Transcript mozambique
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% •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. 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 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 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 PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE WHO SHOULD REPORT •All Health Professionals Medical doctors Pharmacists Health technicians Nurses Care providers •Patients… 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 SUSPECT REPORT 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 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 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 Patient flow Report flow Feedback Information flow Patient/Public Trad. Healers C. Leaders District Health Center Out Patient Hospital Rural/General Provincial/Central Investigation team pMTCT VCT Private Sector Day Hospital (DH) DH Chief Pharmacist CIMed CTTF MOH Education Pharmaceutical Depart. Depart. Media Importers/Industry DCP 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 PV Training plan- Mozambique Title Training of trainers in Pharmacovigilance Objectives Recognize, manage and report ADRs and develop a training plan Contents Pharmacovigilance/ARVs safety issues Target group Health professionals (medical Doctors, Pharmacists, nurses) Duration 5 Days Methodology Lecture, group discussion, role play, case study, plenary discussion Evaluation Daily summarization at the end of each day on group basis Evaluation forms which includes (strength, weakness, suggestion) Follow up By focal person, Quality site visits PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE OBRIGADA (thank you)