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Abstract
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.
Highlights
Pharmacovigilance collects spontaneous reports or–nowadays–analyzes prescription data, social internet platforms or electronic health records in hospitals to gather information of drug usage and subsequent adverse events (AE) which could be attributed to the usage of a drug, i.e., adverse drug reactions (ADR) [1, 2]
OpenVigil Food and Drug Administration (FDA) consists of a single program file written in the PHP (PHP Hypertext Preprocessor) programming language
OpenVigil FDA offers an intuitive access for physicians and pharmacists to FDA Adverse Event Reporting System (AERS) pharmacovigilance data
Summary
Pharmacovigilance collects spontaneous reports or–nowadays–analyzes prescription data, social internet platforms or electronic health records in hospitals to gather information of drug usage and subsequent adverse events (AE) which could be attributed to the usage of a (new) drug, i.e., adverse drug reactions (ADR) [1, 2].The U.S American Food and Drug Administration (FDA) has recently began to establish a powerful way to access Adverse Events Reporting System (AERS) pharmacovigilance recordsPLOS ONE | DOI:10.1371/journal.pone.0157753 June 21, 2016OpenVigilFDA: Pharmacovigilance Data Access and Clinical Applicationsfrom mid-2003 until to date: the openFDA Application Programming Interface (API) via internet using standard data transport methods and data formats (HTTP/JSON) [3].One year after the initial beta release, implementations for the programming language Ruby and the statistical environment R as well as several web-based services are available (Table 1). Pharmacovigilance collects spontaneous reports or–nowadays–analyzes prescription data, social internet platforms or electronic health records in hospitals to gather information of drug usage and subsequent adverse events (AE) which could be attributed to the usage of a (new) drug, i.e., adverse drug reactions (ADR) [1, 2]. The U.S American Food and Drug Administration (FDA) has recently began to establish a powerful way to access Adverse Events Reporting System (AERS) pharmacovigilance records. Analysis options are limited: the web-based services do not provide sufficient research options, whereas the library for data import in R requires a deep understanding of both openFDA and R by the user. This substantial gap is closed by OpenVigil FDA
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