WHOART和MedDRA在药品不良反应监测中的应用

Use of WHOART and MedDRA in Adverse Reaction Monitoring

WHO不良反应术语集(WHOART)和国际医学用语词典(MedDRA)是目前在上市后药品不良反应监测中用于分类和编码药品不良反应的常用术语集。通过介绍WHOART和MedDRA的术语定义、内容、结构、特点以及在药品不良反应监测中的应用;分析WHOART在我国使用的现状,探讨了WHOART和MedDRA在我国药品不良反应监测中的适用性及优缺点。

World Health Organization Adverse Reaction Terminology（WHOART） and Medical Dictionary for Regu- latory Activities（MedDRA） developed by International Conference on Harmonisation are most often used terminology to classify and code adverse reaction terms in post-marketing safety surveillance and drug adverse reaction monitoring. This article introduced term definitions, rules and conventions, hierarchy structure, characteristics, the applications in coding and data analysis of WHOART and MedDRA. On the basis of analyzing the strongpoint and shortcoming of WHOART and MedDRA terminology now in use, the current status of WHOART and potential use of MedDRA in China are discussed.