A decision support tool to facilitate the development of a pharmacovigilance system within the context of the Medicine Patent Pool

Huysamen, Biance (2020-04)

Thesis (MEng)--Stellenbosch University, 2020.

Thesis

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.

AFRIKAANSE OPSOMMING: In die moderne gesondheidsorglandskap het innoverende medisynevervaardigings- en verspreidingstelsels al hoe meer algemeen geword, veral hulpbronbeperkte omgewings. Een so 'n innoverende stelsel is die Medicine Patent Pool (MPP); die MPP het die doel om die beskikbaarheid en bekostigbaarheid van behandeling vir MIV, TB, en Hepatitis C te verbeter deur patente aan generiese farmaseutiese vervaardigers vry te stel. Maar, die implementering van die MPP bring sekere uitdagings met betrekking tot die gebreke in die vervaardiging en verspreiding van geneesmiddels na vore wat die farmaseutiese waardeketting en die monitering van medisyneveiligheid beïnvloed (Burrone, 2016). Die konteks waarin die MPP van stapel gestuur word, vereis doeltreffende monitering en geneesmiddelbewaking stelsel. Geneesmiddelbewaking is die wetenskap en toepassing van die opsporing, evaluering en monitering van nadelige reaksies op medikasie, met die doel om die risiko's van medisyne tot die minimum te beperk deur die effektiewe en doeltreffende rapportering van nadelige reaksies op medikasie (World Health Organization, 2002). Hierdie navorsingsondersoek is daarop gemik om die gebrek aan 'n effektiewe PV-stelsel in die omgewings van die MPP, wat die konteks van hulpbronbeperkte omgewings en die siektelas van HIV, TB en Hepatitis C, aan te spreek deur die onwikkeling van ‘n besluitsteun hulpmiddel wat die ontwikkeling van ‘n effektiewe geneesmiddelbewaking stelsel fasiliteer. 'n Stelselingenieurswese benadering is gevolg om die probleem te kontekstualiseer en aan te spreek. Aanvanklik is sistematiese literatuuroorsigte gedoen om 'n uitdagingslandskap te ontwikkel rakende die faktore van (i) tradisionele geneesmiddelbewaking-stelsels, (ii) die MPP, (iii) HIV, TB, en Hepatitis C, en (iv) hulpbronbeperkte omgewings binne die konteks van die farmaseutiese waardeketting. Hierdie uitdagingslandskap is ontwikkel om 'n oorsiggewende perspektief te verkry van die verskillende uitdagings wat 'n besluitsteun hulpmiddel in ag moet neem. Aan die hand van die insigte wat uit die uitdagingslandskap verkry is, is 'n vereiste-spesifikasie ontwikkel vir die besluitsteun hulpmiddel wat die ontwikkeling van ‘n effektiewe geneesmiddelbewaking stelsel in diekonteks van die MPP-medisyneverskaffingstelsels fasiliteer. Bykomende sistematiese literatuuroorsigte rakende die faktore van (i) tradisionele PV-stelsels, (ii) die MPP, (iii) HIV, TB, en Hepatitis C, en (iv) hulpbronbeperkte omgewings is ondersoek om vereistes te indentifiseer wat hierdie faktore vereis van ‘n geneesmiddelbewaking-stelsels. Verder is 'n verifikasieproses met vakkundiges uitgevoer om die geïdentifiseerde vereistes te evalueer. Ten einde die vereiste-spesifikasie aan te spreek, is moontlike intervensiestrategieë geïdentifiseer. Intervensiestrategieë is daarna gesintetiseer om komponente vir die besluitsteun hulpmiddel te ontwikkel. Gegewe hierdie bevindinge, is ‘n besluitsteun hulpmiddel ontwikkel wat die ontwikkeling van ‘n effektiewe geneesmiddelbewaking stelsel fasiliteer. Die besluitsteun hulpmiddel word genoem die Customised Vigilance System Implementation Tool (CVSIT). Deur ‘n validasieproses is bevind dat die CVSIT 'n aanpasbare instrument is, aangesien dit 'n unieke strategie ontwikkel gebaseer op 'n spesifieke projek se profiel. Die CVSIT is gavalideer deur (i) die toepassing van 'n gevallestudie en (ii) semi-gestruktureerde onderhoude met vakkundiges te voer om die toepasbaarheid en bruikbaarheid van die hulpmiddel te evalueer.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/107795
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