药品使用不当相关医疗纠纷41例分析
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摘要
背景药品在临床治疗过程中发挥着重要作用,而因药品使用不当引发医疗纠纷事件层出不穷,关注药品使用不当相关医疗纠纷是保障医疗质量、促进医患和谐的重要举措。目的分析药品使用不当相关医疗纠纷,以指导临床上合理用药的安全管理。方法于2018年7月从中国裁判文书网(http://wenshu.court.gov.cn/)进行高级检索,共纳入41例以药品使用不当为诉因的判例,对其进行文本分析,提取立案年份、地区、医院级别、医疗事故、诉讼原因、医疗损害鉴定、责任程度(参与度)、判决结果、索赔金额、赔偿金额、药品使用不当原因等信息,计算审判时间、赔偿系数、参与度、赔偿比重。结果 41例以药品使用不当为诉因的判例中,一审22例,二审19例,申请医疗损害鉴定72次,平均每例鉴定1.76次,4例为医疗事故,34例存在不同程度参与度;41例平均索赔金额为704 220.60元,37例平均赔偿金额为211 865.10元,赔偿比重为30.1%;实际以药品使用不当为原因的医疗纠纷共29例,包括用药差错25例、药物不良反应2例、原因尚不明确2例,其中抗菌药物、激素、镇静镇痛药品、解毒药品在使用过程中存在剂量、时间、联合用药、方案调整等多方面差错。结论药品使用不当相关医疗纠纷形势不容乐观,通过信息化、制度化、流程化的方法加强临床用药的安全性,同时进一步理清纠纷处置的鉴定、赔偿程序,保障医患双方的合法权益。
Background Drugs play an important role in the process of clinical treatment,and medical disputes are caused by improper use of drugs. Paying attention to medical disputes related to improper use of drugs is an vital measure to ensure medical quality and promote harmony between doctors and patients. Objective To guide the safety management of clinical rational drug use by analyzing medical disputes cases related to drug misuse.Methods We selected and analyzed documents of 41 legal precedents caused by drug misuse from China Judgments Online(http://wenshu.court.gov.cn/) through advanced search in July 2018,extracted the year of filing,district,hospital level,medical accident,accident grade,lawsuit reason,appraisal method,degree of responsibility(participation),judgment result,amount of claim,amount of compensation,cause of improper drug use,and calculated trial time,compensation coefficient,participation and proportion of compensations.Results Among 41 cases of drug misuse,22 cases were sentenced in the court of first instance and 19 cases in the court of second instance.Among them,the appraisements of medical damage were applied for 72 times and average 1.76 times per case.Four cases were judged to be medical accidents and 34 cases were identified as fault participation.The mean compensation of the total 41 cases was 704 220.60 yuan,the mean compensation of 37 cases was 211 865.10 yuan,and the proportion of compensations was 30.1%.Twenty-nine medical disputes were directly caused by drug misuse,including 25 cases of medication errors,2 cases of adverse drug reactions and 2 cases of unclear cause.There were frequent misuse of antibiotics,hormones,sedatives,analgesics and antidotes in dosage,time,combination of drugs and treatment adjustment.Conclusion The situation of medical disputes related to drug misuse is not optimistic.The safety of clinical pharmacy should be strengthened through informatization,institutionalization and process management.At the same time,the procedures of identification and compensation for disputes should be further clarified to protect the legitimate rights and interests of both doctors and patients.
