WHO Programme
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WHO Programme for International Drug Monitoring
The WHO Programme for International Drug Monitoring provides a forum for WHO member states to collaborate in the monitoring of drug safety. Within the Programme, individual case reports of suspected adverse drug reactions are collected and stored in a common database, presently containing over 5 million case reports. In each of the countries participating in the Programme, the government has designated a National Centre for pharmacovigilance.
The WHO Programme, which was established in 1968, consists of a network of the National Centres, WHO Headquarters, Geneva and the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre, in Uppsala, Sweden. As of May 2010, 98 countries had joined the WHO Drug Monitoring Programme, and in addition, 32 'associate members' were awaiting compatibility between the national and international reporting formats.
The administration of the WHO Programme is shared. In accordance with an agreement between WHO and the Government of Sweden, WHO Headquarters is responsible for policy issues, while the operational responsibility rests with the Uppsala Monitoring Centre (UMC).
Functions of the WHO Programme for International Drug Monitoring include:
- Identification and analysis of new adverse reaction signals from the case report information submitted to the National Centres, and sent from them to the WHO ICSR database. A data-mining approach (BCPNN) is used at the UMC to support the clinical analysis made by a panel of signal reviewers
- Provision of the WHO database as a reference source for signal strengthening and ad hoc investigations. Web-based search facilities and customized services are available
- Information exchange between WHO and National Centres, mainly through 'Vigimed', an e-mail information exchange system
- Publication of periodical newsletters, (WHO Pharmaceuticals Newsletter and Uppsala Reports), guidelines and books in the pharmacovigilance and risk management area
- Supply of tools for management of clinical information including adverse drug reaction case reports. The main products are the WHO Drug Dictionary and the WHO Adverse Reaction Terminology
- Provision of training and consultancy support to National Centres and countries establishing pharmacovigilance systems
- Computer software for case report management designed to suit the needs of National Centres (VigiFlow)
- Annual meetings for representatives of National Centres at which scientific and organizational matters are discussed
- Methodological research for the development of pharmacovigilance as a science.
Being a member of the WHO Programme
In 2009 the UMC produced a booklet for national centres setting out the workings of the WHO Programme for International Drug Monitoring. This has now been translated into Spanish. The booklet covers the advantages of membership - things that countries receive automatically from the UMC (access to VigiBase, Signal, terminologies and software, guidelines and resources, and access to the international network). The booklet also sets out what is expected from national centres, including reporting format compatibility and quality, frequent submission of ICSRs, and involvement in Vigimed and the National Centres Annual Meeting.
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Joining the WHO Programme for International Drug Monitoring
A document describing the procedure for joining the WHO Programme for International Drug Monitoring is available: Joining the WHO Programme (pdf file). Contact should also be made with Sten Olsson at the UMC, or Mary Couper at WHO; the basic process is illustrated by this diagram.
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Countries participating in the WHO Programme for International Drug Monitoring
98 Official Member Countries (dark blue)
32 Associate Members (medium blue)
(countries in pale blue are not members of the WHO Programme.)
Please click on the map (correct as of April 2009) to open the large version in a new window.
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Official member countries and their year of entering the Programme
- ANDORRA (2008)
- ARGENTINA (1994)
- ARMENIA (2001)
- AUSTRALIA (1968)
- AUSTRIA (1991)
- BARBADOS (2008)
- BELARUS (2006)
- BELGIUM (1977)
- BOTSWANA (2009)
- BRAZIL (2001)
- BRUNEI DARUSSALAM (2005)
- BULGARIA (1975)
- CANADA (1968)
- CHILE (1996)
- CHINA (1998)
- COLOMBIA (2004)
- COSTA RICA (1991)
- CROATIA (1992)
- CUBA (1994)
- CYPRUS (2000)
- CZECH REPUBLIC (1992)
- DENMARK (1971)
- EGYPT (2001)
- ESTONIA (1998)
- ETHIOPIA (2008)
- FIJI (1999)
- FINLAND (1974)
- FRANCE (1986)
- GERMANY (1968)
- GHANA (2001)
- GREECE (1990)
- GUATEMALA (2002)
- HUNGARY (1990)
- ICELAND (1990)
- INDIA (1998)
- INDONESIA (1990)
- ISLAMIC REPUBLIC OF IRAN (1998)
- IRELAND (1968)
- ISRAEL (1973)
- ITALY (1975)
- JAPAN (1972)
- JORDAN (2002)
- KAZAKHSTAN (2008)
- KENYA (2010)
- REPUBLIC OF KOREA, (1992)
- KYRGYZSTAN (2003)
- LATVIA (2002)
- LITHUANIA (2005)
- THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA (2000)
