Challenges for Challenges for tthe WHO Programme for he WHO Programme for International Drug MonitoringInternational Drug Monitoring

Mary Couper, Shanthi Pal, Mitsuko Imai, Mary Couper, Shanthi Pal, Mitsuko Imai, Maria Cuadrillero, Ana GarciaMaria Cuadrillero, Ana Garcia

WHO International Pharmacovigilance Programme Full and Associate members

StrengthsStrengths

Global PV network Global PV network National Centres National Centres MeetingsMeetings

Only available global Only available global database of ADRs database of ADRs

Over 40 years track Over 40 years track record in medicine record in medicine safetysafety

Public health Public health approachapproach

No hidden agendasNo hidden agendas

WeaknessesWeaknesses

Inadequate Inadequate representation in representation in AfricaAfrica

Only Spontaneous Only Spontaneous reportingreporting

no denominator no denominator datadataPoor quality Poor quality reportsreports

Little or no budget Little or no budget

PHPs: Vertical PHPs: Vertical approach approach

OpportunitiesOpportunities

Donor interest in PVDonor interest in PV

New partnersNew partners

Malaria, HIV AIDS, Malaria, HIV AIDS, neglected diseases neglected diseases

•urgent PV needsurgent PV needs

•investing in new investing in new methodsmethods

ThreatsThreats

Lucrative businessLucrative business

Lack of Lack of harmonization harmonization

Duplication of Duplication of efforts efforts

An analysis of pharmacovigilance An analysis of pharmacovigilance activities in 55 low- and middle-activities in 55 low- and middle-income countriesincome countries

– Sten OlssonSten Olssonaa, Shanthi Pal, Shanthi Palbb, Andy , Andy StergachisStergachiscc, Mary Couper, Mary Couperaa

– Drug Safety 2009/2010Drug Safety 2009/2010

(a: WHO CC, Uppsala; b: WHO QSM; c: UWa)(a: WHO CC, Uppsala; b: WHO QSM; c: UWa)

Fig. 6a. Challenges to PV

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Fig. 6b. Type of Assistance Needed

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3 tiers-approach for 3 tiers-approach for WHOWHO1.1. 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 before Indicators Indicators Fundraising (EuropeAid; BMGF; FP7) Fundraising (EuropeAid; BMGF; FP7) Centres of excellence (Ghana, Morocco) Centres of excellence (Ghana, Morocco) PVSFPVSF

Maintain as the cheapest, easiest, most sustainable method

Cohort event monitoring; ECDD; EML; DTC

Measure, support, optmise