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WHO Programme for International Drug Monitoring UMC perspective on Kazakhstan and other member-countries in the region Nadja Jastrebova Pharmacovigilance Consulting Global Services Section

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Nadja Jastrebova, Uppsala Monitoring Centre Thalidomide - phocomelia

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WHO Drug Monitoring Programme Founding Members (1968)

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Nadja Jastrebova, Uppsala Monitoring Centre PV today Adverse reactions Inadequate/incorrect useProduct quality problemsOther safety challenges

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Official and associate member countries (2014)

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Nadja Jastrebova, Uppsala Monitoring Centre Population coverage

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Nadja Jastrebova, Uppsala Monitoring Centre Member obligations Send high quality ICSRs frequently Actively participate in the WHO Programme Being a member of the WHO Medicines Safety Programme

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Nadja Jastrebova, Uppsala Monitoring Centre WHO International PV Programme WHO-CC Netherlands Lareb WHO-CC Netherlands Lareb WHO-HQ Geneva WHO-HQ Geneva WHO-CC Sweden UMC WHO-CC Sweden UMC National Centres WHO-CC Ghana UMC-A WHO-CC Ghana UMC-A Healthcare Pharma industry Pharma industry WHO-CC Morocco CAPM WHO-CC Morocco CAPM Patient safety data Patients (directly) Patients (directly)

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Nadja Jastrebova, Uppsala Monitoring Centre UMC - WHO Collaborating Centre for International Drug Monitoring the Uppsala Monitoring CentreEstablished as a foundation 1978Agreement between Sweden and WHOWHO-HQ responsible for policy issuesInternational administrative boardSelf financing

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Nadja Jastrebova, Uppsala Monitoring Centre UMCs vision and main tasks Improve worldwide patient safety and welfare by reducing the risk of medicines Collect and analyse individual case safety reports (ICSRs) worldwide Communicate potential patient safety issues Actively support and provide training in Pharmacovigilance Develop the science of Pharmacovigilance

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Nadja Jastrebova, Uppsala Monitoring Centre VigiBase WHO global ICSR database The oldest and largest global ICSR database Used for global and country specific signal detection Free to search in by National Centres of member countries Customized searches are performed on request from companies and other interested

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Nadja Jastrebova, Uppsala Monitoring Centre VigiBase and report accumulation Americas Europe Asia Oceania Africa Total

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6.000 ICSRs 2.900.000 143.500.000 5.600.000 9.500.000 45.600.000 29.800.000 3.600.000 16.800.000 Population

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Nadja Jastrebova, Uppsala Monitoring Centre Quality of ICSRs vigiGrade - Completeness Score Way of measuring the amount of information on ICSRs Calculated from 8 parameters important for analysis: Type of reportPrimary sourceGenderAge at onsetTime to onsetIndicationOutcomeFree text

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Nadja Jastrebova, Uppsala Monitoring Centre Countries % Quality of ICSRs vigiGrade - Completeness Score

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Nadja Jastrebova, Uppsala Monitoring Centre Reporting format Country ACountry C Country B hari yang baik UMC

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Nadja Jastrebova, Uppsala Monitoring Centre Reporting format and harmonization E2B Country A E2B Country B Country C E2B UMC

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Nadja Jastrebova, Uppsala Monitoring Centre Signal detection Periodic screening of VigiBase dataManual review of literature and ICSRsClinical assessment by international expert panelPublication/communication to National Centres UMC is not a regulatory body

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Nadja Jastrebova, Uppsala Monitoring Centre

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http://www.who-umc.org

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Nadja Jastrebova, Uppsala Monitoring Centre Training 43 Web lectures from UMC PV Courses

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Nadja Jastrebova, Uppsala Monitoring Centre Publications

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Nadja Jastrebova, Uppsala Monitoring Centre Thank you for your attention! Nadja.Jastrebova@who-umc.org

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Nadja Jastrebova, Uppsala Monitoring Centre Quality vs. quantity

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Nadja Jastrebova, Uppsala Monitoring Centre Quality vs. quantity 4 + Enter to see non-European countries