基础知识和基本概念.pptVIP

TCH 药品不良反应监测基本概念与基础知识 吴桂芝 成都 2007.6 国家药品不良反应监测中心 药品不良反应Adverse (Drug) Reaction, ADR 指合格药品在正常用法用量下出现的与用药目的无关的或意外的有害反应。 排除了治疗失败、药物过量、药物滥用、不依从用药和用药差错的情况 药品不良反应Adverse (Drug) Reaction, ADR A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological functions. ——WHO Technical Report No. 498 (1972) 副作用 (Side Effect) 是指药品按正常用法用量使用时所出现的与药品的药理学活性相关，但与用药目的无关的作用。 Any unintended effect of a pharmaceutical product occurring at normal dosage