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KMID : 1011320120050010031
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 1 p.31 ~ p.39
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Comparison between WHO-UMC Causality Categories and Korean Algorithm Version 2.0 for Causality Evaluation of Adverse Drug Reactions
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Kim Bo-Ri
Lee Jung-Sun
Han Ok-Youn
Jeong Seung-Hee
Yim Hyeon-Woo
Jung Kyoung-Eun
La Hyen-O
Park Young-Min
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Abstract
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Objective: Adverse drug reactions (ADRs) can cause serious problems to human and evaluating ADRs are very important. We have evaluated ADRs with WHO-UMC causality categories (WHO-categories) and Korean algorithm (K-algorithm). The purpose of this study is to compare causality evaluations of ADRs between WHO-categories and K-algorithm for improvement of ADRs evaluation process in this hospital.
Methods: From July 2009 to March 2010, total 1,525 ADRs cases were reported from all medical departments and evaluated by trained pharmacists and clinicians. Among them, we analyzed 1,161 ADRs cases for agreement using weighted kappa (Kw) statistics by degree of severity, seriousness and length of experience.
Results: Total agreement between WHO-categories and K-algorithm was showed 63.0% agreement (Kw=0.48). According to the degree of severity, the agreement was 50.4% (Kw=0.53) in moderate and severe group and 13.2% (Kw=0.39) in mild group. The agreement related to experience of primary evaluators showed 62.0% (Kw=0.44) in the primary evaluators group below 6 months and 69.0% (Kw=0.61) in the group more than 6 months.
Conclusion: The causal assessment of ADRs in our hospital showed a moderate agreement. More careful evaluation is required for mild cases and the simultaneous evaluation using two algorithms could be helpful in these cases. However, it is still difficult for evaluators with little experience. For accuracy improvement of ADRs evaluation, it is necessary to make these algorithms more widespread and easier.
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KEYWORD
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Adverse drug reactions, WHO-UMC causality categories, Korean algorithm
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