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Context: A growing body of evidence supports over‐the‐counter access to oral contraceptives in the United States. An important consideration for over‐the‐counter approval is consumers' ability to understand key package label messages related to safety and effectiveness without clinician involvement. We developed a prototype over‐the‐counter Drug Facts Label for a combined oral contraceptive pill and conducted a pilot label comprehension study to evaluate consumer understanding of key messages for use. Methods: In November–December 2020, we conducted interviews with 163 adults and teens in the United States who were aged 12–49 years and identified as female or another gender but had a uterus and the ability to become pregnant. We developed 11 primary endpoints based on assessment of clinical risks that could occur if consumers fail to heed them, including messages about contraindications and directions for use; 11 secondary endpoints represented additional important information but with lower potential for clinical consequences if not understood. We evaluated endpoint comprehension by computing frequencies, percentages, and 2‐sided Exact (Clopper‐Pearson) 95% confidence intervals for observed proportions. Results: Ten of the 11 primary endpoints and 10 of the 11 secondary endpoints were each understood by ≥95% of participants. The remaining primary endpoint on use with prior blood clots was understood by 89% of participants. The remaining secondary endpoint on the product being designed for "people who have the ability to become pregnant" was understood by 83% of participants. Conclusion: Participants understood the key label information required for safe and effective combined oral contraceptive use without clinician involvement. [ABSTRACT FROM AUTHOR]

Context: Removing the prescription requirement and making oral contraceptive pills available over the counter (OTC) could increase contraceptive access in the United States. Despite current efforts to make a progestin‐only pill (POP) available OTC, there are no qualitative data exploring the experiences of POP users and their perspectives on making POPs available OTC. Methods: We conducted six online, asynchronous focus group discussions with 36 POP users between July and November 2020. We stratified focus group discussion placement based on three reasons for POP use: breastfeeding, having a contraindication to estrogen (for a reason other than breastfeeding), and for any other reason. We thematically analyzed these data using inductive and deductive coding. Results: The majority of participants described their overall POP experience as positive, mostly because they experienced minor or no side effects and thought the pill was effective. Participants overwhelmingly supported OTC availability of POPs and expressed interest in purchasing an OTC POP. Over one‐third of participants had very limited knowledge or held inaccurate assumptions about POPs before they started using this method and many stressed the need to disseminate accurate information and resources about POPs to the public. Conclusions: Most focus group discussion participants were satisfied with POPs and supported OTC access. While misconceptions and concerns about POPs should be addressed, an OTC POP has the potential to be a safe, effective, and convenient contraceptive option in the United States. [ABSTRACT FROM AUTHOR]