达比加群酯和利伐沙班用药错误报告分析及防范策略

Analysis and prevention of medication errors of dabigatran etexilate and rivaroxaban

目的探讨达比加群酯和利伐沙班用药错误(ME)的发生情况及影响因素,为制定针对性的防范措施提供依据。方法收集全国临床安全用药监测网2016年1月1日至2020年12月31日期间达比加群酯和利伐沙班的ME报告,对ME的分级、错误内容、引发错误人员、发现错误人员和引发因素进行分析。结果达比加群酯和利伐沙班ME报告共计100例,占总ME报告(59949例)的0.17%,严重ME报告5例,占总严重ME报告(508例)的0.98%。经逐例审阅最终符合要求的是98例,男65例、女33例,平均年龄62.45(29~92)岁;B级错误最多,76例(77.55%);严重ME 4例(4.08%),表现为出血及出血倾向,错误因素为药物相互作用和围术期用药。医师引发错误(45例,45.92%)中错误内容前3位为适应证、用量和数量/频次;药师引发错误(43例,43.88%)中错误内容前3位为数量、规格和品种;发现错误的人员主要是药师(77例,78.57%);引发错误的因素前3位分别为知识欠缺/培训不足、疲劳和药名相似/外观相似。结论达比加群酯/利伐沙班严重ME占比大于总ME占比;重点需要关注处方和调配环节,同时需要加强医务人员合理用药培训和调整工作强度,减少和避免知识欠缺/疲劳,可以根据条件引进临床决策支持系统(如处方/医嘱前置审核)及自动化整盒发药机辅助减少ME。

Objective To discuss the occurrence and influencing factors of medication errors(ME)of dabigatran etexilate and rivaroxaban,and provide evidence for formulating targeted preventive measures.Methods The ME reports of dabigatran axetil and rivaroxaban between January 1,2016 and December 31,2020 of the National Clinical Safety Drug Monitoring Network were collected,and the classification,error content,error causing personnel,error finding personnel and causing factors of ME were analyzed.Results A total of 100 ME reports of dabigatran etexilate and rivaroxaban accounted for 0.17%of the total ME reports(59949 cases),of which 5 were severe ME reports,which accounted for 0.98%of the total severe ME reports(508 cases).After a case-by-case review,98 cases finally met the requirements,including 65 males and 33 females,with an average age of 62.45(29~92)years.Grade B errors were the most,76 cases(77.55%);severe ME reports 4 cases(4.08%),manifested as bleeding and bleeding tendency,and the wrong factors were drug interaction and perioperative anticoagulant use.The top three errors caused by physicians(45 cases,45.92%)were indications,dosage and quantity/frequency;the top three errors caused by pharmacists(43 cases,43.88%)were the quantity,specification,and variety.The people who found the errors were mainly pharmacists(77 cases,78.57%).The top three factors causing errors were lack of knowledge/inadequate training,fatigue,and look-alike/sound-alike medicine.Conclusion The proportion of severe ME of dabigatran etexilate/rivaroxaban is greater than of total ME.It is important to pay attention to the procedure of prescription and dispensing.Equally,it is necessary to strengthen the training of medical staff in rational drug use and adjust the work intensity to reduce and avoid lack of knowledge/fatigue.Clinical decision support system such as pre-review prescriptions and automated drug delivery systems can be introduced to assist in reducing ME according to conditions.