Simon Mumford
10 July 2023, 11:30 PM
Women wishing to terminate a pregnancy will have more access to the MS-2 Step (Mifepristone and Misoprostol) pills after the Therapeutic Goods Administration (TGA) approved an application from MS Health (a not-for-profit pharmaceutical company established to deliver vital reproductive health products and medicines) to amend restrictions from August 1.
MS-2 Step is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation.
A number of changes to prescribing requirements have been made.
Previously, MS-2 Step was only able to be prescribed by a medical practitioner (a doctor) who had been certified to prescribe the medicine, and then dispensed by a pharmacist who was a registered dispenser. This meant only 1 in 10 medical practitioners could prescribe MS-2 and 3 in 10 pharmacists can dispense it.
The TGA’s decision means that 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. Further, restrictions on dispensing that limited access to registered pharmacists have also been lifted.
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.
The TGA’s decision will assist in addressing important access issues for patients who require this medication.
The decision to approve these amendments was informed by expert advice from the Advisory Committee on Medicines, an independent committee with expertise in scientific, medical and clinical fields and including consumer representation.
The Federal Government welcomed the TGAs decision to remove a number of restrictions on health professionals who prescribe and dispense MS-2 Step (mifepristone and misoprostol).
The Pharmaceutical Benefits Advisory Committee has also recommended, based on independent clinical expertise, that prescription of MS-2 Step by nurse practitioners be subsidised on the Pharmaceutical Benefits Scheme.
The TGA’s decision brings Australia in line with comparable international jurisdictions, such as Canada, and will improve access to health care for women seeking a medical termination.
Assistant Minister for Health and Aged Care Ged Kearney said, “We welcome these changes that remove red tape and improve equitable access to healthcare for all Australians."
“We know that women experience structural barriers trying to access the health care that they need, particularly in regional and rural areas. That’s why it’s so important that all health practitioners can perform the care that they are already trained to provide."
“These changes recognise the importance of health practitioners that women see regularly – their GP, their nurse practitioner and their community pharmacist.
“Our Government has no higher priority than strengthening primary care, and welcome the changes that allow these trusted and highly skilled providers to provide care within their scope of practice.”
HEALTHCARE PRACTITIONERS