Developing a challenges landscape relating to drug safety, provision, and distribution in resource-limited settings for the case of HIV/AIDS

• Published in: South African Journal of Industrial Engineering Vol. 29; no. 3; pp. 54 - 68
• Main Authors: de Kock, I.H., Bam, L., Huysamen, B.
• Format: Journal Article
• Language: English; Portuguese
• Published: Bedfordview South African Institute of Industrial Engineers (SAIIE) 01.11.2018; South African Institute for Industrial Engineering; The Southern African Institute for Industrial Engineering; Stellenbosch University
• Subjects: Acquired immune deficiency syndrome; AIDS; Drug delivery systems; Drug resistance; Engineering, Industrial; HIV; hiv/aids drug distribution; hiv/aids drug manufacturing; hiv/aids drugs; Human immunodeficiency virus; Infectious diseases; Low income groups; Manufacturers; Manufacturing; Medical personnel; Medicine; Patient safety; Pharmaceutical industry; Pharmaceuticals; Pharmacology; Product safety; Quality; Quality control; R&D; Research & development; System effectiveness; un medicine patent pool; South Africa; Africa; Tanzania
• ISSN: 1012-277X; 2224-7890; 2224-7890
• DOI: 10.7166/29-3-2048

Since 2010, pharmaceutical organisations have begun to provide drug patents in sub-Saharan Africa through the UN Medicine Patent Pool. This initiative allows any pharmaceutical manufacturer to access these patents and manufacture the drugs, thereby aiming to decrease the associated lead times and costs. The participation of numerous manufacturers, some of whom may not have well-established quality control systems in the market, intensifies the need for effective drug quality monitoring. Research indicates that it is often the case that these ‘niche drug provision systems’ face many challenges with the quality of new-generation drugs and the implementation of effective pharmacovigilance (PV)1 systems for the reporting of adverse drug reactions. The lack of resource efficiency in adverse drug reaction reporting within the sub-Saharan context is also a growing concern.Sedert 2010 het farmaseutiese organisasies deur middel van die UN Medicine Patent Pool medisyne patente vrygestel vir lae- en middelinkomste lande. Hierdie inisiatief laat toe dat enige farmaseutiese vervaardiger die patente kan gebruik om medisyne te vervaardig; sodoende word die koste en vervaardigingstyd verminder. Aangesien ’n aantal verskillende vervaardigers, waarvan sommiges nie goed gevestigde kwaliteit stelsels het nie, kan deelneem, moet daar goeie ‘pharmacovigilance’ (PV) toegepas word. Navorsing dui egter daarop dat dit dikwels die geval is dat hierdie plaaslike medisyne vervaardigers baie uitdagings ervaar in verband met medisyne voorsiening wat weer effektiewe PV-stelsels impliseer. Die gebrek aan menslike hulpbronne vir die monitering van negatiewe reaksies op die medisyne in hierdie lande is ook ’n groeiende probleem.