Transcript staffing of the pharmacovigilance centres late nineties

PHARMACOVIGILANCE
The South African
perspective
Medicine Control Council
The Medicines Control Council of South
Africa is an independent and impartial
statutory body tasked with the
regulation of medicines based on
quality, efficacy and safety in terms of
the Medicines and Related Substances
Control Act (Act 101 of 1965).
MEDICINES CONTROL COUNCIL
Responsibility for approving medicines for use
in South Africa and the control thereof
Sect 1(3) “In determining whether or not the
registration or availability of a medicine is in the
public interest, regard shall be had only to the
safety, quality and therapeutic efficacy thereof in
relation to its effect on the health of man or any
animal, as the case may be”
Medicine Control Council
Inspectorate
Medicine Regulatory Affairs
Ops &
admin
Pharm &
analytical
Clinical
Evaluation
&
Trials
Directorate
Dept
Of
Health
Committee
10 different
COMMITTEES OF COUNCIL
Clinical Committee
2. Pharmaceutical and Analytical Committee
3. Clinical Trials Committee
4. Biologicals Committee
5. Veterinary Clinical Committee
6. Scheduling Committee
7. Complementary Medicines Committee
8. African Traditional Medicines Committee
9. Pharmacovigilance Committee
10. Veterinary Policy Committee
11. AIDS Vaccine Task (Sub Committee of CTC)
1.
REGISTRAR/
CLUSTER MANAGER
Medicine
Evaluation
& Research
Pharmaceutical
Analytical
Veterinary
Clinical
Evaluation
& Trials
Amendments
Operations
&
Administration
Finance
Biological
Clinical
Trials
HIV Vaccine
Inspection
&
Law Enforcement
Council
Support
Information
management
Scheduling
Complementary
medicines
Clinical
Secretary&
Administration
Pharmacovigilance
GMP
Licensing
Law
Enforcement
STAFFING OF THE PHARMACOVIGILANCE
CENTRES LATE NINETIES
MEDICINES REGULATORY AFFAIRS
Ms Matsoso
Registrar of medicines
CAPE
TOWN
PRETORIA
Admin
Dianne Louw
operations and admin
clinical,
pharmaceutical and analytical
inspectorate ,law enforcement
ONDERSTEPOORT
Vetrinary
Has own staff
National DRAs and
Pharmacovigilance
Centres
ministry of Health
Complementary
Medicines
Clinical
Trials
Uppsala
Monitori
ng Centre
Inspectorate
MCC
NADEMC
Public
health
Healthlink
Clinical
Consulting
UCT teaching
hospital
SAMJ/SAPJ
TRAMED
Teaching
Industry
SAMF
MIC
ADR forms distributed
feedback
Reports submitted to NADEMC
Entered into database
Receipt acknowledged
Evaluation Process
ADRs presented to MCC
Manufacturer & reporter informed
Action taken by manufacturer
Selected reports to WHO
Published in SAMJ
National Pharmacovigilance
Collaborating Centres
MRA, MCC,
DOH (Dissemination of
information to clinicians
and other Health care
Providers.
The Medunsa
Pharmacovigilan
ce Centre (MPC).
Adolescence and
Adults
National Adverse
Drug Event
Monitoring Centre
(NADEMC) - UCT
The Bloemfontein
Pregnancy registry
and pediatric
monitoring centre.
STAFFING OF THE PHARMACOVIGILANCE
CENTRES CURRENT
MEDICINES REGULATORY AFFAIRS
Ms Mtasoso
Registrar of medicines
Ops & Admin
Law enforcement
Dr RN Misra
Director: clinical trials and evaluations
Pharmacovigalance
CAPE
TOWN
Pharmacist
Pharmacist
Khin ohnn
Clinical
Clinical Trial
PRETORIA
MEDUNSA
UNIT
Bloemfontein UNIT
Co Ordinator
Mukesh Dheda
Officer
Officer
Admin
Dianne Louw
Dr S Khole
to create
vacant
Officer
to create
vacant
Admin
to create
vacant
admin
vacant
to create
Admin
to create
vacant
Officer
to create
vacant
Pharmaceutical % Analaytical
ONDERSTEPOORT
Vetrinary
Has own staff
Reporting of Adverse Reactions
To report an Adverse Drug Reaction, fill out the yellow ADR/product
quality reporting form. The form can then be sent either to the
Registrar of Medicines, private bag x828, Pretoria, 0001, Tel: 012
312 0295, fax:012 312 3106
OR
The National Adverse Drug Event Monitoring Center (NADEMC)
C/o Division of pharmacology, UCT,Observatory, 7925. Tel: 021 447
1618, Fax 021 448 6181.
To order more yellow forms for your institution, contact the above
addresses.
Bloemfontein
Pharmacovigilance unit
Monitoring of ARV’s in pregnant women
and paediatric patients.
Establishing a pregnancy registry.
Medunsa Pharmacovigilance
Unit
Youth and
Adult Monitoring of ADR with a focused
surveillance to the Antiretrovirals
Dean and head of school
Advisory Board
Director of Pharmacovigilance unit
Finance committee
Management committee
Pharmacovigilance
centre
Satellite units
Satellite units
Satellite units
Pharmacovigilance and
Public Health:
The Medicines Act makes provision for
the mandatory reporting of adverse
drug reactions by the pharmaceutical
industry. This has not been the case for
health professionals therefore the
culture of spontaneous reporting has
generally been low in South Africa as
evidenced by the low rates in the past.
Adverse Drug Reaction
Reporting Rates in S. Africa
600
500
400
Manufacturer
Direct
300
200
100
19
90
19
91
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
0
Reporting Year
Thank You
Rajen Misra
MbChB;D.For.Med;MFGP;M.ClinPharm
Director :Clinical Evaluations &
Trials, MRA,NDOH