Principles of signal detection in pharmacovigilance
Principles of signal detection in pharmacovigilance
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DOI：
10.2165/00002018-199716060-00002
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发表时间：
1997-06-01
期刊：
影响因子：
4.2
通讯作者：
Gribnau, FWJ
中科院分区：
文献类型：
--
作者：
Meyboom, RHB;Egberts, ACG;Gribnau, FWJ
药物的不良反应是多种多样的。许多情况可能妨碍发出不利影响的信号（即发现预警信号），新的信号往往不同于以往的经验。不同类别的不良反应需要不同的检测方法。目前的药物警戒主要基于自发性报告，主要有助于检测B型效应（通常为过敏或特异质反应的效应，特征为仅在少数患者中发生，通常与剂量无关，且为严重、非预期和不可预测的效应）和异常A型效应（与药物药理学效应相关且与剂量相关的效应）。其他信号来源的例子是处方事件监测、关于发病率和药物使用的大型自动化数据资源（包括记录链接）、病例对照监测和随访研究。C型效应然而，这些效应（与“自发性”疾病频率增加有关）难以研究，并继续构成药物流行病学挑战。可以确定确定信号中包含的证据的七个基本考虑因素：相关性的定量强度、数据的一致性、暴露反应关系、生物相容性、实验结果，可能的类比以及数据的性质和质量。提出了药物警戒中心标准信号管理程序的建议，包括以下步骤：信号描述、文献检索、初步数据清单、收集额外信息、与世界卫生组织国际药物监测中心和相关制药公司协商、汇总数据评估和书面报告。更好地了解检测药物不良反应的条件和机制可能会进一步改善药物警戒策略。
Adverse drug effects are manifold and heterogenous. Many situations may hamper the signalling (i.e. the detection of early warning signs) of adverse effects and new signals often differ from previous experiences.Signals have qualitative and quantitative aspects. Different categories of adverse effects need different methods for detection. Current pharmacovigilance is predominantly based on spontaneous reporting and is mainly helpful in detecting type B effects (those effects that are often allergic or idiosyncratic reactions, characteristically occurring in only a minority of patients and usually unrelated to dosage and that are serious, unexpected and unpredictable) and unusual type A effects (those effects that are related to the pharmacological effects of the drug and are dosage-related). Examples of other sources of signals are prescription event monitoring, large automated data resources on. morbidity and drug use (including record linkage), case-control surveillance and follow-up studies. Type C effects (those effects related to an increased frequency of 'spontaneous' disease) are difficult to study, however, and continue to pose a pharmacoepidemiological challenge.Seven basic considerations can be identified that determine the evidence contained in a signal: quantitative strength of the association, consistency of the data, exposure response relationship, biological plausibility, experimental findings, possible analogies and the nature and quality of the data. A proposal is made for a standard signal management procedure at pharmacovigilance centres, including the following steps: signal delineation, literature search, preliminary inventory of data, collection of additional information, consultation with the World Health Organization Centre for International Drug Monitoring and the relevant drug companies, aggregated data assessment and a report in writing. A better understanding of the conditions and mechanisms involved in the detection of adverse drug effects may further improve strategies for pharmacovigilance.