| アブストラクト | 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. |
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| ジャーナル名 | PloS one |
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| Pubmed追加日 | 2016/6/22 |
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| 投稿者 | Bohm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Hocker, Jan |
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| 組織名 | Institute of Experimental and Clinical Pharmacology, University Hospital;Schleswig-Holstein, Campus Kiel, Kiel, Germany.;Department of Computer Science, Christian-Albrechts University, Kiel, Germany.;Hospital pharmacy, Wicker Kliniken, Bad Wildungen-Reinhardshausen, Germany.;Department of Anaesthesiology and Intensive Care Medicine, University Hospital |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27326858/ |
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