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[上市后监测的必要性]

[The need for 'postmarketing surveillance'].

作者信息

Stricker B H, in 't Veld B A, Feenstra J

机构信息

Erasmus Universiteit, afd. Epidemiologie & Biostatistiek en Interne Geneeskunde, Rotterdam.

出版信息

Ned Tijdschr Geneeskd. 1999 Apr 3;143(14):711-3.

Abstract

Postmarketing surveillance of medicines includes two activities: pharmacovigilance and pharmaco-epidemiology. Despite the importance of postmarketing surveillance, too few surveillance studies are performed. The studies carried out by the pharmaceutical industry predominantly consist of 'seeding trials': offering prescribing physicians financial rewards if they prescribe a particular product, thus trying to change the prescription habits. The results of such trials are scientifically worthless. These activities cast a shadow on sincere postmarketing surveillance. A recent nationwide cohort study by the Inspectorate for Health Care on mortality in users of ibopamine demonstrates that Dutch medical doctors and pharmacists are very co-operative if further studying of a particular adverse reaction is warranted.

摘要

药品上市后监测包括两项活动

药物警戒和药物流行病学。尽管上市后监测很重要,但进行的监测研究却太少。制药行业开展的研究主要包括“诱导试验”:如果开处方的医生开某种特定产品,就给予他们经济奖励,从而试图改变处方习惯。这类试验的结果在科学上毫无价值。这些行为给真诚的上市后监测蒙上了一层阴影。医疗保健监察局最近进行的一项关于异波帕胺使用者死亡率的全国性队列研究表明,如果有必要进一步研究某种特定不良反应,荷兰的医生和药剂师会非常合作。

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