Could Swedish 'yellow cards' be substituted by E-coded summaries?

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C Jorup-Rönström1, M Keisu, B E Wiholm

  • 1Department of Infectious Diseases, Danderyd Hospital, Sweden.

Drug Safety
|January 1, 1990
PubMed

Insights

Reporting adverse drug reactions (ADRs) is crucial for patient safety. This study found that only 21% of ADRs identified in patient records were reported, highlighting a significant under-reporting issue in pharmacovigilance.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Epidemiology
  • Infectious Diseases

Background:

  • The 'yellow card' system is the primary method for reporting adverse drug reactions (ADRs) in Sweden.
  • Effective ADR reporting is essential for monitoring drug safety post-marketing.

Purpose of the Study:

  • To evaluate the completeness of ADR reporting from a hospital department.
  • To assess the potential of integrating ICD codes into ADR surveillance.

Main Methods:

  • Retrospective review of 2490 patient case summaries from 1986.
  • Identification of ADRs using International Classification of Disease (ICD) codes.
  • Comparison of identified ADRs with reports submitted to the Swedish Adverse Drug Reactions Advisory Committee.

Main Results:

  • Of 48 identified ADR cases, only 10 (21%) were reported via the 'yellow card' system.
  • Three additional reports were received without corresponding ADR codes in case summaries.
  • Case summary data was largely sufficient for preliminary ADR evaluation.

Conclusions:

  • Significant under-reporting of ADRs exists within the current 'yellow card' system.
  • Supplementing the 'yellow card' system with automatic referral of ICD-coded ADRs warrants further investigation.
  • A large-scale field study is recommended to explore this supplementary reporting system.

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