• Home
  • Search
  • Artificial intelligence and big data for pharmacovigilance and patient safety
  • Cite Icon25
  • https://doi.org/10.1016/j.glmedi.2024.100139Copy DOI Icon

Artificial intelligence and big data for pharmacovigilance and patient safety

Show More
  • Abstract
  • Literature Map
  • References
  • Citations
  • Similar Papers
Abstract

Pharmacovigilance, the science of monitoring drug safety, plays a crucial role in identifying and mitigating adverse drug reactions (ADRs). However, underreporting in pharmacovigilance systems—estimated to have a median rate of 94 %—poses a significant threat to patient safety by hindering the detection of safety signals. The need to address these gaps is paramount, especially with the rising complexity of healthcare data. The advent of artificial intelligence (AI) and big data technologies offers promising solutions to overcome the limitations of traditional pharmacovigilance methods.The application of AI and machine learning (ML) technologies, including natural language processing (NLP) and deep learning, has the potential to revolutionize drug safety monitoring by automating the detection of ADRs from diverse data sources, such as electronic health records (EHRs), spontaneous reporting systems, and social media. These tools can process unstructured data and uncover patterns not easily identifiable through conventional approaches. Additionally, AI can enable real-time pharmacovigilance, which is especially critical in an era of increasing polypharmacy and diverse patient populations. AI-driven models are being utilized to detect drug-drug interactions (DDIs), predict ADRs, and enhance the overall efficiency of pharmacovigilance processes.Despite these advancements, several challenges remain. The performance of AI models is heavily dependent on the quality and quantity of data available. Inadequate or poorly curated datasets can lead to inaccurate ADR detection, particularly in resource-limited settings. Moreover, the heterogeneity of data sources necessitates robust AI models capable of integrating various types of data while ensuring accurate and reliable outputs. There is also a pressing need to address the transparency and explainability of AI models, as the opaque decision-making processes of current algorithms often impede their acceptance among pharmacovigilance professionals.Future directions must focus on improving the quality and standardization of datasets, advancing NLP techniques for better interpretation of clinical narratives, and developing explainable AI models. Regulatory frameworks should evolve to support AI deployment in pharmacovigilance, ensuring the establishment of best practices for AI implementation and the creation of large-scale, publicly available training datasets.Additionally, AI models should go beyond correlation-based approaches by integrating causal inference techniques, which will allow for a more accurate understanding of the relationship between drugs and ADRs. Human oversight will still be required to validate AI findings, but ongoing efforts to improve the robustness of AI systems will reduce dependency on manual interventions and scale the use of AI in pharmacovigilance.The integration of AI and big data in pharmacovigilance has the potential to transform drug safety monitoring, addressing many of the challenges posed by increasing data complexity and the need for real-time analysis. As these technologies continue to evolve, they promise to make pharmacovigilance more efficient, accurate, and comprehensive, thereby improving patient safety and rational drug use.

Similar Papers
  • Research Article

Utilizing AI and big data to predict and prevent adverse drug reactions

  • Jun 27, 2025
  • Journal of Health Physiotherapy and Orthopaedics
  • Mayank Pandey
  • Research Article
  • Citations10

Real-World Surveillance of FDA-Cleared Artificial Intelligence Models: Rationale and Logistics.

  • Feb 01, 2022
  • Journal of the American College of Radiology
  • Keith J Dreyer +2
  • Research Article

AI - Powered Content Management Systems: Automating Workflows and Enhancing User Experience

  • Aug 27, 2022
  • International Journal of Science and Research (IJSR)
  • Venkata Sai Swaroop Reddy
  • Research Article
  • Citations77

Artificial intelligence and big data: ontological and communicative perspectives in multi-sectoral scenarios of modern businesses

  • Jun 28, 2022
  • foresight
  • Manpreet Arora +1
  • Research Article

From algorithms to influence: a global bibliometric analysis of artificial intelligence in marketing communication

  • Jan 02, 2026
  • Academia Revista Latinoamericana de Administración
  • María Belén Prados-Peña +2
  • Research Article
  • Citations7

Artificial Intelligence: The Future of Maxillofacial Prognosis and Diagnosis?

  • Feb 26, 2021
  • Journal of Oral and Maxillofacial Surgery
  • Peter Rekawek +2
  • Research Article
  • Citations1

Artificial intelligence in oncology: global experience and future prospects

  • Oct 22, 2025
  • FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology
  • D I Korabelnikov +1
  • Research Article
  • Citations1

Bridging the Gap: Practical Challenges and Strategic Imperatives in Adopting Gen AI

  • Dec 04, 2024
  • International Conference on AI Research
  • Andrea Di Vetta
  • Research Article

The integration of artificial intelligence into foreign language teaching of maritime students: preparation for professional interviewing

  • Apr 30, 2025
  • Russian Journal of Education and Psychology
  • Vladlena V Lysenko +2
  • Conference Article

FPGA-based Computing in the Era of AI and Big Data

  • Apr 04, 2019
  • Eriko Nurvitadhi
  • Research Article

The Philosophical Construction of Educational Science in Relation to Posthumanism and Transhumanism in Artificial Intelligence

  • Mar 21, 2025
  • Turkish Academic Research Review - Türk Akademik Araştırmalar Dergisi [TARR]
  • Thoriqi Firdaus
  • Research Article

The Impact of AI-Integrated Drone Technology and Big Data on External Auditing Performance, Sustainability, and Financial Reporting Quality on the Emerging Market

  • Sep 26, 2025
  • Accounting and Auditing
  • Abdulkarim Hamdan J Alhazmi +2
  • Research Article

Integration of artificial intelligence in reverse logistics process: enhancing decision-making across planning, execution, and control stages

  • Jul 30, 2025
  • International Journal of Production Management and Engineering
  • Pascual Cortes Pellicer +2
  • Research Article

Integration of the Artificial Intelligence in Higher Education: a Case Study from the University of Tirana (Quality Education SDG)

  • Jun 13, 2025
  • Journal of Lifestyle and SDGs Review
  • Elda Xhumari +5
  • PDF
  • Research Article
  • Citations2

Sustainable Landscape Design and Traditional Villages in Xuzhou, Jiangsu: Low-cost Strategies and Big Data Applications Influencing AI Integration

  • Apr 24, 2024
  • Journal of Information Systems Engineering and Management
  • Lian Wang +2
Cactus Communications logo

Copyright 2026 Cactus Communications. All rights reserved.