A recent study that is part of a long-term research project about the possibility of over-the-counter (OTC) medication abortion found a high interest, among abortion patients, in accessing OTC abortion pills.1
“We asked people seeking abortion at several facilities across the United States whether they’d be interested in accessing medication abortion over the counter if it were available. We found an overwhelming percentage of people who were interested,” says Antonia Biggs, PhD, an associate professor and social psychologist in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco (UCSF).
Sixty-five percent of respondents were personally interested in obtaining OTC abortion pills. Eighty-three percent were interested in OTC availability.
“They valued the privacy over-the-counter access could provide, and they valued its convenience,” says Biggs, a senior researcher with Advancing New Standards in Reproductive Health (ANSIRH). “These are people who are seeking abortions, so it’s not surprising they would be much more supportive and in favor of accessing medication abortion over-the-counter.”
In an earlier, national survey of women’s interest in accessing OTC medication abortion, interest also was high — about 50%. It was lower than among the group of people who were seeking abortion care, but this is not surprising because the general population group included people who are against abortion and people who have never been pregnant.2
“What’s hard about studying this in the general population is that people never imagine it will happen to them, and that’s what is so frustrating about policies that don’t support people’s access to abortion,” Biggs says. “People can dismiss the implications of not allowing people to get access to abortion care, especially if you’re a policymaker and a male who is really unable to understand the importance of abortion access.”
The proportion of people using medication abortion within the first 10 weeks of pregnancy has increased since 2014. Research results indicate that more than 85% were satisfied with the experience.3-5
The idea of OTC abortion medication has become more familiar in recent years because of the COVID-19 pandemic and the focus on healthcare models that do not rely on in-person clinic visits, Biggs notes. Five years ago, no one discussed an OTC abortion medication option in the media. Even doctors had never thought about it.
“Now, as we are seeing more studies coming out of people accessing medication abortions safely and effectively, without a clinical interaction, I think the support for an OTC model grows,” Biggs says. “We have more evidence that demonstrates the safety of an over-the-counter access model.”
UCSF and ANSIRH researchers are working on a series of studies to build evidence for approval of OTC abortion medication.
“We first did a label comprehension study that looks at people’s ability to read and assess labels,” Biggs says. “The next step by the FDA is a self-selection study.”
This step of research demonstrates whether a person could decide, safely and accurately and without clinician help, about using the medication.
“We developed a drug fact label prototype for medication abortion — the kind of label you might see when you buy over-the-counter medication,” Biggs says.
Investigators tested the label among 851 people, including more than one-third who were between the ages of 12 and 17 years. They found high levels of understanding the drug statistics. People could read the label, follow up on instructions, and understand how to take the medication. Young people could do this, too.6
“The label comprehension study is assessed in a general population of people, and the point is to see whether people know what the medication is for, and can they understand its use while they’re in a pharmacy,” Biggs explains. “If the product is over the counter, we found that young people could understand the label. The next step of the self-selection study is to see whether people can figure out whether a medication or drug is appropriate for use for their particular health characteristics. At this stage, it sees if people who want the medication are able to identify their own contraindications to see if they’re eligible for it.”
For example, the label’s wording would indicate the medication should not be taken if the person does not know how far along she is in the pregnancy. “If it says, ‘Don’t use it [under these circumstances],’ are you able to self-select yourself to be eligible for the medication?” she asks. “We’re halfway through data collection for the self-selection study, and we need to study and analyze it.”
The final step would be an actual use study, where participants use the medication and investigators see whether they follow the directions correctly in a simulated OTC use. “[In this step], people take the meds, and you study to see whether they take it correctly and manage their symptoms correctly,” Biggs explains. “That study is in the planning phase, so we’re working on the study design but haven’t started data collection.”
For OTC abortion pills to become a reality, a pharmaceutical company would have to join the effort. “We’re demonstrating proof of concept and hope it will motivate a pharmaceutical company to take this on,” Biggs says.
If the studies continue to show positive results, and the FDA reviews and approves mifepristone and misoprostol for OTC sale, then it is possible that California would offer abortion pills OTC. “In my opinion, this is an emergency crisis related to abortion access,” Biggs says. “If the FDA could approve it quickly, then I see certain states, like California and some other states, being able to have it over the counter.”
Access to OTC abortion medication would be another tool for helping people in need of abortion care in the Dobbs era, in which about half of the country will not have access to abortion care in their own state.
“There’s been an assault on people’s reproductive freedom, and it’s moving people to action,” Biggs says. “You’ve heard about these chilling effects; there’s anger, disbelief, and there’s been a lot of coverage about abortion, so people are more interested in the topic and have become more aware. An OTC model would be one component to increasing access.”
Post-pandemic, people are more comfortable with telemedicine and self-management of their health issues. “What they’re learning is we don’t need to do everything in person in a clinic,” Biggs says. “We have more evidence now, and the telehealth model of care shows that abortion medication is safe and effective, and people prefer not having logistical barriers in getting to a clinic.”
OTC abortion medication would be a way to ensure privacy without judgment as well as more convenience, she adds.
REFERENCES
- Biggs MA, Ralph L, Morris N, et al. A cross-sectional survey of U.S. abortion patients’ interest in obtaining medication abortion over the counter. Contraception 2022;109:25-31.
- Biggs MA, Ralph, L, Raifman S, et al. Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women. Contraception 2019;99:118-124.
- Ehrenreich K, Biggs MA, Grossman D. Making the case for advance provision of mifepristone and misoprostol for abortion in the United States. BMJ Sex Reprod Health 2021;bmjsrh-2021-201321.
- Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. Guttmacher Institute. September 2019.
- Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety, and acceptability of medical abortion at home and in a clinic: A systematic review. Bull World Health Organ 2011;89:360-370.
- Biggs MA, Ehrenreich K, Morris N, et al. Comprehension of an over-the-counter drug facts label prototype for a mifepristone and misoprostol medication abortion product. Obstet Gynecol 2022;139:1111-1122.
A recent study that is part of a long-term research project about the possibility of OTC medication abortion found a high interest, among abortion patients, in accessing OTC abortion pills.
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