pharmaco vigi nance

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?


Post Marketing Topics Unexpected adverse reactions Interactions Risk factors Quality of life Long-term efficacy Cost assessment

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Adverse Drug Reactions are among the top ten causes of mortality

(Lazarou J. et al., 1998)

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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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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

pharmaco vigi nance

Documents