Browsing by Author "Schurer, Maximillian Juan"

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    Towards the interoperability of spontaneous reporting systems in pharmacovigilance : a maturity model approach with a sociotechnical system focus
    (Stellenbosch : Stellenbosch University, 2020-03) Schurer, Maximillian Juan; Louw, Louis; Bam, Louzanne; De Kock, Imke; Stellenbosch University. Faculty of Industrial Engineering. Dept. of Industrial Engineering.
    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.