July 29, 2015 —Summary of "Mifepristone by Prescription: a Dream in the United States but Reality in Australia," Daniel Grossman and Philip Goldstone, Contraception, June 18, 2015.
"Medical abortion with mifepristone and misoprostol has the potential to transform the way women access and experience abortion care in early pregnancy," according to Daniel Grossman, of Ibis Reproductive Health and the University of California-San Francisco's Bixby Center for Global Reproductive Health, and Philip Goldstone of Marie Stopes International.
The researchers wrote that medication abortion "is highly effective, with less than 5% requiring a surgical procedure to complete the process"; "safe with a very low incidence of severe adverse events and few contraindications"; and "is ... very acceptable to women," with "a large proportion indicating a preference for medical over surgical abortion." Further, the authors noted that medication abortion "also means that the way abortion may be provided could potentially be radically different from the way surgical abortion is provided" because health care providers do not need "[s]pecial clinical skills" or "specific medical equipment" to dispense pills. However, the researchers noted that "in most countries where mifepristone is registered, its distribution is highly regulated."
The authors compared the medication abortion administration process in the U.S., where FDA "requires that mifepristone be distributed only by physicians in clinics, offices or hospitals and cannot be dispensed at pharmacies," with Australia's process, where medication abortion can be distributed at pharmacies. Grossman and Goldstone wrote, "Australia's evolving experience with mifepristone provision by prescription is instructive to those in the US interested in seeing such a change here."
Mifepristone Registration in Australia
"Mifepristone became available in Australia many years after the drug had been approved in the US and most of Europe," the researchers wrote, noting that its regulation in Australia was restricted between 1996 and 2006. However, the restrictive requirements were overturned in 2006, and the Australian Therapeutic Goods Administration once again regulated the drug, subsequently authorizing "a limited number of physicians ... to import and prescribe mifepristone for their patients under a specialized scheme," according to the researchers.
The researchers wrote, "Mifepristone was first listed on the Australian Register of Therapeutic Goods for medical abortion up to 49 days' gestation in 2012," but a "composite pack that includes mifepristone 200 mg and four tablets of misoprostol 200 mcg was ... approved ... for use up to 63 days" in 2015. According to the researchers, the drug in both packages "was approved as a Schedule 4 medication, which requires prescribing by a physician and may be dispensed at pharmacies," but it does not require women "to take either mifepristone or misoprostol in the presence of a physician."
As part of the risk-management plan instituted for both products, "physicians must be certified to prescribe mifepristone," which entails "online training that includes prescribing requirements and information about managing the medical abortion process" for general practitioners. Meanwhile, ob-gyns "are exempt from the online learning module." In addition, the labeling encourages ultrasound dating for the pregnancy and requires follow-up, the researchers wrote.
In addition, pharmacists as part of the risk-management plan must "be certified ... to dispense the medication, but this does not require additional training," the authors write, adding that when pharmacists "receiv[e] a prescription for mifepristone, [they] must confirm through a secure website that the prescriber is certified." Meanwhile, MS Health -- "a non-profit pharmaceutical company" that "was established as a subsidiary of Marie Stopes International to register mifepristone in Australia" -- "was required to establish a 24-hour telephone service staffed by nurses to answer questions for patients and to refer them to emergency care when needed."
The researchers noted that while the prescriber is not required to provide emergency care or surgical completion, "referral pathways must be in place." The risk-management plan also "include[s] requiring all patients to provide written consent, and that MS Health provid[e] the consent forms and patient information brochures and also undertak[e] a phase IV post-marketing surveillance study."
Effect on Access in Australia
According to the researchers, the provision of medication abortion in Australia originally may have been curbed by several factors, including the "original gestational age limit of 49 days," as well as how general practitioners might have been "less likely to prescribe 'off-label' than those more familiar with medical abortion provision and the evidence supporting its use to 63 days." Further, "most medical malpractice insurers required general practitioners to have the same level of coverage to provide medical abortion as for surgical abortion, which was significantly more expensive than the usual coverage these physicians held," Grossman and Goldstone wrote. Insurers changed the Australian coverage policy requirements in late 2014 and early 2015.
Citing findings from MS Health, the researchers noted that, "as of May 2015, there were 663 certified prescribers and 1,421 certified dispensers of mifepristone in Australia, although that does not mean that all are actively prescribing or dispensing." They added that the "numbers have increased in 2015 since the approval of the composite pack."
According to the researchers, "there are more certified prescribers and dispensers than the number of facilities providing abortion care ... [i]n every region of the country," even in "some of the more sparsely populated" areas. For example, "[i]n Queensland, there are 11 clinics providing first-trimester abortion care, primarily in and around Brisbane, while there are 102 certified prescribers and 272 certified dispensers, almost half of which are located outside of the metropolitan area," Grossman and Goldstone wrote.
Meanwhile, they noted that "Marie Stopes International's Australian clinics, one of the largest providers of abortion care in the country, still continue to stock mifepristone and misoprostol for on-site provision," with "approximately one third of women with a pregnancy up to 63 days' gestation" at the clinics opting for medication abortions in 2014.
How Prescription Mifepristone Could Affect Access in the U.S.
"Despite the hopes of many, it does not appear that there has been widespread uptake of medical abortion among US providers who were not already offering abortion care," the researchers wrote, noting that a 2007 analysis "found that almost all providers of medical abortion only were located within 50 miles of the nearest surgical abortion provider."
Grossman and Goldstone wrote that the reasons for the slow uptake "are not entirely clear," although they likely include restrictions that require physicians to deliver the medication on site, as well as abortion stigma. In addition, willing providers might be prevented from offering such care because of "implicit or explicit policies in their group practice or even in their facility lease that prevent them from offering these services" or because of "prohibitively expensive" malpractice insurance. Further, the researchers noted that several states impose "onerous facility requirements that make it difficult to provide the service" even if providers offer only medication abortion care.
Meanwhile, Grossman and Goldstone wrote that making mifepristone available via pharmacies through prescription "could have a significant impact on access to medical abortion" in the U.S. They wrote, "Even if the increase in the number of providers were less modest than in Australia, prescription access would greatly facilitate the provision of medical abortion by telemedicine," such as by allowing "telemedicine to expand to facilities that do not stock mifepristone or possibly directly to women in their homes."
However, they noted that such policies could have the potential downside of making it more difficult for women who have easy access to clinics to get medication abortion if the clinics stop providing the drug on site, although the authors note that "[o]btaining medications at pharmacies is the standard way most patients obtain medicines" and so this "should not be an insurmountable barrier."
Grossman and Goldstone wrote that while altering mifepristone's regulatory status "may be complicated," the resulting "potential improvements in access to early medical abortion could be great -- both in terms of the number and distribution of providers, as well as the expansion of the use of telemedicine." They added, "The Australian experience should motivate the community of providers and advocates in the US to help make this dream a reality."