11

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

22

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

77

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

2020

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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2323

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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