Pharmacovigilance (PV) which is also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects related to drugs and pharmaceutical products.
As such, pharmacovigilance mainly focuses on adverse drug reactions, or ADRs, which may be defined as any unwanted, unintended or noxious response of a drug, which can include including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or treatment of disease). Medication errors in form of drug overdose, misuse and abuse of a drug. Drug prescription during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may lead to adverse drug reaction.
Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources. plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.
WHO started a Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Since 1978 the Programme has been carried out by Uppsala Monitoring Centre (UMC) in Sweden. Together with the UMC in Uppsala, WHO promotes PV at the country level. By the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Uppsala Monitoring Centre (UMC) in Sweden
The ultimate goal of UMC in pharmacovigilance is to support good decision-making regarding the benefits and risks of treatment options for patient taking medicines.
the main focus is on:
1. Screening, analyzing international adverse reaction data; main aim is to detect, as early as possible, potential issues of importance for patients and public health in relation to the use and safety of medicines.
2. Supporting effective communication of the most focused, up-to-date scientific information.
3. Providing tools for data entry, management, retrieval, reference and research.
4. Education and training in setting up and running national pharmacovigilance programs, as well as in using the UMC Tools.
The WHO Program
Since 1978, UMC has tried to expand its Pharmacovigilance network world wide and now as of May 2016, 124 countries have joined the WHO Program for International Drug Monitoring, and in addition 29 ‘associate members’ are awaiting full membership.
UMC as WHO Collaborating Centre, adhere to WHO policies and work and share WHO’s vision of better health for all, but UMC is organizationally and professionally distinct from WHO itself.
To be specific Uppsala Monitoring Centre is an independent foundation and a center for international service and scientific research. their priorities are the safety of patients and the safe and effective use of medicines in every part of the world.
In accordance with an agreement between WHO and the Government of Sweden, the WHO Headquarters is responsible for policy issues, while the operational responsibility rests with the Uppsala Monitoring Centre (UMC).
Joining the WHO Programme
Members of the WHO Programme for International Drug Monitoring, 1968 – 2015
as of 10 May 2016
Dark blue = Full member; pale blue = Associate member
UMC has issued a booklet for national Centre’s setting out the guidelines and workings of the WHO Programme for International Drug Monitoring. The booklet has been translated in Spanish and French. It covers the advantages of being a member – 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.
WHO Programme Members
Countries participating in the WHO Programme for International Drug Monitoring, with year of joining
Full Member Countries (124) and Year of Joining
Afghanistan 2016
Andorra 2008
Angola 2013
Argentina 1994
Armenia 2001
Australia 1968
Austria 1991
Bangladesh 2014
Barbados 2008
Belarus 2006
Belgium 1977
Benin 2011
Bhutan 2014
Bolivia 2013
Botswana 2009
Brazil 2001
Brunei Darussalam 2005
Bulgaria 1975
Burkina Faso 2010
Cambodia 2012
Cameroon 2010
Canada 1968
Cabo Verde 2012
Chile 1996
China 1998
Colombia 2004
Dem Rep of Congo 2010
Costa Rica 1991
Côte d’Ivoire 2010
Croatia 1992
Cuba 1994
Cyprus 2000
Czech Republic 1992
Denmark 1971
Egypt 2001
Eritrea 2012
Estonia 1998
Ethiopia 2008
Fiji 1999
Finland 1974
France 1986
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Germany 1968
Ghana 2001
Greece 1990
Guatemala 2002
Guinea 2013
Hungary 1990
Iceland 1990
India 1998
Indonesia 1990
Islamic Republic of Iran 1998
Iraq 2010
Ireland 1968
Israel 1973
Italy 1975
Jamaica 2012
Japan 1972
Jordan 2002
Kazakhstan 2008
Kenya 2010
Republic of Korea 1992
Kyrgyzstan 2003
Lao People’s Democratic Republic 2015
Latvia 2002
Liberia 2013
Lithuania 2005
The Former Yugoslav Republic ofMacedonia 2000
Madagascar 2009
Malaysia 1990
Mali 2011
Malta 2004
Mauritius 2014
Mexico 1999
Republic of Moldova 2003
Montenegro 2009
Morocco 1992
Mozambique 2005
Namibia 2008