Background Drugs play an important role in the process of clinical treatment,and medical disputes are caused by improper use of drugs. Paying attention to medical disputes related to improper use of drugs is an vital measure to ensure medical quality and promote harmony between doctors and patients. Objective To guide the safety management of clinical rational drug use by analyzing medical disputes cases related to drug misuse.Methods We selected and analyzed documents of 41 legal precedents caused by drug misuse from China Judgments Online(http://wenshu.court.gov.cn/) through advanced search in July 2018,extracted the year of filing,district,hospital level,medical accident,accident grade,lawsuit reason,appraisal method,degree of responsibility(participation),judgment result,amount of claim,amount of compensation,cause of improper drug use,and calculated trial time,compensation coefficient,participation and proportion of compensations.Results Among 41 cases of drug misuse,22 cases were sentenced in the court of first instance and 19 cases in the court of second instance.Among them,the appraisements of medical damage were applied for 72 times and average 1.76 times per case.Four cases were judged to be medical accidents and 34 cases were identified as fault participation.The mean compensation of the total 41 cases was 704 220.60 yuan,the mean compensation of 37 cases was 211 865.10 yuan,and the proportion of compensations was 30.1%.Twenty-nine medical disputes were directly caused by drug misuse,including 25 cases of medication errors,2 cases of adverse drug reactions and 2 cases of unclear cause.There were frequent misuse of antibiotics,hormones,sedatives,analgesics and antidotes in dosage,time,combination of drugs and treatment adjustment.Conclusion The situation of medical disputes related to drug misuse is not optimistic.The safety of clinical pharmacy should be strengthened through informatization,institutionalization and process management.At the same time,the procedures of identification and compensation for disputes should be further clarified to protect the legitimate rights and interests of both doctors and patients.
引文
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[17]玉顺子.药物不良事件引起的医疗纠纷案例分析[J].中国医院药学杂志,2014,34(17):1523-1526.YU S Z.Case analysis on the adverse drug reaction events induced medical disputes[J].Chinese Journal of Hospital Pharmacy,2014,34(17):1523-1526.
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[19]麻醉药品和精神药品管理条例[EB/OL].(2008-03-28)[2018-09-10].http://www.gov.cn/zhengce/content/2008-03/28/content_6269.htm.
[20]宁超.医疗损害赔偿纠纷判例研究——以中国裁判文书网2005—2015年997个判例为对象[D].太原:山西医科大学,2016.NING C.Study on precedent case about the dissension of medical damage compensation——taking 977 cases of China Judgments Online from 2005 to 2015 as the object of study[D].Taiyuan:Shanxi Medical University,2016.
[21]安林静,刘婉姝,张丽娜,等.移动护理信息系统在临床用药安全实践中的效果评价[J].解放军药学学报,2017,33(4):382-383.ANLJ,LIUWS,ZHANGLN,etal.Effectivenessof mobile care information system in clinical drug safety[J].Pharmaceutical Journal of Chinese People's Liberation Army,2017,33(4):382-383.
[22]沈文超,丁艳.我院促进临床合理用药的信息化实践[J].中国药房,2015,26(10):1426-1428.SHEN W C,DING Y.Information practice of the promoting of rational drug use in our hospital[J].China Pharmacy,2015,26(10):1426-1428.
[23]聂丽丽,陈妍妍,廖家智,等.基于临床药学知识库的全过程临床用药管理系统构建[J].中国医院管理,2016,36(1):66-67.NIE L L,CHEN Y Y,LIAO J Z,et al.Construction and evaluation of clinical pharmacy management system based on the clinical knowledge base[J].Chinese Hospital Management,2016,36(1):66-67.
[24]杜欣,张诚,孙爱华,等.血液科病区实施药品安全管理的方法与效果[J].中国药房,2015,26(14):1885-1887.DU X,ZHANG C,SUN A H,et al.Methods and effects of the implementation of drug safety management in the ward of hematology department[J].China Pharmacy,2015,26(14):1885-1887.
[25]孙喜琢,李野,杨秀梅,等.规范合理用药管理保障医患用药安全[J].药学服务与研究,2011,11(1):1-5.DOI:10.5428/pcar20110101.SUN X Z,LI Y,YANG X M,et al.Normalizing management of rational use of medicines,guaranteeing safe use of drugs for patients and doctors[J].Pharmaceutical Care and Research,2011,11(1):1-5.DOI:10.5428/pcar20110101.
[26]侯庆源,邱波,张金燕,等.我院加强药品安全管理的实践[J].中国药房,2011,22(37):3477-3479.HOU Q Y,QIU B,ZHANG J Y,et al.Experience of enhancing thedrugsafetymanagementinourhospital[J].China Pharmacy,2011,22(37):3477-3479.
