Comprehension of an over-the-counter drug facts label prototype for a mifepristone and misoprostol medication abortion product
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Most adolescents can comprehend package labeling on medication abortion drugs.
“most adolescents can comprehend package labeling on emergency contraception (Raymond et al., 2009) and medication abortion drugs (Biggs et al., 2022)”
From The role (and limits) of developmental neuroscience in determining adolescents' autonomy rights: The case for reproductive and voting rights (2024) · cites this paper as Biggs et al., 2022
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Rapid assessment of literacy levels of adult primary care patients.
Tc, D., Crouch, M. A., Sw, L., Rh, J., Bates, P. T., Rb, G., & Bairnsfather, L. E. (1991) · PubMed · Cited by 580 · see citing works
Disparities in Health Care and the Digital Divide
Saeed, S. A., & Masters, R. M. (2021) · Current Psychiatry Reports · doi:10.1007/s11920-021-01274-4 · Cited by 578 · see citing works
Incidence of Emergency Department Visits and Complications After Abortion
Upadhyay, U. D., Desai, S., Zlidar, V. M., Weitz, T. A., Grossman, D., Anderson, P., & Taylor, D. (2014) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000000603 · Cited by 267 · see citing works
Self-citationDavis, T. C., Wolf, M. S., Arnold, C. L., Byrd, R. S., Long, S. W., Springer, T. P., Kennen, E. M., & Bocchini, J. A. (2006) · PEDIATRICS · doi:10.1542/peds.2006-1139 · Cited by 205 · see citing works
Gerdts, C., Fuentes, L., Grossman, D., White, K., Keefe‐Oates, B., Baum, S. E., Hopkins, K., Stolp, C. W., & Potter, J. E. (2016) · American Journal of Public Health · doi:10.2105/ajph.2016.303134 · Cited by 167 · see citing works
Self-citationRaymond, E. G., Grossman, D., Mark, A. G., Upadhyay, U. D., Dean, G., Creinin, M. D., Coplon, L., Perritt, J. B., Atrio, J., Taylor, D., et al. (2020) · Contraception · doi:10.1016/j.contraception.2020.04.005 · Cited by 161 · see citing works
Self-citationMedication Abortion Up to 70 Days of Gestation
Society of Family Planning (2020) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000004082 · Cited by 149 · see citing works
TelAbortion: evaluation of a direct to patient telemedicine abortion service in the United States
Raymond, E. G., Chong, E., Winikoff, B., Platais, I., Mary, M., Lotarevich, T., Castillo, P. W., Kaneshiro, B., Tschann, M., Fontanilla, T. M., et al. (2019) · Contraception · doi:10.1016/j.contraception.2019.05.013 · Cited by 135 · see citing works
Self-citationCartwright, A. F., Karunaratne, M. S., Barr‐Walker, J., Johns, N. E., & Upadhyay, U. D. (2018) · Journal of Medical Internet Research · doi:10.2196/jmir.9717 · Cited by 127 · see citing works
Chong, E., Shochet, T., Raymond, E. G., Platais, I., Anger, H. A., Raidoo, S., Soon, R. A., Grant, M., Haskell, S., Tocce, K. M., et al. (2021) · Contraception · doi:10.1016/j.contraception.2021.03.019 · Cited by 96 · see citing works
Self-citationSafety and Efficacy of Telehealth Medication Abortions in the US During the COVID-19 Pandemic
Upadhyay, U. D., Koenig, L. R., & Meckstroth, K. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.22320 · Cited by 91 · see citing works
Predicted changes in abortion access and incidence in a post-Roe world
Myers, C. K., Jones, R. K., & Upadhyay, U. D. (2019) · Contraception · doi:10.1016/j.contraception.2019.07.139 · Cited by 90 · see citing works
Upadhyay, U. D., Schroeder, R., & Roberts, S. C. M. (2020) · Contraception X · doi:10.1016/j.conx.2020.100049 · Cited by 77 · see citing works
Comprehension of a prototype emergency contraception package label by female adolescents
Raymond, E. G., L’Engle, K. L., Tolley, E. E., Ricciotti, N., Arnold, M. V., & Park, S. (2009) · Contraception · doi:10.1016/j.contraception.2008.09.004 · Cited by 73 · see citing works
Self-citationOshima, S. M., Tait, S. D., Thomas, S. M., Fayanju, O. M., Ingraham, K. L., Barrett, N. J., & Hwang, E. S. (2021) · Journal of Medical Internet Research · doi:10.2196/24947 · Cited by 54 · see citing works
Schonberg, D., Wang, L.-F., Bennett, A. K., Gold, M., & Jackson, E. (2014) · Contraception · doi:10.1016/j.contraception.2014.07.004 · Cited by 53 · see citing works
Gambir, K., Garnsey, C. L., Necastro, K. A., & Ngo, T. D. (2020) · BMJ Global Health · doi:10.1136/bmjgh-2020-003934 · Cited by 46 · see citing works
