Yu Hui-Min, Huang Ya-Min, Xiao Jian, Zhang Lu, Huang Hang-Xing, Huang Ling, Li Jing-Yang, Huang Xin-Qiong
Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.
Institute for Rational and Safe Medication Practices, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China.
Eur J Clin Pharmacol. 2025 Jul;81(7):1055-1067. doi: 10.1007/s00228-025-03842-6. Epub 2025 Apr 29.
This study aimed to develop a visualization platform for querying and analysing data from the FDA Adverse Event Reporting System (FAERS) to support the efficient collection, review, and analysis of adverse drug reactions (ADRs) for pharmacovigilance.
Data acquisition, cleaning, and integration processes were conducted to prepare FAERS data for analysis. The platform was designed with key functionalities, including multi-condition query, drug and ADR query, primary ID query, and interactive visualizations. Usability was demonstrated through a case study investigating the association between sulfonylureas and serious skin ADRs. Additionally, the platform's accuracy was validated by comparing its outputs with manually retrieved and visualized data using a separate test case involving aspirin and tremor.
The platform provides an interface with advanced query and visualization features, enabling users to efficiently retrieve, analyse, and visualize ADR data. Usability was illustrated by dynamically exploring FAERS data to identify safety signals for sulfonylureas and serious skin ADRs. The validation process confirmed the platform's reliability by showing consistent results with manually processed data, demonstrating its potential to streamline PV workflows and improve data interpretation.
The visualization platform represents a novel and practical tool for pharmacovigilance research. By offering intuitive data query and analysis capabilities, the platform supports drug safety monitoring and promotes the development of pharmacovigilance practices.
本研究旨在开发一个可视化平台,用于查询和分析来自美国食品药品监督管理局不良事件报告系统(FAERS)的数据,以支持药物警戒中不良药物反应(ADR)的高效收集、审查和分析。
进行数据采集、清理和整合过程,为分析准备FAERS数据。该平台设计了关键功能,包括多条件查询、药物和ADR查询、主键查询以及交互式可视化。通过一项调查磺脲类药物与严重皮肤ADR之间关联的案例研究证明了其可用性。此外,通过使用一个涉及阿司匹林和震颤的单独测试用例,将平台的输出与手动检索和可视化的数据进行比较,验证了平台的准确性。
该平台提供了一个具有高级查询和可视化功能的界面,使用户能够高效地检索、分析和可视化ADR数据。通过动态探索FAERS数据以识别磺脲类药物和严重皮肤ADR的安全信号说明了其可用性。验证过程通过显示与手动处理数据一致的结果,证实了平台的可靠性,证明了其简化药物警戒工作流程和改进数据解释的潜力。
该可视化平台是药物警戒研究的一种新颖且实用的工具。通过提供直观的数据查询和分析功能,该平台支持药物安全监测并促进药物警戒实践的发展。