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Developing Pharmacovigilance: New Challenges and Opportunities
Developing Pharmacovigilance: New Challenges and Opportunities
WHO HQ +
6 Regional WHO
offices Collaborating
Centre, Uppsala
National
Centres
Pharmacovigilance in WHO HQ
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Resource mobilisation
WHO Programme
October 2008
Functions
• Receive and manage ADR data
• Analyse:
• Signal detection :Identification of previously unknown drug reactions
• Communicate
France
5%
countries. Germany
United States
50%
6%
Other Countries
11%
Thalidomide was the reason for the programme
…..in the 60s
2007
Primary
reason
!!remains
• 125 Patients
• 24 Patients experienced ADRs (19%)
So What?
Where is the denominator?
XX number of countries trained
So What?
Why don’t they report?
What more can we do?
Am I SAFE
with this
?medicine
Can we become more patient centred ?
Yes, we can!!
Reports of medication errors in
WHO ICSR database in 2005
2%
Medication errors
Total reports
98%
Reports of medication errors by therapeutic groups in WHO database
18.7%
20%
7% 6%
5%
2.4%
0%
Analgesics
Antipsychotic
Antineoplastic
Antithrombotic
Antidepressants
agents
agents
agents
Pharmacovigilance system
RHR Herbals
Chemical
NCD
Safety
Safetyofof
Safety
Medicines
medicines
ininWHO
WHOHQ HQ
ICD etc HIV/AIDS
Parasitic
TB
Diseases
Regional
Malaria
TDR Offices
Low presence of some countries in
the programme
• Capacity building : multi regional, multilingual trainings,
regional centres of excellence in PV
• Local evidence for the need for pharmacovigilance
• What gets measured, gets done (DG, WHO)
• Indicators for PV
Post-training: improving reporting
• The know–do gap: understanding it
• Reporting tools expensive
• Vigiflow : free when used only as a reporting tool
• Also discuss 'incentives'
• CME points
• Feedback
• Access to Information
Lack of denominator / exposure data
• Active surveillance to complement
• Cohort Event Monitoring
• Malaria, HIV
• Pregnancy registers
To complement and NOT replace spontaneous reporting
What more with the database
• EML
• Dependence liability
• Counterfeit detection
• Support RUD programme with evidence
Optimising 'Donor' interest
• BMGF:
• HIV/AIDS proposal
• Malaria pregnancy registry
• Developing a global strategy
• EC:
• EC/ACP/WHO Partnership on Pharmaceutical Policies now in
its 5th year
• Working with African countries to ensure a quality
pharmaceutical response to malaria entering its second year
• Optimizing drug safety monitoring to enhance patient safety
and achieve better health outcomes
What does the future look Maintain
like as the cheapest,
easiest, most sustainable
method
1. As before
(global spontaneous reporting, training) Cohort event
monitoring
2. Better than before
(Active surveillance studies in some countries,
multilingual, sentinel sites)
Network, support,
3. As never before measure, fundraise
(ISMN, WAPS, EML, RUD, Indicators, capital)
Major planned activities for 2009
• Development of a global strategy for pharmacovigilance to increase
awareness
• PV landscape assessment for ascertaining state of the art
• Expansion of the programme with a focus on China and India
• More Francophone countries supported in PV
• Cohort event monitoring method developed, piloted in 2 African
countries (in malaria)
• Indicators for PV
• Expansion and development of database
• Pilot project on medication errors strengthened / expanded to
other centres
• Strengthening PV in HIV/AIDS
• PV capacity in countries supported
Pharmacovigilance
!! is about me
Thank you
Thank you