Mifepristone by prescription: a dream in the United States but reality in Australia

The requirement that mifepristone be dispensed only by physicians in offices, clinics or hospitals — and not by prescription in pharmacies — has likely limited uptake by providers in the United States. However, in several other countries, provision by prescription in pharmacies is allowed, including in Australia. Mifepristone was first registered in Australia in 2012, and in 2015, a composite package including 200 mg mifepristone and four tablets of misoprostol 200 mcg was registered. Both were approved as Schedule 4 medications, which require prescribing by a physician and may be dispensed at pharmacies. As part of the registration for both products, a risk management plan was instituted that has several components. First, physicians must be certified to prescribe mifepristone. General practitioners wishing to become certified must complete online training that includes prescribing requirements and managing the medical abortion process; obstetrician-gynecologists are exempt from the online learning module. Pharmacists must also be certified in order to dispense the medication, although this does not require additional training. When a pharmacist receives a prescription for mifepristone, she or he must confirm through a secure website that the prescriber is certified. In every region of the country, there are more certified prescribers and dispensers of mifepristone than the number of facilities providing abortion care. The experience in Australia demonstrates the feasibility of mifepristone by prescription and should be a model for expanding access to early medical abortion in the United States.