Here are some frequently asked questions about VigiBase. Please contact us if you need additional information.
As well as member countries of the WHO Programme, VigiBase can be made available to anyone with a health profession degree (physician, dentist, nurse, pharmacist). If you request data, please state the purpose of your request. Each request is assessed as a security measure to protect the data. A fee may be charged. Anyone requesting data from VigiBase, must read and accept the conditions for use in the UMC caveat document.
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Health professionals, patients and some pharmaceutical companies, report their experience of suspected adverse effects of medicines (commonly known as adverse drug reactions – ADRs) to their national pharmacovigilance centre. These individual case safety reports (ICSRs) are reviewed and analysed locally and may lead to regulatory action in that country if there are grounds for concern. The reports are then sent to VigiBase by member countries of the WHO Programme. ICSRs also known as 'spontaneous' or voluntary reports are generated during the post-marketing phase of drugs, which is when they are licensed and approved for general use through prescription or retail purchase.
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Most national centres will review case reports before they are sent to UMC. A number of them make an assessment of the probability that a pharmaceutical product caused the suspected reaction (a causality assessment). Some do not carry out or document such assessments.
As part of the entry processing for VigiBase, each incoming report is checked according to pre-defined quality criteria. Syntactic accuracy is obtained using controlled vocabularies: entered values are compared and checked against reference classifications and look-up tables containing permissible data values.
Clinical assessment at UMC takes place only on combinations of drug+adverse effect which are thought to be highly likely to represent a possible signal. This process then results in a decision as to whether or not the evidence is strong enough to publish a signal.
Data is available for the entire period since the WHO Programme started in 1968. Then, ten countries participated in the Programme: Australia, Canada, Czechoslovakia, Federal Republic of Germany, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA. Since then, there has been an accelerating accumulation of reports as new countries joined the WHO Programme.
VigiBase is continuously updated with reports, sometimes daily, as they are submitted by member countries of the WHO Programme for International Drug Monitoring. Most national centres report quarterly or even more frequently; date of occurrence is noted when supplied; date of entry into VigiBase is recorded. For information on the current situation, you are welcome to contact us.
Reports from patients/consumers are increasingly accepted by national centres around the world and are sent to VigiBase, where they are flagged. When performing customised searches, all cases requested for the search are included.
Yes, when such reports are included in the reports sent by member countries. Not all countries include such reports.
Yes, all case reports from 1968 onwards are stored in VigiBase and remain available, even if the products are no longer on the market.
Yes. All ICSRs in VigiBase are automatically coded to both MedDRA and WHO-ART. In order to receive VigiBase data coded with MedDRA, users must provide their MedDRA ID for checking. For users who do not have a valid MedDRA subscription, WHO-ART preferred terms can be provided instead.
Yes, as long as the terms and conditions in the Caveat Document are observed.
An original case report can be obtained only from the reporting country. Case reports in VigiBase do not identify the patient or reporter and reference to the original case report is made through a national case identification number. Contact should be made with the country’s pharmacovigilance centre, please see the members map.
To enable efficient statistical analysis, UMC puts considerable effort into maintaining the VigiBase data. This includes combining data from different source formats, coding medical terms to MedDRA (Medical Dictionary for Regulatory Activities) and drug data to WHODrug Global (UMC’s standardised drug dictionary), and checking ATC classification, through automatic processes and manual coding. UMC also works with the member countries to increase the quality of their ICSRs and provides guidance about quality and why it makes a difference in analysis. Read more in the publication Individual Case Safety Reports and VigiBase – the vital importance of quality.