省级药品不良反应聚集性信号监测与处置工作机制探讨

doi:10.19803/j.1672-8629.2022.02.14

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (2): 180-184.
DOI: 10.19803/j.1672-8629.2022.02.14

省级药品不良反应聚集性信号监测与处置工作机制探讨

路长飞, 崔小康, 刘文文, 张华琦, 高文政, 吴世福^*

山东省药品不良反应监测中心,山东济南250014

收稿日期:2021-11-20 出版日期:2022-02-15 发布日期:2022-02-15
通讯作者: ^*吴世福,男,主任中药师,药品不良反应监测。E-mail：wushifu@shandong.cn
作者简介:路长飞,男,硕士,主管药师,药品不良反应监测。

The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level

LU Changfei, CUI Xiaokang, LIU Wenwen, ZHANG Huaqi, GAO Wenzheng, WU Shifu^*

Shandong Provincial Centre for ADR Monitoring, Jinan Shandong 250014, China

Received:2021-11-20 Online:2022-02-15 Published:2022-02-15

摘要/Abstract

摘要： 目的从省级层面探讨药品不良反应聚集性信号监测与处置工作机制。方法基于山东省监测工作实践,归纳总结聚集性信号内在逻辑和特点,明确聚集性信号监测与处置具体要求,提出完善药品不良反应聚集性信号监测的建议。 结果与结论 药品不良反应聚集性信号监测和处置要强调落实药品上市许可持有人主体责任,注重风险控制为先、多方专业合作、闭环处置等原则。

关键词: 药品不良反应, 药品上市许可持有人, 聚集, 信号, 处置

Abstract: Objective To explore the working mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level. Methods Based on ways of monitoring in Shandong Province, the patterns and characteristics of adverse drug reaction cluster signals were summarized, specific requirements were clarified and advice on improving the monitoring of ADR cluster signals was given. Results and Conclusion The monitoring and disposal of adverse drug reaction cluster signals requires that the main responsibilities of drug marketing authorization holders are fulfilled, risk control be given the top priority, multi-sided collaboration and closed-loop disposal be ensured.

Key words: adverse drug reaction, drug marketing authorization holder, cluster, signal, disposal

中图分类号:

R95R994.11

路长飞, 崔小康, 刘文文, 张华琦, 高文政, 吴世福. 省级药品不良反应聚集性信号监测与处置工作机制探讨[J]. 中国药物警戒, 2022, 19(2): 180-184.

LU Changfei, CUI Xiaokang, LIU Wenwen, ZHANG Huaqi, GAO Wenzheng, WU Shifu. The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 180-184.

参考文献

[1] CFDA. CFDA has ordered the immediate stop of the sale and use of six batches of riboflavin sodium phosphate injection from Hubei Tongji Banda Ebei Pharmaceutical Co., Ltd.[EB/OL].(2014-08-12)[2020-11-13].https://www.nmpa.gov.cn/yaopin/ypjgdt/20140812202901646.html.
[2] CFDA. CFDA has ordered a full recall of the products and investigated Anhui Lianyi Pharmaceutical Co., Ltd.[EB/OL].(2015-02-17)[2020-11-13].https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20150217141701737.html.
[3] CFDA. Notice concerning quality issues of Honghua injection and Xiyanping injection from Shanxi Zhendong Ante Biopharmaceutical Co., Ltd. and Jiangxi Qingfeng Pharmaceutical Co., Ltd. (No. 153 of2017).[EB/OL].(2017-09-23)[2020-11-13].https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20170923225201502.html.
[4] CDR. CDR issued the announcement on the annual report for national ADR monitoring (2019)[EB/OL].(2020-04-10)[2020-11-13].http://www.cdr-adr.org.cn/tzgg_home/202004/t20200410_47300.html.
[5] FENG HY, HOU YF, WU GZ, et al.The establishing and running of pre-warning system on adverse event cluster signal[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2012, 9(12): 745-748.
[6] FENG HY, YANG L, SONG QJ, et al.Proposal and practice of building the early warning system on cluster adverse drug events based on the adverse drug reaction monitoring[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015,12(11): 665-668.
[7] FENG HY, GE WC, XIA XD, et al.Construction and practice of early warning system sharing platform on cluster adverse drug events[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(12): 727-730.
[8] FENG HY, LIU J, DONG D, et al.Analysis of the risk factors influencing the adverse drug cluster events early warning system[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2016, 13(4): 219-222.
[9] HUANG QQ, SUN J.Analysis of adverse events aggregation signals in Jiangsu province from 2021 to the First Half of 2017[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2018, 27(1): 42-44.
[10] SUN J, HUANG QQ, GAN G, et al.Discussion on the strategy of drug manufactures to deal with the adverse drug event clustering signal[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(11): 671-673.
[11] NMPA. Notice of direct reporting of adverse drug reactions by MAH (No. 66 of2018)[EB/OL].(2018-09-30)[2020-11-13].https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180930174301286.html.
[12] GE WC.Analysis of cluster signals of adverse drug events in Anhui province[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(2): 123-125, 128.

