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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE. INTRODUCING PV INTO MALARIA PROGRAMME. Sevene E, Mariano A, Mola D Faculty of Medicine Pretoria, September 2004. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE. INTRODUCTION. Introduction of the new policy in the treatment of malaria

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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE

INTRODUCING PV INTO MALARIA

PROGRAMME

Sevene E, Mariano A, Mola D

Faculty of Medicine

Pretoria, September 2004

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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • INTRODUCTION
  • Introduction of the new policy in the treatment of malaria
  • Need of PV systems to monitor antimalarial drugs
  • Proposal of implementation of PV in Mozambique
  • Pilot phase in two districts (Namaacha and Matutuíne)
  • Safety monitoring of all drugs is a public health need
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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • THE PILOT PHASES

Objectives

  • Test the proposed national ADR report form
  • Test the training materials
  • Train health professionals
  • Test communication between health staff and CIMed
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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • THE PILOT PHASES

Activities

  • Development of ADR forms
  • Training health professionals
      • methodology
      • training materials
      • guidebook
  • Quality assurance visits
  • How to fill the form
      • Flow of information
  • Membership application
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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • THE PILOT PHASES

Results

  • The first version of the ADR report form was printed
  • The program and methodology to use in the training were finalized
  • The guidebook for health professionals is ready to be printed
  • The flow of information from district level to CIMed was tested
  • Admission to UMC/WHO programme
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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • THE PILOT PHASES

Results

  • About 30 health professionals were trained
  • CIMed received 45 ADR reports
  • 2 were unclassified
  • Out of the 43 reports
  • 33 (76.7%) were from Namaacha
  • 10 (23.3%) from Matutuíne
  • Only 2 medical doctors reported
  • The other reports were from technicians, nurses and agents (medium and basic level)
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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • THE PILOT PHASES

Conclusions and recommendations

  • Is possible to implement a PV system in Mozambique
  • The contributions of different health professionals are crucial
  • The health professionals from different levels are able to fill in the ADR forms and send to CIMed
  • Implementation has to be followed by supervisory site visits to improve and stimulate reporting
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PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
  • THE PILOT PHASES

Conclusions and recommendations

  • We found differences between the 2 districts
  • The implementation of the PV system needs time and trained personal.
  • Collaboration with Malaria control programme and other DCP could help to expanding and sustaining the system
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SUSPECT

REPORT

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