{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T01:20:23Z","timestamp":1792113623174,"version":"4.4.0"},"reference-count":24,"publisher":"Guttmacher Institute","issue":"1","license":[{"start":{"date-parts":[[2022,11,9]],"date-time":"2022-11-09T00:00:00Z","timestamp":1667952000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000008","name":"David and Lucile Packard Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000008","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Perspect Sexual Reproductive"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Context<\/jats:title><jats:p>A growing body of evidence supports over\u2010the\u2010counter access to oral contraceptives in the United States. An important consideration for over\u2010the\u2010counter approval is consumers' ability to understand key package label messages related to safety and effectiveness without clinician involvement. We developed a prototype over\u2010the\u2010counter 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In November\u2013December 2020, we conducted interviews with 163 adults and teens in the United States who were aged 12\u201349\u2009years 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\u2010sided Exact (Clopper\u2010Pearson) 95% confidence intervals for observed proportions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ten of the 11 primary endpoints and 10 of the 11 secondary endpoints were each understood by \u226595% 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 \u201cpeople who have the ability to become pregnant\u201d was understood by 83% of participants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Participants understood the key label information required for safe and effective combined oral contraceptive use without clinician involvement.<\/jats:p><\/jats:sec>","DOI":"10.1363\/psrh.12214","type":"journal-article","created":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T00:21:12Z","timestamp":1668039672000},"page":"28-37","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Pilot label comprehension study for an over\u2010the\u2010counter combined oral contraceptive pill in the United States"],"prefix":"10.1363","volume":"55","author":[{"given":"Kate","family":"Grindlay","sequence":"first","affiliation":[{"name":"Ibis Reproductive Health  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Key","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell D.","family":"Bradford","sequence":"additional","affiliation":[{"name":"PEGUS Research, Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Amato","sequence":"additional","affiliation":[{"name":"PEGUS Research, Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Blanchard","sequence":"additional","affiliation":[{"name":"Ibis Reproductive Health  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Grossman","sequence":"additional","affiliation":[{"name":"Advancing New Standards in Reproductive Health (ANSIRH), Department of Obstetrics, Gynecology and Reproductive Sciences University of California, San Francisco  Oakland California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"259","published-online":{"date-parts":[[2022,11,9]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Centers for Disease Control and Prevention.Current contraceptive status among women aged;2015\u20132017:15\u201049. Accessed November 10 2021.https:\/\/www.cdc.gov\/nchs\/products\/databriefs\/db327.htm"},{"key":"e_1_2_8_3_1","volume-title":"Contraceptive Technology","author":"Trussell J","year":"2018"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1089\/jwh.2015.5312"},{"key":"e_1_2_8_5_1","doi-asserted-by":"crossref","unstructured":"LindbergL Vande VusseA MuellerJ KirsteinM.Early impacts of the COVID\u201019 pandemic: findings from the 2020 Guttmacher survey of reproductive health experiences. Accessed November 10 2021.https:\/\/www.guttmacher.org\/report\/early-impacts-covid-19-pandemic-findings-2020-guttmacher-survey-reproductive-health","DOI":"10.1363\/2020.31482"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2012.11.021"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ogc.2015.07.002"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e31820afc46"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.whi.2017.11.006"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2013.04.005"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003473"},{"key":"e_1_2_8_12_1","unstructured":"American Academy of Family Physicians.Over\u2010the\u2010counter oral contraceptives. Accessed November 10 2021.https:\/\/www.aafp.org\/about\/policies\/all\/otc-oral-contraceptives.html"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e31818345f0"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2012.01.008"},{"key":"e_1_2_8_15_1","unstructured":"U.S. Food & Drug Administration.Label comprehension. Accessed November 10 2021.https:\/\/www.accessdata.fda.gov\/scripts\/cder\/training\/otc\/topic3\/topic3\/da_01_03_0170.htm"},{"key":"e_1_2_8_16_1","unstructured":"U.S. Food & Drug Administration.Code of Federal Regulations Title 21 Sec. 201.66: format and content requirements for over\u2010the\u2010counter (OTC) drug product labeling. Accessed November 10 2021.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr=201.66"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr6503a1"},{"key":"e_1_2_8_18_1","unstructured":"RovnerJ.FDA OKs prescription\u2010free Plan B for all ages ending battle. Accessed November 10 2021.https:\/\/www.npr.org\/sections\/health-shots\/2013\/06\/11\/190684947\/fda-oks-prescription-free-plan-b-for-all-ages-ending-battle"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0234962"},{"key":"e_1_2_8_20_1","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).Guidance for industry label comprehension studies for nonprescription drug products. 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