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.
Download ReportTranscript 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.
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