Author: Rekha Joshi
Abstract: Pharmacovigilance is an essential aspect of drug safety evaluation, traditionally relying on data from clinical trials and spontaneous reporting systems. However, with the increasing complexity of medical treatments and the diversity of patient populations, there is a growing need to integrate realworld data, particularly from patients themselves, to enhance pharmacovigilance practices. Patient-Reported Outcomes (PROs), which include data collected directly from patients regarding their health status and the effects of treatments, offer a novel approach to improving the safety evaluation of drugs. This paper explores the significance of integrating PROs in pharmacovigilance, examining how patient feedback can supplement traditional safety monitoring systems, identify adverse drug reactions (ADRs) more effectively, and ultimately improve patient safety. Furthermore, the paper highlights the challenges and opportunities associated with the implementation of PROs in pharmacovigilance, proposing strategies for better utilization of patient-centered data in assessing drug safety.
Keywords: Pharmacovigilance, Patient-Reported Outcomes, Drug Safety, Adverse Drug Reactions, Real-World Data, Patient-Centric, Safety Evaluation
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