An investigation into the prospects of existing technologies to address the challenges faced in pharmacovigilance systems

Lamprecht, Izak van Biljon (2018-12)

Thesis (MEng)--Stellenbosch University, 2018.

Thesis

ENGLISH ABSTRACT: Healthcare systems, especially those within resource-limited countries, are facing increasing pressures, which can, in part, be attributed to the struggles of balancing resource inventories, while still providing clinical care of high quality. Pharmacovigilance (PV), a system developed to ensure universal drug safety, constitutes one component of healthcare systems globally. PV systems in resource-limited countries are struggling to operate both efficiently and effectively, while continuously maintaining and ensuring universal drug safety. These PV systems are burdened by the lack of expertise and knowledge to (i) prioritise the challenges faced daily; (ii) identify the root causes of these challenges; and (iii) determine how these root causes of the challenges can be addressed by technology. In this research, these three requirements are addressed. First, a systematic review is conducted to identify 15 challenges that are experienced in PV systems, especially those in resource-limited countries. These 15 challenges (referred to as the PV challenge landscape in this research) are prioritised with the use of: a PV system and PV challenge landscape matrix developed in this research and input from several subject matter experts. Seven challenges are regarded as priority, namely: culture, partnerships, transparency, insufficient resources, country-specific factors, technical capacity, and adverse drug-reaction under-reporting. Second, an investigation into several translation techniques is conducted in order to determine which technique(s) is appropriate to be used to translate these challenges from a strategic to an operational level, and to identify the root causes of the challenges. The value chain analysis and the 5Why method, in combination with fishbone diagrams, are considered to be appropriate techniques. Following the implementation of these techniques, the identified root causes are once again prioritised based on inputs from SMEs in order to maintain focus on the root causes that have the most significant impact on PV systems whilst ensuring that the scope of the research remains feasible. It is concluded that 14 of the identified root causes should be prioritised for further investigation in this research. Third, literature is reviewed to identify an appropriate technology selection framework that can be used to assess the technology landscape with regards to it being implemented in PV to address the root causes identified in this research. The technology selection framework developed by Chan & Kaufman (2010) is considered an appropriate framework, since it incorporates many elements one can associate with PV. 15 technologies that could potentially be used to address the most prominent root causes of the PV challenge landscape are identified with the use of grey literature and a focus group. With the use of Chan & Kaufman's (2010) technology selection framework, these technologies are assessed in order to determine which technologies are feasible to be implemented in PV. It is concluded that 13 of the originally identified technologies are feasible for addressing the prioritised root causes of the PV challenge landscape. Subsequently, a link between the 14 prioritised root causes of the prioritised PV challenge landscape and the 13 technologies is established, where it is described how each root cause can potentially be addressed by one or more of the 13 technologies. This research significantly contributes to the PV system by identifying opportunities to utilise technology to address the root causes of some of the most prominent challenges in PV. Additionally, this research makes a methodological contribution by proposing a combination of techniques that can be used to: scan and prioritise the challenge landscape in PV, prioritise and identify the root causes of the challenges experienced in PV, and identify and assess potential solutions that can be used to address these root causes.

