PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE INTRODUCING PV INTO HIV/AIDS PROGRAMME Sevene E, Mariano A, Mola D Faculty of Medicine / Ministry of Health Pretoria, September 2004
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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
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Population: 19 million
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Prevalence of HIV: 14%
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The highest prevalence (20%) is found along the central Provinces
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An estimated 1.2 million Mozambicans are living with HIV
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290,000 of them with AIDS.
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
INTRODUCTION
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83,000 people died of AIDS-related diseases in 1997
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As a result of HIV/AIDS infection, life expectancy will decrease to 37 years if no treatment available
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20 Day Hospitals are available
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40,000 patients registered in Day Hospitals
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Only 4,000 are on ARVT
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
INTRODUCTION
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Introduction of the ARVT is crucial
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Need of PV systems to monitor the new drugs
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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
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Safety monitoring of all drugs is a public health need
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
OBJECTIVES OF THE SYSTEM
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Detect and report ADR
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Assess signals to evaluate causality
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Assess the risk-benefit profile and implications to public health
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Prevention of ADR by promoting rational drug use
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Communicate and recommend to authorities and the public
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Recommend appropriate response or action
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
WHO SHOULD REPORT
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All Health Professionals Medical doctors Pharmacists Health technicians Nurses Care providers
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Patients …
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
WHAT SHOULD BE REPORTED?
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All suspected ADR (including non serious)
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For new drugs/combinations (anti-malarial, ARV, anti-TB) should be reported all suspected event
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An increase of frequency of known ADR
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Treatment failure
SUSPECT REPORT
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
HOW SHOULD MONITORING ACCUR?
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Spontaneous report
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ADR report form will be available in the health facilities.
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The filled form should be sent to CIMed according to the flow of information.
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Cohort studies
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Selected sites
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Needs investigators collaboration
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
WHAT DOES THE REPORTER RECEIVE?
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A acknowledgement letter of the reception of the report
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Report of causality assessment
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A drug information bulletin
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A new report form
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Drug information when requested
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
WHAT HAPPEN WITH THE REPORT IN CIMed?
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Assess causality
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Investigation by investigators team and/or Therapeutic Committee.
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Information about the report will be sent to the reporter.
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Make decision about the drug (DP)
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Report regularly to DCP
Patient/Public
Trad. Healers C. Leaders
Hospital Rural/General Provincial/Central District Health Center Out Patient pMTCT VCT Day Hospital (DH)
Private Sector
Patient flow Report flow Feedback Information flow Investigation team DH Chief Pharmacist
Media CIMed
CTTF
MOH
Education Depart.
Pharmaceutical Depart.
DCP Importers/Industry UMC WHO
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
WHAT ARE THE RESOURCES AVAILABLE?
1. Pharmacovigilance center already exist 2. Disease control programme have started implementing their action plans 3. The 3 by 5 initiative
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE
WHAT ARE THE CRITICAL SUCCESS FACTOR?
1. Lack of Human Resources 2. Coordination CIMed Programmes Health Providers 3. Training health professionals 4. Stimulate reporting
Title Objectives Contents PV Training plan- Mozambique
Training of trainers in Pharmacovigilance Recognize, manage and report ADRs and develop a training plan Pharmacovigilance/ARVs safety issues
Target group Duration Methodology
Health professionals (medical Doctors, Pharmacists, nurses) 5 Days Lecture, group discussion, role play, case study, plenary discussion
Evaluation Follow up
Daily summarization at the end of each day on group basis Evaluation forms which includes (strength, weakness, suggestion) By focal person, Quality site visits
PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE