Wallander M A
Department of Drug Surveillance, AB Hässle, Mölndal, Sweden.
Scand J Prim Health Care Suppl. 1990;1:89-91.
Safety deals with the surveillance and detection of possible threats that can arise against a patient. It might not be an obvious one, like an anaphylactic shock, but a bizarre syndrome of late onset preceded by vague signs or symptoms. To be able to conclude about a possible causal relationship between a drug and such a state with as short a delay in time as possible, the collection and analysis of adverse events during the total clinical trial program of a drug is mandatory. To ask investigators for adverse drug reactions instead is to produce an effective filter, which may help in keeping the incidence figures down in the international data sheet but which also may prove to be hazardous for the pharmaceutical industry in the long run.
安全性涉及对可能危及患者的潜在威胁进行监测和检测。这可能并非像过敏性休克那样显而易见，而是一种在出现模糊症状或体征后延迟发作的罕见综合征。为了能够尽快确定药物与这种状态之间可能存在的因果关系，在药物的整个临床试验过程中收集和分析不良事件是必不可少的。相反，仅向研究人员询问药物不良反应就像是设置了一个有效的过滤器，这可能有助于降低国际数据表中的发病率数据，但从长远来看，这对制药行业可能也会证明是有害的。
