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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]

Objective: To assess whether evidence-based information on progestin-only pills (POPs) and over-the-counter (OTC) oral contraceptives (OCs) increases support among clinicians for bringing a POP or combined oral contraceptive (COC) OTC and to identify concerns clinicians may have about OTC access to OCs. Materials and Methods: In 2018 a survey of 778 clinicians assessed support for bringing a POP and COC OTC before and after receiving evidence-based information, which was pretested through in-depth interviews. Clinicians were randomized into two groups, stratified by clinician type. One group received information about OTC access to OCs generally, and the second group received OTC information plus information about POPs. Levels of support between arms were compared using robust Poisson models. Results: Before receiving information, 31% of clinicians supported moving a POP OTC. After receiving information, 39% of clinicians who only received OTC information supported moving a POP OTC compared to 61% who received OTC and POP information (relative risk = 1.53, 95% confidence interval: 1.34 to 1.75). Support for bringing a COC OTC increased marginally for those who received OTC and POP information, while support among those who received only OTC information increased by 12 percentage points (to 50%). Among clinicians opposed to moving a POP OTC after receiving information, top concerns included safety (26%), effectiveness (19%), potential for incorrect use (19%), and loss of preventive screenings (15%). Conclusion: Evidence-based information, particularly around POPs, has the potential to change clinician attitudes and address misconceptions about POPs and OTC access. [ABSTRACT FROM AUTHOR]

Background: Access to contraception is a vital component of preventing unintended pregnancies. This study was conducted to assess the prevalence of and factors associated with U.S. women's difficulty accessing prescription contraception (pill, patch, or ring). Materials and Methods: We performed a nationally representative survey of adult women at risk of unintended pregnancy (aged 18-44, not pregnant or seeking pregnancy, sexually active, not sterilized) using a probability-based web panel. In November to December 2011, 2046 women completed the survey. Weighted proportions were calculated and logistic regression was used to identify covariates associated with difficulty obtaining or refilling prescription contraception. Results: A total of 1385 (68%) women had ever tried to get a prescription for hormonal contraception. Among this population, 29% reported ever having problems obtaining a prescription or refills. In multivariable regression, uninsured (vs. privately insured) and Spanish-speaking (vs. English-speaking) women were significantly more likely to report difficulties; women with a high school degree and those with some college (vs. a college degree or higher) were significantly less likely to report difficulty. Difficulties included cost barriers or lack of insurance (14%), challenges obtaining an appointment or getting to a clinic (13%), the clinician requiring a clinic visit, exam, or Pap smear (13%), not having a regular doctor/clinic (10%), difficulty accessing a pharmacy (4%), and other reasons (4%). Conclusions: One-third of adult U.S. women who have ever tried to obtain prescription contraception reported access barriers. While the Affordable Care Act may resolve some of these issues, these data indicate that additional factors may still need to be addressed. [ABSTRACT FROM AUTHOR]

Context Women having abortions are at high risk for future unintended pregnancy, and removing the prescription requirement for oral contraceptives may increase continuation and adoption of this effective method. Methods A survey fielded from May to July 2011 collected information from 651 women aged 15-46 seeking abortion services at six urban clinics from across the United States. Descriptive statistics, chi-square tests and logistic regression analyses were conducted to estimate women's interest in over-the-counter access to oral contraceptives. Results Eighty-one percent of respondents supported over-the-counter access to oral contraceptives; while 42% of women planned to use the pill after their abortion, 61% said they would likely use this method if it were available over the counter. Thirty-three percent of women who planned to use no contraceptive following their abortion said they would use an over-the-counter pill, as did 38% who planned to use condoms afterward. In multivariable analysis, several subgroups had increased odds of likely over-the-counter use: women who were older than 19 (odds ratios, 1.8 for those aged 20-29 and 1.6 for those aged 30-46), were uninsured (1.5), had ever used the pill (1.4), had had difficulty obtaining a prescription refill for hormonal contraceptives (2.7) or planned to use the pill postabortion (13.0). By contrast, compared with white respondents, women of other races or ethnicities were less likely to say they would use over-the-counter pills (0.4-0.7). Conclusions Interest in a hypothetical over-the-counter oral contraceptive was high in this sample, and this delivery model has the potential to reduce unintended pregnancy among abortion patients. [ABSTRACT FROM AUTHOR]