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

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

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  1. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE INTRODUCING PV INTO MALARIA PROGRAMME Sevene E, Mariano A, Mola D Faculty of Medicine Pretoria, September 2004

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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

  9. SUSPECT REPORT

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