孙雯娟;邹羽真;张凡;张路;赵林;白春梅;张锋;徐燕;茅枫;李菁;顾宇;范欣荣;王孟昭;周道斌;张占杰;赵彬;杜小莉;张波;孙学勤;龙笑;常青;胡冰水;潘慧;吴文铭;
SUN Wenjuan;ZOU Yuzhen;ZHANG Fan;ZHANG Lu;ZHAO Lin;BAI Chunmei;ZHANG Feng;XU Yan;MAO Feng;LI Jing;GU Yu;FAN Xinrong;WANG Mengzhao;ZHOU Daobin;ZHANG Zhanjie;ZHAO Bin;DU Xiaoli;ZHANG Bo;SUN Xueqin;LONG Xiao;CHANG Qing;HU Bingshui;PAN Hui;WU Wenming;Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Department of Hematology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical Col

• 1:中国医学科学院北京协和医院药剂科
• 2:中国医学科学院北京协和医院血液内科
• 3:中国医学科学院北京协和医院肿瘤内科
• 4:中国医学科学院北京协和医院信息中心

摘要(Abstract)：

目的 设计抗肿瘤药物安全管理系统，从处方源头拦截超剂量医嘱，保障抗肿瘤药物临床应用的安全性。方法 制订88种抗肿瘤药物阈值拦截/警示策略，建立抗肿瘤药物安全管理系统，对超剂量抗肿瘤药物医嘱进行拦截/警示。调取2021年1—6月抗肿瘤药物安全管理系统中的拦截/警示数据并进行统计分析。结果 抗肿瘤药物安全管理系统共拦截/警示医嘱665条，其中触发拦截功能的医嘱共642条(96.54%),触发警示功能的医嘱共23条(3.46%);拦截/警示的药品以口服片剂为主(74.29%);被拦截医嘱中，频次错误占比最高(64.22%),其次为途径错误(11.73%)和剂量错误(9.92%)。拦截超剂量医嘱564条，涉及抗肿瘤药物28种；拦截次数最多的抗肿瘤药物为甲氨蝶呤片，平均超剂量7倍；注射用培美曲塞二钠平均超剂量倍数排名第1,平均超剂量1000倍。拦截超途径医嘱78条，涉及5种抗肿瘤药物。结论 抗肿瘤药物安全管理系统从处方环节杜绝了医嘱超剂量用药错误，切实保障了抗肿瘤药物的用药安全。
Objective To design a safety management system for antitumor drugs, which can intercept or warn the overdose of medical orders from the prescription source, and ensure the safety of clinical application of antitumor drugs. Methods The threshold of interception and warning strategy of 88 kinds of antitumor drugs were developed, and the safety management system of antitumor drugs was established to intercept or warn the overdose orders. The interception and warning data from January 2021 to June 2021 in the safety management system of antitumor drugs were extracted and analyzed. Results A total of 665 medical orders were intercepted or warned by the safety management system of antitumor drugs, and the majority of the intercepted or warned drugs were oral tablets(74.29%). The intercepted orders were 642(96.54%),and the warned orders were 23(3.46%). Among the intercepted medical orders, frequency error(64.22%) has the highest proportion, followed by route error(11.73%) and dose error(9.92%). A total of 564 medical orders were intercepted, involving 28 kinds of antitumor drugs. Methotrexate tablets ranked first in overdose quantity, with an average of seven times. Pemetrexed ranked first in overdose multiples, with an average overdose of 1000 times. 78 medical orders were intercepted for over pathway, involving 5 kinds of antitumor drugs. Conclusion The safety management system of antitumor drugs can eliminate the error of overdose in prescription and guarantee the safety of antitumor drugs.

关键词(KeyWords)： 抗肿瘤药物;安全管理系统;超剂量;用药安全
antitumor drugs;safety management system;over dose;medication safety

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 孙雯娟;邹羽真;张凡;张路;赵林;白春梅;张锋;徐燕;茅枫;李菁;顾宇;范欣荣;王孟昭;周道斌;张占杰;赵彬;杜小莉;张波;孙学勤;龙笑;常青;胡冰水;潘慧;吴文铭;
SUN Wenjuan;ZOU Yuzhen;ZHANG Fan;ZHANG Lu;ZHAO Lin;BAI Chunmei;ZHANG Feng;XU Yan;MAO Feng;LI Jing;GU Yu;FAN Xinrong;WANG Mengzhao;ZHOU Daobin;ZHANG Zhanjie;ZHAO Bin;DU Xiaoli;ZHANG Bo;SUN Xueqin;LONG Xiao;CHANG Qing;HU Bingshui;PAN Hui;WU Wenming;Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Department of Hematology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical Col

