A Pharmacovigilance Framework for Real-World Evidence in Pharmacy Practice

Thesis Abstract

This study addresses the critical gap in integrating pharmacovigilance (PV) systems with real-world evidence (RWE) to enhance safety monitoring and decision-making in daily pharmacy practice. Despite regulatory advances and increasing data availability from electronic health records, spontaneous reports, and claims databases, there remains a lack of a cohesive framework that translates RWE into actionable PV insights for pharmacists. The aim is to develop and validate a robust PV framework for RWE in community and hospital pharmacy settings that enables systematic collection, appraisal, integration, and dissemination of safety signals arising from real-world use of medicines. Specific objectives include (1) identifying real-world data sources and data quality criteria relevant to pharmacy practice; (2) specifying data governance, interoperability, and ethical considerations for RWE in PV; (3) constructing a theoretical model linking PV processes with RWE generation, signal detection, validation, and communication to pharmacists; (4) operationalizing indicators and metrics of framework performance (completeness, timeliness, sensitivity, and specificity) and (5) evaluating the framework through a mixed-methods pilot in four pharmaceutical care settings. The study employs a sequential exploratory mixed-methods design underpinned by the Diffusion of Innovations theory and the Safety Culture theory to ground the framework’s adoption and safety outcomes. Phase I comprises a qualitative interview study with 40 practitioners (pharmacists in community and hospital settings) and 15 PV coordinators, followed by a Delphi consensus process with 20 experts to refine framework components. Phase II involves a quantitative survey of 200 pharmacists to assess the acceptability and perceived utility of the proposed framework, followed by a retrospective data analysis of 18,000 anonymized patient records from three collaborating health systems to test signal detection and validation workflows. Instruments include semi-structured interview guides, a PV-RWE framework checklist, an RWE quality assessment instrument, and a validated attitudinal survey on PV practices. Data collection will employ purposefully sampled participants with broad representation across urban and rural settings, and the retrospective dataset will be de-identified in accordance with ethical guidelines. Quantitative analysis will utilize descriptive statistics, multivariate logistic regression to identify determinants of framework adoption, and time-to-signal detection analyses using Cox proportional hazards models. For data integration and signal validation, a Bayesian hierarchical model will be applied to combine spontaneous reports, structured data, and unstructured notes, followed by thematic analysis of interview transcripts to elucidate contextual factors influencing framework implementation. The expected outputs include a comprehensive PV-RWE framework comprising data governance protocols, interoperable data schemas, signal detection and validation workflows, and communication templates tailored to pharmacy practice. The study anticipates identifying key drivers and barriers to effective PV-RWE integration, as well as measurable improvements in signal timeliness, accuracy of safety judgments, and pharmacist confidence in risk communication. The anticipated contribution to knowledge lies in delivering a theory-informed, practically implementable framework that bridges PV systems and real-world data ecosystems within pharmacy settings. This framework advances methodological rigor by combining Bayesian signal integration with mixed-methods validation and by operationalizing quality metrics for RWE in PV. It also informs policy and professional practice by providing guidelines for data governance, ethical considerations, and professional communication strategies aligned with patient safety and pharmacovigilance standards. The study concludes with recommendations for scale-up, including dedicated training modules for pharmacists, standardized data-sharing agreements, and integration pathways into existing PV information systems. Implications extend to regulators and health systems seeking to harness RWE for proactive safety management, post-marketing surveillance, and optimization of pharmacotherapy in diverse populations.