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Evaluation of the Extent of Under-Reporting of Serious Adverse Drug Reactions

The Case of Toxic Epidermal Necrolysis

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Abstract

Introduction: Toxic epidermal necrolysis (TEN) is a life-threatening adverse drug reaction (ADR) that is primarily the result of drug exposure (incidence 0.4–1.3 per million person-years). Life-threatening ADRs such as TEN should be reported to ADR monitoring programmes, which collect reports for suspected ADRs and alert the public and medical practitioners to new drug hazards. In Canada, reports are made to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP).

Objective: To examine the extent of under-reporting for TEN in Canada.

Design: A retrospective case series design was used to collect all TEN cases for the period January 1995 to December 2000.

Methods: The CADRMP and 22 burn centres across Canada were contacted for all TEN patients treated during the specified time period.

Patient Groups Studied: The study population consisted of patients admitted to burn treatment sites across Canada, patient cases reported to the CADRMP and patient cases recorded by the Canadian Institute for Health Information (CIHI) hospital discharge summaries as the International Classification of Diseases Version 9 Clinical Modification (ICD-9-CM) code 695.1.

Results: Twenty-five TEN cases (six fatal) were reported to CADRMP from January 1995 to December 2000. During this period, 14 (63.6%) burn treatment sites reported admission of 250 TEN cases. Hospital discharge summaries using the ICD-9-CM code 695.1 indicated that 4349 cases were admitted to hospital during this time period and it was estimated that 15.5% (n = 674) of these cases were TEN. Using the burn facility data as the denominator, 10% (25 of 250) of TEN cases were reported to CADRMP. Using CIHI data as a denominator, only 4% (25 of 674) of TEN cases were reported to CADRMP.

Conclusions: There is serious under-reporting of TEN. Lack of reporting of life-threatening ADRs can compromise population safety. There is a need to increase awareness of ADR reporting programmes.

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Acknowledgements

No funding was used to assist in the preparation of this manuscript and there are no potential sources of conflict that are directly relevant to the contents of this manuscript.

The authors would like to thank the burn facilities that responded to the request for toxic epidermal necrolysis (TEN) cases. We would like to thank the Canadian Institute for Health Information (CIHI) for providing information on the Canadian profile of TEN. The authors would like to thank the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) for the list of reported TEN cases. The opinions expressed in this paper do not reflect those of Health Canada.

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Authors and Affiliations

  1. Department of Pharmacology, Division of Clinical Pharmacology, University of Toronto; HOPE Research Centre, Sunnybrook and Women’s College Health Sciences Centre, Toronto, Ontario, Canada

    Nicole Mittmann & Neil H. Shear

  2. Department of Pharmacy, Sunnybrook and Women’s College Health Sciences Centre, Toronto, Ontario, Canada

    Sandra R. Knowles

  3. Ross Tilley Burn Centre, Sunnybrook and Women’s College Health Sciences Centre, Toronto, Ontario, Canada

    Manuel Gomez, Joel S. Fish & Robert Cartotto

  4. Department of Dermatology, University of Toronto, Toronto, Ontario, Canada

    Neil H. Shear

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  1. Nicole Mittmann
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Mittmann, N., Knowles, S.R., Gomez, M. et al. Evaluation of the Extent of Under-Reporting of Serious Adverse Drug Reactions. Drug-Safety 27, 477–487 (2004). https://doi.org/10.2165/00002018-200427070-00004

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