Most People Can Determine if They’re Eligible for OTC Abortion Pill, Study Shows

Most people seeking medication abortion were able to correctly determine if they were eligible based on a prototype drug facts label, a diagnostic study found.

After reading the medication abortion label, 88% of participants (n=168) had concordant self-selection on their eligibility with clinical assessment, reported Lauren Ralph, PhD, MPH, of Advancing New Standards in Reproductive Health (ANSIRH) at the University of California San Francisco, and colleagues.

A majority (94%) selected that it was okay for them to use the over-the-counter (OTC) product and 93% expressed interest in buying and using it, they wrote in a JAMA Internal Medicine research letter.

“The study highlights the potential for self-assessment tools to empower individuals in managing their reproductive health, particularly in settings where traditional clinical evaluations are less accessible or less preferred,” Ralph told MedPage Today.

Ralph also noted that the strong safety profile of medication abortion “supports over-the-counter availability” so ANSIRH has been “conducting a variety of studies over the past 5 years to gather the necessary evidence to support a future over-the-counter switch.”

Before FDA would support making mifepristone and misoprostol medication abortion available OTC, robust evidence is needed that shows patients seeking medication abortion can correctly identify if they are eligible based on packaging. ANSIRH leveraged both community-based and medical experts to develop a prototype OTC medication abortion product package and drug facts label to mimic what an OTC product would look like. They recruited people seeking an in-person medication abortion at five facilities in Illinois, Minnesota, and Colorado from July to December 2024.

Participants age 15 or older seeking a medication abortion who could read and speak English interacted with the prototype OTC mifepristone-misoprostol package and drug facts label. Research assistants then asked these participants if the product was “okay for [them] to use today” and if the materials were easily understandable.

Most participants thought the package information was straightforward and clear. The few who weren’t interested in the OTC medication abortion product cited wanting to interact with a clinician first, limited trust of newer or OTC products, and wanting to have the same experience as their previous medication abortion.

Only 9% of participants were deemed ineligible for medication abortion during the clinical encounter, for reasons such as negative pregnancy test, miscarriage, having an intrauterine device, and the fetus being too far along. A total of 14 women (about 9%) who said it was okay to use the product were ineligible.

Of those who chose not to pursue medication abortion after reading the label, most were eligible (7/10). Reasons for not pursuing it included concern about gestational duration, medical contraindications, and possible ectopic pregnancy.

“These findings broaden a small body of research demonstrating that people seeking clinician-supported abortion are largely accurate in self-reporting their [medication abortion] eligibility, including their gestational duration,” the researchers wrote. Moreover, the results support more “autonomous models of [medication abortion] care with limited or asynchronous clinician involvement.”

Abortion access has been strained ever since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision overturned the federal right to abortion in 2022. Since then, interest in OTC medication abortion has grown, wrote Sonya Borrero, MD, MS, of the University of Pittsburgh Center for Research on Health Care, in an accompanying invited commentary.

Borrero noted that the study, as well as ANSIRH’s past research, strengthens the evidence base that OTC medication abortion could be viable. She argued that this work “should be considered alongside extensive data demonstrating the safety of medication abortion, its low risk of serious complications, and its nonaddictive profile — characteristics that align with FDA criteria for consideration of nonprescription use.”

It’s unlikely that medication abortion would win OTC approval from this FDA, as the agency is conducting a safety review of mifepristone. Adding to the heated political climate around abortion, Sen. Josh Hawley (R-Mo.) has introduced a bill to ban the drug, and Louisiana has pushed to prosecute out-of-state doctors who have provided telemedicine abortion in the state.

In all, 168 people completed study activities out of 260 people approached; the most common reasons for not participating was lack of time or interest.

Mean participant age was 27.3. Demographically, 43% of participants were non-Hispanic White, 34% were Hispanic, 17% were non-Hispanic Black or African American, and the rest were other races and ethnicities.

One-third had traveled from out of state for abortion care and 27% had a prior medication abortion. About a third also reported household food insecurity.

The researchers noted that the findings had limited generalizability to those accessing facility-based medication abortion, and that more research is needed on a larger sample and to gauge both patients’ and clinicians’ risk tolerance for incorrect self-selection.

Ralph added that the group will continue to study the accuracy of self-selection using the prototype package and test new questions to ensure those eligible do not rule themselves out.

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