PHARMACOVIGILANCEThe 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

Medicine Regulatory AffairsDept

OfHealth

Ops & admin Clinical

Evaluation&

TrialsDirectorate

Pharm &analytical

Inspectorate

Committee10 different

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)

REGISTRAR/CLUSTER MANAGER

ClinicalEvaluation

& Trials

Operations &

Administration

MedicineEvaluation& Research

Inspection&

Law Enforcement

PharmaceuticalAnalytical

Amendments

ClinicalPharmaco-vigilance

Licensing

GMP

Finance

Veterinary

LawEnforcement

ClinicalTrials Scheduling

Complementarymedicines

Informationmanagement

Secretary&Administration

Council Support

Biological

HIV Vaccine

STAFFING OF THE PHARMACOVIGILANCE CENTRES LATE NINETIES

A d m inD ian ne Louw

C A P ET O W N

o p era tio n s a nd a dm inc lin ica l,

p h arm ace utica l a nd a na lytica lin sp ecto rate ,law e nfo rcem e nt

P R E T O R IA O N D E R S T E PO O R TV e trin a ry

H a s o w n sta ff

M E D IC IN E S R E G U LA T O R Y A F F A IR SM s M a tso so

R e g is tra r o f m e d ic in es

UCT teaching hospital

UCT teaching hospital

NADEMC

UppsalaMonitoring Centre

MCC

Public health

TRAMEDMIC

SAMF

Clinical Consulting

National DRAs and Pharmacovigilance CentresComplementary

Medicines

Inspectorate

Clinical Trials

ministry of Health

Teaching Industry

SAMJ/SAPJ

Healthlink

ADR forms distributed

Reports submitted to NADEMC

Receipt acknowledged

Evaluation Process

ADRs presented to MCC Selected reports to WHO

Manufacturer & reporter informed

Action taken by manufacturer

Published in SAMJ

Entered into database

feedback

National Pharmacovigilance Collaborating Centres

MRA, MCC, DOH (Dissemination of information to clinicians

and other Health care Providers.

The Medunsa Pharmacovigilance Centre (MPC).Adolescence and Adults

The Bloemfontein Pregnancy registry and pediatric monitoring centre.

National Adverse Drug Event Monitoring Centre (NADEMC) - UCT

STAFFING OF THE PHARMACOVIGILANCE CENTRES CURRENT

Ops & Admin Law enforcement

Pharmacis t

Adminto createvacant

AdminD ianne Louw

Pharmacis tKhin ohnn

CAPETOW N

adminvacant

to create

Dr S Kholeto createvacant

Adminto createvacant

Officerto createvacant

Officerto createvacant

Co Ord inatorMukesh Dheda

PRETORIA

Officer

MEDUNSAUNIT

Officer

B loemfontein UNIT ONDERSTEPOORTVetrinary

Has own staff

Pharm acovigalance Clinica l C linical T ria l

Dr RN M israD irector: clinica l trials and eva luations

Pharmaceutica l % Analaytica l

MEDICINES REGULATORY AFFAIRSMs Mtasoso

Registrar of medicines

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

Director of Pharmacovigilance unit

Management committee

Pharmacovigilance centre

Satellite units

Satellite units

Finance committee

Satellite units

Advisory Board

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

0

100

200

300

400

500

600

ManufacturerDirect

No.

of

Rep

ort

s

Reporting Year

Thank You

Rajen MisraMbChB;D.For.Med;MFGP;M.ClinPharm

Director :Clinical Evaluations & Trials, MRA,NDOH