OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

• Published in: PloS one Vol. 11; no. 6; p. e0157753
• Main Authors: Böhm, Ruwen, von Hehn, Leocadie, Herdegen, Thomas, Klein, Hans-Joachim, Bruhn, Oliver, Petri, Holger, Höcker, Jan
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 21.06.2016; Public Library of Science (PLoS)
• Subjects: Access to Information; Adverse Drug Reaction Reporting Systems; Affect - drug effects; Algorithms; Antiemetics - adverse effects; Archives & records; Big Data; Biology and Life Sciences; Computer and Information Sciences; Contingency tables; Data Mining; Drug Interactions; Drug Therapy, Combination; Drugs; Epilepsy - drug therapy; Health care; Humans; Incident reporting (Medical care); Information retrieval; Inspection; Laws, regulations and rules; Licenses; Medical personnel; Medicine and Health Sciences; Neuralgia - drug therapy; Ontology; Pain; Pharmacology; Pharmacovigilance; Physical Sciences; Physicians; Prescription Drugs - adverse effects; Programming languages; Protein Kinase Inhibitors - pharmacology; Protein Kinase Inhibitors - therapeutic use; Queries; Regulatory agencies; Research and Analysis Methods; Risk Factors; Social Sciences; Therapeutic applications; United States; United States Food and Drug Administration; User interface; United States; United States > US; Germany
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0157753

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.