一张药方,诊所赔偿43万,警惕!

2016-12-30 佚名 红杏e生、国家食品药品监督管理局

事件经过 2016年9月17日,新疆乌鲁木齐市一名60岁的患者胃痛于一家诊所就医,患者自述有胃痛、恶心的症状,前一天家里人吃了两顿牛肉,都有类似症状,尤以患者严重。经医生检查,诊断为急性胃肠炎(患者有糖尿病史)。 诊所刘医生给患者开了四组药物静脉注射治疗:第一组是奥美拉唑40毫克加0.9%生理盐水;第二组是维生素C 1.0克,加维生素B6 0.1克,加氯化钾5毫升,

事件经过


2016年9月17日,新疆乌鲁木齐市一名60岁的患者胃痛于一家诊所就医,患者自述有胃痛、恶心的症状,前一天家里人吃了两顿牛肉,都有类似症状,尤以患者严重。经医生检查,诊断为急性胃肠炎(患者有糖尿病史)。


诊所刘医生给患者开了四组药物静脉注射治疗:第一组是奥美拉唑40毫克加0.9%生理盐水;第二组是维生素C 1.0克,加维生素B6 0.1克,加氯化钾5毫升,加10%生理盐水250毫升;第三组药物同第二组;第四组是盐酸左氧氟沙星0.3克100毫升。


(图为刘医生开具的用药处方)


输液过程中患者并没有出现任何的不适症状,但输完液后几分钟,患者出现神志不清的状况。医生立即给患者刺激人中穴、吸氧,三角肌部位肌注肾上腺素10毫克,心肺复苏按压胸部和人工呼吸,同时拨打120。二十分钟后,患者症状无缓解,120到来,患者被接去医院急救。大概两小时后,患者家属来到刘医生诊所,告之患者过敏性休克死亡。


事故责任不清,医生赔偿43万


事件发生后,患者家属提出了60万元的赔偿要求;医生坚持要通过尸检来判定责任,同时上报了当地卫计委和社区领导。家属坚决不同意尸检,而且把尸体火化了。在各方压力下,最后经卫计委和社区领导的调解,达成协议,刘医生给予患者家属43万元赔偿。


43万,包括哪些内容


在此次赔偿中,刘奇医生赔偿的43万元包括以下四部分:


一、丧葬费:墓地、火化、骨灰盒共计5万元;


二、误工费:患者两个女儿、两个女婿共四人的误工费及交通费用2万元;


三、被抚养人生活费:患者母亲、公公、婆婆的生活费,三人五年的费用合计16万元;


四、死亡精神损失费20万元。


(图为赔偿费清单)


根据《医疗事故处理条例》第50条的规定,医疗事故赔偿的项目包括11项,具体到本案例,主要涉及以下4项:


1、误工费:患者有固定收入的,按照本人因误工减少的固定收入计算,对收入高于医疗事故发生地上一年度职工年平均工资3倍以上的,按照3倍计算;无固定收入的,按照医疗事故发生地上一年度职工年平均工资计算。说明:在本案中,因患者死亡,误工费主要计算的是患者女儿、女婿共四人处理事故本身的误工费。


2、丧葬费:按照医疗事故发生地规定的丧葬费补助标准计算。


3、被扶养人生活费:以死者生前或者残疾者丧失劳动能力前实际扶养且没有劳动能力的人为限,按照其户籍所在地或者居所地居民最低生活保障标准计算。对不满16周岁的,扶养到16周岁。对年满16周岁但无劳动能力的,扶养20年;但是,60周岁以上的,不超过15年;70周岁以上的,不超过5年。本案中患者母亲、公公、婆婆都超过70周岁,三人的生活费都是按五年计。


4、精神损害抚慰金:按照医疗事故发生地居民年平均生活费计算。造成患者死亡的,赔偿年限最长不超过6年;造成患者残疾的,赔偿年限最长不超过3年。


警示:


再综合以上案例,患者死于过敏性休克,文中没有指出具体因为哪种药物过敏,但分析下,最有可能引起过敏性休克的就是“盐酸左氧氟沙星”,所以再次提醒大家提高对该药物的警示,一定不要忘记说明书的这段话“对喹诺酮类药物过敏者禁用”。


下面附上药品不良反应信息通报(第56期) 警惕左氧氟沙星注射剂的严重不良反应,望大家警惕:



左氧氟沙星是氧氟沙星的左旋体,属第三代喹诺酮类药物。左氧氟沙星注射剂是临床使用广泛的抗感染药,因其抗菌谱广、疗效好、使用方便等原因,在抗菌治疗领域发挥着重要作用。然而,随着药品的大量应用,其不良反应也日益突显。


国家药品不良反应监测中心病例报告数据库分析显示,左氧氟沙星注射剂导致的严重过敏反应以及临床的不合理使用情况仍较为突出,为使医务人员、药品生产经营企业以及公众了解左氧氟沙星注射剂的安全性问题,再次通报该品种。


警惕左氧氟沙星注射剂的严重不良反应


2012年,国家药品不良反应监测数据库共收到左氧氟沙星注射剂严重不良反应/事件病例报告1431例。严重不良反应/事件累及系统排名前三位的依次为:全身性损害、皮肤及其附件损害、呼吸系统损害,三者合计占总例次的60.24%。


