shanthi pal quality assurance and safety of medicines ...4 16th world health assembly 1963 assembly...
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ShanthiShanthi PalPal
Quality Assurance and Safety of MedicinesQuality Assurance and Safety of Medicines
World Health OrganizationWorld Health Organization
WHO Programme for International Drug MonitoringWHO Programme for International Drug Monitoring
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In1960s..In the sixties…
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Forty+ years laterForty+ years later…………
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16th World Health Assembly 16th World Health Assembly 19631963
Assembly Resolution Assembly Resolution 16.36 16.36 -- Clinical Clinical and Pharmacological Evaluation of and Pharmacological Evaluation of DrugsDrugsINVITES Member States to arrange INVITES Member States to arrange
for a systematic collection of for a systematic collection of information on serious adverse drug information on serious adverse drug reactions observed during the reactions observed during the development of a drug and, in development of a drug and, in particular, after its release for general particular, after its release for general use.use.
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WHO Drug Monitoring WHO Drug Monitoring ProgrammeProgrammeFounding Members 1968Founding Members 1968
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96 Full Members and 28 Associate
Members
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WHO Programme for WHO Programme for International Drug MonitoringInternational Drug Monitoring
HQHQ--WHO WHO + 6 Regional + 6 Regional
officesoffices
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
NationalNationalCentresCentres
HIV/AIDS
Malaria
VaccinesO
ther
s
Chaga
s
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Advisory Committee on Safety Advisory Committee on Safety of Medicinal Products (of Medicinal Products (ACSoMPACSoMP))
The Advisory Committee on Safety of Medicinal The Advisory Committee on Safety of Medicinal Products shall provide advice on pharmacovigilance Products shall provide advice on pharmacovigilance policy and issues related to the safety and policy and issues related to the safety and effectiveness of medicinal productseffectiveness of medicinal products
to the relevant Assistant Directorto the relevant Assistant Director--General in WHO General in WHO and through him / her and through him / her –– to the Collaborating Centre for International to the Collaborating Centre for International
Drug Monitoring (Drug Monitoring (thethe Uppsala Monitoring Centre), Uppsala Monitoring Centre), and and
–– to the Member States of WHO.to the Member States of WHO.
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Pharmacovigilance in Pharmacovigilance in WHO HQWHO HQ
1.1. Exchange of InformationExchange of Information2.2. Policies, guidelines, normative Policies, guidelines, normative
activitiesactivities3.3. Country supportCountry support4.4. CollaborationsCollaborations5.5. Resource mobilisation Resource mobilisation
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1. Exchange of 1. Exchange of InformationInformation
National Information Officers National Information Officers
Publications (WHO Pharm Newsletter, Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Restricted Pharm List, Drug Alerts, WHO Drug Information)Drug Information)
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2. Policies, Guidelines and 2. Policies, Guidelines and Normative Activities Normative Activities
GuidelinesGuidelines–– The Importance of The Importance of
Pharmacovigilance (2002)Pharmacovigilance (2002)
–– Safety Reporting Safety Reporting -- A guide A guide to detecting and reporting to detecting and reporting adverse drug reactions adverse drug reactions (2002)(2002)
–– Policy perspectives on Policy perspectives on medicines medicines (Pharmacovigilance) 2004 (Pharmacovigilance) 2004
–– Safety monitoring of Safety monitoring of herbal medicines (2004)herbal medicines (2004)
–– Pharmacovigilance in Pharmacovigilance in Public HealthPublic Health
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3. Country support3. Country support
Training courses on pharmacovigilance Training courses on pharmacovigilance
Address specific / stated needs: kava, ARVs, Address specific / stated needs: kava, ARVs, antimlalarialsantimlalarials……..
Annual Meeting of Pharmacovigilance CentresAnnual Meeting of Pharmacovigilance Centres
10 courses offered in 2008
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4. Collaborations & 4. Collaborations & Partnerships within WHOPartnerships within WHO
MalariaMalariaHIV/AIDSHIV/AIDSLeprosy Leprosy Lymphatic Filariasis Lymphatic Filariasis LeishmaniasisLeishmaniasisChagasChagasPatient Safety Patient Safety Poisons and Chemicals SafetyPoisons and Chemicals SafetyTraditional MedicinesTraditional MedicinesVaccinesVaccines
Over a 100 million people targeted for either diethylcarbamazine citrate (DEC) plus albendazole or ivermectin plus albendazole.
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5. Resource Mobilisation5. Resource Mobilisation
Gates foundationGates foundationEuropean commissionEuropean commissionGlobal FundGlobal FundOthersOthersHuman resources: Human resources: PvSFPvSF
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WHO Collaborating CentreWHO Collaborating Centrethethe Uppsala Monitoring CentreUppsala Monitoring Centre
Established as a foundation 1978Established as a foundation 1978Based on agreement Sweden Based on agreement Sweden --WHOWHOInternational administrative boardInternational administrative boardWHO Headquarters responsible for WHO Headquarters responsible for policypolicySelf financingSelf financing
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Signal detectionSignal detection
Primary UMC taskPrimary UMC task
Identification of previously Identification of previously unknown drug reactionsunknown drug reactions
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What is a signal?What is a signal?
A WHO signal is a A WHO signal is a hypothesishypothesistogether with data and together with data and arguments. A signal is not only arguments. A signal is not only uncertainuncertain but also but also preliminarypreliminary in in nature: the situation may change nature: the situation may change substantially over time one way substantially over time one way or another.or another.
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Flow of ADR Flow of ADR reportsreports
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Technical supportTechnical support
GuidelinesGuidelines–– Reporting format etc.Reporting format etc.
TerminologiesTerminologies–– WHO Adverse Reaction TerminologyWHO Adverse Reaction Terminology–– WHO Drug DictionaryWHO Drug Dictionary
ATC ClassificationATC Classification
Software developmentSoftware development–– VigiFlowVigiFlow–– VigiSearch/VigiMineVigiSearch/VigiMine
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Pharmacovigilance Pharmacovigilance trainingtraining
–– UppsalaUppsala2 weeks2 weeks2525--40 40 participantsparticipants12th course 12th course May 2009May 2009
–– Regional Regional courses with courses with WHOWHO
–– National National courses courses
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CommunicationCommunication
Internet website: Internet website: http://www.whohttp://www.who--umc.orgumc.org
Vigimed mailing listVigimed mailing list
PublicationsPublications
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3 tiers3 tiers--approach for WHOapproach for WHO1.1. As beforeAs before
(Spontaneous reporting)(Spontaneous reporting)
Regional trainingsRegional trainings
2.2. More than beforeMore than before(Active surveillance)(Active surveillance)
Tools Tools Handbooks Handbooks Nigeria, Tanzania, GhanaNigeria, Tanzania, Ghana
3.3. As never beforeAs never beforeIndicators Indicators Consumers Consumers Medication errors Medication errors
Maintain as the cheapest, easiest, most sustainable method
Cohort event monitoring; ECDD; EML; DTC
Measure, support, optmise
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New development areas in New development areas in UMCUMC
Active surveillance supportActive surveillance support–– Cohort Event MonitoringCohort Event Monitoring
Patient safety focus including medication errorsPatient safety focus including medication errors
Improved reporting/analysis of vaccine reactions (AEFI)Improved reporting/analysis of vaccine reactions (AEFI)–– Flu pandemic planningFlu pandemic planning
Integrate Chinese ADR databaseIntegrate Chinese ADR database