Patient-centered approach for improving prescription drug warning labels

Objective: To use a patient-centered approach to refine warning labels promoting the safe use of prescription drugs among patients, regardless of literacy level. Methods: Ten discussion groups were conducted among adults recruited from a general internal medicine clinic and four adult education classes. Participants completed face-to-face cognitive interviews with literacy assessment to determine comprehension of the 10 most commonly used drug warning labels, followed by a discussion group that solicited feedback for revising text and icons. Results: In all, 85 adults participated; 56% had limited literacy skills. Feedback from discussion groups indicated that the majority of icons were confusing, used difficult language, and text and icons were often discordant. Participants sought actionable language in the most simple and concise manner. In comprehension testing, five of the warning labels reached a set standard of >80% comprehension; the remaining labels were revised and three others modified on patients' request. A universal icon that conveyed 'Caution' was used for one label ("use only on your skin") as patients were unable to agree on an acceptable visual representation. Conclusion: A patient-centered approach to designing consumer medication information could improve the comprehensibility of existing warning labels. Practice implications: Pharmacies should review existing drug warnings to assess adequacy among patients, particularly those with limited literacy. Pharmacists should confirm patients understand auxiliary warnings to support safe and effective use.