Comprehension of an over-the-counter drug facts label prototype for a mifepristone and misoprostol medication abortion product

Abstract

The most prevalent medication abortion regimen in the United States involves taking mifepristone and misoprostol. Although the U.S. Food and Drug Administration (FDA) recently eliminated the in-person dispensing requirement for mifepristone, they still require it to be prescribed by or under the supervision of a certified health care professional who meets certain qualifications. Medication abortion is an ideal candidate for over-the-counter (OTC) use. The medications are extremely safe, effective, and not toxic; have low potential for abuse; people can self-screen for eligibility and contraindications; and laboratory testing and ultrasonography are not required. As more people access medication abortion without the in-person visit, evidence supporting an OTC switch grows.

Telemedicine, mail-order, and online models of care that reduce or eliminate the in-person visit are proving to be as safe, acceptable, and effective as in-person care. Given medication abortion's established safety record and the need to make abortion more accessible, research assessing whether it should be moved OTC is warranted. For an OTC switch, the FDA requires label comprehension, self-selection, and actual-use studies demonstrating safe use of the medications without clinical supervision. Label-comprehension studies assess whether people can understand key concepts in the drug facts label, such as indications for use, dosing regimen, eligibility, contraindications, risks, warning signs, and side effects. These drive the development of primary and secondary communication objectives, which, according to the FDA, should be stated a priori and achieve greater than 80% comprehension. The FDA also recommends that label-comprehension studies include a general population of consumers with varying literacy levels. To move levonorgestrel emergency contraception OTC, the FDA required a separate label-comprehension study among adolescents aged 17 years and younger. An exploratory pilot label-comprehension study for an OTC medication abortion product conducted in South Africa among 100 reproductive-aged women demonstrated moderate understanding of key concepts and identified areas for modifying the label, which informed our drug facts label design.

The current study developed a drug facts label prototype for a combination mifepristone and misoprostol medication abortion product and conducted a label-comprehension study to evaluate understanding of key label concepts among people of varying literacy levels and ages in the United States.

Objective

To develop a drug facts label prototype for a combination mifepristone and misoprostol product and to conduct a label-comprehension study to assess understanding of key label concepts.

Methods

We followed U.S. Food and Drug Administration guidance, engaged a multidisciplinary group of experts, and conducted cognitive interviews to develop a drug facts label prototype for medication abortion. To assess label comprehension, we developed 11 primary and 13 secondary communication objectives related to indications for use, eligibility, dosing regimen, contraindications, warning signs, side effects, and recognizing the risk of treatment failure, with corresponding target performance thresholds (80–90% accuracy). We conducted individual structured video interviews with people with a uterus aged 12–49 years, recruited through social media. Participants reviewed the drug facts label and responded to questions to assess their understanding of each communication objective. After transcribing and coding interviews, we estimated the proportion of correct responses and exact binomial 95% CIs by age and literacy group.

Results

We interviewed 851 people (of 1,507 people scheduled); responses from 844 were eligible for analysis, and 35.7% (n=301) of participants were aged 12–17 years. The overall sample met performance criteria for 10 of the 11 primary communication objectives (93–99% correct) related to indications for use, eligibility for use, the dosing regimen, and contraindications; young people met nine and people with limited literacy met eight of the 11 performance criteria. Only 79% (95% CI 0.76–0.82) of the overall sample understood to contact a health care professional if little or no bleeding occurred soon after taking misoprostol, not meeting the prespecified threshold of 85.0%.

Conclusion

Overall, high levels of comprehension suggest that people can understand most key drug facts label concepts for a medication abortion product without clinical supervision and recommend minor modifications.

High levels of comprehension suggest that people can understand most key concepts of a nonprescription medication abortion drug facts label prototype without clinical supervision.