Transcript PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA WORKING TOGETHER TODAY TO MAKE SOUTH AFRICA SAFE TOMORROW!!! PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA 11/5/2015

PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
WORKING TOGETHER TODAY TO MAKE
SOUTH AFRICA SAFE TOMORROW!!!
PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
11/5/2015
CURRENT SITUATION…
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1987 Established National Adverse Events
Monitoring Centre (Cape Town)
Spontaneous Reporting of all drugs
registered in South Africa (receive reports
from Industry and HCP)
Collaborating Centre of WHO Monitoring
Centre in Uppsala
PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
11/5/2015
CURRENT SITUATION…
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Pharmacovigilance committee within the MCC
established 2002: performs a regulatory function
in Pharmacovigilance, makes recommendations
to MCC in terms of availability of medicines and
related substances; advises on ‘Dear Healthcare
Professional’ safety letters and Medicines Safety
Alerts (Drug Alerts), Urgent Safety Update
Notifications (Package inserts and
communications by Industry), international
signals, alerts and warnings.
PHARMACOVIGILANCE PLAN FOR
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11/5/2015
CURRENT SITUATION…
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ADR Reporting Guidelines and Form (accessible
from website www.mccza.com)
Industry required to report actively. Internal
pharmacovigilance systems ‘should’ be in place.
PHARMACOVIGILANCE PLAN FOR
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11/5/2015
CURRENT SITUATION…
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Many years experience of spontaneous
reporting and associated signal detection
PHARMACOVIGILANCE PLAN FOR
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11/5/2015
CURRENT SITUATION…
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Comprehensive Plan approved by Cabinet
November 2003 – included Pharmacovigilance!
April 2004, launched ARV Program
Current infrastructure insufficient to support
needs of program
Task of Pharmacovigilance for ART must be
comprehensive enough to support program.
PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
11/5/2015
PHARMACOVIGILANCE
NEEDS:
Pharmacovigilance in HIV and AIDS Program
 Create awareness and consciousness of safety
issues in ART among HCP and Public Who, How,
By When?
 Identify new ADE/ADR specific to ART How?
 Monitor known ADR’s – develop therapeutic
guidelines enhance therapeutic success in South
African setting Who? How?
 Counteract myths Who? How?
PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
11/5/2015
RESPONSE TO
PHARMACOVIGILANCE NEEDS
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Continue spontaneous reporting to NADEMC
Who? How?
MEDUNSA Pharmacovigilance Centre coordinating focus surveillance –Adult ART, drug
interactions (CAM, ATM, foods) Who? How?
Bloemfontein Centre – Paed ART + Pregnancy
Registry Who? How?
Data Mining (?) automated databases Who?
How?
PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
11/5/2015
SYSTEM STRATERGIES:
SIGNAL
GENERATION
HYPOTHESIS
TESTING
COMMUNICATION
PHARMACOVIGILANCE PLAN FOR
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11/5/2015
SIGNAL DETECTION: Passive
Surveillance
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Spontaneous reporting – NADEMC
Evaluation of data
PHARMACOVIGILANCE PLAN FOR
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SIGNAL DETECTION: Active
Surveillance
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Cohorts
* Prescription Event Monitoring (ARV
naïve patients) – detect new signals,
guide investigation of all significant events
* Intensive Drug Safety Monitoring
(Investigate Extent, Frequency and Severity of
known events)
* Registries
PHARMACOVIGILANCE PLAN FOR
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SIGNAL DETECTION:
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Automated databases – data mining of
data bases How?
PHARMACOVIGILANCE PLAN FOR
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HYPOTHESIS TESTING
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Create Expert Panel to determine which
signals warrant investigation
To confirm signal – design focussed
studies at sentinel sites
Selection criteria for sites – well
functioning – create a nucleus of sites –
form a base group – used in the future to
recruit rural sites to develop network.
PHARMACOVIGILANCE PLAN FOR
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HYPOTHESIS TESTING
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Qualitative issues – insight into
“experiences” of ART ADRs
PHARMACOVIGILANCE PLAN FOR
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COMMUNICATION AND RISK
MANAGEMENT
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To HCP  Patients and Treatment
Buddies Who? How?
Reporting to Regulatory Authority 
responsible public awareness Who? How?
Media strategy Who? How?
Creation of toll free 24 hour help line for
patients and HCP Who? How?
PHARMACOVIGILANCE PLAN FOR
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TRAINING PRIORITES
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Priorities include:
Education on pharmacovigilance
Promote reporting
Understand therapies
Train the trainers to  educate the
patient  empower the patient
PHARMACOVIGILANCE PLAN FOR
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TRAINING STRATEGY
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Audit current training structures in the
provinces. Who? How?
Incorporate Pharmacovigilance training into
these established training for HIV Who? How?
Evaluate existing gaps in Pharmacovigilance
Who? How?
Develop training manuals relevant to gaps and
audiences Who? How?
PHARMACOVIGILANCE PLAN FOR
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11/5/2015
TRAINING CONTENT
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ART And ADR’S
Signs and Symptoms
Management
Use booklet already developed from
NADEMC to address issues of Why, How,
When and To Whom to report.
PHARMACOVIGILANCE PLAN FOR
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PHARMACOVIGILANCE
CENTRE
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CULMINATE INTO …
Forum for Communication and Training
Focussed surveillance fuelling research initiatives
Panel of experts to inform policy and therapeutic
guideline
Patients aware and conscious of ADRs and
understand that they are part of risk aspect of
effectiveness-risk continuum
PHARMACOVIGILANCE PLAN FOR
SOUTH AFRICA
11/5/2015