1. Zambia Pharmacovigilance Action Plan National Plan Revision Proposal Dr Albert Mwango Mrs Bernice MwaleSeptember 2004

2. Background Need for Pharmacovigilance  Studies show increase in medicines related morbidity and mortality  High financial burdens are associated with treating these Adverse drug reactions  There is limited information on drugs in Zambia  Irrational drug use is common

3. Background Legal  In the new legislation which comes in to effect in January 2005, the PVC activities will be overseen by the Pharmaceutical Regulatory Authority (PRA)  The PRA will set up the Zambia Pharmacovigilance Center (ZPVC) & co- ordinate all PV activities

4. Background Implementation  Original plan was centered on Anti-malarials ADR reporting as pathfinder  The aim is to revise current plan to be more inclusive for all drugs especially new drugs like ARVs  ART programme will adopt suggested Pharmacovigilance system

5. Geographical Overview  Nine (09) Provinces  Each province has a provincial capital and is divided into districts  Seventy two (72) districts in the country Zambia’s Provinces

6. Key Information flow Courier info flow MoH-Ministry of Health CBoH-Central Board of Health NMCP-National Malaria Control Program UNZA- University of Zambia TDRC-Tropical Diseases Research Center UMC-Uppsala Monitoring Center WHO-World Health Center Proposed Organogram for Zambian Pharmacovigilance (PV) System UMCWHO Safety Review Expert Panel Health facilities Public Pharmacies, Antenatal Clinics Private Clinics Patients & Public District PVC Professional Regulatory Bodies & Associations MoH/CBoH NMCP,UNZA TDRC Media Provincial PVC Zambia PV Center Manufacturers & Distributors

7. Roles and Responsibilities  Zambia PV Center Create database of ADRs of registered drugs Provide triplicate ADR forms Collect and archive information Timely response to signals and provide feedback  District PV Center Collect ADR forms from health facilities & public Verify and forward information fortnightly basis to ZPVC Forward feedback to reporters

8. Roles and Responsibilities  Health Facilities Originate ADRs reports Forward reports to DPVC Archive triplicate copy Institute appropriate action on ADR based on feedback  Media Support promotion of PV activities thru MoH/CBoH and professional bodies Disseminate information in all media

9. Roles and Responsibilities  Safety Review Expert Panel Comprised of  The National PV Coordinator  Clinical Pharmacologist  Physician  Pediatrician  Obstetrician  Pharmacist  Additional expertise on Adhoc basis To analyze reports & provide recommendations  WHO/UMC Serve as repository of information Support logistics, Provide guidelines and technical support Respond to special issues on Drug Safety

10. Roles and Responsibilities  TDRC,UNZA Provide information on research findings Include PV in pre- service training  Professional Regulatory Bodies To promote compliance to reporting ADRs Ensure that that only qualified personnel prescribe & dispense

11. Roles and Responsibilities  MoH & CBoH Provide policy direction Resource mobilization Support PV activities thru specific Health Programmes  PRA Source of information on quality, safety and efficacy of drugs Assess and advise on recommendations from the Safety Review Expert Panel

12. Roles and Responsibilities  Professional Bodies Create public awareness on drug safety Encourage their members to participate in PV activities  Manufactures & Distributors To provide information on the drugs supplied Provide reports on ADRs and related information Take appropriate action following signal decisions Participate in post marketing surveillance

13. Other Concerns  Managing Non-serious ADRs Acknowledge all receipt of reports Provide information on management recommended in National Guidelines  Resources Available Health Programmes resources Co-operating Partners Ministry of Health

14. Other Concerns  Critical Success Factors Well established Health programmes GF resources and others e.g. PEPFAR, DFID On-going trainings Clearly defined responsibilities

15. Obstacles  Bring on board all National/regional Health Programmes  Identifying Isolated groups and bring them on board  Resource Mobilization- who will be responsible  Setting up Monitoring and Evaluation systems/team  Motivation of reporters especially Health Care Professionals

16. Pharmacovigilance Trainings Who will be training?  Use current trainings of existing Health Programmes e.g. ART, Malaria, & Anti-TB programmes  Orient Trainers in existing Health Programmes or provide special training for isolated groups Who will be trained?  Target groups Health care teams Non-health agents Workplace programmes Professional bodies meetings e.g. MCZ, PSZ Pre-service training Medical, Pharmacy, Nursing etc

17. Pharmacovigilance Trainings(2)  What is the objective of training? To allow the trainees: To be able to define and recognize ADRs and related aspects Understand the importance and reasons for ADR monitoring and reporting Know how to report an ADR using an ADR Report Form

18. Pharmacovigilance Trainings(3)  Manuals already in existence for Rational Drug Use  Training material can be reviewed and added to  What do you want to achieve? Incorporate PV awareness in all health programmes Reduce ADR related mortality & morbidity Identify new ADRs Promote rational use of drugs Increase drug information Reduce financial burden on health sector

19. Activity Road Map  Debrief of CBoH and PRA  Multi-programme joint meeting  Review Budget and Logistics  Infusion of PV in health programmes  Launch of ZPVC (Timelines to be set after consultations)

20. Thank you! Safe trip home Albert Bernice