Pharmacovigilance in public health programmes Author: Oscar O Simooya, Copperbelt University, Kitwe, Zambia Presented at the training course for introducing

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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Hippocrates (460 –377 B.C.)Hippocrates (460 –377 B.C.)

‘ Above all, do no harm ’

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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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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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Weaknesses of PV

relatively new conceptrole not well recognisedpoorly funded, considered a luxurynot seen as a component of PHPs

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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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Opportunities

PHPs may provide resources, reliable

databases,M&E tools leading to …….

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Opportunities

1. rationale drug use2. better patient adherence3. improved drug procurement

All this will lead to …….

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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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The malaria PV The malaria PV project – an project – an updateupdate

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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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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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Preparation of proposals and protocols

prepared and submitted in all countries.

Includes detailed budgets for operation of PV

centres

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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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Training of health workers

On going in all countries, latest in DRC for

nursing staff, from 13th August 2004

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Preparation of case report forms

AVAILABLE IN ALL COUNTRIES

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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

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Thank you for your attention and Thank you for your attention and patiencepatience

Documents

Pharmacovigilance in public health programmes Author: Oscar O Simooya, Copperbelt University, Kitwe, Zambia Presented at the training course for introducing