Being a member of the WHO Programme - Uppsala Monitoring Centre

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Information about potential safety hazards: Signal documentThe case information submitted to VigiBase is screened on a regular basis for signs of any medicineinducedproblems that have yet to be identified.Since 1998, routine data mining of VigiBase has been performed on a quarterly basis, usingstatistical methods. A triage (filter) procedure is used to find drug-ADR pairs of interest and expertclinical review is undertaken by UMC and an international panel of experts. The results of theseintensive analyses are available to national centres as a restricted memorandum called SIGNAL andthe WHO Pharmaceuticals Newsletter.The data mining tool, VigiMine, used for analysis and detection of drug–ADR pairs of interest,using several filtering and sorting functions, is available only on request. Meanwhile, VigiLyze isbeing further developed with improved analytical features.Terminologies and software: WHO Drug Dictionary, WHO-ART and VigiFlowThe WHO Drug Dictionaries and WHO Adverse Reaction Terminology (WHO-ART) aremaintained by UMC. These terminologies are built on information derived from ICSRs frommember countries and are used for coding and analysis of drugs and adverse reactions. TheWHO-DD is accessible via VigiLyze, VigiFlow (see below) and the WHO Drug DictionaryBrowser. The latest version of WHO-ART is available via VigiLyze and VigiFlow or as a filedistributed to member countries on request.National centres are requested to submit their national ICSRs to UMC in an internationalstandardized format (ICH-E2B). For member countries that lack an E2B compatible databasefor ICSR management, UMC has developed the web-based tool VigiFlow. This is designedto function as a complete case management system and national report database. No localinstallation is needed and the only requirement is an internet connection (minimum speedof 1 Mbit/s) and a web browser.WHO-ARTMedDRAWHO DrugDictionaryIntdisE2BNationalPharmacovigilanceCentreNationalDatabasee.g. VigiFlowVigiLyzeFigure 2. The National Centre sends ICSRs to VigiBase at the UMC. This information helps create WHO-ART and theWHO-DD. International safety information can be retrieved from VigiBase by the VigiLyze tool for use by national centres.4Membership benefits
The system, currently available in English, French, Spanish and Russian can be used simultaneouslyon a central and regional level, with an unlimited number of users, which facilitates the workflow and saves resources. VigiFlow is easy to handle with built-in help texts and error messages.Search and statistics can be performed on the reports entered, which are also easily forwarded toUMC to be included in VigiBase.The system provides access to the latest versions of the terminologies described above, as wellas the International Classification of Diseases (ICD-10) and MedDRA (Medical Dictionary forRegulatory Activities). Since UMC is maintaining and constantly developing VigiFlow, anannual license fee is charged for access to the complete version of the system. However, a limitedversion is available free of charge, intended for countries that are not interested in the full reportmanagement functionality but need a system for reporting ICSRs to the WHO Programme.Some specialised tools are available for patient reporting and cohort event monitoring; moreinformation is available from UMC.Support and resources: Guidelines, publications and websitesUMC offers guidance and support for the establishment and running of a pharmacovigilance centreand a national programme. Several guidelines and publications for good pharmacovigilance practicehave been developed by WHO/UMC and are available free of charge in several languages.The UMC and WHO headquarters also produce their respective newsletters: Uppsala Reportsand WHO Pharmaceuticals Newsletter. These are free publications available to a wide audience.Uppsala Reports, issued four times a year, contains information about developments in pharmacovigilancein general, at UMC and at national centres in particular. The WHO PharmaceuticalsNewsletter, issued six times a year, provides a record of regulatory decisions, warnings and labelingchanges made by countries on grounds of safety. Member countries are also offered a heavilydiscounted subscription to the secondary literature review journal Reactions Weekly, the mainjournal for scanning the medical literature on adverse drug reactions, through an agreement withthe publisher.The WHO and UMC websites have a lot of useful information about the WHO Programme,current activities, definitions and concepts in pharmacovigilance, meetings and courses aroundthe world and an FAQ section. Most of the publications mentioned are also available as pdf filesfor download from the web. Please make frequent visits to: www.who.int/medicines and www.who-umc.org.Access to the international network: Vigimed, meetings and coursesSince worldwide collaboration and information sharing is crucial in pharmacovigilance for promotionof patient safety, member countries are encouraged to communicate frequently with eachother. One forum for such communication is Vigimed, a web platform set up by UMC to stimulatediscussions and facilitate rapid exchange of information between national centres. Vigimed is a closedsite so that members may feel confident sharing preliminary findings, suspicions and opinions withother pharmacovigilance professionals, knowing that such information will not be seen by or givento other parties, the public or to media without consent of the originator.Membership benefits 5
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Being a member of the WHO Programme - Uppsala Monitoring Centre

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