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Variability in Acetaminophen Labeling Practices: a Missed Opportunity to Enhance Patient Safety

  • Toxicology Investigation
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Abstract

Confusion regarding a drug’s active ingredient may lead to simultaneous use of multiple acetaminophen-containing prescriptions and increase the risk of unintentional overdose. The objective of this study was to examine prescription labeling practices for commonly prescribed acetaminophen-containing analgesics, specifically focusing on how active ingredient information and concomitant use warnings were conveyed. Patients with new acetaminophen-containing prescriptions were recruited upon discharge from an emergency department in Chicago or at an outpatient, hospital-based pharmacy in Atlanta. Label information was transcribed from prescription bottles and patients’ knowledge of active ingredient was assessed by in-person interviews. Among the 245 acetaminophen-containing prescriptions, hydrocodone was the most common second active ingredient (n = 208, 84.8 %) followed by oxycodone (n = 28, 11.4 %). Acetaminophen was identified by its full name on 6.9 % (n = 17) of labels; various abbreviations were used in 93.1 % of cases. One hundred forty-seven bottles used auxiliary warning labels with the majority of labels (n = 130, 88.4 %) warning about maximum dose and 11.5 % (n = 17) about concomitant use. Most of the study participants (n = 177, 72.2 %) were not able to identify acetaminophen as an active ingredient in their prescription. There was no significant association between the use of unabbreviated labels including warning information and patients’ awareness of acetaminophen as an active ingredient (36.4 vs. 27.3 %, p = 0.50). We noted high variability in labeling practices and warning information conveyed to patients receiving acetaminophen-containing prescriptions. Missed opportunities to adequately convey risk information may contribute to the burden of acetaminophen-related liver injury.

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Funding

This project was funded by an investigator-initiated research grant from McNeil Consumer Healthcare.

Conflicts of Interest

Dr. McCarthy reported receiving grant funding from the Emergency Medicine Foundation/Purdue Pharma Pain and Prescription Management Grant. Dr. Parker reported receiving unrestricted research grant funding from McNeil Consumer Healthcare and Abbott Laboratories and having provided consultation services to Johnson & Johnson and McKing Consulting Corporation. Dr. Wolf reported receiving unrestricted research grant funding from McNeil Consumer Healthcare and Abbott Laboratories and having provided consultation services (health literacy, study design for comprehension testing for OTC & Rx product use) to McNeil Consumer Healthcare and Abbott Laboratories.

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Authors and Affiliations

  1. Center for Clinical Epidemiology & Population Health, Marshfield Clinic Research Foundation, Marshfield, WI, USA

    Jennifer P. King

  2. Feinberg School of Medicine, Division of General Internal Medicine and Geriatrics, Health Literacy and Learning Program, Northwestern University, Chicago, IL, USA

    Jennifer P. King, Rebecca J. Mullen & Michael S. Wolf

  3. Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Danielle M. McCarthy

  4. Division of Gastroenterology and Hepatology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA

    Marina Serper

  5. Department of Health Policy and Management/Behavioral Science and Health Education, Rollins School of Public Health of Emory University, Atlanta, GA, USA

    Kara L. Jacobson

  6. Division of General, Emory University School of Medicine, Atlanta, GA, USA

    Ruth M. Parker

  7. Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA

    Michael S. Wolf

Authors
  1. Jennifer P. King
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  2. Danielle M. McCarthy
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  3. Marina Serper
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  4. Kara L. Jacobson
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  5. Rebecca J. Mullen
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  6. Ruth M. Parker
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  7. Michael S. Wolf
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Corresponding author

Correspondence to Jennifer P. King.

Additional information

These data were presented in a poster at the Health Literacy Annual Research Conference (HARC) in Bethesda, MD on Oct 22, 2012.

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King, J.P., McCarthy, D.M., Serper, M. et al. Variability in Acetaminophen Labeling Practices: a Missed Opportunity to Enhance Patient Safety. J. Med. Toxicol. 11, 410–414 (2015). https://doi.org/10.1007/s13181-015-0464-1

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  • DOI: https://doi.org/10.1007/s13181-015-0464-1

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