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Could Swedish 'yellow cards' be substituted by E-coded summaries?
C Jorup-Rönström1, M Keisu, B E Wiholm
1Department of Infectious Diseases, Danderyd Hospital, Sweden.
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.
Abstract:
Case summaries of 2490 patients treated at the Department of Infectious Diseases, Danderyd Hospital, in 1986 were reviewed for discharge diagnoses where the International Classification of Disease (ICD) code indicated an adverse drug reaction (ADR) [E 939,9 in ICD 8]. Of 48 patients whose case summaries indicated an ADR, only 10 (21%) had been reported on 'yellow cards' to the Swedish Adverse Drug Reactions Advisory Committee. The Committee had also received from the same department 3 reports where the case summary lacked an ADR code. The information on drug treatment with respect to dosage, duration and treatment with concomitant drugs was not complete in the case summaries but sufficient for a preliminary evaluation of the suspected reactions in all but 4 of the cases. On the basis of these findings the authors do not reach an outright conclusion in favour of replacing the 'yellow card' system but the possible benefits of a system in which 'yellow cards' are supplemented by automatic referral of all case summaries containing an ICD code indicating an adverse drug reaction was judged sufficient to recommend and initiate a large field study.