Transcript Zambia Pharmacovigilance Action Plan

Zambia Pharmacovigilance
Action Plan
National Plan Revision Proposal
Dr Albert Mwango
Mrs Bernice Mwale
September 2004
Background
Need for Pharmacovigilance
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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
Background
Legal
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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) & coordinate all PV activities
Background
Implementation
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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
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Nine (09) Provinces
Each province has a
provincial capital and
is divided into districts
Seventy two (72)
districts in the country
Zambia’s Provinces
Proposed Organogram for Zambian
Patients & Public
Health facilities
Public
Pharmacies,
Antenatal Clinics
Private Clinics
District
PVC
Provincial
PVC
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
Zambia
PV
Center
Safety Review
Expert Panel
Professional Regulatory
Bodies
& Associations
Pharmacovigilance (PV) System
MoH/CBoH
Media
NMCP,UNZA
TDRC
UMC
WHO
Manufacturers
& Distributors
Roles and Responsibilities
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Zambia PV Center
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Create database of
ADRs of registered
drugs
Provide triplicate ADR
forms
Collect and archive
information
Timely response to
signals and provide
feedback
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District PV Center
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Collect ADR forms
from health facilities &
public
Verify and forward
information fortnightly
basis to ZPVC
Forward feedback to
reporters
Roles and Responsibilities
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Health Facilities
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Originate ADRs reports
Forward reports to
DPVC
Archive triplicate copy
Institute appropriate
action on ADR based
on feedback
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Media
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Support promotion of
PV activities thru
MoH/CBoH and
professional bodies
Disseminate
information in all
media
Roles and Responsibilities
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Safety Review Expert
Panel
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WHO/UMC
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Comprised of
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The National PV
Coordinator
Clinical Pharmacologist
Physician
Pediatrician
Obstetrician
Pharmacist
Additional expertise on
Adhoc basis
To analyze reports &
provide recommendations
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Serve as repository of
information
Support logistics,
Provide guidelines and
technical support
Respond to special issues on
Drug Safety
Roles and Responsibilities
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TDRC,UNZA
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Provide information on
research findings
Include PV in preservice training
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Professional
Regulatory Bodies
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To promote compliance
to reporting ADRs
Ensure that that only
qualified personnel
prescribe & dispense
Roles and Responsibilities
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MoH & CBoH
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Provide policy direction
Resource mobilization
Support PV activities
thru specific Health
Programmes
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PRA
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Source of information
on quality, safety and
efficacy of drugs
Assess and advise on
recommendations from
the Safety Review
Expert Panel
Roles and Responsibilities
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Professional Bodies
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Create public awareness on
drug safety
Encourage their members to
participate in PV activities
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Manufactures &
Distributors
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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
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Managing Non-serious ADRs
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Acknowledge all receipt of reports
Provide information on management
recommended in National Guidelines
Resources Available
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Health Programmes resources
Co-operating Partners
Ministry of Health
Other Concerns
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Critical Success Factors
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Well established Health programmes
GF resources and others e.g. PEPFAR, DFID
On-going trainings
Clearly defined responsibilities
Obstacles
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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 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
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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:
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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)
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Manuals already in existence for Rational Drug Use
Training material can be reviewed and added to
What do you want to achieve?
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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
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Debrief of CBoH and PRA
Multi-programme joint meeting
Review Budget and Logistics
Infusion of PV in health programmes
Launch of ZPVC
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(Timelines to be set after consultations)
Thank you!
Safe trip home
Albert
Bernice