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MICHAEL S. WOLF, PH.D., M.P.H., is Assistant Professor of Medicine, Institute for Healthcare Studies, Northwestern University, Chicago, IL. TERRY C. DAVIS, PH.D., is Professor of Medicine and Pediatrics, Louisiana State University (LSU) Health Sciences Center—Shreveport. HUGH H. TILSON, M.D., DR.P.H., is Clinical Professor, Epidemiology and Health Policy, University of North Carolina at Chapel Hill. PAT F. BASS III, M.D., M.S., is Assistant Professor of Medicine and Pediatrics, LSU Health Sciences Center—Shreveport. RUTH M. PARKER, M.D., is Professor of Medicine, Department of Medicine, School of Medicine, Emory University, Atlanta, GA.

Address correspondence to Dr. Wolf at the Institute for Healthcare Studies, Northwestern University, 676 North St. Clair Street, Suite 200, Chicago, IL 60611 (mswolf{at}northwestern.edu).

Purpose. The common causes for misunderstanding prescription drug warning labels (PWLs) among adults with low literacy were studied. Methods. A total of 74 patients reading at or below the sixth-grade level and receiving care at the primary care clinic at the Louisiana State University Health Sciences Center in Shreveport were recruited to participate in structured interviews. Patients were asked to interpret and comment on eight commonly used warning labels found on prescription medications. Correct interpretation was determined by expert panel review of patients’ verbatim responses. Qualitative methods were employed to code responses and generate themes regarding the misunderstanding of these PWLs. Results. Among this sample of patients with low literacy skills, rates of correct interpretation for the eight warning labels ranged from 0% to 78.7%. With the exception of the most basic label, less than half of all patients were able to provide adequate interpretations of the warning label messages. Five themes were derived to describe the common causes for misunderstanding the labels: single-step versus multiple-step instructions, reading difficulty of text, use of icons, use of color, and message clarity. Labels were at greater risk for being misunderstood if they included multiple instructions, had a greater reading difficulty, included unfamiliar terms, or used confusing icons that were discordant with text messages. Participants also frequently imposed an incorrect meaning on label colors, which led to further confusion. Conclusion. Patients with low literacy skills demonstrated a lower rate of correct interpretation of the eight most commonly used PWLs than did those with higher literacy skills. Multiple-step instructions, reading difficulty of text, the use of icons, the use of color, and message clarity were the common causes of label misinterpretation. Index terms: Comprehension; Labeling; Patients; Prescriptions; Readability

 

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