OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.
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.
Institute of Experimental and Clinical Pharmacology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Ruwen
R
Böhm
Institute of Experimental and Clinical Pharmacology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Leocadie
L
von Hehn
Institute of Experimental and Clinical Pharmacology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Thomas
T
Herdegen
Department of Computer Science, Christian-Albrechts University, Kiel, Germany.
Hans-Joachim
HJ
Klein
Institute of Experimental and Clinical Pharmacology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Oliver
O
Bruhn
Hospital pharmacy, Wicker Kliniken, Bad Wildungen-Reinhardshausen, Germany.
Holger
H
Petri
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Jan
J
Höcker
D022126:Access to Information; D016907:Adverse Drug Reaction Reporting Systems; D000339:Affect / Q000187:drug effects; D000932:Antiemetics / Q000009:adverse effects; D057225:Data Mining; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000188:drug therapy; D006801:Humans; D009437:Neuralgia / Q000188:drug therapy; D060735:Pharmacovigilance; D055553:Prescription Drugs / Q000009:adverse effects; D047428:Protein Kinase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration
D000932:Antiemetics; D055553:Prescription Drugs; D047428:Protein Kinase Inhibitors