Association of Travel Distance to Nearest Abortion Facility With Rates of Abortion
Thompson, K., Sturrock, H. J. W., Foster, D. G., & Upadhyay, U. D. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.15530 · Cited by 46 · see citing works
Simplified medical abortion screening: a demonstration project
Raymond, E. G., Tan, Y.-L., Comendant, R., Sagaidac, I., Hodorogea, S., Grant, M. M., Sanhueza, P., Pratt, E. V., Gillespie, G., Boraas, C. M., et al. (2017) · Contraception · doi:10.1016/j.contraception.2017.11.005 · Cited by 42 · see citing works
Self-citationDesign and comprehensibility of over-the-counter product labels and leaflets: a narrative review
Tong, V., Raynor, D. K., & Aslani, P. (2014) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-014-9975-0 · Cited by 40 · see citing works
Accuracy of self-assessment of gestational duration among people seeking abortion
Ralph, L. J., Ehrenreich, K., Barar, R. E., Biggs, M. A., Morris, N., Blanchard, K., Kapp, N., Moayedi, G., Perritt, J. B., Raymond, E. G., et al. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.11.1373 · Cited by 40 · see citing works
Self-citationComprehension of a prototype over-the-counter label for an emergency contraceptive pill product
Raymond, E. G. (2002) · Obstetrics and Gynecology · doi:10.1016/s0029-7844(02)02086-0 · Cited by 39 · see citing works
Self-citationA research agenda for moving early medical pregnancy termination over the counter
Kapp, N., Grossman, D., Jackson, E., Castleman, L. D., & Brahmi, D. (2017) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.14646 · Cited by 32 · see citing works
Self-citationMark, A. G., Foster, A. M., Grossman, D., Prager, S., Reeves, M. F., Velásquez, C. V., & Winikoff, B. (2019) · Contraception · doi:10.1016/j.contraception.2019.02.008 · Cited by 32 · see citing works
Self-citationFDA Initiative for Drug Facts Label for Over-the-Counter Naloxone
Cohen, B. R., Mahoney, K., Baro, E., Squire, C. M., Beck, M., Travis, S., Pike-McCrudden, A., Izem, R., & Woodcock, J. (2020) · New England Journal of Medicine · doi:10.1056/nejmsa1912403 · Cited by 28 · see citing works
Godfrey, E. M., Fiastro, A. E., Jacob‐Files, E., Coeytaux, F. M., Wells, E. S., Ruben, M. R., Sanan, S., & Bennett, I. M. (2021) · Contraception · doi:10.1016/j.contraception.2021.04.021 · Cited by 22 · see citing works
Kaller, S., Muñoz, M. G. I., Sharma, S., Tayel, S. A., Ahlbach, C., Cook, C., & Upadhyay, U. D. (2021) · Contraception X · doi:10.1016/j.conx.2021.100067 · Cited by 19 · see citing works
The mifepristone REMS: A needless and unlawful barrier to care✰
Kaye, J., Reeves, R., & Chaiten, L. (2021) · Contraception · doi:10.1016/j.contraception.2021.04.025 · Cited by 18 · see citing works
Kapp, N., Methazia, J., Eckersberger, E., Griffin, R., & Bessenaar, T. (2019) · Contraception · doi:10.1016/j.contraception.2019.09.009 · Cited by 7 · see citing works
Self-citationComprehension of a Prototype Over-the-Counter Label for an Emergency Contraceptive Pill Product
Raymond, E. G., Dalebout, S. M., & Camp, S. I. (2002) · Obstetrics and Gynecology · doi:10.1097/00006250-200208000-00024 · Cited by 7 · see citing works
Self-citationThe no-test abortion is a patient-centered abortion
Fay, K. E., Kaiser, J. E., & Turok, D. K. (2020) · Contraception · doi:10.1016/j.contraception.2020.05.018 · Cited by 5 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Self-Managed Abortion in the United States
Verma, N., & Grossman, D. (2023) · Current Obstetrics and Gynecology Reports · doi:10.1007/s13669-023-00354-x · Cited by 39 · see citing works
Self-citationRohrer, C. D., & Modrek, S. (2023) · BMC Women s Health · doi:10.1186/s12905-023-02230-5 · Cited by 10 · see citing works
Maslowsky, J., Buss, E., & Wray-Lake, L. (2024) · Developmental Cognitive Neuroscience · doi:10.1016/j.dcn.2024.101435 · Cited by 8 · see citing works
Ehrenreich, K., Baba, C. F., Raifman, S., & Grossman, D. (2023) · Women s Health Issues · doi:10.1016/j.whi.2023.03.007 · Cited by 7 · see citing works
Self-citationMorris, N., Biggs, M. A., Baba, C. F., Seymour, J. W., White, K., & Grossman, D. (2024) · Women s Health Issues · doi:10.1016/j.whi.2024.03.003 · Cited by 6 · see citing works
Self-citationSchroeder, R., Freedman, L. R., Becker, A. J., Ahlbach, C., & Biggs, M. A. (2025) · Perspectives on Sexual and Reproductive Health · doi:10.1111/psrh.12289 · Cited by 6 · see citing works
