上海交通大学附属第六人民医院2010至2013年严重用药错误分析

Analysis of severe medication errors in the Sixth People＆#39;s Hospital Affiliated to Shanghai Jiao Tong University from 2010 to 2013

目的 了解医院严重用药错误（SME）的发生情况及成因,为制定防范措施提供依据.方法 收集上海交通大学附属第六人民医院2010至2013年药物不良反应/事件报告,从中选出所有E～I级（E级：对患者造成暂时性伤害;F级：导致患者住院或延长住院时间;G级：对患者造成永久性伤害;H级：导致患者生命垂危;I级：导致患者死亡）ME（即SME）报告进行回顾性分析.主要分析指标为SME的分级、临床表现、发生原因、涉及药品和科室. 结果 共收集到药物不良反应/事件报告511份,其中SME报告80份,占15.66％;2010-2013年SME报告在当年药品不良反应/事件报告中的占比分别为22.52％（59/262）、16.67％ （10/60）、3.95％（3/76）和7.08％ （8/113）.80份SME报告中,2010、2011、2012、2013年分别占73.75％（59份）、12.50％（10份）、3.75％（3份）、10.00％（8份）;E、H、I级ME报告分别占95.00％（76份）、3.75％（3份）、1.25％（1份）.E级ME以皮疹多见;H级ME均为过敏性休克;I级ME造成患者死亡.80份报告涉及81例次ME,发生原因为单次用药剂量过大者78例次（96.30％）,日剂量过大、溶媒用量过少和有禁忌证用药各1例次.81例次ME涉及18种药品,其中76例次（93.83％）涉及14种抗菌药物.80份报告涉及14个科室,占比居前3位者分别为急诊科（46.25％,37/80）、骨科（15.00％,12/80）和普外科（11.25％,9/80）. 结论 我院SME以E级为主,主要原因为单次用药剂量过大,但也有导致患者死亡的I级ME发生.应采取有效措施加强医院SME的防范.

Objective To understand occurrence and causes of severe medication errors （SME） in hospital and provide a basis for formulating preventive measures.Methods Adverse drug reactions or adverse events cases which were reported by the Sixth People＆#’s Hospital Affiliated to Shanghai Jiao Tong University from 2010 to 2013 were collected.And the ME cases of category E to I （Categories E through I were respectively errors occurred that may have contributed to or resulted in temporary harm to the patient [E],hospitalization or prolonged hospitalization [F],permanent patient harm [G],required intervention necessary to sustain life [H],and the patient＆#’s death [I].SME contained ME of category E to I.） were selected and analyzed retrospectively.Main analysis indexes included category,clinical manifestation,triggering factor,and involved drug and department.Results A total of 511 adverse drug reactions or adverse events cases were collected.Of them,80 SME cases （15.66%） were selected.Proportion of SME cases in 2010 to 2013 were respectively 22.52% （59/262）,16.67% （10/60）,3.95% （3/76）,and 7.08% （8/113） to all the adverse drug reactions or adverse events cases in that year.Of the 80 SME cases,the proportion in 2010,2011,2012,and 2013 were respectively 73.75% （59 cases）,12.50% （10 cases）,3.75% （3 cases）,and 10.00% （8 cases） and the proportion of category E,H,and I were respectively 95.00% （76 cases）,3.75% （3 cases）,and 1.25% （1 case）.The most manifestation of ME of category E was skin rash and all the symptoms of ME of category H were anaphylactic shock.ME of category I caused the patient＆#’s death.In 80 SME cases,there were 81 records including 78 records （96.30%） of excessive doses for one time and 1 record each of excessive doses for a day,insufficient solvent,and contraindication.The 80 SME cases were related to 18 kinds of drugs and,of them,76 records （93.83%） were related to 14 kinds of antibacterial agents.The 80 SME cases were associated with 14 departments and the top three were respectively the department of emergency （46.25 %,37/80）,osteology （15.00%,12/80）,and general surgery（11.25%,9/80）.Conclusions The ME of category E was primary SME in our hospital and the main triggering factor was excessive doses for one time.However,there was 1 ME case of category I which resulted in the patient＆#’s death.So some effective preventive measures should be carried out to strengthen prevention.