San Francisco—When providing drugs that induce abortion, is it appropriate to screen by medical history alone, or should ultrasonography or pelvic examination be required?
That is of special interest to pharmacists, who—based on the action of the FDA in December—will be authorized to dispense mifepristone if they become certified to do so.
In a recent multicenter cohort study of 3,779 patients with eligible abortions, 95% of abortions were complete without additional medical intervention, and 0.54% were followed by a major abortion-related adverse event. Results were published in the Journal of American Medical Association Internal Medicine.
University of California San Francisco–led researchers say their study "provides evidence that screening patients for medication abortion using history alone maintains high effectiveness and low risk; this screening approach may facilitate more equitable access to abortion care by enabling a wider variety of clinicians to offer this essential service."
Usually, screening for medication abortion eligibility typically includes ultrasonography or pelvic examination. "To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring tests before medication abortion and instead screened patients for pregnancy duration and ectopic pregnancy risk by history alone," the authors noted. "However, few U.S.–based studies have been conducted on the outcomes and safety of this novel model of care."
The study team sought to evaluate the outcomes and safety of that approach to medication abortion care, involving only history-based screening and no testing. Originally, because of a Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex (mifepristone) since 2011, the drug could not be dispensed by retail pharmacies like most other medications; instead, pregnant patients can only obtain the drug directly from a certified medical provider who has filled out a prescriber agreement form from the manufacturer about the proper use of the drug.
More recently, the FDA stated that pharmacies can dispense mifepristone if they are certified to do so. Last December, the FDA modified the REMS, removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals. That opened the way for pharmacy distribution in certain cases, although it remains unclear exactly what will have to be done for certification and when that might be available.
The retrospective cohort study included patients obtaining a medication abortion without preabortion ultrasonography or pelvic examination between February 1, 2020, and January 31, 2021, at 14 independent, Planned Parenthood, academic-affiliated, and online-only clinics throughout the U.S.
Medications were dispensed either in person or by mail. Effectiveness was defined as complete abortion after 200 mcg of mifepristone and up to 1,600 mcg of misoprostol without additional intervention, and major abortion-related adverse events were defined as the need for hospital admission, major surgery, or blood transfusion.
Study participants, who lived in 34 states and most (73.7%) in urban areas, were racially and ethnically diverse, including:
• 870 (23.0%) Black patients
• 533 (14.1%) Latinx/Hispanic patients
• 1,623 (42.9%) White patients
• 327 (8.7%) who identified as multiracial or with other racial or ethnic groups.
The majority (66.4%) of medications were dispensed in person, while the remainder were mailed to patients.
Researchers were able to obtain follow-up data for 2,825 abortions (74.8%). Across the sample, only 12 abortions (0.54%; 95% CI, 0.18%-0.90%) were followed by major abortion-related adverse events, and four patients (0.22%; 95% CI, 0.00%-0.45%) were treated for ectopic pregnancies.
In addition, the follow-up identified nine (0.40%; 95% CI, 0.00%-0.84%) patients who had pregnancy durations of greater than 70 days on the date the mifepristone was dispensed that were not identified at screening. Overall, the adjusted effectiveness rate was calculated at 94.8% (95% CI, 93.6%-95.9%), with effectiveness similar when medications were dispensed in-person (95.4%; 95% CI, 94.1%-96.7%) or mailed (93.3%; 95% CI, 90.7%-95.9%).
"In this cohort study, screening for medication abortion eligibility by history alone was effective and safe with either in-person dispensing or mailing of medications, resulting in outcomes similar to published rates of models involving ultrasonography or pelvic examination," the authors wrote. "This approach may facilitate more equitable access to this essential service by increasing the types of clinicians and locations offering abortion care."
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