Transcript No Slide Title - World Health Organization

Pharmacovigilance
Shanthi Pal, M.Pharmacy, PhD
Quality Assurance and Safety of Medicines
WHO
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
 Participants will learn what they could do in
pharmacovigilance
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Medicine Safety
To undergo treatment
you have to be very
healthy, because apart
from your sickness
you have to withstand
the medicine.
Molière
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Pharmacovigilance
What IS this?
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?
Adverse Drug Reactions are among the top ten
causes of mortality
(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%.
(Bhalla et al, 2003; 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
HQ
WHO
Collaborating
Centre, Uppsala
National
Centres
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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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Why Pharmacovigilance for Procurement and
Management Supply Plans?
 It is not always the product that determines drug
safety but how it is used
 There is a high risk of misuse of drugs
Disease
Population
Drug
Health care system
 More than 50% of ADRs are preventable
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Public Health or
community health
Science and art of preventing disease,
prolonging life and promoting health and
efficiency through organized community
efforts.
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Public Health Programmes
 Specific to each country (developed or
developing)
 Dependent on:
The specific burden of illness
The epidemiology of prevalent disease
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DEVELOPING COUNTRIES
 Endemic and/or epidemic diseases
Tuberculosis, Leprosy, HIV/AIDS, STD
Malaria, Schistosomiasis, Amoebiasis,
Leishmaniasis, Trachoma, Lymphatic filariasis, Onchocerciasis,

High morbidity and mortality rates
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PHP
 Education
 Environmental modifications
 Nutrition intervention
 Lifestyle and behavioural changes
 Mass free distribution of drugs
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PHP ORGANIZATION
SPONSORS
WHO
OTHERS
Others
Filariasis
HIV/AIDS
LEVETuberculosis
L Malaria
Vaccines
PROGRAMME MANAGERS
LOCAL COORDINATOR FOR
HEALTH PROGRAMMES
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PUBLIC
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HEALTH
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PROGRAMMES
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HEALTH WORKERS
PATIENTS
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PHP monitoring
 Incidence and prevalence of the disease
 Morbidity and mortality rates
 Number of patients treated
 Number of drug units delivered
What about the risk / effectiveness of drugs
used?
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PHP guidelines (WHO, National)
Inadequate (no) reference to:
 ADRs
 Pharmacovigilance
 Reporting
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New Challenges in PHPs
 Mass treatment regimens
 Nutritional aspects
 Unlabelled and off-labelled indications
(pregnant or breast feeding woman, small children, elderly
people)
 Drug resistances
 New drugs
 Co-morbidities
 Adherence
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Eroding confidence in the malaria programme
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Italian
Cohort
I
C O
N A
Naive
Antiretroviral
Main reasons of discontinuation
of first HAART regimen within
1st year: ICONA
Toxicity
Failure
Non-adherence
Other
Continued
Monforte et al. AIDS 1999
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HIV / AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
WHO-PV
(UMC)
WHO
PROGRAMMES
EXISTING SYSTEMS
HIV/AIDS
Filariasis
Tuberculosis
Malaria
Vaccines
NATIONAL PUBLIC
HEALTH
PROGRAMMES
PV Coordinator
National PV centre
Health
workers
Health
workers
PATIENTS
PATIENTS
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Urgent need for synergistic collaboration
PHP
 opportunity to implement PV
activities
 Offer a cohort of patients under
controlled conditions to be
monitored for safety over a
period of time
PV
 detect, evaluate, and prevent
adverse events
 promote rational use of drugs in
mass treatment programmes
 Evaluate the impact of the
programmes
 improve acceptability of the
programme
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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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PV and PHP Synergy
 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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Malaria Collaboration

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Joint training course
Joint reviews of specific antimalarials
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Artemesinin derivatives
Chlorproguanil-dapsone
Amodiaquine-artesunate
Joint initiatives for collaboration with
pharmaceutical industry – Novartis
Agreement
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Collaboration with HIV/AIDS
 Workshop in Pretoria 2004
 Action plan developed by ACSoMP 2005
 Joint training course planned for April 2006
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Collaboration with TDR
 Chlorproguanil-dapsone example
 Joint initiatives on post-marketing
surveillance studies (Phase 4 clinical trials)
 Joint initiatives on development of pregnancy
registers for antimalarials and antrietrovirals
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"Dying from a disease is sometimes
unavoidable. But, dying from an adverse
drug reaction is unacceptable".
- Dr Vladimir Lepakhin
Geneva 2005
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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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Thank You
Merci beaucoup !