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Pharmacovigilance

Dr Shanthi Pal

Quality Assurance and Safety of Medicines

WHO

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Objectives

• To discuss the need for pharmacovigilance

• To present WHO’s role in promoting pharmacovigilance

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Medicine Safety

• To undergo treatment you have to be very healthy, because apart from your sickness you have to stand the medicine.

Molière

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Pharmacovigilance

What IS this?

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Vigilance

Vigilare = to watch

alert watchfulness

forbearance of sleep; wakefulness

watchfulness in respect of danger; care; caution; circumspection

the process of paying close and continuous attention

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Pharmacovigilance

• The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems

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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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• Pre-marketing safety data

Animal Experiments : Relevant?

Clinical Trials: Complete?

Why Pharmacovigilance?

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Why Pharmacovigilance?

• Post-marketing Topics Unexpected adverse reactions Interactions Dependence Long-term efficacy, Resistance Risk factors Quality (Counterfeit) Cost assessment

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Why Pharmacovigilance?

• Adverse Drug Reactions are the 4th to 6th largest cause of mortality in the USA

(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%.

• UK Study : 10.1 % (Bhalla et al, 2003)

• French study : 10.3 % prevalence of ADRs (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 InternationalDrug Monitoring

WHOHQ

WHO CollaboratingCentre, Uppsala

NationalCentres

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Mary CouperMedical Officer

Lembit RägoCoordinator QSM

Vladimir LepakhinADG/HTP

Caroline Mullen Secretary

Shanthi PalTechnical Officer

Christine EncrenazTechnical OfficerSCRIHS

Safety of Medicines TeamSafety of Medicines TeamSafety of Medicines TeamSafety of Medicines Team

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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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Exchange of Information

• WHO Pharmaceuticals Newsletter• WHO Drug Alerts• WHO Drug Information• WHO Restricted Pharmaceuticals List• (Vigimed - electronic exchange)• (Uppsala Reports)• (Signal)

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Technical support to countries

• Technical guidelines on all aspects of pharmacovigilance

(Several publications and documents)• Training courses on

pharmacovigilance

(Regional Training Courses, biennial course by UMC and HQ)

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WHO Collaborating Centre (Uppsala Monitoring Centre)

ADR database• No of reports: more than 3 million• Each year increase ~250,000 / year• Top 5 reporting countries

• USA• United Kingdom• Germany• Australia• Canada

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WHO Collaborating Centre (Uppsala Monitoring Centre)

ADR Reports• Analysis• Data mining (BCPNN)• Output

– Feedback to National Centres– Signal documents– Ad hoc research results

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Future challenges

• Raise awareness

• Monitor all medicines

• Integrate work throughout WHO

• Improve training activities

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In conclusion ….

• The work of WHO in the area of safety monitoring of medicines is necessary if we are to achieve the mission of EDM:

• Medicines should be Available, Affordable, Safe and Properly used.

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Thank you

‘People who are vigilant do not die; people who are negligent are as if dead’.

- Shakyamuni Buddha