Changes to MS-2 Step dispensing restrictions

From 1 August 2023, pharmacists will no longer need to be registered or undertake specific training to dispense MS-2 Step (mifepristone and misoprostol) to patients across Australia.

The Therapeutic Goods Administration (TGA) has approved an application from MS Health to amend restrictions on the prescribing of MS-2 Step, which is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation.

The changes to prescribing requirements include:

  • MS-2 Step can now be prescribed by any healthcare practitioner with appropriate qualifications and training, without the need for certification – this may include nurse practitioners.
  • Restrictions on dispensing that limited access to registered pharmacists have also been lifted.

These changes have been welcomed by the Pharmaceutical Society of Australia (PSA) with PSA National President Dr Fei Sim FPS noting that this move will significantly improve women’s access to healthcare.

“This move will improve the access to care for women, making MS-2 step available in more pharmacies and in more communities in Australia,” says Dr Sim.

“This approach recognises that pharmacists are medicine experts and that dispensing MS-2 Step and counselling patients on its use is already within the scope of practice of pharmacists.

“By removing unnecessary red tape, pharmacists can help more Australian women access reproductive care, in line with international experience.

“Pharmacists follow a robust process to ensure all medicines are dispensed safely and effectively,” she says.

Monash University’s Professor Danielle Mazza this decision will help to “destigmatise and increase access to abortion” in Australia.

“[The changes will] bring Australia into line with countries such as Canada, which in 2017 completely deregulated mifepristone providing evidence not only of continued safety but also a marked increase in the number of providers,” says Professor Mazza.

“Restrictive arrangements since medical abortion became available in Australia in 2012 led to access problems, particularly for women who had limited incomes and/or lived in rural and regional areas.

“Previously, GPs have had to undertake mandatory training and register before they could provide the abortion pill, then re-register every three years. As a result, only about 10% of GPs in Australia are registered to prescribe.

“The removal of the need for pharmacists to register to dispense mifepristone means that now all pharmacies will be able to stock and dispense this medication and women won’t have to hunt around to try and find a local pharmacy that does.

“The TGA’s decision will encourage GPs to provide medical abortion, offering women a safe option to use at home. It also enables nurse practitioners to prescribe the abortion pill.

“This recognises their capacity to deliver women’s sexual and reproductive health care and makes medical abortion more available in areas where women don’t have access to a GP who provides this service.”

The Royal Australian College of General Practitioners (RACGP) has also welcomed the changes with RACGP President Dr Nicole Higgins saying that it’s a significant step forward to improve access to holistic reproductive care.

“This is a huge step forward to improve access, particularly for those living in rural and remote communities,” says Dr Higgins.

“As a GP in a regional centre, I know all too well that there are significant barriers to reproductive care in rural and remote areas. These services are vital, and they must be affordable and accessible for everyone who needs them.

“The TGA’s changes will enable greater access to medical abortion for women throughout Australia and will reduce unnecessary red tape for the GPs who provide these essential services.”

The TGA states that in noting these revised restrictions, a new warning/instruction has been included in the Product Information, which provides information about circumstances where a person should be referred to a medical practitioner.