Principle of adverse drug reaction causality judgement and interpretation of causality assessment method both in China and abroad.
- Author:
Xu WEI
1
;
Yan-Ming XIE
Author Information
1. Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. weixu.007@163.com
- Publication Type:Journal Article
- MeSH:
Adverse Drug Reaction Reporting Systems;
standards;
China;
Drug Therapy;
Drug-Related Side Effects and Adverse Reactions;
Humans;
Pharmaceutical Preparations;
administration & dosage
- From:
China Journal of Chinese Materia Medica
2012;37(18):2744-2747
- CountryChina
- Language:Chinese
-
Abstract:
Adverse drug reaction (ADR) causality judgement is a routine procedure in pharmacovigilance, no unified judgement standard and categories standard are established. Temporal relations, consistency, specificity, intensity of reaction are the basic principle of ADR causality jugement we should abide by. There are many ADR causality assessment methods, which classifies standard algorithms, expert judgement, bayesian approches. The implicit definitions of some categories standard, incomplete information from case reports coupled with vast differences in the application of clinical judgements are the major problems facing ADR evaluation. Almost every kind of method shares certain common feature, that is, causal relationship of ADR is classified about five categories. However, causality assessment methods differ in basic principle, evaluation standard, specificity and sensitivity. There are some advantages and disadvantages among methods, but no causality assessment method can be applied to all ADR evaluation to date.
