Electronic healthcare databases for active drug safety surveillance: is there enough leverage?
Electronic healthcare databases for active drug safety surveillance: is there enough leverage?
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DOI：
10.1002/pds.3197
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发表时间：
2012-06-01
影响因子：
2.6
通讯作者：
Sturkenboom, Miriam
中科院分区：
文献类型：
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作者：
Coloma, Preciosa M.;Trifiro, Gianluca;Sturkenboom, Miriam
目的为了提供估计的数量和类型的药物，可以监测安全性监测使用电子医疗databases.Methods使用数据从8个欧洲数据库（行政索赔，医疗记录）和队列研究的背景下，我们确定了药物暴露量的信号检测所需的不同程度的相对风险（RR）。我们提供了可以监测的药物数量和类型的估计值，作为实际使用的函数，最小可检测RR和经验得出的以下不良事件的发生率：（i）急性心肌梗死;（ii）急性肾功能衰竭;（iii）过敏性休克;（iv）大疱性出疹;（v）横纹肌溶解症;和（vi）上消化道出血。我们进行了数据模拟，以了解数据库规模的扩大如何影响该系统的能力。在欧盟药品不良反应网络中使用2289种药物的59 594 132人年随访结果显示，对于急性心肌梗死等常见事件，有531种药物（占总数的23%）的RR = 2，如果存在，可以进行研究。对于一个罕见的事件，如横纹肌溶解症，有19种药物（1%）的关联相同的幅度可以investigated.Conclusion积极监测使用医疗保健数据为基础的网络信号检测是可行的，虽然杠杆这样做可能是低的不常使用的药物和罕见的结果。扩大数据库网络的规模，包括来自不同人群的数据和增加随访时间是必要的，以最大限度地利用这些监测系统。版权所有（C）2012约翰威利父子有限公司
Purpose To provide estimates of the number and types of drugs that can be monitored for safety surveillance using electronic healthcare databases.Methods Using data from eight European databases (administrative claims, medical records) and in the context of a cohort study, we determined the amount of drug exposure required for signal detection across varying magnitudes of relative risk (RR). We provide estimates of the number and types of drugs that can be monitored as a function of actual use, minimal detectable RR, and empirically derived incidence rates for the following adverse events: (i) acute myocardial infarction; (ii) acute renal failure; (iii) anaphylactic shock; (iv) bullous eruptions; (v) rhabdomyolysis; and (vi) upper gastrointestinal bleeding. We performed data simulation to see how expansion of database size would influence the capabilities of such system.Results Data from 19 647 452 individuals (59 594 132 person-years follow-up) who used 2289 drugs in the EU-ADR network show that for a frequent event such as acute myocardial infarction, there are 531 drugs (23% of total) for which an association with RR = 2, if present, can be investigated. For a rare event such as rhabdomyolysis, there are 19 drugs (1%) for which an association of same magnitude can be investigated.Conclusion Active surveillance using healthcare data-based networks for signal detection is feasible, although the leverage to do so may be low for infrequently used drugs and for rare outcomes. Extending database network size to include data from heterogeneous populations and increasing follow-up time are warranted to maximize leverage of these surveillance systems. Copyright (C) 2012 John Wiley & Sons, Ltd.