[1]	贾晋生, 刘红亮, 王青, 侯永芳, 李馨龄. 基于知识图谱联合ERNIE-DPCNN模型的药品不良反应自动关联性评价方法研究[J]. 中国药物警戒, 2024, 21(2): 163-166.
[2]	王珊, 谢波, 刘慧敏, 李志浩. 基于FAERS数据库对塞来昔布不良事件信号的分析[J]. 中国药物警戒, 2024, 21(2): 190-194.
[3]	李应芬, 韩雷. 319例注射用脑蛋白水解物药品不良反应报告分析[J]. 中国药物警戒, 2024, 21(2): 195-198.
[4]	徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.
[5]	郭清华, 彭笑笑, 朱萍, 刘西霖, 杨颖华, 陈志海. 氨氯地平过量致多器官功能障碍综合征1例分析[J]. 中国药物警戒, 2024, 21(2): 204-207.
[6]	方美琳, 郑慧敏, 王存泽, 王凌, 阮君山. 注射用奥沙利铂致全身肌肉疼痛1例分析[J]. 中国药物警戒, 2024, 21(2): 208-210.
[7]	陈玉艳, 张明霞, 张涛, 张晋. 斯鲁利单抗注射液致间质性肺炎不良反应1例分析[J]. 中国药物警戒, 2024, 21(2): 213-215.
[8]	曹桂萍, 邓琳琳, 朱干红, 陆颖, 马爽, 陈玲玲, 刘丽丽. 天麻首乌片致严重肝损伤1例分析[J]. 中国药物警戒, 2024, 21(2): 216-218.
[9]	高云娟, 赵旭, 白天凯, 柏兆方, 王伽伯, 宋海波, 肖小河. 基于不良反应监测大数据的药品安全风险发现与识别策略[J]. 中国药物警戒, 2024, 21(1): 1-5.
[10]	郭龙鑫, 高云娟, 吴承钊, 龙敏娟, 祝胜凯, 宋海波, 赵旭, 肖小河. 基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探[J]. 中国药物警戒, 2024, 21(1): 15-19.
[11]	熊玮仪, 任经天. 抗肿瘤药说明书安全性信息上市后修订的考虑要点[J]. 中国药物警戒, 2024, 21(1): 94-97.
[12]	蒋文硕, 杨莉. 694例癫痫医师药师联合门诊患者药品不良反应分析[J]. 中国药物警戒, 2024, 21(1): 102-106.
[13]	陈华炎, 江东波, 郭春连, 杨家琪, 黎雨欣, 蔡伟明. 326例奈玛特韦片/利托那韦片治疗新型冠状病毒感染安全性分析[J]. 中国药物警戒, 2024, 21(1): 107-110.
[14]	夏旭东, 黎美霞, 孙阳, 杨胜亚. 药品上市许可持有人药物警戒远程检查流程探讨[J]. 中国药物警戒, 2023, 20(9): 967-970.
[15]	刘赛月, 吕小琴, 周耘. 疑似药品不良反应死亡病例调查及报告实施要点[J]. 中国药物警戒, 2023, 20(9): 971-974.

省级药品不良反应聚集性信号监测与处置工作机制探讨

The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics