Transcript Pharmacovigilance - World Health Organization

Pharmacovigilance
Dr Mary Couper
Quality Assurance and Safety
of Medicines
WHO
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World Health Organization
Procurement and Supply
Management Plan
2.6 Ensuring rational use of medicines
Is there a system for monitoring adverse
drug reactions and drug resistance? If
yes, describe briefly how the system
works. If no, describe plans to establish
a system.
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Learning objectives
• Participants will be aware of what
pharmacovigilance is
• Participants will learn why safety
monitoring is important
• Participants will learn what WHO is
doing in pharmacovigilance
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Medicine Safety
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• To undergo
treatment you
have to be very
healthy, because
apart from your
sickness you
have to
withstand the
medicine.
Molière World Health Organization
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
Risk factors
Quality of life
Long-term efficacy
Cost assessment
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Why pharmacovigilance?
Factors influencing change
• Toxicity (adverse drug
reactions)
• Lack of patient
adherence
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Prescription
Dr A. Who
31 December 2005
Re: Mr Joseph Bloggs
R/
1)
2)
atenolol 100 mg/d
3)
acetylsalicylic acid 150mg/d
4)
simvastatin 10 mg/d
5)
bezafibrate 200 mg/d
6)
metformin 500 mg/d
7)
fluoxetine 50 mg/d
8)
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abacavir + lamivudine + zidovudine 1 BD
sildenafil
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Why Pharmacovigilance for Procurement
and Management Supply Plans?
• It is not always the product that determines
drug safety but how it is used
• More than 50% of ADRs are preventable
• there is a high risk of misuse of drugs
Disease
Population
Drug
Health care system
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Populations
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Mass treatment regimens,
Low standard of living and education,
Cultural specificities,
not always suffering from the diseases
unlabelled and off labelled indications
 (pregnant or breast feeding woman, small
children, elderly people),
 Drug and disease interactions.
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Urgent need for synergistic collaboration
PHP
PV
 detect, evaluate, and
 opportunity to
prevent adverse events
implement PV
 promote rational use of
activities
drugs in mass treatment
 Offer a cohort of
programmes
patients under
 Evaluate the impact of
controlled conditions
the programmes
to be monitored for
 improve acceptability of
safety over a period of
the programme
time
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Trachomatis
Filariasis
Tuberculosis
Malaria
Vaccines
INTEGRATING P.H.P AND PV
FUNCTIONAL AND STRUCTURAL RELATIONSHIP
W.H.O
PROGRAMMES
WHO ADVISORY
COMMITTEE
WHO-PV
(UMC)
DRUG REGULATORY
AUTHORITY
Trachomatis
Filariasis
Tuberculosis
Malaria
Vaccines
NATIONAL PUBLIC
HEALTH
PROGRAMMES
Expert Safety Review
Panel
PV Coordinator
National PV centre
DISTRICT
INVESTIGATION
TEAM
PATIENTS
PATIENTS
Health workers
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WHO Programme for
International Drug Monitoring
WHO
HQ
WHO
Collaborating
Centre, Uppsala
National
Centres
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WHO Programme for International
Drug Monitoring (HQ)
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•
•
•
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Policy
Exchange of Information
Technical support to countries
Advisory Committee on Safety of
Medicinal Products
World Health Organization
Exchange of Information
•
•
•
•
WHO Pharmaceuticals Newsletter
WHO Drug Alerts
WHO Drug Information
WHO Restricted Pharmaceuticals
List
• International Conference of Drug
Regulatory Authorities (ICDRA)
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Policies, Guidelines and Normative
Activities
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• Guidelines
– The Importance of Pharmacovigilance
(2002)
– Safety Reporting - A guide to detecting
and reporting adverse drug reactions
(2002)
– Pharmacovigilance in public health
– Safety monitoring of herbal medicines
– Advisory Committee on the Safety of
Medicines (ACSOMP)
World Health Organization
Country Support
• Strengthen spontaneous reporting
systems
• Establish active surveillance component
in public health programmes
HIV/AIDS
Malaria
Lymphatic filariasis
• Work with the WHO Collaborating Centre
for International Drug Monitoring (the
Uppsala Monitoring Centre)
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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 Programme for
International Drug Monitoring
WHO
HQ
WHO
Collaborating
Centre, Uppsala
National
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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WHO Programme for
International Drug Monitoring
WHO
HQ
WHO
Collaborating
Centre, Uppsala
National
Centres
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National centres
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•
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•
•
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China
India
Indonesia
Philippines
Sri Lanka
Thailand
Vietnam
Associate members:
• Nepal
• Pakistan
World Health Organization
Procurement and Supply
Management Plan
2.6 Ensuring rational use of
medicines
There should be a system for
monitoring adverse drug reactions
and drug resistance. Describe
briefly how the system works.
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World Health Organization