PHARMACOVIGILANCE

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PHARMACOVIGILANCE

• The South African perspective

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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).

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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

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Medicine Control Council
Dept Of Health
Inspectorate
Medicine Regulatory Affairs
Clinical Evaluation Trials Directorate
Ops admin
Pharm analytical
Committee 10 different
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COMMITTEES OF COUNCIL

1. 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)

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REGISTRAR/ CLUSTER MANAGER
Secretary Administration
Clinical Evaluation Trials
Operations Administration
Medicine Evaluation Research
Inspection Law Enforcement
GMP
Pharmaceutical Analytical
Amendments
Council Support
Finance
Licensing
Biological
Information management
Veterinary
Clinical Trials
Law Enforcement
Scheduling
Complementary medicines
Pharmaco- vigilance
Clinical
HIV Vaccine
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STAFFING OF THE PHARMACOVIGILANCE CENTRES LATE
NINETIES
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National DRAs and Pharmacovigilance Centres
ministry of Health
Complementary Medicines
Clinical Trials
Uppsala Monitoring Centre
Inspectorate
MCC
NADEMC
UCT teaching hospital
Public health
Clinical Consulting
Healthlink
SAMJ/SAPJ
TRAMED
MIC

Teaching
Industry
SAMF
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ADR forms distributed
feedback
Reports submitted to NADEMC
Receipt acknowledged
Entered into database
Evaluation Process
ADRs presented to MCC
Selected reports to WHO
Published in SAMJ
Manufacturer reporter informed
Action taken by manufacturer
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National Pharmacovigilance Collaborating Centres
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STAFFING OF THE PHARMACOVIGILANCE CENTRES CURRENT
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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 [phone], fax012 312
  3106
• OR
• The National Adverse Drug Event Monitoring Center
  (NADEMC)
• C/o Division of pharmacology, UCT,Observatory,
  7925. Tel [phone], Fax [phone].
• To order more yellow forms for your institution,
  contact the above addresses.

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Bloemfontein Pharmacovigilance unit

• Monitoring of ARVs in pregnant women and
  paediatric patients.
• Establishing a pregnancy registry.

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Medunsa Pharmacovigilance Unit

• Youth and
• Adult Monitoring of ADR with a focused
  surveillance to the Antiretrovirals

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Dean and head of school
Advisory Board
Director of Pharmacovigilance unit
Finance committee
Management committee
Pharmacovigilance centre
Satellite units
Satellite units
Satellite units
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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.

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Adverse Drug Reaction Reporting Rates in S. Africa
No. of Reports
Reporting Year
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Thank You

• Rajen Misra
• MbChBD.For.MedMFGPM.ClinPharm
• Director Clinical Evaluations Trials, MRA,NDOH