Being a member of the WHO Programme - Uppsala Monitoring Centre

More documents

Recommendations

Info

Figure 1. World map showing the offi cial and associatemember countries as of October 2012.Offi cial MemberAssociate MemberBackgroundWhen a country becomes a member of the WHO Medicines Safety Programme, it is essentialthat national centre staff are fully aware of the benefits and obligations of membership. Thisdocument gives an overview of the services provided by WHO and UMC as well as therequirements that national centres are expected to meet.The WHO Medicines Safety Programme was set up in 1968 as a direct consequence of thethalidomide tragedy. In the 1960s it was discovered that this medicine could cause limbdeformities in babies if taken by pregnant women. This was the modern starting point ofpharmacovigilance, the science focusing on patient problems caused by the use of medicines.The intention of the WHO Programme was to ensure that early signs of previously unknownmedicine-related safety problems would be identified and information about them shared andacted upon throughout the world.The WHO Medicines Safety Programme has grown to become a global network of pharmacovigilancecentres in over 140 countries. In each participating country the Ministry of Health, orequivalent, has appointed a national centre for pharmacovigilance responsible for maintainingcontacts with WHO on issues related to medicine safety. The network of national centres iscoordinated by a WHO Collaborating Centre for International Drug Monitoring in Uppsala,Sweden, known as the Uppsala Monitoring Centre (UMC). This is a foundation created by theSwedish government on the basis of an agreement with WHO. A provision of this agreement isthat WHO headquarters is responsible for all policy issues relating to the Programme.UMC manages a database of Individual Case Safety Reports (ICSRs) received from nationalcentres in the WHO network. The database, called VigiBase, currently contains over 8million descriptions of individual cases in which medicines, including vaccines and biologicals,have been suspected of contributing to an adverse reaction in the exposed patient.2Background
Membership benefits – what you get from us· Access to VigiBase– containing worldwide medicine safety data· Early information about potential safety hazards– based on analyses of worldwide data and communications from member countries· Terminologies and software– tools for reporting, storing, structuring, searching, and analysing ICSRs· Support, training, guidelines and resources– on pharmacovigilance practice· Access to the international network– knowledge and expertise of member countriesAccess to VigiBase: Using the VigiSearch toolVigiBase is the name of the WHO global ICSR database containing more than 8 millioncase reports of suspected adverse drug reactions submitted by the increasing number of membercountries since 1968. The information in VigiBase is shared free of charge and withoutrestrictions with members and associate members of the WHO Programme. Member countrieshave different approaches to confidentiality of case information and provision of data to thirdparties. The present WHO position on confidentiality is that case information from VigiBasemay be provided to any inquirer with a health professional education, provided the rules of aCaveat statement are accepted. This statement explains the limitations of the data in VigiBaseand the implications for interpretation. Case reports in VigiBase do not contain identificationof the patient or the reporter.VigiBase is a valuable reference source for medicine safety information and for comparisonsof national experiences. A new easy-to-use web-based tool, called VigiLyze, will replaceVigiSearch in late 2012. VigiLyze will enable member countries to search, filter and analysedata in the global database more efficiently. This includes clickable graphic objects and summarydata using several standard presentation formats. More importantly, the integrated access toindividual case reports allows more in-depth analysis of drug safety issues through aninteractive, streamlined and intuitive interface. VigiLyze brings the VigiBase data set withinthe reach of member countries and will contribute further to improving patient safety.VigiLyze is provided free of charge to member and associate member countries. If the facilitiesin VigiLyze are not sufficient for users, customized searches can be performed on request, byUMC staff, free of charge to members of the WHO programme, while non-members will becharged for this service.Membership benefits 3
Page 1: Being a member ofthe WHO MedicinesS
Page 5 and 6: The system, currently available in
Page 7 and 8: Member countries are expected to su

Being a member of the WHO Programme - Uppsala Monitoring Centre

Create successful ePaper yourself

Delete template?

Save as template?