Drug safety is the core of ensuring patient safety, and government departments and medical institutions at all levels attach great importance to patient drug safety in China. Pharmacovigilance is the risk management throughout the whole life cycle of drugs, and the construction of pharmacovigilance system is an effective means for medical institutions to monitor drug use risk and ensure drug use safety. Based on the system construction centered on "vigilance", this paper started from the aspects of organizational structure setting, working mode and work content, focused on the monitoring of drug quality problem, adverse drug reaction, prevention of medication error, monitoring of drug abuse, risk prevention and control of medication in operating rooms and other medication risk prevention measures, summarized the pharmacovigilance system construction in medical institutions and its role in risk prevention, control and management of drug use, and provided references for medical institutions to develop pharmacovigilance system construction and improve drug use safety level.

1.World Health Organization. Patient safety: making heath care safe[EB/OL]. (2017-11) [2023-04-20]. http://apps.who.int/iris/handle/10665/255507.

2.国家卫生健康委员会办公厅. 关于进一步加强患者安全管理工作的通知[EB/OL]. (2018-04-12) [2023-04-20]. http://www.nhc.gov.cn/yzygj/s7658/201804/00a8be2958e144e5a1439faf995ba982.shtml.

3.国家卫生健康委, 国家中医药管理局. 关于进一步加强用药安全管理提升合理用药水平的通知[EB/OL]. (2022-07-27) [2023-04-20]. http://www.nhc.gov.cn/yzygj/s7659/202207/007020b813ce446ba3cab3258775270a.shtml.

4.World Health Organization. The WHO programme for international drug monitoring[EB/OL]. (2022) [2023-04-20]. https://www.who.int/teams/regulation-prequalification/regulationand-safety/pharmacovigilance/health-professionals-info/pidm.

5.中华人民共和国药品管理法[S]. 2019.

6.国家药品监督管理局. 关于发布《药物警戒质量管理规范》的公告[EB/OL]. (2021-05-07) [2023-04-20]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151 827179.html.

7.国家药品监督管理局药品评价中心, 中国药师协会, 中国药学会医院药学专业委员会, 等. 医疗机构药物警戒体系建设专家共识[J]. 中国药物应用与监测, 2022, 19(3): 135-144. DOI: 10.3969/j.issn.1672-8157. 2022.03.001.

8.王敏. 医疗机构药品不良反应监测现状与对策研究[J]. 药学服务与研究, 2016, 11(7): 416-419. [Wang M. Current situation of adverse drug reaction monitoring in hospitals and related countermeasures[J]. Pharmaceutical Care and Research, 2016, 11(7): 416-419.] DOI: 10.5428/pcar20160510.

9.姚翀, 刘东杰, 郭代红, 等. 临床药物不良事件主动监测与智能评估警示系统Ⅱ的研发[J]. 中国药物应用与监测, 2020, 17(6): 387-391. [Yao C, Liu DJ, Guo DH, et al. The development on active surveillance and assessment system-Ⅱ of adverse drug events[J]. Chinese Journal of Drug Application and Monitoring, 2020, 17(6): 387-391.] DOI: 10.3969/j.issn.1672-8157.2020.06.009.

10.Oliveira JL, Lopes P, Nunes T, et al. The EU-ADR web platform: delivering advanced pharmacovigilance tools[J]. Pharmacoepidemiol Drug Saf, 2013, 22(5): 459-467. DOI: 10.1002/pds.3375.

11.Patadia VK, Coloma P, Schuemie MJ, et al. Using realworld healthcare data for pharmacovigilance signal detection- the experience of the EU-ADR project[J]. Expert Rev Clin Pharmacol, 2015, 8(1): 95-102. DOI: 10.1586/17512433.2015.992878.

12.叶小飞. 上市后药品不良反应信号检测方法的进展与思考[J]. 海军军医大学学报, 2022, 43(2): 117-122. [Ye XF. Progress and thinking of signal detection methodology on post-marketing adverse drug reaction surveillance[J]. Academic Journal of Naval Medical University, 2022, 43(2): 117-122.] DOI: 10.16781/j.CN31-2187/R.20211309.

13.耿魁魁, 吴淑华, 刘圣, 等. 触发器技术在医院药物不良反应主动监测系统构建中的应用[J]. 药物不良反应杂志, 2015, 17(5): 348-352. [Geng KK, Wu SH, Liu S, et al. Construction of active monitoring system for adverse drug reactions based on the trigger technology[J]. Adverse Drug Reactions Journal, 2015, 17(5): 348-352.] DOI: 10.3760/cma.j.issn.1008-5734.2015.05.006.

