Information about potential safety hazards: Signal documentThe case information submitted to VigiBase is screened on a regular basis for signs <strong>of</strong> any medicineinducedproblems that have yet to be identified.Since 1998, routine data mining <strong>of</strong> VigiBase has been performed on a quarterly basis, usingstatistical methods. A triage (filter) procedure is used to find drug-ADR pairs <strong>of</strong> interest and expertclinical review is undertaken by UMC and an international panel <strong>of</strong> experts. The results <strong>of</strong> <strong>the</strong>seintensive analyses are available to national centres as a restricted memorandum called SIGNAL and<strong>the</strong> <strong>WHO</strong> Pharmaceuticals Newsletter.The data mining tool, VigiMine, used for analysis and detection <strong>of</strong> drug–ADR pairs <strong>of</strong> interest,using several filtering and sorting functions, is available only on request. Meanwhile, VigiLyze isbeing fur<strong>the</strong>r developed with improved analytical features.Terminologies and s<strong>of</strong>tware: <strong>WHO</strong> Drug Dictionary, <strong>WHO</strong>-ART and VigiFlowThe <strong>WHO</strong> Drug Dictionaries and <strong>WHO</strong> Adverse Reaction Terminology (<strong>WHO</strong>-ART) aremaintained by UMC. These terminologies are built on information derived from ICSRs from<strong>member</strong> countries and are used for coding and analysis <strong>of</strong> drugs and adverse reactions. The<strong>WHO</strong>-DD is accessible via VigiLyze, VigiFlow (see below) and <strong>the</strong> <strong>WHO</strong> Drug DictionaryBrowser. The latest version <strong>of</strong> <strong>WHO</strong>-ART is available via VigiLyze and VigiFlow or as a filedistributed to <strong>member</strong> countries on request.National centres are requested to submit <strong>the</strong>ir national ICSRs to UMC in an internationalstandardized format (ICH-E2B). For <strong>member</strong> countries that lack an E2B compatible databasefor ICSR management, UMC has developed <strong>the</strong> web-based tool VigiFlow. This is designedto function as a complete case management system and national report database. No localinstallation is needed and <strong>the</strong> only requirement is an internet connection (minimum speed<strong>of</strong> 1 Mbit/s) and a web browser.<strong>WHO</strong>-ARTMedDRA<strong>WHO</strong> DrugDictionaryIntdisE2BNationalPharmacovigilance<strong>Centre</strong>NationalDatabasee.g. VigiFlowVigiLyzeFigure 2. The National <strong>Centre</strong> sends ICSRs to VigiBase at <strong>the</strong> UMC. This information helps create <strong>WHO</strong>-ART and <strong>the</strong><strong>WHO</strong>-DD. International safety information can be retrieved from VigiBase by <strong>the</strong> 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 <strong>of</strong> users, which facilitates <strong>the</strong> workflow and saves resources. VigiFlow is easy to handle with built-in help texts and error messages.Search and statistics can be performed on <strong>the</strong> reports entered, which are also easily forwarded toUMC to be included in VigiBase.The system provides access to <strong>the</strong> latest versions <strong>of</strong> <strong>the</strong> terminologies described above, as wellas <strong>the</strong> International Classification <strong>of</strong> 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 <strong>the</strong> complete version <strong>of</strong> <strong>the</strong> system. However, a limitedversion is available free <strong>of</strong> charge, intended for countries that are not interested in <strong>the</strong> full reportmanagement functionality but need a system for reporting ICSRs to <strong>the</strong> <strong>WHO</strong> <strong>Programme</strong>.Some specialised tools are available for patient reporting and cohort event monitoring; moreinformation is available from UMC.Support and resources: Guidelines, publications and websitesUMC <strong>of</strong>fers guidance and support for <strong>the</strong> establishment and running <strong>of</strong> a pharmacovigilance centreand a national programme. Several guidelines and publications for good pharmacovigilance practicehave been developed by <strong>WHO</strong>/UMC and are available free <strong>of</strong> charge in several languages.The UMC and <strong>WHO</strong> headquarters also produce <strong>the</strong>ir respective newsletters: <strong>Uppsala</strong> Reportsand <strong>WHO</strong> Pharmaceuticals Newsletter. These are free publications available to a wide audience.<strong>Uppsala</strong> Reports, issued four times a year, contains information about developments in pharmacovigilancein general, at UMC and at national centres in particular. The <strong>WHO</strong> PharmaceuticalsNewsletter, issued six times a year, provides a record <strong>of</strong> regulatory decisions, warnings and labelingchanges made by countries on grounds <strong>of</strong> safety. Member countries are also <strong>of</strong>fered a heavilydiscounted subscription to <strong>the</strong> secondary literature review journal Reactions Weekly, <strong>the</strong> mainjournal for scanning <strong>the</strong> medical literature on adverse drug reactions, through an agreement with<strong>the</strong> publisher.The <strong>WHO</strong> and UMC websites have a lot <strong>of</strong> useful information about <strong>the</strong> <strong>WHO</strong> <strong>Programme</strong>,current activities, definitions and concepts in pharmacovigilance, meetings and courses around<strong>the</strong> world and an FAQ section. Most <strong>of</strong> <strong>the</strong> publications mentioned are also available as pdf filesfor download from <strong>the</strong> web. Please make frequent visits to: www.who.int/medicines and www.who-umc.org.Access to <strong>the</strong> international network: Vigimed, meetings and coursesSince worldwide collaboration and information sharing is crucial in pharmacovigilance for promotion<strong>of</strong> patient safety, <strong>member</strong> countries are encouraged to communicate frequently with eacho<strong>the</strong>r. One forum for such communication is Vigimed, a web platform set up by UMC to stimulatediscussions and facilitate rapid exchange <strong>of</strong> information between national centres. Vigimed is a closedsite so that <strong>member</strong>s may feel confident sharing preliminary findings, suspicions and opinions witho<strong>the</strong>r pharmacovigilance pr<strong>of</strong>essionals, knowing that such information will not be seen by or givento o<strong>the</strong>r parties, <strong>the</strong> public or to media without consent <strong>of</strong> <strong>the</strong> originator.Membership benefits 5