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Sevene E, Mariano A, Mola D Faculty of Medicine / Ministry of Health Pretoria, September 2004

PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE. INTRODUCING PV INTO HIV/AIDS PROGRAMME. Sevene E, Mariano A, Mola D Faculty of Medicine / Ministry of Health Pretoria, September 2004. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE. INTRODUCTION. Population: 19 million Prevalence of HIV: 14%

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Sevene E, Mariano A, Mola D Faculty of Medicine / Ministry of Health Pretoria, September 2004

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  1. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE INTRODUCING PV INTO HIV/AIDS PROGRAMME Sevene E, Mariano A, Mola D Faculty of Medicine / Ministry of Health Pretoria, September 2004

  2. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • INTRODUCTION • Population: 19 million • Prevalence of HIV: 14% • The highest prevalence (20%) is found along the central Provinces • An estimated 1.2 million Mozambicans are living with HIV • 290,000 of them with AIDS.

  3. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • INTRODUCTION • 83,000 people died of AIDS-related diseases in 1997 • As a result of HIV/AIDS infection, life expectancy will decrease to 37 years if no treatment available • 20 Day Hospitals are available • 40,000 patients registered in Day Hospitals • Only 4,000 are on ARVT

  4. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • INTRODUCTION • Introduction of the ARVT is crucial • Need of PV systems to monitor the new drugs • Proposal of PV system in Mozambique was developed in order to be implemented in collaboration with diseases control programmes (malaria, HIV/AIDS, TB, immunization) to achieve the goal of monitoring all drugs in the market • Safety monitoring of all drugs is a public health need

  5. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • OBJECTIVES OF THE SYSTEM • Detect and report ADR • Assess signals to evaluate causality • Assess the risk-benefit profile and implications to public health • Prevention of ADR by promoting rational drug use • Communicate and recommend to authorities and the public • Recommend appropriate response or action

  6. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • WHO SHOULD REPORT • All Health Professionals • Medical doctors • Pharmacists • Health technicians • Nurses • Care providers • Patients…

  7. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • WHAT SHOULD BE REPORTED? • All suspected ADR (including non serious) • For new drugs/combinations (anti-malarial, ARV, anti-TB) should be reported all suspected event • An increase of frequency of known ADR • Treatment failure

  8. SUSPECT REPORT

  9. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • HOW SHOULD MONITORING ACCUR? • Spontaneous report • ADR report form will be available in the health facilities. • The filled form should be sent to CIMed according to the flow of information. • Cohort studies • Selected sites • Needs investigators collaboration

  10. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • WHAT DOES THE REPORTER RECEIVE? • A acknowledgement letter of the reception of the report • Report of causality assessment • A drug information bulletin • A new report form • Drug information when requested

  11. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • WHAT HAPPEN WITH THE REPORT IN CIMed? • Assess causality • Investigation by investigators team and/or Therapeutic Committee. • Information about the report will be sent to the reporter. • Make decision about the drug (DP) • Report regularly to DCP

  12. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • WHAT ARE THE RESOURCES AVAILABLE? • Pharmacovigilance center already exist • 2. Disease control programme have started implementing their action plans • 3. The 3 by 5 initiative

  13. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE • WHAT ARE THE CRITICAL SUCCESS FACTOR? • Lack of Human Resources • 2. Coordination • 3. Training health professionals • 4. Stimulate reporting CIMed Programmes Health Providers

  14. PV Training plan- Mozambique

  15. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE OBRIGADA (thank you)

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