摘要
目的 探究药品不良反应报告体系结构变动和潜在改进空间,为提高药品安全监管效能提供参考。方法 采用描述性统计分析法和结构分析法,对我国2014—2023年药品不良反应报告的报告来源、报告人职业、患者年龄、药品类别及给药途径变动情况进行分析。结果 我国药品不良反应报告来源、报告人职业、患者年龄、药品类别及给药途径的结构变动度分别为20.00%,6.20%,27.20%,9.40%,16.62%。≥65岁患者(VSV=13.20)结构变动值最大且呈正向变动;药品经营企业来源(VSV=-9.70)、静脉注射途径(VSV=-6.51)及中药类别(VSV=-4.70)呈负向变动。结论 要健全行业法律法规,提升企业主体责任落实能力,提高公众药品不良反应的认知度和参与意识,强化特定年龄段用药安全监测及指导策略,提高中药不良反应监测水平,加强静脉注射不良反应的监管。
Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR) reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40% and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20) had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51) and traditional Chinese medicine category(VSV=-4.70) showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.
作者
黄映霓
孟光兴
李艳香
HUANG Yingni;MENG Guangxing;LI Yanxiang(School of Pharmaceutical Business,Guangdong Pharmaceutical University,Zhongshan 528400,China;Key Laboratory for Technology Research and Evaluation of Pharmacovigilance,National Medical Products Administration,Zhongshan 528400,China)
出处
《医药导报》
北大核心
2025年第6期982-988,共7页
Herald of Medicine
基金
广东省药品监督管理局2022年科技创新项目(2022ZDZ06)
广东省科技厅2022年项目-国际科技合作领域“药物警戒体系下的粤港澳大湾区药品安全监管与产业协同发展问题研究”。
关键词
药品不良反应报告
结构变动分析
不良反应监测
药品安全
Adverse drug reaction report
Structural change analysis
Adverse drug reaction monitoring
Drug safety
