For a study, researchers sought to create a drug facts label prototype for a mifepristone and misoprostol combination product and perform label comprehension research to evaluate knowledge of key label ideas. To create a drug facts label prototype for pharmaceutical abortion, they followed FDA guidelines, enlisted the help of a multidisciplinary group of specialists, and conducted cognitive interviews. They created 11 major and 13 subsidiary communication objectives relating to indications for use, eligibility, dosage regimen, contraindications, warning signals, side effects, and identifying the risk of treatment failure, with corresponding target performance criteria (80–90% accuracy). Individual structured video interviews were undertaken with persons with uteruses aged 12–49 years old who were recruited via social media. Participants read the medication information label and answered questions to determine their grasp of each communication goal. After transcribing and coding interviews, they evaluated the proportion of right replies and precise binomial 95% CIs by age and literacy group.
We interviewed 851 persons (out of 1,507 planned), and 844 replies were suitable for analysis. About 35.7% (n=301) of participants were aged 12–17 years. The sample satisfied performance requirements for 10 of the 11 key communication objectives (93–99% accurate) about indications for use, eligibility for use, dosage regimen, and contraindications; young individuals met nine, and persons with inadequate literacy met eight. However, only 79% (95% CI 0.76–0.82) of the sample knew to call a health care provider if there was little or no bleeding immediately after taking misoprostol, falling short of the predetermined criterion of 85.0%.
Overall, strong levels of understanding indicated that most essential drug facts and label ideas for a medication abortion product might be understood without clinical supervision, and modest adjustments are recommended.