Developing consumer-centered, nonprescription drug labeling: A study in acetaminophen

Jennifer P. King, Terry C. Davis, Stacy Cooper Bailey, Kara L. Jacobson, Laurie A. Hedlund, Lorenzo Di Francesco, Ruth M. Parker, Michael S. Wolf

Research output: Contribution to journalArticlepeer-review

51 Scopus citations

Abstract

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 acetaminophen 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 benefit consumers.

Original languageEnglish (US)
Pages (from-to)593-598
Number of pages6
JournalAmerican Journal of Preventive Medicine
Volume40
Issue number6
DOIs
StatePublished - Jun 2011

Funding

JPK has worked on projects funded by unrestricted research grants from McNeil Consumer Healthcare . TCD has received unrestricted research grant funding from McNeil Consumer Healthcare and Abbott Foundation , and has served as a paid consultant to McNeil Consumer Healthcare and Abbott Laboratories. She owns stock in Pfizer, Abbott, and Johnson & Johnson. SCB has worked on an unrestricted research grant funded by McNeil Consumer Healthcare and has served as a paid consultant to Abbott Laboratories. RMP has received unrestricted research grant support from McNeil Consumer Health , Johnson & Johnson , Abbott Foundation , and McKing Consulting . None of this support is a source of a conflict of interest. MSW has received unrestricted research grant funding from McNeil Consumer Healthcare and Abbott Foundation , and has served as a paid consultant to McNeil Consumer Healthcare, Abbott Laboratories and Earthbound LLC. This work was supported by an unrestricted research grant from McNeil Consumer Healthcare . The funder did not contribute to the study design, data collection, or interpretation of findings. Rather, discussions with the investigators and funder were held primarily on implications of findings, not on the decision to publish or prohibit the release of any data.

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Epidemiology

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