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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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