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Risk of Unintentional Overdose with Non-Prescription Acetaminophen Products

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Abstract

Background

There is increasing concern over the risk of consumer unintentional misuse of non-prescription (a.k.a. ‘over-the-counter’) medications containing acetaminophen, which could lead to acute liver failure.

Objective

To determine the prevalence of potential misuse and overdose of over-the-counter medications containing acetaminophen, either alone or in combination.

Design

Cross-sectional, structured interviews with literacy assessment.

Setting

One academic and one community-based general internal medicine practice in Chicago, IL, and one academic general internal medicine practice and a public hospital clinic in Atlanta, GA.

Patients

Five hundred adults seeking primary care, ages 18–80.

Measurement

Demonstration of how and when patients would take over-the-counter medications containing acetaminophen, alone or in combination with one another, over a 24-hour period.

Results

Overall, 23.8 % of participants demonstrated they would overdose on a single over-the-counter acetaminophen product by exceeding a dose of four grams in a 24-hour period; 5.2 % made serious errors by dosing out more than six grams. In addition, 45.6 % of adults demonstrated they would overdose by ‘double-dipping’ with two acetaminophen-containing products. In multivariable analyses, limited literacy (Relative Risk Ratio (RR) 1.65, 95 % Confidence Interval (CI) 1.03–2.66) and heavy acetaminophen use in the past six months (RR 1.70, 95 % CI 1.10–2.64) were independently associated with overdosing over-the-counter products.

Conclusion

Misunderstanding of the active ingredient and proper instructions for over-the-counter medications containing acetaminophen is common. The potential for errors and adverse events associated with unintentional misuse of these products is substantial, particularly among heavy users of acetaminophen and those with limited literacy.

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References

  1. Qato DM, Alexander GC, Conti RM, Johnson M, Schumm P, Lindau ST. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States. JAMA. 2008;300:2867–2878.

    Article  PubMed  CAS  Google Scholar 

  2. Department of Health and Human Services. Over-the-counter human drugs; labeling requirements; final rule. Fed Regist. 1999;64:13254–13303.

    Google Scholar 

  3. King JP, Davis TC, Bailey SC, et al. Developing consumer-centered, nonprescription drug labeling a study in acetaminophen. Am J Prev Med. 2011;40:593–598.

    Article  PubMed  Google Scholar 

  4. Fosnocht D, Taylor JR, Caravati EM. Emergency department patient knowledge concerning acetaminophen (paracetamol) in over-the-counter and prescription analgesics. Emerg Med J. 2008;25:213–216.

    Article  PubMed  CAS  Google Scholar 

  5. Heard K, Sloss D, Weber S, Dart RC. Overuse of over-the-counter analgesics by emergency department patients. Ann Emerg Med. 2006;48:315–318.

    Article  PubMed  Google Scholar 

  6. Stumpf JL, Skyles AJ, Alaniz C, Erickson SR. Knowledge of appropriate acetaminophen doses and potential toxicities in an adult clinic population. J Am Pharm Assoc. 2007;47:35–41.

    Article  Google Scholar 

  7. Slone Epidemiology Center. Patterns of Medication Use in the United States 2006: A Report from the Slone Survey. 2006. http://www.bu.edu/slone/SloneSurvey/AnnualRpt/SloneSurveyWebReport2006.pdf. (Accessed April 6, 2012).

  8. de Achaval S, Suarez-Almazor M. Acetaminophen overdose: a little recognized public health threat. Pharmacoepidemiol Drug Saf. 2011;8:827–829.

    Article  Google Scholar 

  9. Li C, Martin BC. Trends in emergency department visits attributable to acetaminophen overdoses in the US: 1992–2007. Pharmacoepidemiol Drug Saf. 2011;8:810–818.

    Article  Google Scholar 

  10. Manthripragada AD, Zhou EH, Budnitz DS, Lovegrove MC, Willy ME. Characterization of acetaminophen overdose-related emergency department visits and hospitalizations in the United States. Pharmacoepidemiol Drug Saf. 2011;8:19–826.

    Google Scholar 

  11. Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42:1364–1372.

    Article  PubMed  CAS  Google Scholar 

  12. Ostapowicz G, Fontana RJ, Schiodt FV, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002;137:947–954.

    PubMed  Google Scholar 

  13. Bower WA, Johns M, Margolis HS, Williams IT, Bell BP. Population-based surveillance for acute liver failure. Am J Gastroenterol. 2007;102:2459–2463.