14.陈超, 郭代红, 薛万国, 等. 住院患者药品不良事件主动监测与评估警示系统的研发[J]. 中国药物警戒, 2013, 10(7): 411-414. [Chen C, Guo DH, Xue WG, et al. Development of alarming system to actively monitor and assess the adverse drug events in hospitalized patients[J]. Chinese Journal of Pharmacovigilance, 2013, 10(7): 411-414.] DOI: 10.3969/j.issn.1672-8629.2013.07.008.

15.Yu CX, Guo DH, Yao C, et al . Development and validation of a nomogram for predicting drug-induced acute kidney injury in hospitalized patients: a case-control study based on propensity-score matching[J]. Front Pharmacol, 2021, 12(3) : 657853. DOI: 10.3389/fphar.2021.657853. eCollection 2021.

16.Zhu Y, Guo DH, Kong XH, et al. A risk-prediction nomogram for neutropenia or febrile neutropenia after etoposidebased chemotherapy in cancer patients: a retrospective cohort study[J]. Pharmacology, 2022, 107(1-2): 69-80. DOI: 10.1159/000519333.

17.王快, 黎丽, 潘碚彬, 等. 信息化监测模式对某三级甲等医院药品不良反应报告质量的影响[J]. 中国药业, 2022, 31(5): 23-28. [Wang K, Li L, Pan BB, et al. Influence of information monitoring mode on the quality of adverse drug reaction reports in tertiary A hospitals[J]. China Pharmaceuticals, 2022, 31(5): 23-28.] DOI: 10.3969/j.issn.1006-4931.2022.05.005.

18.合理用药国际网络中国中心组临床安全用药组, 中国药理学会药源性疾病学专业委员会, 中国药学会医院药学专业委员会, 等. 中国用药错误管理专家共识[J]. 药物不良反应杂志, 2014, 16(6) : 321-326. DOI: 10.3760/cma.j.issn.1008-5734.2014.06.001.

19.Goedecke T, Ord K, Newbould V, et al. Medication errors: New EU good practice guide on risk minimisation and error prevention[J]. Drug Saf, 2016, 39(6): 491-500. DOI: 10.1007/s40264-016-0410-4.

20.冯慧, 钱娜. 医院药房管理中采用高警示药品分级标识的效果分析[J]. 中国处方药, 2023, 21(2): 52-54. [Feng H, Qian N. Effect analysis of high warning drug classification in hospital pharmacy management[J]. JournalL of China Prescription Drug, 2023, 21(2): 52-54.] DOI: 10.3969/j.issn.1671-945X.2023.02.014.

21.合理用药国际网络中国中心组临床安全用药组, 中国药理学会药源性疾病学专业委员会, 药物不良反应杂志社. 医疗机构手术室用药错误防范指导原则[J] . 药物不良反应杂志, 2021, 23(8): 396-402. DOI: 10.3760/cma.j.cn114015-20210712-00785.

22.中国药学会医院药学专业委员会. 我国高警示药品推荐目录2015版 [EB/OL]. (2015-06-16) [20123-04-20]. http://www.cpahp.org.cn/zwhhd/news/201506/1614.htm.

23.樊迪, 孙倩雯, 贾富平, 等. 利用信息化技术加强高警示药品风险控制研究[J]. 药物流行病学杂志, 2016, 25(4): 254-257. [Fan D, Sun QW, Jia FP, et al. Using Information Technology to Strengthen Control the Risk of High-alert Medication[J]. Chinese Journal of Pharmacoepidemiology, 2016, 25(4): 254-257.] DOI: 10.19960/j.cnki.issn1005-0698.2016.04.014.

24.合理用药国际网络中国中心组临床安全用药组, 中国药理学会药源性疾病学专业委员会, 中国药学会医院药学专业委员会, 等. 高警示药品用药错误防范技术指导原则[J]. 药物不良反应杂志, 2017, 19(6): 403-408. DOI: 10.3760/cma.j.issn.1008-5734.2017.06.002.

25.中国药理学会治疗药物监测研究专业委员会药品风险管理学组. 超说明书用药专家共识[J]. 药物不良反应杂志, 2015, 17(2): 101-103. DOI: 10.3760/cma.j.issn. 1008-5734.2015.02.011.

