VigiBase Frequently Asked Questions
Here are some frequently asked questions about VigiBase. Please contact us if you need additional information.
Who may access VigiBase data?
As well as member countries of the WHO Programme for International Drug Monitoring (WHO PIDM), 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.
How do I make a request for access to VigiBase data?
Please contact us.
Where do the reports in VigiBase come from?
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 PIDM. 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.
What is the WHO Programme for International Drug Monitoring?
Please find more information here.
Are the case reports in VigiBase clinically assessed and verified?
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.
How far back does the data go?
Data is available for the entire period since the WHO PIDM started in 1968. Then, 10 countries participated in the programme: Australia, Canada, Czechoslovakia, Federal Republic of Germany, Ireland, Netherlands, New Zealand, Sweden, UK, USA. Since then, there has been an accelerating accumulation of reports as new countries joined the WHO PIDM.
How often is VigiBase updated?
VigiBase is continuously updated with reports, sometimes daily, as they are submitted by member countries of the WHO PIDM. 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.
Are patient/consumer reports included?
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.
Does VigiBase include reports from manufacturers?
Yes, when such reports are included in the reports sent by member countries. Not all countries include such reports.
Can I find individual case safety reports on herbal preparations?
Can I find safety information on products no longer on the market?
Yes, all case reports from 1968 onwards are stored in VigiBase and remain available, even if the products are no longer on the market.
Are adverse effects coded to MedDRA?
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.
Read more about WHO-ART Visit MedDRA web site
May I publish data from VigiBase?
Yes, as long as the terms and conditions in the Caveat Document are observed. Please refer to the Guideline for using VigiBase in studies for more information about the data in VigiBase.
How can I get hold of an original case report?
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.
Does UMC do anything to increase the quality of the data in VigiBase?
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.
Is any VigiBase data available to the public?
The WHO tool VigiAccess enables public access to a limited view of some VigiBase data. Due to data protection laws and agreements between WHO PIDM members and the WHO, individual case safety reports cannot be viewed in VigiAccess. For those same reasons, VigiAccess groups the search results both by active ingredient and by continental region, so you will not be able to retrieve data for specific brand names nor for individual WHO PIDM members. For more detailed questions about the data, please contact your national regulatory authority.