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

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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
• 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 drugsincorrect
  use of drugscounterfeit 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,ME 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 others 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