    Article  PubMed  Google Scholar 

  14. Summary Minutes of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee, June 29 and 30, 2009. 2009 Meeting Materials, Drug Safety and Risk Management Advisory Committee 2009. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm126014.htm. (Accessed April 6, 2012).

  15. Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002;40:771–781.

    Article  PubMed  Google Scholar 

  16. American Association for Public Opinion Research. Standard definitions: Final dispositions of case codes and outcome rates for surveys. 2011. http://www.aapor.org/For_Researchers/4362.htm. (Accessed 15 August, 2011).

  17. Davis TC, Long SW, Jackson RH, et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993;25:391–395.

    PubMed  CAS  Google Scholar 

  18. McNutt LA, Wu C, Xue X, Hafner JP. Estimating the relative risk in cohort studies and clinical trials of common outcomes. Am J Epidemiol. 2003;157:940–943.

    Article  PubMed  Google Scholar 

  19. Zou G. A modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159:702–706.

    Article  PubMed  Google Scholar 

  20. Davis CS. Statistical methods for the analysis of repeated measurements. New York: Springer-Verlag; 2002.

    Google Scholar 

  21. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13–22.

    Article  Google Scholar 

  22. Wolf MS, Gazmararian JA, Baker DW. Health literacy and functional health status among older adults. Arch Intern Med. 2005;165:1946–1952.

    Article  PubMed  Google Scholar 

  23. Davis TC, Wolf MS, Bass PF, et al. Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med. 2006;21:847–851.

    Article  PubMed  Google Scholar 

  24. Wolf MS, Davis TC, Tilson HH, Bass PF, Parker RM. Misunderstanding of prescription drug warning labels among patients with low literacy. Am J Health Syst Pharm. 2006;63:1048–1055.

    Article  PubMed  Google Scholar 

  25. Davis TC, Wolf MS, Bass PF, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145:887–894.

    PubMed  Google Scholar 

  26. Lokker N, Sanders L, Perrin EM, et al. Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics. 2009;123:1464–1471.

    Article  PubMed  Google Scholar 

  27. Department of Health and Human Services. Organ-specific warnings; internal analgesic, antipyretic and antirheumatic drug products for over-the-counter human use; final monograph. Fed Regist. 2009;74:19385–19409.

    Google Scholar 

  28. McNeil Consumer Healthcare. New Initiative to Help Encourage Appropriate Use of Acetaminophen. 2011. http://www.tylenol.com/page2.jhtml?id=tylenol/news/newdosing.inc. (Accessed April 6, 2012)

  29. National Coalition for Prescription Drug Programs. NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen. Scottsdale, AZ; July 2011). http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266631.pdf (Accessed April 6, 2012).

  30. Federal Trade Commission (2010c), “Regulation of nonprescription drug products”, Federal Trade Commission. Available at: www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM148055.pdf (Accessed April 6, 1202).

  31. U.S. Food and Drug Administration. Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications. Drug Safety and Availability, 2011. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf (Accessed April 16, 2011).

  32. Centers for Disease Control and Prevention. The PROTECT Initiative: Advancing Children's Medication Safety. Medication Safety Program, 2011. http://www.cdc.gov/MedicationSafety/protect/protect_Initiative.html. (Accessed April 6, 2012).

  33. Yin HS, Mendelsohn AL, Wolf MS, Parker RM, Fierman A, van Schaick L, Bazan IS, Kline MD, Dreyer BP. Parents' medication administration errors: role of dosing instruments and health literacy. Arch Pediatr Adolesc Med. 2010;164:181–186.

    Article  PubMed  Google Scholar 

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Acknowledgements

This project was supported by an unrestricted grant from McNeil Consumer Healthcare (PI: Wolf). The funding for this study was under an Investigator-Initiated Research (IIR) mechanism through McNeil Consumer Healthcare, and the funder had no role in the study design, data collection, analysis, or interpretation of findings

Conflict of Interest

Drs. Wolf and Davis have previously provided research consultation services (health literacy, study design for comprehension testing for OTC product use) for McNeil Consumer Healthcare. Dr. Wolf and Stacy Bailey are Consultants to Abbott Labs. All other authors declare they do not have a conflict of interest.

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Correspondence to Michael S. Wolf PhD MPH.

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Wolf, M.S., King, J., Jacobson, K. et al. Risk of Unintentional Overdose with Non-Prescription Acetaminophen Products. J GEN INTERN MED 27, 1587–1593 (2012). https://doi.org/10.1007/s11606-012-2096-3

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  • DOI: https://doi.org/10.1007/s11606-012-2096-3

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