Nepal 2006
Netherlands 1968
New Zealand 1968
Niger 2012
Nigeria 2004
Norway 1971
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Oman 1995
Panama 2016
Peru 2002
Philippines 1995
Poland 1972
Portugal 1993
Romania 1976
Russian Federation 1998
Rwanda 2013
Saudi Arabia 2009
Senegal 2009
Serbia 2000
Sierra Leone 2008
Singapore 1993
Slovakia 1993
Slovenia 2010
South Africa 1992
Spain 1984
Sri Lanka 2000
Sudan 2008
Suriname 2007
Swaziland 2015
Sweden 1968
Switzerland 1991
United Republic ofTanzania 1993
Thailand 1984
Togo 2007
Tunisia 1993
Turkey 1987
Uganda 2007
Ukraine 2002
United Arab Emirates 2013
United Kingdom 1968
Uruguay 2001
U.S.A. 1968
Uzbekistan 2006
Venezuela 1995
Vietnam 1999
Zambia 2010
Zimbabwe 1998
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Associate Members (29)
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Albania
Algeria
Anguilla
Antigua & Barbuda
Azerbaijan
Bahrain
Bosnia and Herzegovina
British Virgin Islands
Burundi
Chad
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Dominica
Gambia
Georgia
Grenada
Guinea-Bissau
Haiti
Malawi
Maldives
Mongolia
Montserrat
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Pakistan
Papua New Guinea
Qatar
Saint Kitts and Nevis
Saint Lucia
Saint Vincent and the Grenadines
Syrian Arab Republic
Tajikistan
Zanzibar
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The ten founder members of the WHO Programme in 1968 were Australia, Canada, Czechoslovakia, Federal Republic of Germany, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA.
VigiBase®
VigiBase® is the name of the WHO Global ICSR (individual case safety reports) database; it consists of reports of adverse reactions received from member countries since 1968. VigiBase is regularly updated with incoming ICSRs on a continuous basis. National centres are recommended to send reports at least quarterly; some centres report more frequently.
The VigiBase data resource is the largest and most comprehensive in the world, and it is developed and maintained by the UMC on behalf of the World Health Organization. By December 2015 over 13 million reports were contained in the database. VigiBase is a computerized pharmacovigilance system, in which information is recorded in a structured, hierarchical form to allow for easy and flexible retrieval and analysis of the data. The case reports in the WHO database do not identify the patient or reporter. Its purpose is to provide the evidence from which potential medicine safety hazards may be detected.
The VigiBase database system includes linked databases containing medical and drug classifications: WHO-ART/Med DRA, WHO ICD, and WHO Drug Dictionary. These classifications enable structured data entry, retrieval, and analysis at different levels of precision and aggregation.
Fact sheet about ICSR submission
The fact sheet gives details on what kind of ICSRs should be forwarded to UMC by members of the WHO Programme. It emphasizes that all adverse events occurring in a post-marketing situation should be submitted to UMC, including ICSRs on medication errors, counterfeit/substandard medicines and therapeutic failure
Quality of data
The quality of ICSR data in VigiBase is crucial; the consequence of poor quality data is the risk of drawing wrong or delayed conclusions about a patient or a safety signal, which in turn could lead to patients being harmed unnecessarily.
Access to data
In 2012 a new access policy was set out by the UMC, which may be seen in
In April 2015 VigiAccess was launched. There anyone can search for summary statistics from VigiBase, more information on VigiAccess is found here.
Vigimed
Vigimed is a web-based forum for those working at national centres in the WHO Programme to enable them to have easy access to safety concerns in other countries, to check regulatory status, and to expedite the sharing of drug information.
Vigimed is part of the UMC Collaboration Portal, a web-based platform managed by the UMC.
Anyone who wishes to join Vigimed or any other a part of the UMC Collaboration Portal has to document that (s)he is an authorised staff member of a National Centre or a Drug Regulatory Authority of a participating country.
The request to be accepted as a member should be submitted to info@who-umc.org accompanied by:
– an individual/personal e-mail,
– full postal address, and
– telephone number including country code.
Details on how to access and use Vigimed will be sent to new participants by e-mail.
Reference: wikipedia, who.int,who-umc.org