[27]魏盈盈,杜光.从医疗纠纷案例看药师在合理用药中的作用[J].中国医院药学杂志,2011,31(17):1457-1459.WEI Y Y,DU G.The role of pharmacists in rational drug use from medical dispute cases[J].Chinese Journal of Hospital Pharmacy,2011,31(17):1457-1459.
[2]王进发.87例医疗事故鉴定中以药物使用为主因的案例分析[J].中国医院药学杂志,2011,31(6):501-503.WANG J F.Case analysis of 87 cases of medical accident identification based on drug use[J].Chinese Journal of Hospital Pharmacy,2011,31(6):501-503.
[3]余明永.医疗损害赔偿纠纷[M].北京:法律出版社,2010.YU M Y.Medical damage compensation disputes[M].Beijing:Law Press,2010.
[4]邓姣娟,穆娇,刘龙清,等.98例医疗过错鉴定的回顾性分析[J].中国法医学杂志,2015,30(4):401-403.DOI:10.13618/j.issn.1001-5728.2015.04.016.DENG J J,MU J,LIU L Q,et al.Retrospective study on 98cases of medical treatment faults[J].Chinese Journal of Forensic Medicine,2015,30(4):401-403.DOI:10.13618/j.issn.1001-5728.2015.04.016.
[5]《法律法规案例注释版系列》编写组.医疗事故处理条例[M].北京:中国法制出版社,2015.
[6]最高人民法院《关于审理人身损害赔偿案件适用法律若干问题的解释》[J].人民检察,2004,49(1):75-77.Interpretation of the Supreme People's Court on several questions on the application of law in the trial of personal damage compensation cases[J].People's Procuratorial Monthly,2004,49(1):75-77.
[7]宁超,王蓉,李淼,等.医疗损害责任纠纷重复鉴定4例[J].中国司法鉴定,2017,8(5):105-108.DOI:10.3969/j.issn.1671-2072.2017.05.021.NING C,WANG R,LI M,et al.Repeated identification of medical damage liability disputes in 4 cases[J].Chinese Journal of Forensic Sciences,2017,8(5):105-108.DOI:10.3969/j.issn.1671-2072.2017.05.021.
[8]中国裁判文书网.李梅、刘美伦等与中国人民解放军第一〇五医院医疗损害责任纠纷一审民事判决书[EB/OL].(2016-10-28)[2018-09-10].http://wenshu.court.gov.cn/content/content?DocID=4543ffd7-d3e5-4dc5-a971-39b257ac6450&KeyWord.
[9]中国裁判文书网.何某与武汉科技大学附属天佑医院、湖北省妇幼保健院医疗损害责任纠纷二审民事判决书[EB/OL].(2016-02-14)[2018-09-10].http://wenshu.court.gov.cn/content/content?DocID=6645e18b-a038-404d-bbbe-2e6257b7322e&KeyWord=.
[10]中国裁判文书网.张婷辉与秦皇岛市妇幼保健院医疗损害责任纠纷一审民事判决书[EB/OL].(2017-09-08)[2018-09-10].http://wenshu.court.gov.cn/content/content?DocID=ed3cbb64-89ce-4bf4-ac4e-a7e80011ea52&KeyWord=.
[11]中华人民共和国药品管理法[M].北京:中国民主法制出版社,2015.
[12]中华人民共和国执业医师法(中华人民共和国主席令第5号)[EB/OL].(1998-06-26)[2018-09-10].http://www.moh.gov.cn/mohyzs/s3580/200804/18250.shtml.
[13]处方管理办法[M].北京:中国法制出版社,2006.
[14]邓斌,洪晓丹,姚秋燕,等.4例超说明书用药致医疗纠纷的典型案例分析[J].中国医院药学杂志,2018,38(1):88-91.DENG B,HONG X D,YAO Q Y,et al.Case analysis of 4typical medical disputes caused by off-label use of drugs[J].Chinese Journal of Hospital Pharmacy,2018,38(1):88-91.
[15]中国裁判文书网.程金珍与乐平市人民医院医疗损害责任纠纷一审民事判决书[EB/OL].(2018-02-05)[2018-09-10].http://wenshu.court.gov.cn/content/content?DocID=3dbf009a-65d2-4433-895c-a87c00349c19&KeyWord=.
