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The Uppsala Monitoring Centre Monica Plöen

WHO Collaborating Centre for International Drug Monitoring The WHO Programme for International Drug Monitoring. The Uppsala Monitoring Centre Monica Plöen. WHO Collaborating Centre the Uppsala Monitoring Centre. Established as a foundation 1978 Based on agreement Sweden - WHO

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The Uppsala Monitoring Centre Monica Plöen

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  1. WHO Collaborating Centre for International Drug MonitoringThe WHO Programme for International Drug Monitoring The Uppsala Monitoring Centre Monica Plöen

  2. 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

  3. UMC activities WHO Programme Funding Commercial sector activities WHO Drug Dictionaries

  4. UMC organization

  5. WHO Drug Monitoring ProgrammeFounding Members 1968

  6. Member countries 1968-2009

  7. Cumulative number of correct reports processed per year

  8. Country Distribution in VigibaseOctober 2009

  9. SwissMedic 2001 Web based E2B format Less report delay Free text possible Mandatory fields Error checks National database VigiFlow – a software for management of ADR case data

  10. UMC Function 1Signal detection • Primary UMC task • Identification of previously unknown drug reactions

  11. Signal WHO definition • 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.

  12. Advantages of computerized signal detection • Necessary for huge databases • Automatic, no time loss • Objective, unbiased • Reproducible • Flexible (adjustable)

  13. 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)

  14. 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

  15. SSRI Neonatal convulsions or neonatal withdrawal syndrome

  16. Signal Detection & Follow-up Combinations.db (reported quarterly) Triage(filter) Quarterly analysis BCPNN Vigibase National Centres

  17. 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

  18. Signal Detection & Follow-up Combinations.db (reported quarterly) Triage(filter) Quarterly analysis BCPNN Review panel Vigibase National Centres

  19. 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

  20. 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

  21. Some WHO Signals detected with data mining A Confirmatory literature review B RCT showing increased risk C Labelling change

  22. UMC functions 2 • Signal strengthening • Web-based search programme (Vigisearch/Vigimine) • Search requests

  23. Data available to non-members • By request to WHO Collaborating Centre • To degree health professionals • Caveat document

  24. UMC functions 3 • Comparing national experiences

  25. 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

  26. UMC functions 4 • Identification of risk factors

  27. Potential Risk Factors • Other drugs • Sex/gender • Age • Genetic constitution • Dosage • Duration of treatment • Route of administration • Indication

  28. 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

  29. 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

  30. The common name problem Common nameBotanical nameChemical relation Chinese, Asian Ginseng Panax ginsengMeyer Standard American GinsengPanax quinquefoliusL. Similar Tienchi GinsengPanax pseudoginsengWall. Similar Siberian GinsengEletherococcussenticosusMaxim. Different Russian GinsengAcanthopanax senticosusHarms. Different Brazilian GinsengRumex hymenosepalusTorr. Different Wild red Am. GinsengPfaffia paniculata(Mart.) Kunze. Different Alaskan GinsengEchinopanax horridum(Sm.) Decne. Different Wild GinsengAralia nudicaulisL. Different Ayurvedic GinsengWithania somnifera(L.) Dunal Different Ginseng of the Andes’ Lepidium meyeniiWalpers Different

  31. 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

  32. 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

  33. UMC - a communication centre • WHO Pharmaceuticals Newsletter • Uppsala Reports • Internet home page • http://www.who-umc.org • Vigimed e-mail discussion group

  34. Thank you for your attention!

  35. 1 2 5 3 4 Process for joining WHO Programme Ministry of Health • Ministry of Health (or equivalent) designates National Centre National Centre • Ministry of Health sends formal application to WHO-HQ, Geneva • National Centre sends sample reports to the UMC the UMC • UMC notifies WHO-HQ that reports are compatible WHO-HQ Geneva • WHO-HQ advises Ministry of Health of admittance to the Programme

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