(Southern African Institute for Industrial Engineering, 2018-11-09) Huysamen, Biance; De Kock, Imke H.; Bam, Louzanne
ENGLSH ABSTRACT: 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.