Browsing by Author "Huysamen, Biance"
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- ItemA decision support tool to facilitate the development of a pharmacovigilance system within the context of the Medicine Patent Pool(Stellenbosch : Stellenbosch University, 2020-03) Huysamen, Biance; De Kock, Imke; Bam, Louzanne; Stellenbosch University. Faculty of Industrial Engineering. Dept. of Industrial Engineering.ENGLISH ABSTRACT: In the modern-day healthcare landscape, innovative drug manufacturing and distribution systems have become increasingly prevalent, especially in resource limited settings (RLS). One such innovative system is the Medicines Patent Pool (MPP), which seeks to increase the availability and affordability of treatments for HIV, TB, and Hepatitis C by making available specific patents to generic pharmaceutical manufacturers. However, the implementation of the MPP has led to the emergence of certain challenges with respect to inadequacies in drug manufacturing and distribution, which affect the pharmaceutical value chain and drug safety monitoring (Burrone, 2016). The context within which the MPP was launched thus call for effective drug safety monitoring and pharmacovigilance (PV) systems. PV is the science and application of the detection, assessment, and monitoring of adverse drug reactions (ADRs) in response to drugs, with the objective of minimising drugs risks through the effective and efficient reporting of ADRs (WHO, 2002b). This research inquiry is thus aimed at addressing the lack of an effective PV system in the environments covered by the MPP; such a system must also consider the context of RLS and the disease burden of HIV, TB and Hepatitis C (which are referred to as the MPP drug provision systems) by proposing a decision support tool that facilitates the development of context-specific PV systems. A system engineering approach was thus followed to contextualise and address the development of said tool. Initially, systematic literature reviews were conducted to develop a challenges landscape pertaining to four niche factors, namely, (i) traditional PV systems, (ii) the MPP, (iii) HIV, TB, and Hepatitis C, and (iv) RLS within the context of the pharmaceutical value chain. This challenges landscape was developed to gain a systems perspective understanding of the various challenges that a context-specific PV system would have to address. Building on the insights gained from this challenges landscape, a requirement specification was developed for a context-specific PV system within the context of the MPP drug provision systems. Additional systematic literature reviews focused on the four factors listed above, within the context of identifying the requirements that these factors call for in a drug safety monitoring system. Furthermore, a verification process was conducted with subject matter experts (SMEs) to evaluate the identified requirements. Building on these findings, a requirement specification was drafted to guide the development of a decision support tool. In order to address the requirement specification, possible intervention strategies were identified. The identified intervention strategies were then synthesised to develop components for an alternative, context-specific PV system. Based on these findings, a decision support tool that would facilitate the development of a context-specific PV systems was developed. This decision support tool is refered to as the Customised Vigilance System Implementation Tool (CVSIT). Through validation processes it was found that the CVSIT is a robust, adaptable tool, that provides a customized strategy based on a specific projects profile. It was validated by means of (i) a case study and (ii) semi-structured interviews with SMEs to evaluate the applicabiity and practicability of the tool.
- ItemDeveloping a challenges landscape relating to drug safety, provision, and distribution in resource-limited settings for the case of HIV/AIDS(Southern African Institute for Industrial Engineering, 2018-11-09) Huysamen, Biance; De Kock, Imke H.; Bam, LouzanneENGLSH 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.