Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis

Drug Saf. 2004;27(7):477-87. doi: 10.2165/00002018-200427070-00004.


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.

Publication types

  • Evaluation Study

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards*
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data
  • Burn Units / statistics & numerical data
  • Burns, Chemical / epidemiology
  • Burns, Chemical / mortality
  • Canada / epidemiology
  • Diagnosis-Related Groups
  • Humans
  • Medical Records
  • Outcome Assessment, Health Care*
  • Retrospective Studies
  • Stevens-Johnson Syndrome / epidemiology*
  • Stevens-Johnson Syndrome / mortality