药品不良事件( ADE ):世界卫生组织将不良事件也定义为不良感受, 是指药物治疗过程中所发生的任何不幸的医疗卫生事件, 而这种事件不一定与药物治疗有因果报应关系。从药物治疗的角度出发, 我们可以得到药品不良事件的定义, 是指与药物相联系的机体损害。药品不良事件包括二个要素: 一是不良事件的发生是由上市药品引起, 二是产生的结果对人体有害。
近年来,我国药品不良事件频发,有的不良事件造成了多人死伤的严重后果,药品安全问题成为公众关注的焦点。
In recent years, the practice shows that some serious drug adverse reaction events have cause harm to public health, and the problem of drug safety have become the focus of public concern.
更大的问题是,受问题支配的FDA的不良反应事件报告系统不能系统的衡量药品引起的真实副作用的多少。
The bigger issue is that the FDA's problem-ridden Adverse Event Reporting System isn't a systematic measure of how often drugs really cause side effects.
处方事件监测用非干预性、观察性药品不良反应监测方法,1981年在英国最早开展。
Prescription Event monitoring (PEM) is a non-interventional observational method of adverse drug reaction monitoring, which was established first in England in 1981.
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