VigiBase: signalling harm and pointing to safer use

VigiBase allows for analysis on the suspected harm suffered by patients all over the world and how it might be prevented.

A purposeful database

VigiBase holds over 16 million anonymized reports of suspected adverse effects of medicines suffered by patients (as of November 2017). It is a pharmacovigilance database, at the heart of a pharmacovigilance system, in which information is recorded in a structured, hierarchical form to allow easy and flexible retrieval and analysis of the data. Its purpose is to provide the evidence from which potential medicine safety hazards (signals) may be detected and communicated. VigiBase is developed and maintained by UMC on behalf of WHO.

Coherence and quality

The VigiBase database system is linked to medical and drug classifications, including terminologies such as WHO-ART/MedDRA, WHO ICD, and the medicinal products dictionary, WHODrug. These classifications enable structured data entry, retrieval and analysis at different levels of precision and aggregation, which are vital in order to enable effective and accurate analysis. As part of the automated entry process for VigiBase, each incoming report is checked according to predefined quality criteria. Syntactic accuracy is obtained using controlled vocabularies: values entered are then compared and checked against reference classifications and 'look-up tables' containing permissible data values.

The international picture of harm to patients

The aim of the WHO Programme is to ensure that early signs of previously unknown medicines-related safety problems are identified; that information about them is shared so that action to protect patients may be taken by individual countries where necessary. VigiBase was developed to support that goal.

Read more about the WHO Programme

Each country receives spontaneous reports of suspected adverse effects nationally. These will be reviewed and analysed locally and may lead to regulatory action. Member countries are committed to share these reports in VigiBase, where post-marketing data from a majority of the world’s countries is collected in one place. Gathering information into a global database facilitates the detection of drug safety signals – which might not be apparent from the data of a single country – and increases the probability of detecting rare adverse drug reactions from the international data. Although VigiBase data is more heterogeneous than data from national pharmacovigilance databases, due, for example, to different medical practices and regulatory requirements, it offers ​opportunities to make comparisons of countries and to identify and analyse differences between countries or regions. 

The VigiBase system is dependent on national centres for the timeliness, completeness, and quality of reports and relies to a large extent on the goodwill of the participating pharmacovigilance centres. National centres regularly use VigiBase data, via VigiLyze, for signal detection, signal strengthening, in thank-you notes to reporters (health professionals, patients, and others), and in publications.

Covering all corners of the world

Since 1978 UMC has been responsible for the development and maintenance of VigiBase. Over 110 more countries have since joined the original ten countries that formed the network in the late 1960s. This gives the database broad global population coverage, although there is disproportionate representation of a few countries within the total number of reports, and other countries have higher reporting rates per million population than others.

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Last modified on: November 22, 2017