自发药物不良反应报告与事件监测：一项比较
Spontaneous adverse drug reaction reporting vs event monitoring: a comparison.
作者信息
Fletcher A P
机构信息
Post Marketing Surveillance Unit, IMS International Ltd, London.
出版信息
J R Soc Med. 1991 Jun;84(6):341-4. doi: 10.1177/014107689108400612.
Abstract
Spontaneous adverse drug reaction (ADR) reporting is the mainstay of national and international drug safety evaluation in the post-approval phase. A major criticism of the method has been a high, but essentially unquantifiable, level of under-reporting by doctors. A direct comparison has been made between spontaneous ADR reporting and an observational event monitoring system for a group of more than 44,000 patients receiving one or other of a group of seven new drugs. The data suggests that under-reporting by the spontaneous system may be as high as 98% for several clinical events believed to be associated with drug treatment.
摘要
自发药物不良反应（ADR）报告是药品批准后阶段国家和国际药品安全性评估的主要手段。该方法的一个主要批评意见是医生上报率很高，但基本上无法量化。针对一组超过44000名正在接受七种新药中一种或另一种治疗的患者，对自发ADR报告与观察性事件监测系统进行了直接比较。数据表明，对于一些被认为与药物治疗相关的临床事件，自发报告系统的漏报率可能高达98%。
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