Zambia Pharmacovigilance Action Plan

National Plan Revision Proposal

Dr Albert Mwango

Mrs Bernice Mwale September 2004

BackgroundNeed 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

BackgroundLegal

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

BackgroundImplementation

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

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

Key Information flowCourier info flowMoH-Ministry of HealthCBoH-Central Board of HealthNMCP-National Malaria Control ProgramUNZA- University of ZambiaTDRC-Tropical Diseases Research CenterUMC-Uppsala Monitoring CenterWHO-World Health Center

Proposed Organogram for Zambian Pharmacovigilance (PV) System

UMC WHOSafety Review Expert Panel

Health facilitiesPublic

Pharmacies, Antenatal Clinics

Private ClinicsPatients & Public

District PVC

Professional Regulatory Bodies

& AssociationsMoH/CBoH NMCP,UNZA

TDRC

Media

ProvincialPVC

ZambiaPV

Center

Manufacturers & Distributors

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

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

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

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

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

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

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

Other Concerns Critical Success Factors

Well established Health programmes GF resources and others e.g. PEPFAR, DFID On-going trainings Clearly defined responsibilities

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

Pharmacovigilance TrainingsWho 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

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

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

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)

Thank you! Safe trip home

Albert Bernice