一、严重病例的临床表现


左氧氟沙星注射剂严重不良反应/事件居前3位的不良反应表现依次为:过敏性休克(198例次,7.94%)、呼吸困难(197例次,7.90%)和过敏样反应(171例次,6.85%)。


【典型病例】


患者,女,40岁,55公斤,因“泌尿系统感染”就诊,给予盐酸左氧氟沙星氯化钠注射液0.3克静脉滴注,约10分钟后,患者出现皮肤瘙痒、全身皮肤湿冷、心慌、胸闷、测血压90/50 mmHg,心率为55次/分钟,考虑为过敏性休克。给予肾上腺素0.5 mg 肌注、地塞米松10 mg静注等抗休克治疗。约10分钟后患者上述症状缓解,测血压120/75 mmHg、心率85次/分钟,观察治疗两小时后出院。


二、不合理用药问题


国家药品不良反应监测数据库分析显示:该产品存在临床不合理使用现象,而不合理用药增加了用药风险。不合理用药主要表现为:


1、超适用人群给药


左氧氟沙星注射剂说明书中明确提示18岁以下患者禁用,《抗菌药物临床应用指导原则》喹诺酮类抗菌药物注意事项中提示“18岁以下未成年患者避免使用本类药物。”但国家药品不良反应监测数据库中,仍有18岁以下患者使用了左氧氟沙星注射剂的病例报告。


2、存在相互作用的不合理用药


2.1 左氧氟沙星注射剂说明书提示左氧氟沙星应避免与茶碱同时使用,如确需同时应用,应监测茶碱的血药浓度以调整其剂量。但国家药品不良反应监测数据库中,有3例与茶碱类注射剂合用的病例报告,并且未监测血药浓度、调整剂量。


2.2 左氧氟沙星注射剂说明书提示左氧氟沙星注射剂不宜与其他药物同瓶混合静脉滴注,或在同一根静脉输液管内进行静脉滴注。但国家药品不良反应监测数据库中有左氧氟沙星注射剂与其他药物同瓶混合静脉滴注的病例报告。


3、禁忌证用药


左氧氟沙星注射剂说明书【禁忌】中明确指出对喹诺酮类药物过敏者禁用,但国家药品不良反应监测数据库中,有喹诺酮类药物过敏患者使用了左氧氟沙星注射剂的病例报告。


4、不符合特殊病理、生理状况下用药原则


《抗菌药物临床应用指导原则》指出:喹诺酮类抗菌药偶可引起抽搐、癫痫等严重中枢神经系统不良反应,在肾功能减退或有中枢神经系统基础疾病的患者中易发生,因此本类药物不宜用于有癫痫或其他中枢神经系统基础疾病的患者。但国家药品不良反应监测数据库中,有癫痫病史患者使用了左氧氟沙星注射剂的病例报告。


5、超适应证用药


左氧氟沙星注射剂说明书【适应症】中明确说明本品适用于敏感细菌所引起的中、重度感染;《抗菌药物临床应用指导原则》也指出:通常不宜常规预防性应用抗菌药物的情况:普通感冒、麻疹、水痘等病毒性疾病。但国家药品不良反应监测数据库中有非细菌感染患者使用左氧氟沙星注射剂的病例报告。


6、给药剂量不合理


《抗菌药物临床应用指导原则》中指出肾功能减退患者应用本类药物时,需根据肾功能减退程度减量用药。说明书中【老年患者用药】也提示本品主要经肾脏排泄,因高龄患者大多肾功能低下,可能会出现持续高血药浓度,应注意用药剂量并慎重给药。但国家药品不良反应监测数据库中有多例老年人给药未调整剂量的报告。


三、相关建议


1、左氧氟沙星口服后吸收良好、生物利用度高,建议临床医生根据患者的实际情况选择合适的给药途径,能口服治疗者不建议使用注射给药的方式。


2、鉴于与左氧氟沙星注射剂相关的严重不良反应较多,除与药品本身特性有关外,还与多种因素如患者个体差异、超剂量使用、不合理给药途径、不当配伍用药、输液速度过快等有关,建议临床医生在使用本品时,需注意剂量、特殊人群,避免超适应症用药,严禁禁忌症用药;注意左氧氟沙星注射剂的过敏反应,对喹诺酮类药物过敏的患者禁用,过敏体质患者、高敏状态患者慎用;有癫痫或其他中枢神经系统基础疾病的患者慎用;严禁本品与其他药品混合同瓶滴注,注意配伍用药,防止发生药物相互作用,避免与偏碱性液体、头孢类抗生素、中药注射剂等配伍使用。


3、建议药品生产企业修改完善药品说明书相关内容,加强上市后药品不良反应监测并积极开展质量和工艺方面的研究,同时做好安全用药宣传和培训,指导临床合理用药,保障公众用药安全。

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    2016-12-31 ycmayy
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    2016-12-30 雾夜芭蕾

    左氧氟沙星背锅很大

    0

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    2016-12-30 雾夜芭蕾

    说出来好笑又无奈

    0

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    2016-12-30 ys2323

    判的有点重吧?

    0

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    2016-12-30 天涯183

    学习了,左氧临床不做皮试

    0

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    2016-12-30 399

    学习了,还是第一次听说

    0

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    2016-12-30 刘煜

    注意左氧氟沙星的过敏反应。

    0

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    2016-12-30 顾小北大魔王

    这个有点厉害了(???_??)?

    0

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