DOES PROOF OF CAUSALITY EVER EXIST IN PHARMACOVIGILANCE

被引:18
作者
AURICHE, M [1 ]
LOUPI, E [1 ]
机构
[1] PASTEUR MERIEUX SERUMS & VACCINES,DEPT POSTMKT SURVEILLANCE,DEPT PHARMACOVIGILANCE,F-69007 LYON,FRANCE
关键词
D O I
10.2165/00002018-199309030-00008
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof of a causal relationship between a drug and a specific event is quite exceptional. In most cases, this relationship remains subjective and is no more than inner conviction. Several means are at our disposal to achieve causal assessment: spontaneous reporting, clinical trials, cohorts with and without controls, and case-control studies, with each having advantages and limitations. The search for causality in pharmacovigilance is a necessary scientific goal, but a high degree of suspicion may be all that is necessary to withdraw a drug from the market if it is suspected of causing serious adverse effects.
引用
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页码:230 / 235
页数:6
相关论文
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