salus why is it important? tomas bergvall, msc uppsala monitoring centre who collaborating centre...
TRANSCRIPT
SALUSwhy is it important?
Tomas Bergvall, MScUppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring
Eudravigilance Expert Working Group
London May 28 2015
Pharmacovigilance How do we enable decision makers to
make wise therapeutic decisions?
WHO Programme for International Drug Monitoring
1968 2014
EHR sources
UMC EHR research timeline
Denominators
LongitudinalData not collected
for causality assessment
Lack of power*’Objective’
No clinical suspicion
Longitudinal health records
Case reports
Health records
!
Embedded reporting
Reporter can focus on documenting their
clinical suspicion
Basic data already there
Stronger case reports
Health record
s
Health records add to case
reports
Health record
s
DenominatorsTemporal patternsRisk group identification
Case reports add to health
records
Health record
s
Causality assessment- Supportive evidence- Alternative explanations
Challenges Local expertise is needed MedDRA, ICD, SNOMED, WHO-ART… Common data models Privacy and social acceptance
Case reports
Health records
!
Case reports
Health records
Literature
Registries
Web search
es
Social mediaPatient
commu-nities
!
Pharmacovigilance How do we enable decision makers to
make wise therapeutic decisions?
Present information that makes sense! Focus on the strengths!
What did we achieve?
Over to the coordinator…