The Uppsala Monitoring Centre Monica Plöen
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Transcript of The Uppsala Monitoring Centre Monica Plöen
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WHO Collaborating Centre for International Drug Monitoring
The WHO Programme for
International Drug Monitoring
The Uppsala Monitoring Centre
Monica Plöen
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WHO Collaborating Centrethe Uppsala Monitoring Centre
• Established as a foundation 1978
• Based on agreement Sweden - WHO
• International administrative board
• WHO Headquarters responsible for policy
• Self financing
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UMC activities
WHO Programme
Commercial sector activities
Funding
WHO Drug Dictionaries
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UMC organizationDirector
Marie Lindquist
Finance and Core servicesBirgitta Toreheim
6 people
External AffairsSten Olsson
5 people
Safety Support and ServicesMonica Plöen
22 people
MarketingAnnika Wallström
11 people
ResearchNiklas Norén
7 people
Production, Development and QualityJohanna Eriksson
17 people
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WHO Drug Monitoring ProgrammeFounding Members 1968
WHO Drug MonitoringProgramme
WHO Drug MonitoringProgrammeFounding membersFounding members
1968
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Member countries 1968-2009
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Cumulative number of correct reports processed per year
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Country Distribution in VigibaseOctober 2009
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WHO-ART WHO Drug Dictionary
National Centre
E2b
National Centre
Intdis
Home-built tools
Eudra-vigilance
VigiFlow
Win ADR(simple entry tool)
Home-built tools
MedDRA
VigiSearch/ VigiMine
Custom Searches
WHO database
VigiBase
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VigiFlow – a software for management of ADR case data
• SwissMedic 2001
• Web based
• E2B format
• Less report delay
• Free text possible
• Mandatory fields
• Error checks
• National database
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UMC Function 1Signal detection
• Primary UMC task
• Identification of previously unknown drug reactions
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Signal
• Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.
• Note: – A signal is an evaluated association which is considered important to
investigate further.– A signal may refer to new information on an already known association.
– Usually more than a single report is required to generate a signal,
depending upon the seriousness of the event and the quality of the information.
WHO definition
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Advantages of computerized signal detection
• Necessary for huge databases
• Automatic, no time loss
• Objective, unbiased
• Reproducible
• Flexible (adjustable)
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Method developed by the UMC• BCPNN
– Bayesian Confidence Propagation Neural Network
• Select combinations ”standing out”, for clinical review– Represented by a high value of Information
Component (IC)
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IC interpretation
• IC = 0 : Combination reported as often as expected relative to the background
• IC > 0 : Combination reported more frequently than expected
• IC025 > 0 : Also the lower value of the 97,5% confidence interval is higher than expected from the background
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SSRI Neonatal convulsions or neonatal withdrawal syndrome
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Signal Detection & Follow-upCombinations.db
(reported quarterly)
Quarterly analysisBCPNN
Vigibase
National Centres
Triage (filter)
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Triage filter - selection of associations
• IC025 > 0; two or more countries
• Quarterly IC increase of 1 or more
• New drugs and serious ADRs irrespective of IC value
• (Target reaction terms (e.g. SJS), two or more reports, irrespective of IC value)
Literature check
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Signal Detection & Follow-upCombinations.db
(reported quarterly)
Triage (filter)
Quarterly analysisBCPNN
Vigibase
Review panel
National Centres
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Signal review panel
• 40 experts from around the world
• Evaluate signals, together with UMC staff and National Centres
• Select associations for follow-up
• Write signals in the SIGNAL document
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The SIGNAL document
• Sent to all National Centres
• Individualized section available to industry
• All recipients encouraged to comment on topics presented
Or published in WHO Pharmaceutical Newsletter
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Some WHO Signals detected with data mining
Drug Safety Issue Quantitatively highlighted WHO Signal Accepted as drug related
Topiramate -glaucoma 2nd quarter 2000 April 2001 October 2001c
Infliximab – pericardial effusion 4th quarter 2001 Dec 2002 August 2004c
Infliximab- vasculitis 2nd quarter 2000 Sept 2002 August 2004c
SSRIs – neonatal convulsions 4th quarter 1999 Dec 2001 May 2005a
Abacavir – MI 2nd quarter 2004 May 2005 April 2008b
A Confirmatory literature reviewB RCT showing increased riskC Labelling change
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UMC functions 2
• Signal strengthening
– Web-based search programme (Vigisearch/Vigimine)
– Search requests
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Data available to non-members
• By request to WHO Collaborating Centre
• To degree health professionals
• Caveat document
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UMC functions 3
• Comparing national experiences
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International Differences(Quantitative and Qualitative)
• Disease prevalence• Genetic• Social• Cultural• Healthcare systems• Health professional practices• Indication for, and use of medicines• Pharmaceutical formulations• Drug monitoring practices
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UMC functions 4
• Identification of risk factors
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Potential Risk Factors
• Other drugs• Sex/gender• Age• Genetic constitution• Dosage• Duration of treatment• Route of administration• Indication
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WHO Drug Dictionary
• A source of international drug names
• Includes all drugs reported to VigiBase
• Information on MAH, form, strength, source etc.
• Drugs classified according to the ATC (Anatomical-Therapeutic-Chemical) classification system
• Ingredient names according to INN
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WHO herbal ADR databaseValid scientific botanical names
• No internationally standardized and accepted classification of all botanical names of medicinal herbs exist
• the UMC has created a list of preferred botanical names and their synonyms
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Common name Botanical name Chemical relation
Chinese, Asian Ginseng Panax ginseng Meyer StandardAmerican Ginseng Panax quinquefolius L. SimilarTienchi Ginseng Panax pseudoginseng Wall. SimilarSiberian Ginseng Eletherococcus senticosus Maxim. DifferentRussian Ginseng Acanthopanax senticosus Harms. Different Brazilian Ginseng Rumex hymenosepalus Torr. DifferentWild red Am. Ginseng Pfaffia paniculata (Mart.) Kunze. DifferentAlaskan Ginseng Echinopanax horridum (Sm.) Decne. DifferentWild Ginseng Aralia nudicaulis L. DifferentAyurvedic Ginseng Withania somnifera (L.) Dunal DifferentGinseng of the Andes’ Lepidium meyenii Walpers Different
The common name problem
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Technical support to the WHO Programme
• Guidelines– Why and how to set up PV centres
• Terminologies– WHO Adverse Reaction Terminology– WHO Drug Dictionary
• Software development– Vigiflow– Paniflow– CEM-flow– Vigisearch/Vigimine– DD Browser
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UMC involvement in local activities 2005-2009
• 2005– India, Germany, Moldova, Turkey, Italy, Poland, Argentina
• 2006– Uzbekistan, Brazil, Barbados
• 2007– India, Nepal, South Africa, Ghana, China, UAE
• 2008– Namibia, Philippines, India, Botswana
• 2009– Uganda, Saudi Arabia, India, Tanzania, Nigeria,
Mozambique
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UMC - a communication centre
• WHO Pharmaceuticals Newsletter• Uppsala Reports
• Internet home page http://www.who-umc.org
• Vigimed e-mail discussion group
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Thank you for your attention!
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Process for joining WHO Programme
1. Ministry of Health (or equivalent) designates National Centre
Ministry of Health
National Centre
the UMC
WHO-HQGeneva
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formal application to WHO-HQ, Geneva
3. National Centre sends sample reports to the UMC
4. UMC notifies WHO-HQ that reports are compatible
5. WHO-HQ advises Ministry of Health of admittance to the Programme