SPONTANEOUS ADVERSE DRUG REACTION REPORTING VS EVENT MONITORING - A COMPARISON

被引：86
|
作者：
FLETCHER, AP
机构：
来源：
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE | 1991年 / 84卷 / 06期
关键词：
POST MARKETING SURVEILLANCE; ADVERSE DRUG REACTION; SPONTANEOUS REPORTING; EVENT MONITORING;
D O I：
10.1177/014107689108400612
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
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.
引用
收藏
页码：341 / 344
页数：4
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