VigiBase, the WHO Global ICSR Database System: Basic Facts
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VigiBase, the WHO Global ICSR Database System: Basic Facts
Marie Lindquist Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Key Words Pharmacovigilance; WHO; Individual case safety report; Database system; Classifications Correspondence Address Marie Lindquist, Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Box 1051, 75140 Uppsala, Sweden (email: marie.lindquist@ who-umc.org).
The main aim of the WHO International Drug Monitoring Programme, started in 1968, is to identify the earliest possible pharmacovigilance signals. The program now has more than 80 member countries from all parts of the world contributing individual case safety reports (ICSRs) to the WHO Global ICSR Database System, VigiBase. VigiBase is maintained and developed on behalf of WHO by the Uppsala Monitoring Centre (UMC), situated in Uppsala, Sweden. The database system includes the ICH E2B compatible ICSR database, the WHO Drug
INTRODUCTION The WHO International Drug Monitoring Programme started in 1968, with 10 countries pooling data from their existing national spontaneous adverse reaction reporting systems. The aim of the program was to prevent drug disasters like the devastating fetal malformations caused by thalidomide in the early 1960s. The rationale for bringing spontaneous reports into one international database was to enable the earliest possible detection of drug-related problems, and one of the primary tasks at the outset of the WHO program was to develop an international signaling system. In 1978, the scientific and technical responsibility for the program was transferred from WHO in Geneva to a WHO Collaborating Centre in Uppsala, Sweden, set up specifically for this purpose. The center is a self-funding, nonprofit foundation, now known under its field name, the Uppsala Monitoring Centre (UMC). The UMC is responsible for development of the international system on the basis of a twoway flow of information on suspected adverse reactions to medicines, in collaboration with the national centers participating in the WHO program. The main tasks of the UMC are to:
Dictionaries (WHO-DD and -DDE), and the medical terminologies WHO Adverse Reaction Terminology (WHO-ART), International Classification of Diseases (ICD), and the Medical Dictionary for Regulatory Activities (MedDRA). Apart from data management and quality assurance tools, the VigiBase system includes a web-based reporting tool, an automated signal detection process using advanced data mining, and search facilities, available to the member countries and, on request, to other stakeholders.
• collect and analyse reports of adverse drug reactions from worldwide members of the WHO Drug Monitoring Programme and to issue international signals of drug safety concerns arising from the data; • actively support and provide training both for aspirant countries in establishing their own national drug safety surveillance systems, and for current members in maintaining and developing their sy
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