Pharmacovigilance in public health programmes Author: Oscar O Simooya, Copperbelt University, Kitwe,...
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Transcript of Pharmacovigilance in public health programmes Author: Oscar O Simooya, Copperbelt University, Kitwe,...
Pharmacovigilance in public Pharmacovigilance in public health programmeshealth 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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TopicsTopics
IntroductionDefinitionsChallenges of pharmacotherapySWOT analysis of PHPs and PVUpdate on the malaria PV projectConclusionAcknowledgements
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IntroductionIntroduction
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 ………Therefore ………
the monitoring of the adverse effects of drugs
is an important component of good medical
practice
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Definitions …..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…..Definitions…..
Pharmacovigilance
The science for the detection,assessment and
prevention of adverse reactions to drugs
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Components of public health Components of public health programmes (PHPs)programmes (PHPs)
educationenvironmental modificationnutrition interventionlifestyle and behaviour changepharmacotherapy
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Goals and objectives of Goals and objectives of pharmacovigilancepharmacovigilance
the rationale and safe use of drugsthe assessment and communication of
benefits/risks of drugseducating and informing patients
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Goals and objectives of Goals and objectives of pharmacovigilance …….pharmacovigilance …….
Specific objectives
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 Challenges of pharmacotherapy in PHPs ….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 uplarge numbers exposed, may include special
populations i.e. pregnant &breast feeding mothers
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Challenges of Challenges of pharmacotherapy in PHPs ….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 SWOT analysis of PHPs and PV PV
Strengths of PHPs
well established rolesusually well fundedtechnical guidelinesmonitoring and evaluation proceduresgood databases
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV ……PV ……
Strengths of PV
new drugs , high interest in drug safetyexists in a few African countriesexpertise in assessment of drug safety training in benefit/risk assessmentgood international support, WHO, UMC
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV ……PV ……
Weaknesses of PHPs
lack experience in drug safety monitoringdrugs used in PHPs considered safelack of coordination between PHPs,
duplicationmay cover special populations
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV ……PV ……
Weaknesses of PV
relatively new conceptrole not well recognisedpoorly funded, considered a luxurynot seen as a component of PHPs
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV ……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 SWOT analysis of PHPs and PV ……PV ……
Opportunities
PHPs may provide resources, reliable
databases,M&E tools leading to …….
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV ……PV ……
Opportunities
1. rationale drug use2. better patient adherence3. improved drug procurement
All this will lead to …….
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV ……PV ……
BETTER HEALTH
OUTCOMES AND
RESOURCE SAVINGS
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SWOT analysis of PHPs and SWOT analysis of PHPs and PV …..PV …..
Threats
lack of political/public supportfunding shortfallsmisunderstanding of each other’s roles
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BackgroundBackground
artemisinins highly effective for malariarecommended in combination for use in
malaria endemic regionsefficacy and safety well documented in
SEAnew to malaria area of Africa
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Therefore ……..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 ……..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 workshopLusaka workshop
organised by WHO and UMCattended by national malaria managers &
drug regulatory authoritiescourse based on international PV course run
by UMCbasic skills in ADR monitoring covered
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……. Lusaka workshop. Lusaka workshop
Resolutions
draft action plans from each countryaction plans to be presented to health
authoritiesmonitoring to cover antimalarials but to
extend to HIV/AIDS, TB and immunisation programmes
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Project DescriptionProject 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 descriptionProject description
Specific objectives/activities
training in PV for key personnelintroduce concept of PV to health
authoritiesprepare proposals and protocols for ADR
monitoringcreation of centres for PV, staff, equipment
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Project description Project description
Specific objectives /activities
prepare case report formscreate databasestraining of health personnelstimulation of reportinglinkage to international networks
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AchievementsAchievements
Training of PV resource persons
took place March/April 2003attended by 18 malaria managers and drug
regulatorsbasic skills of ADR monitoring and
operations of PV centres
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AchievementsAchievements
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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AchievementsAchievements
Preparation of proposals and protocols
prepared and submitted in all countries.
Includes detailed budgets for operation of PV
centres
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AchievementsAchievements
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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AchievementsAchievements
Training of health workers
On going in all countries, latest in DRC for
nursing staff, from 13th August 2004
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ChallengesChallenges
Creation of data base compatible with the
WHO programme
AWAITS DEVELOPMENT IN ALL
COUNTRIES
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Needs assessmentNeeds assessment
source funding for activitiescontinued trainingstimulation of reportingcreation of databasesnetworking with other PHPs
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Lessons learntLessons learnt
good progress in all countriesneed for PV recognisedtraining of key personnel vitalgovernment and international support
neededlinkages with international network need
strengthening
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RecommendationsRecommendations
culture of reporting ADRs must be stimulated
development of data basestraining of health workers vitalintegration with other PHPsnetworking with international groups must
continue
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ConclusionConclusion
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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AcknowledgementsAcknowledgements
Participating countriesWorld Health OrganisationUppsala Monitoring CentreUniversity of Cape TownColleagues