Study finds most people can accurately self-screen

Currently, in U.S. states where abortion remains legal, women have to visit specialized clinics to access in-person medication abortion, as drugs like mifepristone and misoprostol are not available over-the-counter (OTC). A recent study makes the argument that these drugs do qualify under the FDA’s over-the-counter criteria, which states that people should be able to rely on the product’s packaging and its drug facts label to decide for themselves if the medicine is safe and appropriate, without having to consult a doctor first.

The researchers recruited individuals who were already at clinics in Illinois, Minnesota, and Colorado to receive medication abortion care, and asked them to do two very simple things. First, they were to read the instructions and the facts label of a prototype OTC package that was shown to them. Second, participants were asked whether they felt confident that the product could be used for their medication abortion.

Most people were able to correctly identify if they were or were not eligible for medication abortion after reading the prototype label. Ninety-three percent also expressed an interest in buying it over-the-counter if it were available. The findings are published in JAMA Internal Medicine.

In search of better access to essential care

Medication abortion uses drugs like mifepristone and misoprostol to end an unwanted pregnancy within the first 10 weeks of gestation. This method is widely recognized as safe and effective, and many women prefer it.

When these medications were first approved, access was tightly restricted. They could only be dispensed in person by a certified clinician in a clinical setting. Post-COVID-19, however, the FDA suspended this in-person dispensing requirement, and women were allowed to obtain the medications via teleconsultation, mail-order, or certified retail pharmacies.

Making medication abortion available OTC is seen as the next step in broadening access, as even with current flexibilities, finding a timely doctor’s appointment or waiting for a mail delivery can still stand in the way of accessing this essential reproductive care.

To use or not to use

To see if mifepristone and misoprostol can pass the FDA criteria for OTC medications, the researchers of this study conducted a six-month investigation at five abortion facilities across three U.S. states. Participants were required to be at least 15 years old, seeking medication for abortion care, and able to read and speak English. A total of 168 individuals who met these criteria were recruited.

Before the participants went in for their medical appointments, a research assistant met with them in the clinic waiting room to obtain consent and conduct an interview. During the interview, participants were given a prototype OTC package for the abortion medications along with a drug facts label. After reading the labels, participants were asked whether they felt confident that the medication was okay for them to use today.

They found that 88% (147 out of 168) of participants correctly determined their own eligibility when compared to a professional clinical assessment. A small group of individuals believed they were eligible, but in reality, they were not. This mismatch largely stemmed from uncertainty about how far along the pregnancy was—some cases had progressed beyond 70 days, while in others, the individuals were not pregnant.

The participants were asked if the instructions were easy to understand and if they would actually be interested in buying such a product over the counter. The answer was a resounding yes regarding the clarity of instructions, but the results for interest in OTC were more nuanced. Ninety-three percent of those who said that the product was okay to use said they would buy it OTC, but 10 participants said they would still prefer consulting with a clinician first before taking the medication.

Recent studies have found that more women in the U.S. are seeking access to an autonomous model of medication abortion. The findings of this study support the growing evidence that people seeking medication abortions can accurately assess their own eligibility.

The researchers, however, noted that larger studies with a wider range of demographics are needed to support efforts to obtain FDA approval and to understand the level of risk patients and clinicians are comfortable with when it comes to self-screening.

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