Restrictions on Mifepristone a Barrier to Miscarriage Care, Surveys Show
Many clinicians believe that the FDA restrictions on mifepristone (Mifeprex), a drug used for medication abortion, create obstacles for the provision of miscarriage care, according to a mixed methods survey study based in Massachusetts.
Among a group of 19 physicians, 89% agreed that the FDA’s risk evaluation and mitigation strategy (REMS) restrictions are a barrier to mifepristone use for the management of early pregnancy loss, reported Sara Neill, MD, of Beth Israel Deaconess Medical Center in Boston.
In a subsequent quantitative survey completed by nearly 200 clinicians, 37% said they did not prescribe mifepristone for early pregnancy loss, and 40% were not or were only somewhat familiar with the REMS program, Neill said during a presentation at the American College of Obstetricians and Gynecologists (ACOG) annual meeting, held in San Diego.
Elizabeth Janiak, ScD, MSc, of Harvard Medical School, one of the co-authors of the study, told MedPage Today that this study highlights “the amount of anxiety and challenge that compliance with the REMS evokes,” even in a state like Massachusetts, which has relatively little abortion stigma.
Mifepristone is currently restricted by the REMS program, which outlines specific requirements for use. While the drug is commonly used for medication abortion, it has also shown efficacy in the managment of early pregnancy loss, which occurs in about 1 million women a year, Neill’s group stated. A randomized controlled trial showed that pretreatment with mifepristone followed by treatment with misoprostol increased the likelihood of successfully managing first-trimester pregnancy loss compared with misoprostol alone.
Last December, the FDA loosened some of the REMS restrictions on mifepristone, scrapping the requirement for prescribers to dispense the medication in person. However there are still some requirements to prescribe the drug, including a special certification for dispensing pharmacies and a necessary prescriber agreement form.
Additionally, while the federal government has loosened some restrictions, that does not stop state legislatures from imposing their own constraints. Nineteen states still require the physician prescribing mifepristone to be physically present when the medication is administered, which prohibits telemedicine prescribing of the drug, according to the Guttmacher Institute.
In this study, Neill’s group conducted in-depth, qualitative interviews among a small group of clinicians about how the REMS restrictions on mifepristone affected miscarriage management. The responses from those interviews were then used to develop a quantitative survey that was distributed to all ob/gyns in Massachusetts through the American Medical Association Physician Masterfile.
The qualitative surveys were administered to a group of 19 physicians; 17 stated that the REMS restrictions were an obstacle to mifepristone use. Some of the barriers that physicians cited were a lack of dispensing pharmacies, concerns about signing the required prescriber agreement, and the belief that REMS indicated that mifepristone was not available to general ob/gyns.
In the following quantitative survey of 197 clinicians, more than a third said they did not prescribe mifepristone for early pregnancy loss. Among a subgroup of 57 clinicians who reported on barriers to mifepristone use, the most common barrier (reported by 53%) was uncertainty about how to comply with the REMS protocols. Additionally, 73% of that group said that removing the REMS regulations would help them use mifepristone for early pregnancy loss.
Because this study was limited to physicians in Massachusetts, a state that does not have strict limits on abortion, these results may be biased, Janiak noted, adding that future research should aim to survey a larger population across more states. Additionally, as abortion restrictions are in flux, Janiak said that future studies should continue to evaluate how medical abortion rules will affect access to miscarriage care.
The study authors reported no potential conflicts of interest.
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