[16]邢玥,董梅.我院163例肿瘤患者营养支持类药品致不良反应的关联性研究[J].中国药房,2018,29(15):2122-2125.DOI:10.6039/j.issn.1001-0408.2018.15.24.XING Y,DONG M.Correlation study on adverse drug reaction induced by nutrition support drugs of 163 cases of tumor patients in our hospital[J].China Pharmacy,2018,29(15):2122-2125.DOI:10.6039/j.issn.1001-0408.2018.15.24.
[17]玉顺子.药物不良事件引起的医疗纠纷案例分析[J].中国医院药学杂志,2014,34(17):1523-1526.YU S Z.Case analysis on the adverse drug reaction events induced medical disputes[J].Chinese Journal of Hospital Pharmacy,2014,34(17):1523-1526.
[18]国家卫生计生委关于印发抗菌药物临床应用指导原则(2015年版)的通知[EB/OL].(2017-08-19)[2018-09-10].http://www.hnpa.org.cn/articles/2277/2017-8/36031.html.
[19]麻醉药品和精神药品管理条例[EB/OL].(2008-03-28)[2018-09-10].http://www.gov.cn/zhengce/content/2008-03/28/content_6269.htm.
[20]宁超.医疗损害赔偿纠纷判例研究——以中国裁判文书网2005—2015年997个判例为对象[D].太原:山西医科大学,2016.NING C.Study on precedent case about the dissension of medical damage compensation——taking 977 cases of China Judgments Online from 2005 to 2015 as the object of study[D].Taiyuan:Shanxi Medical University,2016.
[21]安林静,刘婉姝,张丽娜,等.移动护理信息系统在临床用药安全实践中的效果评价[J].解放军药学学报,2017,33(4):382-383.ANLJ,LIUWS,ZHANGLN,etal.Effectivenessof mobile care information system in clinical drug safety[J].Pharmaceutical Journal of Chinese People's Liberation Army,2017,33(4):382-383.
[22]沈文超,丁艳.我院促进临床合理用药的信息化实践[J].中国药房,2015,26(10):1426-1428.SHEN W C,DING Y.Information practice of the promoting of rational drug use in our hospital[J].China Pharmacy,2015,26(10):1426-1428.
[23]聂丽丽,陈妍妍,廖家智,等.基于临床药学知识库的全过程临床用药管理系统构建[J].中国医院管理,2016,36(1):66-67.NIE L L,CHEN Y Y,LIAO J Z,et al.Construction and evaluation of clinical pharmacy management system based on the clinical knowledge base[J].Chinese Hospital Management,2016,36(1):66-67.
[24]杜欣,张诚,孙爱华,等.血液科病区实施药品安全管理的方法与效果[J].中国药房,2015,26(14):1885-1887.DU X,ZHANG C,SUN A H,et al.Methods and effects of the implementation of drug safety management in the ward of hematology department[J].China Pharmacy,2015,26(14):1885-1887.
[25]孙喜琢,李野,杨秀梅,等.规范合理用药管理保障医患用药安全[J].药学服务与研究,2011,11(1):1-5.DOI:10.5428/pcar20110101.SUN X Z,LI Y,YANG X M,et al.Normalizing management of rational use of medicines,guaranteeing safe use of drugs for patients and doctors[J].Pharmaceutical Care and Research,2011,11(1):1-5.DOI:10.5428/pcar20110101.
[26]侯庆源,邱波,张金燕,等.我院加强药品安全管理的实践[J].中国药房,2011,22(37):3477-3479.HOU Q Y,QIU B,ZHANG J Y,et al.Experience of enhancing thedrugsafetymanagementinourhospital[J].China Pharmacy,2011,22(37):3477-3479.
[27]魏盈盈,杜光.从医疗纠纷案例看药师在合理用药中的作用[J].中国医院药学杂志,2011,31(17):1457-1459.WEI Y Y,DU G.The role of pharmacists in rational drug use from medical dispute cases[J].Chinese Journal of Hospital Pharmacy,2011,31(17):1457-1459.