AFRIKAANSE OPSOMMING: Gesondheidsorgstelsels, veral dié in hulpbronbeprekte lande, ondervind toenemende druk wat gedeeltelik toegeskryf kan word aan die stryd om hulpbronvoorrade te balanseer, en terselfdertyd hoë kwaliteit kliniese sorg te verskaf. Pharmacovigilance (PV), ‘n sisteem wat ontwikkel is om universele dwelmsveiligheid te verseker, vorm een komponent van gesondheidsorgstelsels wêreldwyd. PV stelsels in hulpbronbeperkte lande sukkel om doeltreffend en effektief te funksioneer, en terselfdertyd universele dwelmsveiligheid te handhaaf. Hierdie PV stelsels word belas deur die gebrek aan kundigheid en kennis om (i) die uitdagings wat daagliks aan die dag lê, te prioritiseer; (ii) die kernoorsake van hierdie uitdagings te identifiseer; en (iii) te bepaal hoe hierdie kernoorsake van die uitdagings deur tegnologie aangespreek kan word. In hierdie navorsing word hierdie drie vereistes aangespreek. Eerstens word 'n sistematiese oorsig gedoen om 15 uitdagings wat in PV stelsels ervaar word, veral in die hulpbron-beperkte lande, te identifiseer. Hierdie 15 uitdagings (verwys na as die PV-uitdagingslandskap in hierdie navorsing) word geprioritiseer deur gebruik te maak van 'n PV stelsel en PV-uitdagingslandskapmatriks wat ontwikkel is in hierdie navorsing en insette van verskeie vakkundiges. Sewe uitdagings word as prioriteit beskou, naamlik: kultuur, vennootskappe, deursigtigheid, onvoldoende hulpbronne, landspesifieke faktore, tegniese kapasiteit en nadelige dwelmreaksie onderverslagdoening. Tweedens word 'n ondersoek na verskeie translasie tegnieke gedoen om te bepaal watter tegniek(e) gepas is om hierdie uitdagings van strategiese tot operasionele vlak te transleer, en om die kernoorsake van die uitdagings te identifiseer. Die waardekettinganalise en die 5Hoekom-metode, in kombinasie met visgraatdiagramme, word as toepaslike tegnieke beskou. Na aanleiding van die implementering van hierdie tegnieke word die geïdentifiseerde kernoorsake weer geprioritiseer op grond van insette van vakkundiges om fokus te handhaaf op die kernoorsake wat die grootste impak op PV stelsels het, terwyl dit verseker word dat die omvang van die navorsing uitvoerbaar is. Daar word tot die gevolgtrekking gekom dat 14 van die geïdentifiseerde kernoorsake prioriteit vir verdere ondersoek in hierdie navorsing moet word. Derdens word literatuur hersien om 'n gepaste tegnologie seleksie raamwerk te identifiseer wat gebruik kan word om die tegnologie landskap te assesseer met betrekking tot die implementering daarvan in PV om die kernoorsake wat in hierdie navorsing geïdentifiseer is, aan te spreek. Die tegnologie seleksie raamwerk wat deur Chan & Kaufman (2010) ontwikkel is word beskou as 'n toepaslike raamwerk, aangesien dit baie elemente bevat wat mens met PV kan assosieer. 15 tegnologieë wat potensieel gebruik kan word om die belangrikste kernoorsake van die PV-uitdagingslandskap aan te spreek, word geïdentifiseer met die gebruik van grys literatuur en 'n fokusgroep. Met die gebruik van Chan & Kaufman (2010) se tegnologie seleksie raamwerk, word hierdie tegnologieë geassesseer om te bepaal watter tegnologie moontlik is om in PV geïmplementeer te word. Daar word tot die gevolgtrekking gekom dat 13 van die oorspronklik geïdentifiseerde tegnologieë haalbaar is om die geprioritiseerde kernoorsake van die PV-uitdagingslandskap aan te spreek. Vervolgens word 'n skakel tussen die 14 geprioritiseerde hoofoorsake van die geprioritiseerde PV-uitdagingslandskap en die 13 tegnologieë gevestig. Daar word beskryf hoe elke oorsaak moontlik deur een of meer van die 13 tegnologieë aangespreek kan word. Hierdie navorsing dra aansienlik by tot die PV-stelsel deur geleenthede te identifiseer om tegnologie te gebruik om die kernoorsake van sommige van die prominentste uitdagings in PV aan te spreek. Daarbenewens maak hierdie navorsing 'n metodologiese bydrae deur 'n kombinasie van tegnieke voor te stel wat gebruik kan word om: die uitdagings landskap in PV te ondersoek en te prioritiseer, die kernoorsake van die uitdagings in PV te prioritiseer en te identifiseer, en moontlike oplossings te identifiseer en te assesseer wat gebruik kan word om hierdie oorsake aan te spreek.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/104940
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