Transcript 022-Pharmacovigilance - WHO archives

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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Why Pharmacovigilance?
• Pre-marketing safety data
Animal Experiments : Relevant?
Clinical Trials: Complete?
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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 International
Drug Monitoring
WHO
Collaborating
WHO
HQ
Centre, Uppsala
National
Centres
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Safety of Medicines Team
Lembit Rägo
Coordinator QSM
Vladimir Lepakhin
ADG/HTP
Mary Couper
Medical Officer
Christine Encrenaz
Technical Officer
SCRIHS
Shanthi Pal
Technical Officer
Caroline Mullen
Secretary
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WHO Programme for International
Drug Monitoring (HQ)
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Policy
Exchange of Information
Technical support to countries
Advisory Committee on Safety of
Medicinal Products
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Exchange of Information
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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
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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
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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
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