OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.
OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.
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DOI：
10.1371/journal.pone.0157753
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Höcker J
中科院分区：
文献类型：
--
作者：
Böhm R;von Hehn L;Herdegen T;Klein HJ;Bruhn O;Petri H;Höcker J
药物警戒有助于医疗保健。然而，学术机构和个体医生或药剂师直接访问基础数据是复杂的，并且缺少用于日常临床情况的易于使用的分析模式。这强调了需要一种工具来将药物警戒带到诊所。为了解决这些问题，我们开发了OpenVigil FDA，这是一种新型的基于网络的药物警戒分析工具，它使用美国食品药品监督管理局（FDA）的openFDA在线界面，从不良事件报告系统（AERS）中访问美国和国际药物警戒数据。OpenVigil FDA提供了验证性分析，以（i）识别最可能引起新不良事件的药物，（ii）比较两种药物的安全性特征，（iii）检查两种药物的任意组合是否存在未知的药物-药物相互作用，以及（iv）通过识别混杂因素并使用背景校正消除它们来增强结果的相关性。我们提出了这些应用的例子，并讨论了药物警戒，openFDA和OpenVigil FDA的承诺和限制。OpenVigil FDA是第一个将药物警戒结果直接应用于现实临床问题的公开可用工具。OpenVigil FDA不需要特殊许可证或统计程序。
Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.