Access to abortion drug opened up
The medicines watchdog has lifted tight restrictions on access to the controversial abortion pill RU486 in a move hailed as an “important milestone” for Australian women. The Therapeutic Goods Administration has added Mifepristone (RU486) and GyMiso (misoprostol) to the Australian Register of Therapeutic Goods, greatly enhancing access for doctors and women to the drugs, which have until now been subject to tight controls.
The medicines watchdog has lifted tight restrictions on access to the controversial abortion pill RU486 in a move hailed as an “important milestone” for Australian women.
The Therapeutic Goods Administration has added Mifepristone (RU486) and GyMiso (misoprostol) to the Australian Register of Therapeutic Goods, greatly enhancing access for doctors and women to the drugs, which have until now been subject to tight controls.
The TGA said it had made the decision following rigorous assessment taking into account the safety, efficacy and quality of the medication.
RU486 has been available in Australia since 2006, when ministerial veto over the drug was lifted, but only a small number of practitioners – 187 as at August this year – have been authorised to prescribe it.
But, following last week’s decision, registered medical practitioners who have successfully completed a training course will be able to prescribe the two drugs.
The medicine has been sponsored by a not-for-profit subsidiary of Marie Stopes International, which is planning to roll out an education program for medical practitioners, both online and through personally tailored training sessions.
“It is the sponsor’s intention that access and distribution will be controlled via successful completion of the training and medical practitioner registration with the sponsor,” the TGA said. “The sponsor is planning a comprehensive education program.”
Practitioners who have a fellowship or diploma from the Royal Australia and New Zealand College of Obstetricians and Gynaecologists are exempt from the training requirement.
Distribution is expected to be nationwide.
“Based on the sponsor’s proposed distribution plan, where a pharmacy is nominated by a medical practitioner recognised by the sponsor as having completed appropriate training to prescribe the medicines, and the pharmacy agrees to supply the product, it will be available,” the TGA said.
Health Minister Tanya Plibersek welcomed the regulator’s decision, which she said gave Australian women access to medicines that have long been available to millions elsewhere.
“For more than two decades, tens of millions of women throughout the world have used RU486,” Ms Plibersek said. “This listing means Australian women will have the same options as women in over 46 countries including the UK, USA, New Zealand and in Europe.
Marie Stopes is considering whether to apply to have the drugs, which are out of patent, listed on the Pharmaceutical Benefits Schedule.
A spokeswoman for the organisation said its intention was to ensure all women had access to “affordable choices in sexual and reproductive healthcare”.
The TGA said RU486 was “generally well-tolerated”, and since 2006 there had been 792 documented cases of adverse effects, mostly incomplete abortions that required follow-up surgery.
It said common side effects include nausea, vomiting, diarrhoea, dizziness, abdominal pain, headache, vaginal bleeding, uterine spasm, fatigue and chills.
It said there had been rare instances of significant haemorrhage and cervical tearing, and one recorded death in Australia due to sepsis.
According to the TGA, failure rates are slightly higher for medical abortion (between 2 and 7 per cent of cases) than surgical termination, but both were considered to be “safe and effective”.
“Experience has shown that bleeding and pain are more significant with a medical termination, but medical termination does not involve an anaesthetic and its attendant risk,” the regulator said. “Women may prefer medical termination to surgical termination of their pregnancy, as it occurs in the privacy of home and is less invasive.”
It said doctors should confirm pregnancy before administering the medication, and ectopic pregnancy had to be excluded.
“As for surgical termination, follow up is essential,” the TGA said in its advice.
Published: 02 Sep 2012