happen in 2-5% of cases).
As early medical abortion becomes more widely available in Australia it is essential that all emergency services become familiar with the care of women presenting in conjunction with a home medical abortion, and that appropriate and sympathetic care is rapidly provided.
It is also essential that guidelines for the performance of early medical abortion are closely adhered to. This applies in all cases but particularly to situations where women are travelling away from the site of administration of the mifepristone, often a considerable distance, and planning to carry out the abortion process, which requires the self-administration of the second drug, misoprostol, at home.
It is important to ensure before mifepristone is given that a pregnancy is not an ectopic and that it is of the stated duration (ideally using ultrasound). Attention should be given to the prevention of post-procedure infection. There should be a support person who is well-informed about the procedure, and who undertakes to stay with the woman until the abortion process is complete. Follow-up is vital and the provision of future reliable contraception highly desirable.
Cries from opponents of the PBS listing of mifepristone that this action will increase the rate of unplanned pregnancy in Australia have no basis in fact. The drug has been widely available in many parts of the world for up to thirty years and has been well-researched.
It has been clearly established that women make the decision for abortion quite separately from that about the method of abortion. Making mifepristone more easily available simply increases the choices for Australian women who have already made the (often-difficult) decision to have the abortion.
Importantly, national availability of the drug has the potential to make abortion easier to access for women in rural areas of Australia, as well as less expensive for a group of women who frequently are in dire financial circumstances.
There has also been progress in recent weeks in the reform of Australian abortion law, with the passage through the Tasmanian lower house of legislation decriminalising abortion in that state. This is welcome news. While it would be good to think that the two states most recalcitrant in regard to abortion law reform, NSW and Queensland, might follow suit, this seems unlikely.
However, the eventual national availability of early medical abortion using mifepristone may well make archaic NSW and Queensland abortion laws completely obsolete.
If a woman in early pregnancy can easily consult her general practitioner (or other doctor of her choice) requesting termination, and agreement is reached between them that state law is complied with, the procedure can go ahead in the privacy of the woman’s own home. The state plays no role in this.
Ultimately, abortion law in NSW and Queensland would go the way of laws on duelling and driving a horse-and-carriage on the public way, other pieces of 19th century law that the Queensland parliament has voted out of existence in recent years.
The last seven years have seen a succession of advances for Australian women’s right to choose. Increasingly there is awareness, among the public, the various health professions, and politicians, that abortion is not a criminal or religious matter, but a health issue, and with around 100,000 abortions annually, it is an important health issue for all Australian women.
The events of the past two weeks represent significant progress in our efforts to gain safe legal accessible medical abortion in Australia, but only when women, doctors and pharmacies have easier and less restrictive access to the drug will all our goals be truly met.
Caroline de Costa is professor of obstetrics and gynaecology at James Cook University School of Medicine, Cairns. Michael Carrette is a Cairns gynaecologist.
- World Health Organisation Taskforce on Post-ovulatory Methods of Fertility Regulation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. BJOG 2000; 107: 524-30
- Therapeutic Goods Administration. Registration of Mifepristone Linepharma (RU486) and GyMiso (Misoprostol) 30August 2012; At www.tga.gov.au accessed 1/9/2012
- Victorian Law Reform Commission. Law of Abortion; Final Report. Victorian Government Printer, 2008
- Grimes DA, Creinin MD. Induced abortion: an overview for internists. Annals of Internal Medicine 2004; 140:620-26GoldstoneP, Michelson J, Williamson E. Early medical abortion using low-dose mifepristone followed by buccal misoprostol: a large Australian observational study. Med J Aust 2012; 197(5): 282-6.
This article has also been published at Crikey.