VigiBase® is the name of the WHO Global ICSR database; it consists of reports of adverse reactions received from member countries since 1968. VigiBase is updated with incoming ICSRs on a continuous basis. National centres are recommended to send reports at least quarterly; most national centres adhere to these guidelines, and several report more frequently.The VigiBase data resource is the largest and most comprehensive in the world, and it is developed and maintained by the UMC on behalf of the World Health Organization. By December 2015 over 13 million reports were contained in the database. VigiBase is a computerised pharmacovigilance system, in which information is recorded in a structured, hierarchical form to allow for easy and flexible retrieval and analysis of the data. The case reports in the WHO database do not identify the patient or reporter. Its purpose is to provide the evidence from which potential medicine safety hazards may be detected.The VigiBase database system includes linked databases containing medical and drug classifications: WHO-ART/MedDRA, WHO ICD, and WHO Drug Dictionary. These classifications enable structured data entry, retrieval, and analysis at different levels of precision and aggregation.
Learn basic facts about VigiBase from an article by UMC Director Marie Lindquist published in Drug Information Journal, 2008: VigiBase, the WHO Global ICSR Database System: Basic Facts.
Fact sheet about ICSR submissionThe fact sheet gives details on what kind of ICSRs should be forwarded to UMC by members of the WHO Programme. It emphasizes that all adverse events occurring in a post-marketing situation should be submitted to UMC, including ICSRs on medication errors, counterfeit/substandard medicines and therapeutic failure. Reporting Fact Sheet.
Quality of dataThe quality of ICSR data in VigiBase is crucial; the consequence of poor quality data is the risk of drawing wrong or delayed conclusions about a patient or a safety signal, which in turn could lead to patients being harmed unnecessarily. The document Individual Case Safety Reports and VigiBase - the vital importance of quality emphasizes the significance of good quality data in VigiBase and other ICSR databases, by describing the scientific value of complete information from mainly a medical analysis perspective.
In 2012 a new access policy was set out by the UMC, which may be seen in Access to Global ICSR data pdf. Reference should also be made to the UMC's Caveat document.
In April 2015 VigiAccess was launched. There anyone can search for summary statistics from VigiBase, more information on VigiAccess is found here.
VigiBase page last updated 11 May 2016
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