Pharmacovigilance in public health programmes
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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. 1. Topics. Introduction Definitions

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Pharmacovigilance in public health programmes l.jpg

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

1


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Topics

  • Introduction

  • Definitions

  • Challenges of pharmacotherapy

  • SWOT analysis of PHPs and PV

  • Update on the malaria PV project

  • Conclusion

  • Acknowledgements

2


Introduction l.jpg
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

  • 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

  • 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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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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