Amendments to restrictions for prescribing of MS-2 Step (Mifepristone and Misoprostol)

The Therapeutic Goods Administration (TGA) has approved an application from MS Health to amend restrictions on the prescribing of MS-2 Step (Mifepristone and Misoprostol). 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.  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.

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