Developing pharmacovigilance: new challenges and opportunities Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines. WHO Programme for International Drug Monitoring. WHO HQ + 6 Regional offices. WHO Collaborating Centre, Uppsala. National Centres.
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Developing pharmacovigilance: new challenges and opportunitiesMary Couper and Shanthi PalQuality Assurance and Safety of Medicines
WHO HQ +
Juggling some questions….
Thalidomide was the reason for the programme …..in the 60s
Primary reason remains!!
(59%) were avoidable
Why do preventable errors occur
Where is the denominator?
Why don’t they report?
Can we use our database more effectively?
Where is the patient?
Is the patient safe taking this medicine?
PV is about me !!
Am I SAFE with this medicine?
Yes, we can!!
Actionable learning system
in WHO HQ
To complement and NOT replace spontaneous reporting
Malaria pregnancy registry
Developing a global strategy
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
Maintain as the cheapest, easiest, most sustainable method
(global spontaneous reporting, training)
(Active surveillance studies in some countries, multilingual, sentinel sites)
(ISMN, WAPS, EML, RUD, Indicators, capital)
Cohort event monitoring
Network, support, measure, fundraise
Pharmacovigilance is about me !!