Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (1): 1-5.
DOI: 10.19803/j.1672-8629.20230772

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Discovery and identification strategy for drug safety risks based on big data monitoring of adverse reactions

GAO Yunjuan1,2, ZHAO Xu1△, BAI Tiankai1,2, BAI Zhaofang1, WANG Jiabo3, SONG Haibo4#, XIAO Xiaohe1,*   

  1. 1China Military Institute of Chinese Materia, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China;
    2School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu Sichuan 611137, China;
    3School of Traditional Chinese Medicine, Capital Medical University, Beijing 100069, China;
    4Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China
  • Received:2023-12-11 Online:2024-01-15 Published:2024-01-18

Abstract: Objective To explore how to quickly discover and accurately identify drug safety risks from a vast number of adverse reaction reports from domestic and foreign Chinese and Western medicines. The aim is also to make scientific and effective predictions and control measures for these risks. Methods Drug-induced liver injury data was taken as an example, and the process of discovering, evaluating, confirming, and controlling risks associated with drugs were discussed. Results A preliminary exploration was conducted, leading to the establishment of an integrated strategy and method system for “large-scale adverse reaction monitoring and discovery - multi-model recognition and analysis- disease-symptom-toxicology verification.” This system has been successfully applied in identifying and analyzing drug-induced liver injury. Conclusion This strategy offers a fresh perspective for the continuous development and innovation of drug safety evaluation. It also provides technical support for ensuring public safety in medication and promoting the healthy development of the Chinese and Western medicine industry.

Key words: drug adverse reactions, monitoring, big data, risk discovery, data analysis, machine learning

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