world health organization 1 pharmacovigilance dr shanthi pal quality assurance and safety of...
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1World Health Organization
Pharmacovigilance
Dr Shanthi Pal
Quality Assurance and Safety of Medicines
WHO
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2World Health Organization
Objectives
• To discuss the need for pharmacovigilance
• To present WHO’s role in promoting pharmacovigilance
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3World Health Organization
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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4World Health Organization
Pharmacovigilance
What IS this?
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5World Health Organization
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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6World Health Organization
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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7World Health Organization
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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8World Health Organization
• Pre-marketing safety data
Animal Experiments : Relevant?
Clinical Trials: Complete?
Why Pharmacovigilance?
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9World Health Organization
Why Pharmacovigilance?
• Post-marketing Topics Unexpected adverse reactions Interactions Dependence Long-term efficacy, Resistance Risk factors Quality (Counterfeit) Cost assessment
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10World Health Organization
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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11World Health Organization
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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12World Health Organization
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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13World Health Organization
WHO Programme for InternationalDrug Monitoring
WHOHQ
WHO CollaboratingCentre, Uppsala
NationalCentres
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14World Health Organization
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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15World Health Organization
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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16World Health Organization
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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17World Health Organization
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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18World Health Organization
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19World Health Organization
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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20World Health Organization
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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21World Health Organization
Future challenges
• Raise awareness
• Monitor all medicines
• Integrate work throughout WHO
• Improve training activities
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22World Health Organization
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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23World Health Organization
Thank you
‘People who are vigilant do not die; people who are negligent are as if dead’.
- Shakyamuni Buddha