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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., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: To describe the use of mifepristone in combination with buccal misoprostol in women undergoing an early medical abortion (EMA) in Australia., Design, Setting and Participants: Retrospective, observational study of 13,345 EMAs (gestational age ≤ 63 days) conducted at 15 Marie Stopes International Australia clinics between 1 September 2009 and 31 August 2011., Intervention: Oral mifepristone 200 mg, administered at the clinic, followed 24-48 hours later by buccal misoprostol 800 µg, self-administered at home., Main Outcome Measure: Failure rate (proportion of women with an incomplete abortion requiring surgical aspiration or a continuing pregnancy)., Results: Pregnancy termination follow-up information was available for 83.4% (11 155/13 376) of EMAs. From the patient demographic database, the EMA failure rate was 3.5% (465/13 345). Of these, most (382; 2.9% of total) were incomplete abortions requiring surgical aspiration, and 83 (0.6% of total) were continuing pregnancies. Haemorrhage (16; 0.1%) and known or suspected infection (25; 0.2%) were infrequent. One woman, who did not seek follow-up despite signs of infection, died from sepsis (< 0.01%). In 6755 EMAs with clinic follow-up from April 2010 to August 2011, 6381 women participated in a survey. Most reported medium or heavy bleeding and moderate or severe pain/cramps; most also reported that bleeding, pain/cramps and their overall experience were as expected or better than expected., Conclusions: Mifepristone, with buccal misoprostol self-administered at home, for EMA up to 63 days of gestation had a low failure rate, was well accepted, and provided an effective treatment option with a favourable safety profile for women seeking an abortion in Australia.

Background In 2014, a composite pack containing mifepristone-buccal misoprostol, indicated for use to 63 days gestation replaced the existing regimen for early medical abortion ( EMA) in Australia. Aims To provide updated efficacy and safety information for the use of mifepristone-buccal misoprostol for EMA in Australia, and assess the effect of patient age and gestational age on efficacy. Materials and methods Observational cohort study of 15 008 women attending one of 16 Marie Stopes International clinics in Australia for an EMA (gestational age ≤ 63 days) between 1 March 2013 and 30 September 2015. Administration of 200 mg oral mifepristone in-clinic was followed 24-48 h later by 800 μg buccal misoprostol self-administered at home. Method success was defined as complete abortion not requiring surgical intervention. Results Follow-up information was available for 87.14% (13 078/15 008) of women. Likelihood of follow-up was significantly lower for women from rural or remote locations (adjusted odds ratio, 0.47; P < 0.001). Medical abortion was successful in 95.16% (12 445/13 078) of women with follow-up. Higher patient and gestational ages were associated ( P < 0.001) with a slight increase in method failure. There were 674 serious adverse events (5.15%), mainly due to method failure. Infection (15; 0.11%) and haemorrhage (17; 0.13%) were rare. One death was recorded (<0.01%); however, an association between EMA and cause of death, necrotising pneumonia, was not established. Conclusion Mifepristone-buccal misoprostol is an effective and safe alternative to surgical termination of pregnancy up to 63 days gestation. [ABSTRACT FROM AUTHOR]