Transcript
Pharmacovigilance
SUHARJONO
The science and activities relating to the detection, evaluation, understanding and
prevention of adverse drug reactions or any other drug-related problems
Pharmacovigilance
Pharmacovigilance Major Aims
early detection of unknown safety problems detection of increases in frequency identification of risk factors quantifying risks preventing patients from being affected
unnecessarily
Rational and Safe use of Medicines
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Why Pharmacovigilance?
Pre-marketing safety data Animal Experiments: Relevant? Clinical Trials: Complete?
Why Pharmacovigilance?
Post Marketing Topics Unexpected adverse reactions Interactions Risk factors Quality of life Long-term efficacy Cost assessment
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Why Pharmacovigilance?
Adverse Drug Reactions are among the top ten causes of mortality
(Lazarou J. et al., 1998)
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Why Pharmacovigilance?
The percentage of hospital admissions due to drug related events in some countries is
about or more than 10%.
(Bhalla et al, 2003; Imbs et al, 1999)
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Why Pharmacovigilance?
Economic impact
Drug related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in
2000
(Ernst & Grizzle, 2001)
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WHO Programme for International Drug WHO Programme for International Drug MonitoringMonitoring
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres
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WHO Programme for International Drug Monitoring (HQ)
Policy Exchange of Information Technical support to countries Advisory Committee on Safety of Medicinal
Products
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Technical support to countries
Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)
Annual Meeting of Pharmacovigilance Centres
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WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR database No of reports: more than 3.5 million Each year increase ~160,000 / year
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WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR Reports Analysis Output
Feedback to National Centres Signal documents
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Eroding confidence in the malaria programme
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