Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product

Abstract

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, contrain-dications, 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.

Decreasing reproductive and abortion care barriers: findings on the student health center's role from a student survey

“…Students have high levels of knowledge about where to access most reproductive healthcare products and services and are willing to utilize SHCs for this care. However, SHCs must account for the majority proportion of students experiencing stigma, access, and system barriers even in a large coastal city with state legislation supportive of reproductive and abortion access [2,17]. By continuing to document who has knowledge, trust, and barriers while implementing new services, SHCs can monitor gaps and successes, and maintain focus on communities of need with culturally relevant care to diverse student populations.…”

“…Medication abortion is the most prevalent and growing method of abortion and is increasingly done without an in-person visit both within (telemedicine) and outside the confines of the formal healthcare system (self-management) [20]. International practice, user comfort, and research increasingly shows evidence for this service as an "ideal candidate" for over-the-counter use with the potential to reduce barriers and increase reproductive autonomy [17,23]. Our findings of decreased student willingness to seek medication abortion at the SHC as compared to other health products relevant to telemedicine and OTC provision can inform further research into student perspectives and SHC challenges and successes in telemedicine and OTC reproductive health models.…”

“…Our findings of decreased student willingness to seek medication abortion at the SHC as compared to other health products relevant to telemedicine and OTC provision can inform further research into student perspectives and SHC challenges and successes in telemedicine and OTC reproductive health models. The recent ruling by the FDA allowing pharmacies to dispense Mifepristone suggests that they are endorsing telemedicine and OTC models, which are safe and effective modes to increase access, health equity, and patientcentered abortion care [2,5,17,24].…”

“…Emergency contraception pills are available for over-the-counter (OTC) purchase but require a limited appointment for those needing advice, informational instructions to receive the most effective option for those who weigh over 195 pounds, or payment support through insurance or subsidy program. Lastly, the current U.S. Food and Drug Administration (FDA) and legislationmandated care model for medication abortion provision requires the highest level of scheduling, clinical supervision and intervention from the healthcare system [17].…”

Self-Managed Abortion in the United States

“…Patients are also able to accurately self-assess abortion completion using symptom checklists and urine pregnancy tests [16][17][18]. A prototype over-the-counter label for a mifepristone-misoprostol product was found to be well-understood by potential users, suggesting that people could use these medications safely on their own without clinician involvement [19].…”