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A NEW and extended indication for the medical abortion drug MS-2 Step will be announced on 1 February, making early medical abortions more accessible to Australian women, says a leading family planning expert.
Mifepristone and misoprostol, the two components of MS-2 Step, were registered by the Therapeutic Goods Administration (TGA) in August 2012 and indicated for gestation up to 49 days. The TGA has approved an extension to 63 days. (1)
Dr Phillip Goldstone, medical director of Marie Stopes International Australia, the not-for-profit women’s health organisation granted approval by the TGA to market and distribute the drug through its subsidiary, MS Health, said the extension would give women more time to choose a medical rather than surgical abortion.
“Mifepristone has always been effective up to 9 weeks”, Dr Goldstone told MJA InSight. “Now that the TGA has approved it for that period, that extra 2 weeks will make a big difference for the large proportion of women who would prefer a medical abortion.”
The extension comes as concerning news was received from the Northern Territory, detailed in a letter published online today by the MJA, where the major termination provider in the region has resigned from the public health system. (2)
NT women seeking public access to an abortion must now travel to the only hospital providing the service, Alice Springs Hospital. The alternative, flying interstate, was neither cost-effective nor practical in states that required residency status for a legal abortion, the authors wrote.
“The NT has always had very restricted abortion services”, Dr Goldstone told MJA InSight. “Now it’s an even more restrictive environment.”
The NT and South Australia allow medical abortions, but only in hospital settings, he said.
“Those states’ legislations were written before the advent of medical abortions, so those laws need to be modernised to reflect the reality of what’s available and safe for women.
“We find in our clinics that when given the choice, about 25% of women will opt for a medical abortion”, he said.
Medical abortion could be delivered effectively and safely by a trained GP, and it could be done relatively cheaply, Dr Goldstone said.
Since the drug was made available on the Pharmaceutical Benefits Scheme (PBS) about 18 months ago there had been a gradual increase in the number of GPs willing to do this, he said. (3)
According to MSIA, the cost for the medications was $300-$400 before the PBS listing. When the MS-2 Step composite pack becomes available on 1 February, the cost of the medication to the patient will be $37.70, or $6.10 for concession card patients
Until December of 2014, the biggest obstacle in access to GP-administered medical abortions was the insistence by all but one of the medical indemnity insurance providers that GPs had the same level of indemnity as surgical abortion providers — a cost to the GP of around $15 000, Dr Goldstone said.
Avant, the largest provider of indemnity insurance to Australian GPs, agreed to allow non-procedural coverage, reducing the cost to around $5000.
“That was a huge step”, Dr Goldstone said.
“In conjunction with the extended indication for MS-2 Step, that breakthrough should make it much easier for GPs [to provide] and easier for women to access medical abortions.”
He said legislation that required medical abortions to be performed in hospital settings was overly restrictive and a waste of public hospital resources.
Professor Lyndal Trevena, professor of primary health care at the University of Sydney, warned that GPs wanting to provide medical abortions needed to have “good access to ultrasound services to exclude ectopic pregnancies”.
“They would [also] need timely access to specialist services if there were any concerns”, she told MJA InSight.
The ACT has the least restrictive abortion laws in the country, but only allows medical abortions in private settings. NSW allows medical abortions for women less than 7 weeks pregnant provided by termination specialists or a trained GP.
Victoria allows medical abortions to be provided by certified GPs. In Tasmania only private clinics can provide medical abortions.
In Queensland, GPs can prescribe the drug if they complete an online training course.
1. TGA 2014; Australian Public Assessment Report for mifepristone/misoprostol
2. MJA 2015; Online 27 January
3. PBS 2013; Mifepristone
(Photo: diego_cervo / iStock)
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Thank you for this informative Insight. However just one correction. There are 3 hospitals in the Northern Territory that offer early surgical TOP. Two public hospitals in Darwin and Alice Springs and the private hospital in Darwin. You have misunderstood my letter in MJA in February 2015.
There is very restricted access, one main TOP provider has resigned and there is a casual position covering. At this stage women can still acess early TOP in public hospitals in the NT. However this services is fragile and does not offer early medical abortion. As Chairperson of Family Planning NT I am aware that many women request an early medical abortion and when they find they cannot have it and have to wait for a surgical TOP they fly interstate.
At this stage the Health Department has not clarified its intentions to sustain this services. Additionally the Medical Services Act is woefully dated restricting GPs from providing evidence-based reproductive health care for women in the Northern Territory. However I am delighted to hear that this is available for others in Australia.
Is there any evidence that medical abortion is any different to spontaneous abortion (miscarriage) happening at the same gestational age? According to “Peabeau”‘s logic, if the risk of induced miscarriage is too high for women in remote areas, is pregnancy too great a risk to take outside immediate access to helath care? After all, miscarriage occurs in at least 10% or normal pregnancies, with some women requiring hospitalisation.
GPs must be permitted to allow this essential service. I assume they perform D&C for spontaneous miscarriage in NT
We in Canada suffer from the same problem of distance. I used to perform mid trimester abortions for women from Northern Ontario which is more traumatic and unnecessary. (I practiced in Calgary until I retired). I see no reason that trained GPs should not offer this medical service. I assume that GPs in NT can perform D&C for spontaneous miscarriage.
Marie Stopes must be congratulated for their efforts in making medical abortion available, Their advocacy has been tremendous.
From the TGA’s own data it appears there is a 1.3% hospitalisation rate after medical abortion for persistent bleeding, as well as 4.5% failure rate. There has also been 1 death reported in Australia. They also recommend access to US imaging to exclude ectopics & determine fetal age. All of this means that it is not safe to be performed in a remote area without immediate access to medical and/or hospital services, particularly if women are being sent home to abort a 9 week fetus.
Thank you for this article and with all key stakeholders working together to provide women with safe, timely and effective local medical abortion services by trained GPs with supportive legislation and connecting services, close to where women live, benefits whole communities. For so long women prefering to access medical (and surgical) abortions for an unintended pregnancy and living in regional, rural and remote areas of Australia have had enormous challenges and difficulties. From individual financial costs, limited appropriate local service providers, travel and transport issues, child care, time away from work, accommodation needs, stress and other psychological concerns, all continue to impact on women’s pregnancy choices………even today in this 21st Century. We can do better!