1. Sevene E, Mariano A, Mola D Faculty of Medicine / Ministry of Health Pretoria, September 2004 PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE INTRODUCING PV INTO HIV/AIDS PROGRAMME

2. Population: 19 millionPopulation: 19 million Prevalence of HIV: 14%Prevalence of HIV: 14% The highest prevalence (20%) is found along the central ProvincesThe highest prevalence (20%) is found along the central Provinces An estimated 1.2 million Mozambicans are living with HIVAn estimated 1.2 million Mozambicans are living with HIV 290,000 of them with AIDS.290,000 of them with AIDS. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  INTRODUCTION

3. 83,000 people died of AIDS-related diseases in 199783,000 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 availableAs a result of HIV/AIDS infection, life expectancy will decrease to 37 years if no treatment available 20 Day Hospitals are available20 Day Hospitals are available 40,000 patients registered in Day Hospitals40,000 patients registered in Day Hospitals Only 4,000 are on ARVTOnly 4,000 are on ARVT PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  INTRODUCTION

4. Introduction of the ARVT is crucialIntroduction of the ARVT is crucial Need of PV systems to monitor the new drugsNeed 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 marketProposal 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 needSafety monitoring of all drugs is a public health need PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  INTRODUCTION

5. Detect and report ADRDetect and report ADR Assess signals to evaluate causalityAssess signals to evaluate causality Assess the risk-benefit profile and implications to public healthAssess the risk-benefit profile and implications to public health Prevention of ADR by promoting rational drug usePrevention of ADR by promoting rational drug use Communicate and recommend to authorities and the publicCommunicate and recommend to authorities and the public Recommend appropriate response or actionRecommend appropriate response or action PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  OBJECTIVES OF THE SYSTEM

6. All Health ProfessionalsAll Health Professionals Medical doctors Pharmacists Health technicians Nurses Care providers Patients…Patients… PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  WHO SHOULD REPORT

7. All suspected ADR (including non serious)All suspected ADR (including non serious) For new drugs/combinations (anti-malarial, ARV, anti-TB) should be reported all suspected eventFor new drugs/combinations (anti-malarial, ARV, anti-TB) should be reported all suspected event An increase of frequency of known ADRAn increase of frequency of known ADR Treatment failureTreatment failure PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  WHAT SHOULD BE REPORTED?

8. SUSPECT REPORT

9. Spontaneous reportSpontaneous report ADR report form will be available in the health facilities.ADR report form will be available in the health facilities. The filled form should be sent to CIMed according to the flow of information.The filled form should be sent to CIMed according to the flow of information. Cohort studiesCohort studies Selected sitesSelected sites Needs investigators collaborationNeeds investigators collaboration PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  HOW SHOULD MONITORING ACCUR?

10. A acknowledgement letter of the reception of the reportA acknowledgement letter of the reception of the report Report of causality assessmentReport of causality assessment A drug information bulletinA drug information bulletin A new report formA new report form Drug information when requestedDrug information when requested PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  WHAT DOES THE REPORTER RECEIVE?

11. Assess causalityAssess causality Investigation by investigators team and/or Therapeutic Committee.Investigation by investigators team and/or Therapeutic Committee. Information about the report will be sent to the reporter.Information about the report will be sent to the reporter. Make decision about the drug (DP)Make decision about the drug (DP) Report regularly to DCPReport regularly to DCP PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  WHAT HAPPEN WITH THE REPORT IN CIMed?

13. 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 RESOURCES AVAILABLE?

14. 1.Lack of Human Resources 2. Coordination 3. Training health professionals 3. Training health professionals 4. Stimulate reporting 4. Stimulate reporting PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE  WHAT ARE THE CRITICAL SUCCESS FACTOR? Programmes CIMed Health Providers

15. PV Training plan- Mozambique TitleTraining of trainers in Pharmacovigilance ObjectivesRecognize, manage and report ADRs and develop a training plan ContentsPharmacovigilance/ARVs safety issues Target groupHealth professionals (medical Doctors, Pharmacists, nurses) Duration5 Days MethodologyLecture, group discussion, role play, case study, plenary discussion EvaluationDaily summarization at the end of each day on group basis Evaluation forms which includes (strength, weakness, suggestion) Follow upBy focal person, Quality site visits

16. PHARMACOVIGILANCE SYSTEM - MOZAMBIQUE OBRIGADA (thank you)