All doctors and pharmacists are now authorised to prescribe or supply mifepristone and misoprostol for termination of pregnancy.
Cutting the training, certification and registration requirements on medical termination won’t flood Australia’s abortion deserts with providers, but it’s still a welcome move.
Mifepristone and misoprostol (MS-2 Step, MS Health Pty Ltd) will still only be indicated for use up to nine weeks (63 days) of gestation, but GPs will no longer need additional training to prescribe the medicine.
The changes were announced by the drug regulator early Tuesday morning, along with an out-of-session recommendation of approval from the PBAC, and will come into effect from 1 August.
Wonderful news this morning that the @TGAgovau is deregulating medical abortion prescribing and dispensing in Australia, cutting red tape for GPs and improving access for Australian women…a ? 1/7 pic.twitter.com/vYmNr3JvbD— Prof Danielle Mazza AM (@Danielle_Mazza) July 11, 2023
The authorisation changes are twofold: previously, clinicians had to complete a short course to get certified to prescribe the medicine, and then recertify every three years, and pharmacists had to register as a dispenser.
All these requirements have been dropped.
Nurse practitioners have also been added to the pool of eligible prescribers.
Both the TGA and the PBAC cited access issues as the primary reason for lifting the requirements on health professionals, which was also the thrust of an application submitted to the TGA by non-profit drug sponsor MS Health late last year.
As of December 2021, just 7% of Australian GPs had done the requisite training to prescribe MS-2 Step.
The majority of these doctors are in large metropolitan areas, leaving so-called abortion deserts in regional and remote parts of the country.
According to AMA president Professor Steve Robson, the regulatory changes may not necessarily bring in large swathes of new prescribers, given that many of the GPs who are enthusiastic about prescribing the drug will have already done the training.
“I might be wrong, but I don’t get a sense that there are a huge number of GPs out there waiting in the wings who have said ‘well, if only these restrictions were lifted, we’d be jumping into it tomorrow,’” he told The Medical Republic.
Instead, it’s more likely to capture the doctors who have been meaning to do the training but not got around to it, or those who may have let their certification lapse.
GP and prominent women’s health advocate Professor Danielle Mazza told TMR that the regulatory requirements had contributed to stigma around pregnancy terminations.
“What this does is it sends the message out to all those who have thought about [getting authorised to prescribe MS-2 Step] but haven’t acted, that providing medical abortion is very similar to providing any other health care service,” she said.
Canada previously had similar restrictions on prescribing MS-2 Step, which it removed in November 2017.
The overall abortion and complication rate remained stable following the change, but the number of medical termination providers rapidly.
Professor Mazza said the Canadian experience was particularly encouraging in light of its similar healthcare system.
“[Allowing easier prescribing] kind of normalises it, and I think it kind of gives the green light to practitioners to feel confident that they can easily integrate this kind of service delivery into their practice,” Professor Mazza said.
She was also confident that the right resources are accessible for GPs.
“We have got guidelines on medical abortion at GPs’ fingertips, we have training programs delivered by family planning clinics, hospitals and Primary Health Networks,” Professor Mazza said.
“There’s also the AusCAPPS online community of practice network at the level of primary care practitioners to join up to.
“There are lots of resources out there to support practice – we don’t need anyone mandating us to do our training and making us register and re-register [to prescribe MS-2 Step].”
The AMA’s Professor Robson stressed, however, that rural patients would likely still be at a disadvantage in terms of access.
“Having more prescribers is useful, but a number of women still aren’t within the geographical boundaries that they need to be within to use this safely,” he said.
“If something does not go well, they still [need to] have some sort of access to a hospital that can provide the care they need.”
While MS-2 Step has an efficacy rate of up to 98%, around 5% of people will require surgical intervention for issues like a retained clot and women are advised to stay within two hours’ travel of a hospital for the two weeks following a medical termination.
With this in mind, Professor Robson urged potential prescribers to ensure they have the relevant resources at hand locally and educate themselves on the potential risks.
“[It’s important to] be able to access urgent imaging for a woman before the use of [MS-2 Step] to confirm that it’s not an ectopic pregnancy, for example,” he said.
“[It’s also about GPs] making sure that there are pathways in place for women when things don’t go according to plan and having the capacity to assess women and make sure that they are suitable.”
For instance, the drug is contraindicated in women who are on long-term oral steroids or have Addison’s Disease.
RACGP president Dr Nicole Higgins sought to reassure GPs who may have been surprised by the announcement.
“Some GPs will … be nervous, but this is what we already do,” she told TMR. “We already have these discussions with women.”
The process for managing conscientious objection, she said, will be similar to how conscientious objection is handled in relation to contraception.
“If [GPs] do feel uncomfortable, they can at least make sure that they know who in their community or in their practice is able to provide this service for women,” Dr Higgins said.
Looking to the future, the college president said one of the next objectives will be to improve access and reduce the cost of contraceptives for women, particularly long-acting contraceptives.