Biological medicines are large drug molecules typically derived from living cells. They include, to mention but a few, therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins. Most BM are developed by recombinant DNA (rDNA) technology in which genetically engineering living cells are made to produce the required proteins. Overall, the advent of BM has revolutionised the practice of medicine whereby they are not only increasingly used for diagnosis, treatment and prevention of a variety of medical illnesses and conditions some of which had no alternative therapies, but they have also ensured personalised patient care and specific disease targeting. However, the fast increase in their use has elicited safety concerns in the medical fraternity because, with increasing use of medicines, many new and old problems become eminent and most often these problems influence a change in the respective drug use. As such, to ensure effective use of BM, heath care providers need to be conversant with the common problems associated with their use. Unfortunately, such information is not yet available in standard literature, and worse still, the information from the manufacturers is not only fragmented by different products, but also may have a tinge if bias. This session will provide critical information on the safety and appropriate use of biological medicines, including a zoom into the most commonly used BM in South Africa (mainly for RA), as well as a reflection on the current research on BM in South Africa.
An overview on the challenges in the use of biological medicines
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Prof Andrew Walubo is the Head of the Department of Pharmacology, University of the Free State, and Chief Clinical Pharmacologist, Universitas Academic Hospital, since 1999. He completed his medical degree at Makerere University in Uganda, Master’s studies in Pharmacology in Hong Kong, Doctoral studies in Clinical Pharmacology at the University of Cape Town, a 2-year postdoctoral fellowship in Clinical Pharmacology at Vanderbilt University USA, and a Master’s in Business Administration (MBA) at the University of the Free State. His research focus is on drug metabolism and hepatotoxicity, traditional medicines, clinical pharmacology, quality practices (GLP, GCP & QPBR), immunopharmacology and, recently, drug utilisation (pharmacovigilance). Prof Walubo he has been involved in studying the utilisation of biological medicines in South Africa in which he has supervised a PhD project, while his pharmacovigilance program was heralded by the opening of the anti-retroviral (ARV)-paediatric registry in 2018, the only kind in the world. Prof Walubo has published widely and presented at national and international conferences. He is a Fellow of the American College of Clinical Pharmacologists, and the current president of the College of Clinical Pharmacologists of South Africa. He serves on numerous institutional, national and international committees. In this respect, he is a reviewer and member of the South African Health Products Authority (SAHPRA) experts’ advisory committees, i.e., The Biological Medicines Experts Advisory Committee and Vice-chair of the Advisory Clinical Committee. |
Prevention and management of common adverse reactions of biologics
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Helmuth Reuter is a South African professor of internal medicine and is currently the Head of the Division of Clinical Pharmacology at the Faculty of Medicine and Health Sciences at the University of Stellenbosch. He is also a director of the Winelands Medical Research and the Winelands Rheumatology Centre, which forms part of the Institute of Orthopaedics and Rheumatology (IOR). Prior to his ten year stint in the private sector, he headed the Divisions of Rheumatology and Infectious Diseases at Tygerberg Hospital and was the director of the Ukwanda Centre for Rural Health. |
Framework for the use of biological medicines in South-Africa
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Martlie Mocke-Richter is a dynamic pharmacist holding a (B.Pharm) as well as a (M.Pharm) (Cum Laude) degree. She submitted her PhD in Pharmacology at the University of the Free State at the end of June 2019, with the title: ”Factors influencing the utilization of Biological Medicines in the Free State (South-Africa)”. Her research interest is in the field of Biological Medicines. She has done several presentations nationally as well as internationally. She is employed by the Free State Department of Health, as Clinical pharmacist at the National District Hospital, with several leadership awards.
She is also a member of the Free State Antimicrobial Stewardship Committee (2019), Mangaung District PTC, Mangaung Clinical Governance committee (2018-2019), Mangaung District Antimicrobial Stewardship champion (2018-2019).
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