Design and Analysis of the Operation Effect of the Safety Management System for Antitumor Drugs
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摘要:
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。 Abstract: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. -
Key words:
- antitumor drugs /
- safety management system /
- over dose /
- medication safety
作者贡献:孙雯娟负责数据整理、系统对接、论文撰写;赵彬、孙雯娟负责研究设计;邹羽真、张凡参与数据整理;孙雯娟、张路、赵林、白春梅、徐燕、茅枫、李菁、顾宇、范欣荣、赵彬、龙笑、常青、胡冰水参与拦截规则设计;张锋负责数据调取、系统上线;王孟昭、周道斌、张占杰、杜小莉、张波、孙学勤、潘慧、吴文铭负责论文审阅及修改。利益冲突:所有作者均声明不存在利益冲突 -
表 1 2021年1—6月抗肿瘤药物拦截/警示医嘱基本信息(n=665)
抗肿瘤药物分类 数量[n(%)] 药物剂型 片剂 398(59.85) 注射剂 171(25.71) 胶囊剂 96(14.44) 药物类型 抗代谢类药物 413(62.12) 抗肿瘤靶向药物 146(21.95) 抗肿瘤抗生素 51(7.67) 植物来源的抗肿瘤药物及其衍生物 36(5.41) 其他抗肿瘤药物 11(1.65) 烷化剂 8(1.20) 表 2 2021年1—6月抗肿瘤药物拦截/警示医嘱类型(n=665)
类型 数量[n(%)] 拦截医嘱 642(96.54) 给药频次错误 427(64.22) 给药途径错误 78(11.73) 给药剂量错误 66(9.92) 给药单位错误 51(7.67) 剂量和频次错误 11(1.65) 途径和频次错误 9(1.35) 警示医嘱 23(3.46) 给药频次错误 9(1.36) 给药单位错误 7(1.05) 给药剂量错误 7(1.05) 表 3 2021年1—6月抗肿瘤药物超剂量拦截医嘱分析
药品名称 拦截次数 超剂量总倍数 平均超剂量倍数(最大值,最小值) 甲氨蝶呤片 333 2315 7(2,14) 替吉奥胶囊 37 55.5 1.5(1.5,1.5) 甲磺酸奥希替尼片 36 459 13(2,40) 枸橼酸伊沙佐米胶囊 29 351 12(3,14) 伊布替尼胶囊 15 242 16(3,30) 卡培他滨片 14 34 2.5(1.5,10) 培唑帕尼片 10 22 2.2(2,3) 注射用甲氨蝶呤 10 210 21(21,21) 苹果酸舒尼替尼胶囊 9 27 3(3,3) 利妥昔单抗注射液 9 90 10(10,10) 盐酸多柔比星脂质体注射液 9 9 1(1,1) 注射用放线菌素D 8 36 4.5(1.25,10) 贝伐珠单抗注射液 7 175 25(25,25) 注射用盐酸博来霉素 6 66 11(10,15) 卡铂注射液 5 50 10(10,10) 注射用环磷酰胺 5 35 7(7,7) 吉非替尼片 3 6 2(2,2) 替莫唑胺胶囊 3 4 1.25(1.25,1.25) 多西他赛注射液 3 4 1.1(1.1,1.1) 注射用培美曲塞二钠 2 2000 1000(1000,1000) 注射用达卡巴嗪 2 20 10(10,10) 阿昔替尼片 2 52 26(26,26) 盐酸安罗替尼胶囊 2 10 5(3,7) 来那度胺胶囊 1 21 21(21,21) 注射用顺铂 1 10 10(10,10) 尼妥珠单抗注射液 1 5 5(5,5) 注射用硫酸长春地辛 1 2 2(2,2) 注射用盐酸表柔比星 1 2 2(2,2) 注:超剂量倍数=(拦截/警示医嘱剂量÷正确医嘱剂量)×(拦截/警示医嘱频次÷正确医嘱频次) 表 4 2021年1—6月抗肿瘤药物阈值拦截典型案例
药品名称 拦截剂量 正确剂量 超剂量倍数 错误类型 甲磺酸奥希替尼片 6400 mg qd 160 mg qd 40 剂量错误 来那度胺胶囊 21粒qd 1粒qd 21 剂量错误 注射用达卡巴嗪 5.5 g once 0.55 g once 10 剂量错误 注射用博来霉素 21.3万单位once 2万单位once 10 剂量错误 注射用放线菌素D 5 mg once 0.5 mg once 10 剂量错误 注射用环磷酰胺 17.4 g 1.74 g once 10 剂量错误 注射用顺铂 400 mg once 40 mg once 10 剂量错误 卡培他滨片 15 g bid 1.5 g bid 10 剂量错误 注射用培美曲塞二钠 700 g once 700 mg once 1000 单位错误 伊布替尼胶囊 90粒once 420 mg once 30 单位错误 阿昔替尼片 26片bid 5 mg bid 26 单位错误 贝伐珠单抗注射液 400 mL once 400 mg once 25 单位错误 注射用盐酸博来霉素 30西林once 30万单位once 15 单位错误 利妥昔单抗注射液 600 mL once 600 mg once 10 单位错误 卡铂注射液 450 mL once 450 mg once 10 单位错误 舒尼替尼胶囊 37.5粒qd 37.5 mg qd 3 单位错误 注射用甲氨喋呤 0.04 g tid 0.04 g qw 21 频次错误 甲氨喋呤片 15 mg bid 15 mg qw 14 频次错误 枸橼酸伊沙佐米胶囊 4 mg bid 4 mg qw 14 频次错误 伊布替尼胶囊 840 mg tid 420 mg qd 6 频次错误 甲磺酸奥希替尼片 160 mg qid 160 mg qd 4 频次错误 培唑帕尼片 800 mg tid 800 mg qd 3 频次错误 盐酸安罗替尼胶囊 10 mg tid 10 mg qd 3 频次错误 替吉奥胶囊 3粒tid 3粒bid 1.5 频次错误 表 5 2021年1—6月抗肿瘤药物超途径拦截医嘱分析
药品名称 拦截途径 正确途径 数量[n(%)] 注射用盐酸表柔比星 动脉化疗 静脉滴注 24(30.77) 静脉泵入 静脉滴注 2(2.56) 口服给药 膀胱注射 1(1.29) 利妥昔单抗注射液 静脉输血 静脉滴注 12(15.38) 静脉泵入 静脉滴注 7(8.97) 静脉注射 静脉滴注 2(2.56) 注射用甲氨蝶呤 鞘内注射 眼内注射 11(14.10) 静脉注射 静脉滴注 5(6.41) 局部封闭 静脉滴注 1(1.29) 依托泊苷注射液 动脉化疗 静脉滴注 7(8.97) 静脉注射 静脉滴注 5(6.41) 注射用环磷酰胺 鞘内注射 静脉滴注 1(1.29) -
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