Developing Consumer-Centered, Nonprescription Drug Labeling A Study in Acetaminophen Jennifer P. King, MPH, Terry C. Davis, PhD, Stacy Cooper Bailey, MPH, Kara L. Jacobson, MPH, Laurie A. Hedlund, BA, Lorenzo Di Francesco, MD, Ruth M. Parker, MD, Michael S. Wolf, PhD, MPH Background: In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. Purpose: Elicit subject feedback about active ingredient and dosing information on over-the- counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. Methods: Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. Results: Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that 50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol ® . The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetamino- phen products, and indicated preference for an icon and wording for maximum dose. Conclusions: With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefıt consumers. (Am J Prev Med 2011;40(6):593–598) © 2011 American Journal of Preventive Medicine A cetaminophen, found in prescription and single- ingredient or combination over-the-counter (OTC) products, is one of the most commonly used pain medicines in the U.S., with 25 billion doses sold in 2008. 1,2 Despite its popularity, recent attention has focused on adverse events resulting from the misuse of acetaminophen. In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hos- pitalizations annually. 2–5 Acetaminophen-related adverse drug events have been linked to consumers exceeding the maximum daily dosage and simultaneously using multi- ple acetaminophen products (both prescription and OTC). 4 Notably, half to two thirds of overdoses are unin- tentional, 3–5 suggesting the root cause is likely poor un- derstanding of medication labeling or failure to recognize the consequences of exceeding the recommended maxi- mum daily dosage. In 1999, the Food and Drug Administration (FDA) issued regulations aimed at standardizing the format and content of OTC medication labels with the goal of facili- tating safe and effective use by consumers. 6 The FDA stated that labeling is the most important means to ensure that consumers have access to important warning infor- From the Health Literacy and Learning Program, Division of General Internal Medicine, Northwestern University Feinberg School of Medicine (King, Bailey, Hedlund, Wolf), Chicago, Illinois; the Departments of Med- icine and Pediatrics, Louisiana State University Health Sciences Center (Davis), Shreveport, Louisiana; the Department of Health Policy and Man- agement, Rollins School of Public Health of Emory University (Jacobson); and the Division of General Internal Medicine, Emory University School of Medicine (Di Francesco, Parker), Atlanta, Georgia Address correspondence to: Jennifer P. King, MPH, Northwestern Uni- versity, Feinberg School of Medicine, Division of General Internal Medi- cine, 750 N. Lake Shore Drive, 10th Floor, Chicago IL 60611. E-mail: jenniferking@northwestern.edu. 0749-3797/$17.00 doi: 10.1016/j.amepre.2011.02.016 © 2011 American Journal of Preventive Medicine • Published by Elsevier Inc. Am J Prev Med 2011;40(6):593–598 593