Self-citationBiggs, M. A., Ehrenreich, K., Morris, N., Bachrach, L. R., Crespin, J., & Grossman, D. (2024) · Journal of Pediatric and Adolescent Gynecology · doi:10.1016/j.jpag.2024.07.012 · Cited by 4 · see citing works
Self-citationOver-the-Counter Medication Abortion as a Strategy to Expand Access to Care
Grossman, D., & Murphy, E. C. (2024) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2024.6325 · Cited by 3 · see citing works
Self-citationA Scoping Review of Barriers to Accessing Abortions among Adolescents in the United States
Maslowsky, J., Thyden, N. H., Odom-Konja, R. M., Gimbrone, C., Joanna, P., Esbrook, E., Hanneke, R., & Lindberg, L. (2025) · Journal of Pediatric and Adolescent Gynecology · doi:10.1016/j.jpag.2025.10.003 · Cited by 3 · see citing works
Midwives Safeguarding Abortion Access: Establishing Medication Abortion Services
Weintraub, S. L., Vergo, A. V., Winston, L., Graff, B., & Kattan, D. R. (2023) · Journal of Midwifery & Women s Health · doi:10.1111/jmwh.13556 · Cited by 3 · see citing works
Kapp, N., Bawah, A. A., Mao, B., Agula, C., Menzel, J. L., Antobam, S. K., Asuming, P. O., Saphonn, V., Eckersberger, E., & Pearson, E. (2025) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.18344 · Cited by 1 · see citing works
Self-citationLabel comprehension study for a proposed over-the-counter progestin-only pill
Grindlay, K., Bradford, R. D., Pradeau, S., Guillard, H., & Laurora, I. (2025) · Contraception · doi:10.1016/j.contraception.2025.111360 · Cited by 1 · see citing works
Biggs, M. A., Serrano, S., Valladares, E. S., & Grossman, D. (2022) · Contraception · doi:10.1016/j.contraception.2022.10.008 · Cited by 1 · see citing works
Self-citationNagahama, A., Sagara, A., Aki, H., Yoshimura, H., Hiraide, M., Shimizu, T., Sano, M., Yumoto, T., Hosoe, T., & Tanaka, K. (2025) · Discover Applied Sciences · doi:10.1007/s42452-025-08123-6
Ehrenreich, K., Biggs, M. A., Kaller, S., Ralph, L. J., Blanchard, K., Bustamante, C. K., Cervantes, M., Hauser, D., Hernández, E., Kapp, N., et al. (2026) · Contraception · doi:10.1016/j.contraception.2025.111361
Self-citationThe Growing Evidence Base for Over-the-Counter Medication Abortion
Borrero, S. B. (2026) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2026.0024
Accuracy of Self-Selection for Medication Abortion Using a Prototype Drug Facts Label
Ralph, L. J., Baba, C. F., Ehrenreich, K., Morris, N., Biggs, M. A., Blanchard, K., Hernández, E., Kapp, N., Kromenaker, T., Perritt, J. B., et al. (2026) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2026.0298
Self-citationMerz-Herrala, A. A., Biggs, M. A., Ehrenreich, K., Kaller, S., Ralph, L. J., Scott, K. A., Kapp, N., Kromenaker, T., Perritt, J. B., White, K., et al. (2026) · BMC Health Services Research · doi:10.1186/s12913-026-14505-2
Self-citationMifepristone Patient Agreement Form and Medication Abortion Knowledge
Biggs, M. A., Ehrenreich, K., Kaller, S., Ralph, L. J., & Grossman, D. (2026) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2026.5197
Self-citation
- Authors
- Biggs, M. A., Ehrenreich, K., Morris, N., Blanchard, K., Bustamante, C. K., Choimorrow, S. Y., Hauser, D., Hernandez, Y., Kapp, N., Kromenaker, T., Moayedi, G., Perritt, J. B., Ralph, L., Raymond, E. G., Valladares, E. S., White, K., & Grossman, D.
- Affiliations
- Advocates for Youth (US)
- Corresponding author
- Biggs, M. Antonia
- ORCID
- Venue
- Obstetrics & Gynecology
- Published
- 2022-05-02
- Volume
- 139
- Issue
- 6
- Pages
- 1111-1122
- ISSN
- 0029-7844 (ISSN-L)
- PMC
- PMC9202002
- OpenAlex
- W4282039506
- Cited by
- 20
- References
- 30
- Citations by year
- 2026: 5 · 2025: 5 · 2024: 4 · 2023: 4 · 2022: 2
- FWCI
- 3.31
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Obstetrics and Gynecology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Funders
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD052163)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
- Health Sciences › Health Professions › General Health Professions › Health Literacy and Information Accessibility
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
- Keywords
- abortion pills, mifepristone, misoprostol, label comprehension, health communication, cognitive interviewing, youth, low literacy, dosing regimen, contraindications
- MeSH terms
- Abortion, Induced, Adolescent, Nonprescription Drugs, Female, Humans, Pregnancy, Mifepristone, Misoprostol, Comprehension
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
