Foundations, Methodological progress, and the Technological Transformation in Pharmacovigilance: A Comprehensive Review
Keywords:
Pharmacovigilance, Methodological progress, Emerging TechnologiesAbstract
Pharmacovigilance is a highly essential field of medical science that focuses on the identification, assessment and management of adverse drug reactions. It serves as an important public health requirement to address shortcomings of pre-marketing randomized controlled trials that are often determined in heterogeneous populations to detect rare, long-latency or idiosyncratic adverse events. This review explore the historical evolution of a reactive system of pharmacovigilance elicited by devastating consequences of public health, like the thalidomide incident, into a proactive regulatory system supported by the International Council for Harmonisation guidelines. The article critically assesses the foundational role of spontaneous reporting systems and individual case safety reports grappling with huge methodological challenges including pervasive underreporting and the need to have robust signal detection models such as proportional reporting ratios and Bayesian statistical models. Moreover, this review outlines the progress in predictive risk management that has been made by formulating safety specifications and detailed risk management plans, and at the same time, points out the increased opportunity of real-world data and artificial intelligence use to automate the signal detection and subsequently improve the ability to identify and manage adverse drug reactions. It also elaborates surrounding the exceptionally professionalized surveillance requirements of the latest areas, e.g., vaccine-vigilance and advanced therapy medicinal product, both of which necessitate important longitudinal surveying and bilateral traceability. Currently, pharmacovigilance is in its transitional related to precision monitoring; to set up an actual global system of drug safety, the long-standing problem of regulatory fragmentation has to be overcome through the incorporation of innovative technologies that will be able to fight against the growing complexity of modern therapeutic agents.
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