26.Zhao H, Wei L, Li H, et al. Appropriateness of antibiotic prescriptions in ambulatory care in China: a nationwide descriptive database study[J]. Lancet Infect Dis, 2021, 21(6): 847-857. DOI: 10.1016/S1473-3099(20)30596-X.

27.潘婉玉, 张春慧, 张振香, 等. 老年慢性病共病患者多重用药管理分析与评论[J]. 中国全科医学, 2022, 25(13): 1545-1550. [Pan WY, Zhang CH, Zhang ZX, et al. Polypharmacy management in elderly patients with multimorbidity[J]. Chinese General Practice, 2022, 25(13): 1545-1550.] DOI: 10.12114/j.issn.1007-9572.2022. 00.009.

28.张原, 李丹丹. 我国药品追溯体系建设的思考[J]. 中国药事, 2020, 34(7): 754-758. [Zhang Y, Li DD. On the construction of drug traceability system in China[J]. Chinese Pharmaceutical Affairs, 2020, 34(7): 754-758.] DOI: 10.16153/j.1002 7777.2020.07.004.

29.张青霞, 白向荣, 王子民, 等. 全国临床安全用药监测网年度报告（2022年）[J]. 药物不良反应杂志, 2023, 25(7): 389-397. [Zhang QX, Bai XR, Wang ZM, et al. Annual report of National Monitoring Network for Clinical Safe Medication (2022)[J]. Adverse Drug Reactions Journal, 2023, 25(7): 389-397.] DOI: 10.3760/cma.j.cn114015-20230608-00421.

30.谢靳希, 邓艳萍, 史录文. 美国阿片类药物滥用危机与中国镇痛药使用与监管[J]. 中国药物滥用防治杂志, 2020, 26(4): 192-197. [Xie JX, Deng YP, Shi LW. The Opioids Crisis in the U.S. and the Utilization and Supervision of Analgesics in China[J]. Chinese Journal of Drug Abuse prevention and Treatment, 2020, 26(4): 192-197.] DOI: 10.15900/j.cnki.zylf1995.2020.04.002.

31.张晚霞, 陈敏, 安薇, 等. 我国麻精药品管理研究的文献计量分析[J]. 药物流行病学杂志, 2022, 31(6): 416-421. [Zhang WX, Chen M, An W, et al. Bibliometric analysis of narcotic and psychotropic drugs management research in China[J]. Chinese Journal of Pharmacoepidemiology, 2022, 31(6): 416-421.] DOI: 10.19960/j.cnki.issn1005-0698.2022.06.010.

32.叶玉剑, 钟娜, 赵敏. 镇静催眠药物滥用及干预方式的研究进展[J]. 上海交通大学学报(医学版), 2021, 41(1): 99-102. [Ye YJ, Zhong N, Zhao M. Research progress of sedative-hypnotics abuse and the interventions[J]. Journal of Shanghai Jiao Tong University (Medical Science) , 2021, 41(1): 99-102.] DOI: 10.3969/j.issn.1674-8115.2021.01.018.

33.Manias E, Cranswick N, Newall F, et al. Medication error trends and effects of person related, environment related and communication related factors on medication errors in a paediatric hospital[J]. J Paediatr Child Health, 2019, 55(3): 320-326. DOI: 10.1111/jpc.14193.

34.Parry AM, Barriball KL, While AE. Factors contributing to registered nurse medication administration error: a narrative review[J]. Int J Nurs Stud, 2015, 52(1): 403-420. DOI: 10.1016/j.ijnurstu.2014.07.003.

35.高明娥, 张云霞, 王荟, 等. 临床药师参与病区药品管理保障用药安全[J]. 中国药物与临床, 2016, 16(8): 1225-1226. [Gao ME, Zhang YX, Wang H, et al. Clinical pharmacists participate in ward drug management to ensure drug safety[J]. Chinese Remedies and Clinics, 2016, 16(8): 1225-1226.] DOI: 10.11655/zgywylc2016.08.061.

36.张美玲. 临床药师促进化疗药物用药安全的工作模式探讨[J]. 中国临床药理学杂志, 2015, (2): 139-140. [Zhang ML. Exploration of working mode of clinical pharmacists to promote chemotherapy medication safety[J]. Chinese Journal of Clinical Pharmacology, 2015, (2): 139-140.] DOI: 10.13699/j.cnki.1001-6821.2015.02.018.