Early last year, the FDA modified the Mifepristone REMS Program to state that among other qualifications, mifepristone may only be dispensed by or under the supervision of a certified prescriber or by a certified pharmacy on a prescription issued by a certified prescriber.
Now, a study led by the University of California, San Francisco suggests that removing the in-person dispensing requirement for mifepristone has results in high patient satisfaction and few adverse effects.
The prospective cohort study, with results published in the Journal of the American Medical Association Internal Medicine, included 506 participants and 510 medication abortions that were provided through mail-order pharmacy dispensing after an in-person eligibility screening. All participants were ≤63 days’ gestation at enrollment, and 97.8% had complete abortions, with 91.2% of participants expressing satisfaction with medication abortion. The authors noted that serious adverse events were rare at about 0.6%, and none of those were specifically associated with mail-order dispensing.
“These findings support the US Food and Drug Administration’s decision to remove the in-person dispensing requirement for mifepristone,” according to the study.
Before 2021, the FDA required mifepristone to be dispensed in person, limiting access to medication abortion. Lifting that requirement was controversial, leading the study team to investigate the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy.
Their study was conducted from January 2020 to May 2022 and included 11 clinics in seven states (five abortion clinics and six primary care sites—four of which were new to abortion provision).
Clinical information was collected from medical records, while consenting participants completed online surveys about their experiences 3 and 14 days after enrolling.
All study participants received mifepristone 200 mg and misoprostol 800 mcg, prescribed to a mail-order pharmacy and mailed to participants instead of being dispensed in person. The women had a median age of 27 years and were 38.3% black, 17.4% Hispanic, 27.9% white, and 8.9% multiracial/other.
Most women (85.5%) received their medications within 3 days. “Complete abortion occurred after medication use in 499 cases (97.8%; 95% CI, 96.2%-98.9%),” the authors wrote. “There were 24 adverse events (4.7%) for which care was sought for medication abortion symptoms; 3 patients (0.6%; 95% CI, 0.1%-1.7%) experienced serious adverse events requiring hospitalization (1 with blood transfusion); however, no adverse events were associated with mail-order dispensing.”
The overwhelming majority of women (90.4%) said they would use mail-order dispensing again for abortion care, and 91.2% reported satisfaction with the medication abortion.
“The findings of this cohort study indicate that mail-order pharmacy dispensing of mifepristone for medication abortion was effective, acceptable to patients, and feasible, with a low prevalence of serious adverse events,” the researchers advised. “This care model should be expanded to improve access to medication abortion services.”
The study team recounted how a 2016 to 2017 national survey of obstetrician-gynecologists determined that the proportion of clinicians providing medication abortion would double if they were permitted to prescribe mifepristone through a pharmacy rather than dispense it in person at a clinic.
The researchers suggested this is more important than ever with a Supreme Court decision giving states the right to limit or even ban abortion.
“With the severe restrictions on abortion care imposed since the Dobbs decision, pharmacy dispensing of mifepristone has an important role to play in improving access,” the researchers wrote. “For both patients in states where abortion remains legal and those in states with restrictions who must travel for services, expanded access to medication abortion may reduce delays to care and congestion at abortion clinics where procedural abortion is provided. Pharmacy dispensing also could enable more practitioners, including primary care clinicians, to provide medication abortion by removing the requirement to stock mifepristone.”
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