参考文献(References)：

• [1] World Health Organization.Feedback format for providing comments/suggestions on the draft Global Patient Safety Action Plan 2021-2030[EB/OL].(2020- 08- 28)[2021- 10- 21].https://extranet.who.int/dataformv3/index.php/959279 lang=en.
• [2] Hedegaard H,Miniňo AM,Warner M.Drug Overdose Deaths in the United States,1999—2018[J].NCHS Data Brief,2020(356):1- 8.
• [3] Okumura Y,Sakata N,Takahashi K,et al.Epidemiology of overdose episodes from the period prior to hospitalization for drug poisoning until discharge in Japan:An exploratory descriptive study using a nationwide claims database[J].J Epidemiol,2017,27:373- 380.
• [4] Institute for Safe Medication Practices.High-Alert Medica-tions in Long-Term Care (LTC) Settings [EB/OL].(2021- 05- 20) [2021- 10- 21].https://www.ismp.org/recommendations/high-alert-medications-long-term-care-list.
• [5] Jung HK,Lee J,Lee SN.A case of massive cisplatin overdose managed by plasmapheresis[J].Korean J Intern Med,1995,10:150- 154.
• [6] Hofmann G,Bauernhofer T,Krippl P,et al.Plasma-pheresis reverses all side-effects of a cisplatin overdose-a case report and treatment recommendation[J].BMC Cancer,2006,6:1- 1.
• [7] Chae L,Moon HS,Kim SC.Overdose of vincristine:experience with a patient[J].J Korean Med Sci,1998,13:334- 338.
• [8] Patiroglu T,Unal E,Ozdemir MA,et al.Accidental intramuscular overdose administration of vincristine[J].Drug Chem Toxicol,2012,35:232- 234.
• [9] Iketani O,Ueda T,Yamayoshi Y,et al.Suicide attempt with an overdose of imatinib[J].Br J Clin Pharmacol,2012,74:890- 892.
• [10] 孙雯娟，胡扬，左玮，等.胃癌患者应用卡培他滨出现严重不良反应1例药学监护[J].临床药物治疗杂志，2020,18:84- 86.
• [11] Institute for Safe Medication Practices.Medication Errors in Outpatient Hematology and Oncology Clinics[EB/OL].(2017-12-01)[2021-10-21].https://www.ismp.org/alerts/medication-errors-outpatient-hematology-and-oncology-clinics.
• [12] World Health Organization.Global cancer observatory[EB/OL].(2021- 01- 01)[2021- 10- 21].https://gco.iarc.fr/.
• [13] 国家卫生健康委.抗肿瘤药物临床应用管理办法(试行)[EB/OL].(2020- 12- 22)[2021- 10- 21].http://www.nhc.gov.cn/yzygj/s7659/202012/a7600740bed44d1db7015 ca5a1be2cc0.shtml.
• [14] 陈新谦，金有豫，汤光.新编药物学[M].第18版.北京：人民卫生出版社，2018.
• [15] Vázquez-Cornejo E,Morales-Ríos O,Juárez-Villegas LE,et al.Medication errors in a cohort of pediatric patients with acute lymphoblastic leukemia on remission induction therapy in a tertiary care hospital in Mexico[J].Cancer Med,2019,8:5979- 5987.
• [16] Weingart SN,Zhang L,Sweeney M,et al.Chemotherapy medication errors[J].Lancet Oncol,2018,19:e191-e199.
• [17] Ranchon F,Moch C,You B,et al.Predictors of prescription errors involving anticancer chemotherapy agents[J].Eur J Cancer,2012,48:1192- 1199.
• [18] Ranchon F,Salles G ,Sp?th HM,et al.Chemotherapeutic errors in hospitalised cancer patients:attributable damage and extra costs[J].BMC Cancer,2011,11:2- 10.
• [19] Weingart SN,Mattsson T,Zhu J,et al.Improving Electronic Oral Chemotherapy Prescription:Can We Build a Safer System?[J].J Oncol Pract,2012,8:e168-e173.
• [20] Chaparro JD,Classen DC,Danforth M,et al.National trends in safety performance of electronic health record systems in children's hospitals[J].Am Med Inform Assoc,2017,24:268- 274.
• [21] 胡琳，顾佳慧，杜浩鑫，等.240例用药错误引发医疗损害责任纠纷的案件分析[J].中国药房，2021,32:513- 517.
• [22] NMPA.舒尼替尼说明书[EB/OL].(2020- 08- 17)[2021- 10- 21].https://db.yaozh.com/Search?btn_jiansuo=1& content=%E8%88%92%E5%B0%BC%E6%9B%BF%E5%B0%BC.
• [23] NMPA.替莫唑胺说明书[EB/OL].(2018- 02- 26)[2021- 08-20].https://db.yaozh.com/instruct?comprehensivese-archcontent=%E6%9B%BF%E8%8E%AB%E5%94%91%E8%83%BA&.