Revolutionizing Drug Safety: The Role of Artificial Intelligence and Machine Learning in Pharmacovigilance
Keywords:
Pharmacovigilance, Adverse Drug Reactions (ADRs), Artificial Intelligence (AI), Machine Learning (ML), Drug Safety Monitoring, Real-World DataAbstract
Pharmacovigilance is a crucial process in maintaining drug safety. This article explores the role of artificial intelligence (AI) and machine learning (ML) in advancing pharmacovigilance practices, focusing on their application in adverse drug reaction (ADR) detection and risk management. We examine how AI and ML technologies can streamline real-world data analysis, predict safety signals, and improve decision-making in drug safety monitoring. The paper also discusses the importance of regulatory collaboration, healthcare provider involvement, and patient education in strengthening pharmacovigilance efforts. By integrating these advanced technologies and collaborative frameworks, AI and ML offer significant potential to enhance drug safety, improve patient outcomes, and foster a more efficient pharmacovigilance system.
References
Z. Ahmed, K. Mohamed, S. Zeeshan, and X. Dong, "Artificial intelligence with multi-functional machine learning platform development for better healthcare and precision medicine," Database, vol. 2020, article baaa010, 2020.
A. Wong, J. M. Plasek, S. P. Montecalvo, and L. Zhou, "Natural language processing and its implications for the future of medication safety: a narrative review of recent advances and challenges," Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, vol. 38, no. 8, pp. 822-841, 2018.
Y. Yu, K. Ruddy, A. Mansfield, N. Zong, A. Wen, S. Tsuji, ... and G. Jiang, "Detecting and filtering immune-related adverse events signal based on text mining and observational health data sciences and informatics common data model: Framework development study," JMIR Medical Informatics, vol. 8, no. 6, article e17353, 2020.
M. Aoun and A. K. Sandhu, "Understanding the impact of AI-Driven automation on the workflow of radiologists in emergency care settings," Journal of Intelligent Connectivity and Emerging Technologies, vol. 4, no. 6, pp. 1-15, 2019.
A. Choudhury and O. Asan, "Role of artificial intelligence in patient safety outcomes: systematic literature review," JMIR Medical Informatics, vol. 8, no. 7, article e18599, 2020.
J. L. Vahle, U. Anderson, E. A. Blomme, J. C. Hoflack, and D. P. Stiehl, "Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective," Regulatory Toxicology and Pharmacology, vol. 96, pp. 18-29, 2018.
L. McDonald, B. Malcolm, S. Ramagopalan, and H. Syrad, "Real-world data and the patient perspective: the PROmise of social media?," BMC Medicine, vol. 17, no. 1, p. 11, 2019.
S. Reddy, S. Allan, S. Coghlan, and P. Cooper, "A governance model for the application of AI in health care," Journal of the American Medical Informatics Association, vol. 27, no. 3, pp. 491-497, 2020.
H. G. Eichler, K. Oye, L. G. Baird, E. Abadie, J. Brown, C. L. Drum, ... and G. Hirsch, "Adaptive licensing: taking the next step in the evolution of drug approval," Clinical Pharmacology & Therapeutics, vol. 91, no. 3, pp. 426-437, 2012.
D. Pappa, "The Knowledge Discovery Cube Framework: A Reference Framework for Collaborative, Information-Driven Pharmacovigilance," University of Surrey, 2018.
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