The South African perspective 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 Dept Of Health Inspectorate Medicine Regulatory Affairs Clinical Evaluation & Trials Directorate Ops & admin Pharm & analytical Committee 10 different

COMMITTEES OF COUNCIL Clinical Committee Pharmaceutical and Analytical Committee Clinical Trials Committee Biologicals Committee Veterinary Clinical Committee Scheduling Committee Complementary Medicines Committee African Traditional Medicines Committee Pharmacovigilance Committee Veterinary Policy Committee AIDS Vaccine Task (Sub Committee of CTC)

REGISTRAR/ CLUSTER MANAGER GMP Finance Clinical Secretary& Administration Medicine Evaluation & Research Clinical Evaluation & Trials Operations & Administration 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

STAFFING OF THE PHARMACOVIGILANCE CENTRES LATE NINETIES

National DRAs and Pharmacovigilance ministry of Health Centres Uppsala Complementary Medicines Clinical Trials Inspectorate Uppsala Monitoring Centre MCC NADEMC UCT teaching hospital Public health Clinical Consulting Healthlink SAMJ/SAPJ TRAMED MIC Teaching Industry SAMF

Selected reports to WHO Manufacturer & reporter informed ADR forms distributed feedback Reports submitted to NADEMC Entered into database Receipt acknowledged Evaluation Process ADRs presented to MCC Selected reports to WHO Manufacturer & reporter informed Published in SAMJ Action taken by manufacturer

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

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. There has been inadequate spontaneous reporting of ADRs from clinicians nationwide. ADRs can be reported either by fax, email, telephone or mail by any health care provider to either the reporting center at UCT or directly to the Medicines Control council (MCC). Aggregate reporting from all over the country will assist in improved patient management and medicine regulation.

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

Satellite units Satellite units 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 No. of Reports Reporting Year

Thank You Rajen Misra MbChB;D.For.Med;MFGP;M.ClinPharm Director :Clinical Evaluations & Trials, MRA,NDOH