Objectives: With a panel of experts, we developed a prototype over-the-counter (OTC) Drug Facts Label (DFL) for a combined oral contraception (COC) 0.1mg levonorgestrel/0.02mg ethinyl estradiol pill. The objective of this pilot label comprehension study was to evaluate understanding of our primary communication messages.
Methods: Individual structured interviews were conducted online with 163 participants aged 12-49 who identified as female or had a uterus and were able to become pregnant. We included minimum quotas for teens (n=10 aged ≤15, n=20 aged 16-17), race/ethnicity (n=15 each for Asian Pacific Islander, Black, and Latina identities), and low literacy level (n=30). Eleven primary communication messages were developed based on an assessment of the clinical risks that are likely if consumers fail to heed key communication messages on the DFL, and included those that, if not heeded, represent the greatest potential for clinical consequence to consumers. These included messages about contraindications and directions for use. Additionally, we asked about indications for use, among other secondary endpoints. We did not include pre-specified target thresholds for this pilot study.
Results: After reading the prototype OTC COC label, 10 of the 11 primary communication messages were each understood by ≥95% of participants, and the remaining message (on use with prior blood clots) was understood by 88% of participants; 99% of participants correctly understood what the product was used for.
Conclusions: Participants overwhelmingly understood the key DFL information required for safe COC pill use without clinician involvement, contributing to the evidence on the appropriateness for OTC COC availability.
© 2021 Published by Elsevier Inc.