Download Pharmacovigilance - World Health Organization

Pharmacovigilance in public
health programmes
Author: Oscar O Simooya,
Copperbelt University, Kitwe, Zambia
Presented at the training course for introducing
pharmacovigilance in public health programmes
1 –10 September 2004, Pretoria , South Africa
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Topics

Introduction
 Definitions
 Challenges of pharmacotherapy
 SWOT analysis of PHPs and PV
 Update on the malaria PV project
 Conclusion
 Acknowledgements
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Introduction





no drug is completely safe
drugs may contribute to 5 –10% of all hospital
admissions
10 –20% of all inpatients may suffer a serious
ADR in hospital
ADRs 4th to 6th leading cause of deaths in USA
ADRs may contribute 5 –10% of hopsitalcosts
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Therefore ………
the monitoring of the adverse effects of drugs
is an important component of good medical
practice
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Hippocrates (460 –377 B.C.)
‘ Above all, do no harm ’
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Definitions …..
Public health
The science or art of preventing disease,
prolonging life and promoting health and
efficiency through organised community
effort
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Definitions…..
Pharmacovigilance
The science for the detection,assessment and
prevention of adverse reactions to drugs
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Components of public health
programmes (PHPs)

education
 environmental modification
 nutrition intervention
 lifestyle and behaviour change
 pharmacotherapy
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Goals and objectives of
pharmacovigilance

the rationale and safe use of drugs
 the assessment and communication of
benefits/risks of drugs
 educating and informing patients
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Goals and objectives of
pharmacovigilance …….
Specific objectives



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early detection of hitherto unknown ADRs
detection of increases in frequency of known
ADRs
identification of risk factors and possible
mechanisms underlying ADRs
estimation of benefit/risk
dissemination of information
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Challenges of
pharmacotherapy in PHPs ….

may use agencies and staff with a wide
variety of skills and patients may not be
seen by a physician
 insufficient diagnosis and follow up
 large numbers exposed, may include special
populations i.e. pregnant &breast feeding
mothers
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Challenges of
pharmacotherapy in PHPs ….

use of new drugs with limited experience,
i.e. ARVs, ACTs; use of substandard
drugs;incorrect use of drugs;counterfeit
drugs
 weak health care systems, often poor drug
control/legislation
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SWOT analysis of PHPs and
PV
Strengths of PHPs

well established roles
 usually well funded
 technical guidelines
 monitoring and evaluation procedures
 good databases
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SWOT analysis of PHPs and
PV ……
Strengths of PV

new drugs , high interest in drug safety
 exists in a few African countries
 expertise in assessment of drug safety
 training in benefit/risk assessment
 good international support, WHO, UMC
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SWOT analysis of PHPs and
PV ……
Weaknesses of PHPs

lack experience in drug safety monitoring
 drugs used in PHPs considered safe
 lack of coordination between PHPs,
duplication
 may cover special populations
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SWOT analysis of PHPs and
PV ……
Weaknesses of PV

relatively new concept
 role not well recognised
 poorly funded, considered a luxury
 not seen as a component of PHPs
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SWOT analysis of PHPs and
PV ……
Opportunities
together, PV and PHPs may greatly benefit
each other. PV will assist in the early
identification and prevention of ADRs and
product quality problem ……..
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SWOT analysis of PHPs and
PV ……
Opportunities
PHPs may provide resources, reliable
databases,M&E tools leading to …….
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SWOT analysis of PHPs and
PV ……
Opportunities
1.
2.
3.
rationale drug use
better patient adherence
improved drug procurement
All this will lead to …….
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SWOT analysis of PHPs and
PV ……
BETTER HEALTH
OUTCOMES AND
RESOURCE SAVINGS
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SWOT analysis of PHPs and
PV …..
Threats

lack of political/public support
 funding shortfalls
 misunderstanding of each other’s roles
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The malaria PV
project – an
update
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Background

artemisinins highly effective for malaria
 recommended in combination for use in
malaria endemic regions
 efficacy and safety well documented in SEA
 new to malaria area of Africa
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Therefore ……..
Need to monitor efficacy and safety in new
populations and in areas with co morbid
conditions such as HIV/AIDS, TB and
malnutrition
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Launched ……..
March/April 2003 following training
workshop on phamarcovigilance held in
Lusaka, Zambia to introduce drug safety
monitoring in Burundi, DRC, Mozambique,
Zambia and Zanzibar
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Lusaka workshop

organised by WHO and UMC
 attended by national malaria managers &
drug regulatory authorities
 course based on international PV course run
by UMC
 basic skills in ADR monitoring covered
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…. Lusaka workshop
Resolutions

draft action plans from each country
 action plans to be presented to health
authorities
 monitoring to cover antimalarials but to
extend to HIV/AIDS, TB and immunisation
programmes
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Project Description
Goals

to introduce PV in Burundi, DRC,
Mozambique, Zambia and Zanzibar
 initially planned to monitor ACTs but to roll
out to other PHPs
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Project description
Specific objectives/activities

training in PV for key personnel
 introduce concept of PV to health
authorities
 prepare proposals and protocols for ADR
monitoring
 creation of centres for PV, staff, equipment
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Project description
Specific objectives /activities

prepare case report forms
 create databases
 training of health personnel
 stimulation of reporting
 linkage to international networks
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Achievements

Training of PV resource persons

took place March/April 2003
 attended by 18 malaria managers and drug
regulators
 basic skills of ADR monitoring and
operations of PV centres
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Achievements
Government approval
written commitment to PV obtained in all
countries, in DRC Minister of Health wrote
to WHO supporting PV and in Burundi,
met with Minister of Health to discuss PV
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Achievements
Preparation of proposals and protocols
prepared and submitted in all countries.
Includes detailed budgets for operation of PV
centres
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Achievements
Creation of PV centres, design of case forms
and data base
Location of centres agreed: Burundi –
directorate of pharmacy, DRC – drug
regulatory offices, Mozambique – CIMed,
Zambia – pharmacy board, Zanzibar –
malaria programme
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Achievements
Training of health workers
On going in all countries, latest in DRC for
nursing staff, from 13th August 2004
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Achievements
Preparation of case report forms
AVAILABLE IN ALL COUNTRIES
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Challenges
Creation of data base compatible with the
WHO programme
AWAITS DEVELOPMENT IN ALL
COUNTRIES
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Needs assessment

source funding for activities
 continued training
 stimulation of reporting
 creation of databases
 networking with other PHPs
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Lessons learnt

good progress in all countries
 need for PV recognised
 training of key personnel vital
 government and international support
needed
 linkages with international network need
strengthening
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Recommendations

culture of reporting ADRs must be
stimulated
 development of data bases
 training of health workers vital
 integration with other PHPs
 networking with international groups must
continue
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Conclusion
Good progress made in early implementation
with key personnel in place and active. Need
to scale up activities with stimulation of
reporting and data collection
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Acknowledgements

Participating countries
 World Health Organisation
 Uppsala Monitoring Centre
 University of Cape Town
 Colleagues
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Thank you for your attention and
patience
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