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- MADAGASCAR (2009)
- MALAYSIA (1990)
- MALTA (2004)
- MEXICO (1999)
- REPUBLIC OF MOLDOVA (2003)
- MONTENEGRO (2009)
- MOROCCO (1992)
- MOZAMBIQUE (2005)
- NAMIBIA (2008)
- NEPAL (2006)
- NETHERLANDS (1968)
- NEW ZEALAND (1968)
- NIGERIA (2004)
- NORWAY (1971)
- OMAN (1995)
- PERU (2002)
- PHILIPPINES (1995)
- POLAND (1972)
- PORTUGAL (1993)
- ROMANIA (1976)
- RUSSIAN FEDERATION (1998)
- SAUDI ARABIA (2009)
- SENEGAL (2009)
- SERBIA (2000)
- SIERRA LEONE (2008)
- SINGAPORE (1993)
- SLOVAKIA (1993)
- SOUTH AFRICA (1992)
- SPAIN (1984)
- SRI LANKA (2000)
- SUDAN (2008)
- SURINAME (2007)
- SWEDEN (1968)
- SWITZERLAND (1991)
- UNITED REPUBLIC OF TANZANIA (1993)
- THAILAND (1984)
- TOGO (2007)
- TUNISIA (1993)
- TURKEY (1987)
- UGANDA (2007)
- UKRAINE (2002)
- UNITED KINGDOM (1968)
- URUGUAY (2001)
- U.S.A. (1968)
- UZBEKISTAN (2006)
- VENEZUELA (1995)
- VIET NAM (1999)
- ZAMBIA (2010)
- ZIMBABWE (1998)
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Associate members
- ALGERIA
- ANGOLA
- ANGUILLA
- ANTIGUA & BARBUDA
- AZERBAIJAN
- BAHRAIN
- BENIN
- BHUTAN
- BOSNIA AND HERZEGOVINA
- BRITISH VIRGIN ISLANDS
- BURKINA FASO
- CAMBODIA
- CAMEROON
- DEM REP OF CONGO
- CÔTE D'IVOIRE
- DOMINICA
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- ERITREA
- GEORGIA
- GRENADA
- GUINEA
- GUINEA-BISSAU
- IRAQ
- JAMAICA
- MALI
- MONGOLIA
- MONTSERRAT
- PAKISTAN
- PANAMA
- SAINT KITTS AND NEVIS
- SAINT LUCIA
- SAINT VINCENT AND THE GRENADINES
- ZANZIBAR
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As an indication of the way in which the WHO database of adverse drug reactions operates, we present here some graphs to illustrate recent trends. These will be updated periodically (click on the image to view a larger version).
1. Correct and active ICSRs added to the WHO database from May 2005 to April 2010: mean per 1,000,000 inhabitants
2. Distribution of ICSRs in VigiBase from member countries of the WHO Programme as percentages.
3. Growth of the WHO database since its inception.
Within the WHO Programme, in relation to ADR reporting, the optimal National Pharmacovigilance Centre:
- sends ADR reports frequently (at least once a quarter)
- sends over 200 reports per million inhabitants per year
- sends reports from different areas - geographical and medical
- sends reports from vaccination and other public health programmes
- sends reports containing traditional medicines (herbals)
- sends reports with as much information as possible
- has performed a causality assessment of the reports.
In addition there are quality assurance guidelines related to file format (preferably ICH E2B format), correct position of data, allowed values, correct spelling of ADR terms and drugs, and unique ID-numbers (ie no duplicates).
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Vigimed
Vigimed is the restricted e-mail distribution list set up to stimulate discussion and facilitate rapid exchange of information between representatives of National Centres participating in the WHO International Drug Monitoring Programme.
The latest Vigimed Guide (Adobe Acrobat 124 Kb) is available here for viewing or download. We recommend all users to familiarise themselves with this short document.
Also available is a list of Vigimed members, correct as of 23 April 2009, accessible by clicking the password-protected button below. Please note - a password is needed for access. This is supplied automatically to those entitled to view; if you have a problem, contact Sten Olsson.
Please type the password:
A poster about use of Vigimed can be viewed here: Vigimed, an international drug safety e-mail discussion group (2004).
The Vigimed downloads page also includes a National Centres questionnaire from 2006 plus a summary of responses received to it, as well as a generic protocol on collecting observational ADR data.
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In 2008 the UMC jointly conducted an International Assessment of Country Pharmacovigilance with the World Health Organization-Medicines, Policy and Standards, funded by a grant to the University of Washington from the Bill and Melinda Gates Foundation.
This important survey gathered baseline information on current and future pharmacovigilance activities. Information collected is being used to improve our understanding of needs in this area and will inform efforts to seek financial and training support for pharmacovigilance. Results from this survey were presented to a meeting of funding agencies and policy-makers in April 2008. We would still welcome responses from countries which have not replied. Information will help identify the most urgent pharmacovigilance priorities and funding agendas.
Participation in this survey is voluntary and should take approximately 20 minutes to complete (submission of a complete survey represents consent on your part to participate; please note that individual identifying information will be kept confidential).
Pharmacovigilance Survey 2008 (pdf)
Link to the online questionnaire (web-based version)