Towards the interoperability of spontaneous reporting systems in pharmacovigilance : a maturity model approach with a sociotechnical system focus

Schurer, Maximillian Juan (2020-04)

Thesis (PhD)--Stellenbosch University, 2020.

Thesis

ENGLISH ABSTRACT: It is universally accepted that all medicines have the potential to cause adverse drug reactions (ADRs) during the course of their normal therapeutic use. Drug safety surveillance during the post-marketing authorisation phase generates the majority of drug safety data, even more so than the clinical trials during the drug development process. Pharmacovigilance (PV), is based on the medical assessment of ADRs or drug-related problems, collected within organised health programmes. PV systems, by nature, are complex. The large number, fragmentation, and complexity of existing PV systems, the equally large number of stakeholders within such systems (i.e. pharmaceutical companies, government regulatory authorities, national and international clinical regulatory bodies, healthcare workers, etc.), as well as the significant number of dimensions along which the effectiveness and efficiency could be in uenced and also measured, adds to this complexity. The primary goal of any PV system is to improve and protect patient safety by enabling health care professionals to make more informed therapeutic decisions. Achieving this goal is dependent on the successful communication of relevant ADR information from the patient to the relevant PV authority. One such method of communication is the spontaneous reporting of ADRs, which is widely regarded as the cornerstone of data generation in PV during post-marketing authorisation safety surveillance. Currently, spontaneous reporting systems (SRSs) are faced with problems such as under-reporting and the communication of incomplete, unrepresentative, and uncontrolled data. The lack of standardisation and interoperability among these systems results in a reduced capability to detect and characterise new adverse drug interactions and ADRs. The primary obstacle to achieving interoperability between SRSs is the fundamental difference in the purpose of the existing SRSs. Stakeholders in the PV system operate SRSs with different goals and perspectives such as maintaining regulatory compliance, mitigating financial risk, and for the protection and promotion of patient safety in public health programmes. The aim of this study is to contribute towards the interoperability of SRSs in the PV landscape through the development of a novel maturity model with a sociotechnical system focus. The aim of the model is to promote and improve interoperability by addressing the degree of integration of systems involved, provide guidance on which system components need to be improved, as well as provide a means for measuring interoperability progress across the community of SRSs in the global PV landscape. A multidisciplinary literature review covering PV, capability maturity models, interoperability, and sociotechnical systems served as a theoretical foundation for the development of the model. The development of the model followed an adaptation of the 8-phase procedural model for developing maturity models, proposed by Becker et al. (2009). A comparison of 18 existing maturity models in the fields of: (i) PV; (ii) eHealth; (iii) eHealth/interoperability; (iv) interoperability; and (v) IT infrastructure, was conducted. The model is made up of three domains, seven subdomains, and thirty dimensions which were identified as a result of the preceding literature review and comparison of existing models. Through a combination of verification and validation processes involving subject matter experts, the maturity model was refined. The resulting maturity model was implemented in a case study within a national regulatory authority context, to determine the generalisability and empirical validity of the model. The model was deemed a useful, unique, and valuable contribution to organisations operating SRSs, having achieved the stated aim.

AFRIKAANSE OPSOMMING: Oor die algemeen word dit aanvaar dat alle medisyne die potensiaal het om negatiewe geneesmiddelreaksies te veroorsaak tydens hul normale terapeutiese gebruik. Dwelmveiligheidswaarneming tydens die na-bemarkingsmagtigingsfase genereer die meerderheid van dwelmveiligheidsdata, selfs meer as die kliniese proewe tydens die dwelmontwikkelingsproses. Pharmacovigilance (PV), is gebaseer op die mediese evaluering van geneesmiddelreaksies of dwelmverwante probleme, wat binne georganiseerde gesondheidsprogramme ingesamel word. PV-stelsels is inherent kompleks. Die groot aantal, fragmentasie en kompleksiteit van bestaande PV-stelsels, die ewe groot aantal belanghebbendes binne hierdie stelsels (d.w.s. farmaseutiese maatskappye, staatsregulerende owerhede, nasionale en internasionale kliniese reguleringsliggame, gesondheidswerkers, ens.), sowel as die beduidende aantal dimensies waarlangs die effektiwiteit en doeltreffendheid beinvloed kan word en ook gemeet word, dra by tot hierdie kompleksiteit. Die primeere doel van enige PV-stelsel is om pasieentveiligheid te verbeter en te beskerm deur gesondheidsorgwerkers in staat te stel om meer ingeligte terapeutiese besluite te neem. Die bereiking van hierdie doelwit is afhanklik van die suksesvolle kommunikasie van relevante geneesmiddelreaksie-inligting van die pasient na die betrokke PV-owerheid. Een sodanige kommunikasiemetode is die spontane rapportering van geneesmiddelreaksies, wat algemeen beskou word as die hoeksteen van data-opwekking in PV tydens die veiligheidswaarneming na bemarking. Tans word spontane rapporteringstelsels (SRSe) gekonfronteer met probleme soos onder-rapportering en die kommunikasie van onvolledige, nie-verteenwoordigende en onbeheerde data. Die gebrek aan standardisering en interoperabiliteit tussen hierdie stelsels lei tot 'n verminderde vermoe om nuwe geneesmiddelsinteraksies en geneesmiddelreaksies na te spoor en te karakteriseer. Die primere struikelblok vir die bereiking van interoperabiliteit tussen SRSe is die fundamentele verskil in die doel van die bestaande SRSe. Belanghebbendes in die PV-stelsel bedryf SRSe met verskillende doelwitte en perspektiewe, insluitende: die handhawing van regulatoriese vereistes; die vermindering van finansiele risiko; en die beskerming en bevordering van pasientveiligheid in openbare gesondheidsorgprogramme. Die doel van hierdie studie is om by te dra tot die interoperabiliteit van SRSe in die PV-landskap deur die ontwikkeling van 'n nuwe en oorspronklike volwassenheidsmodel met 'n sosiotegniese stelselfokus. Die doel van die model is om interoperabiliteit te bevorder en te verbeter deur die mate van integrasie van betrokke stelsels aan te spreek, leiding te gee oor watter stelselkomponente verbeter moet word, asook om die interoperabiliteitsprogressies in die wereldwye gemeenskap van SRSe te meet. 'n Multidissiplinere literatuuroorsig oor PV, volwassenheidsmodelle, interoperabiliteit en sosiotegniese-stelsels het gedien as 'n teoretiese grondslag vir die ontwikkeling van die model. Die ontwikkeling van die model het gevolg op 'n aanpassing van die 8-fase prosedure model vir die ontwikkeling van volwassenheidsmodelle, voorgestel deur Becker et al. (2009). 'n Vergelyking van 18 bestaande volwassenheidsmodelle in die velde van: (i) PV; (ii) eHealth; (iii) eHealth/interoperabiliteit; (iv) interoperabiliteit; en (v) IT-infrastruktuur, is uitgevoer. Die model bestaan uit drie domeine, sewe subdomeine en dertig dimensies wat geidentifiseer is as gevolg van die voorafgaande literatuuroorsig en vergelyking van bestaande modelle. Die volwassenheidsmodel is deur 'n kombinasie van verifierings- en valideringsprosesse, waar vakkundiges betrokke was, verfyn. Om die veralgemeenbaarheid en empiriese geldigheid van die model te bepaal, is die gevolglike volwassenheidsmodel in 'n gevallestudie, binne die nasionale konteks van 'n regulerende owerheid, geimplementeer. Die gestelde doel van die model is bereik en die model word geag as 'n nuttige, unieke en waardevolle bydrae tot organisasies wat SRS'e bedryf.

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