1、药品不良反应基础知识与应对处理 邓宜洪2011年 11月This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system
2、are AT89C51 microcontroller and DS18B20 temperature sensor.内容简介药品不良反应的法规回顾国家近年药品不良反应监测的情况药品不良反应与质量风险的关系药品不良反应的应对处理This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temper
3、ature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.一、药品不良反应的法规回顾1. 药品不良反应概念 2. 药品不良事件概念 3. 法规对企业的要求 This paper mainly introduces the design of an intelligent temperature control system which realizes the fu
4、nction of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.案例l （背景： 是你 A医院的业务员）一天， A医院药剂科人员打电话给你，说他们医院使用你在上星期卖给他们医院的傲地（注射用克林霉素磷酸酯）时，患者
5、出现了胸闷、呼吸困难以及休克等严重不良反应，好在经抢救治疗后，病人的这些症状都治好了。但病人却因此多住了两天院，要求医院赔偿药费、误工费及住院相关费用。你接到电话后，该怎么办？This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and s
6、ingle chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.药品不良反应概念l 药品不良反应 （ Adverse Drug Reaction，简写 ADR）：是指 合格药品 在 正常用法用量 下出现的与用药目的无关的有害反应。This paper mainly introduces the design of an intelligent temperature control system which realize
7、s the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.药品不良反应概念l 严重不良反应：1.导致死亡；2.危及生命； 3.致癌、致畸、致出生缺陷；4.导致显著的或者永久的人体伤残或者器官功
8、能的损伤；5.导致住院或者住院时间延长；6.导致其他重要医学事件，如不进行治疗可能出现上述所列情况的。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core co
9、mponents of the system are AT89C51 microcontroller and DS18B20 temperature sensor.药品不良事件概念l 药品不良事件（ adverse drug event，简写 ADE）l 药品不良事件，是指药物治疗过程中出现的任何有害的怀疑与药品有关的医学事件。 (修订草案 2009.6)l （参考） 世界卫生组织将不良事件也定义为不良感受 , 是指药物治疗过程中所发生的任何不幸的医疗卫生事件 , 而这种事件不一定与药物治疗有因果关系。This paper mainly introduces the design of an
10、intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.药品不良事件概念l 药品群体不
11、良事件：是指 同一药品 在使用过程中，在相对集中的时间、区域内，对一定数量 人群 的身体健康或者生命安全造成损害或者威胁，需要予以紧急处置的事件。l 同一药品：指同一生产企业生产的同一药品名称、同一剂型、同一规格的药品。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperatur
12、e sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.思考一：l A医院药剂科反映的情况是药品不良反应还是药品不良事件？This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperatur
13、e measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.药品不良事件药品标准缺陷药品质量问题药品不良反应用药失误药品滥用药品不良事件正常用法用量合格药品其他原因This paper mainly introduces the design of
14、an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.法规对企业的要求l 药品
15、管理法 第七十一条：国家实行药品不良反应报告制度。具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定。l 药品不良反应报告和监测管理办法 （卫生部令 81号， 2011年 7月 1日起施行）This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS
16、18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.法规对企业的要求l 第十三条 经营企业应当建立药品不良反应报告和监测管理制度，设立或者指定机构并配备专（兼）职人员，承担本单位的药品不良反应报告和监测工作。l TIP:公司本部由 质量管理部 承担药品不良反应的报告和监测工作。This paper mainly introduces the design of an intelligent
17、 temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.法规对企业的要求l 第十五条 药品经营企业获知或者发
18、现可能与用药有关的不良反应，应当通过国家药品不良反应监测信息网络报告；不具备在线报告条件的，应当通过纸质报表报所在地药品不良反应监测机构，由所在地药品不良反应监测机构代为在线报告。l 报告内容应当真实、完整、准确。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature s
19、ensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.法规对企业的要求l 第二十一条 药品经营企业发现或者获知新的、严重的药品不良反应应当在 15日内报告，其中死亡病例须立即报告；其他药品不良反应应当在 30日内报告。有随访信息的，应当及时报告。l 第二十七条 药品经营企业获知或者发现药品群体不良事件后，应当立即通过电话或者传真等方式报所在地的县级药品监督管理部门、卫生行政部
20、门和药品不良反应监测机构，必要时可以越级报告；This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are A
21、T89C51 microcontroller and DS18B20 temperature sensor.法规对企业的要求l 第五十九条 药品经营企业有下列情形之一的，由所在地药品监督管理部门给予警告，责令限期改正；逾期不改的，处三万元以下的罚款：l （一）无专职或者兼职人员负责本单位药品不良反应监测工作的；l （二）未按照要求开展药品不良反应或者群体不良事件报告、调查、评价和处理的；l （三）不配合严重药品不良反应或者群体不良事件相关调查工作的。This paper mainly introduces the design of an intelligent temperature con
22、trol system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.思考三：l 哪些药品容易出现药品不良反应 /事件？This paper mainly
23、 introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 tempe
24、rature sensor.二、国家近年药品不良反应监测的情况1. 国家药品不良反应监测中心近五年报告情况2. 2009年国家药品不良反应监测报告解读This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip mi
25、crocomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.国家药品不良反应监测中心近五年报告情况l 2005年， 17.3万份l 2006年， 36.9万份l 2007年， 54.7万份 l 2008年， 60.2万份医疗机构： 85.7%，生产经营企业： 10.4%个人报告 ： 3.8%l 2009年， 63.9万份医疗机构： 84.6%生产经营企业： 12.3%个人报告： 3.1%l 2010年， 69.3万份医疗机构： 84.7%生产经
26、营企业： 12.7%个人报告： 2.5%This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89
27、C51 microcontroller and DS18B20 temperature sensor.2009年国家药品不良反应监测报告解读l 解读一：最常见的药物是 抗感染药1. 报告数量占首位，占化学药品的 55.2%2. 列前 20位的品种中抗感染药有 17个品种3. 前 3位分别是：左氧氟沙星、阿奇霉素、头孢曲松This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement
28、 and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.2009年国家药品不良反应监测报告解读l 解读二：剂型分布以 注射剂 为主1. 注射剂不良反应占 59%2. 化学药品、中成药的药品不良反应报告中，注射剂占有比例分别为 61%和 52%3. 严重的药品不良反应报告的
29、占 79.16%，尤其是中药注射剂 ，占中药的 84.11%This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the syste
30、m are AT89C51 microcontroller and DS18B20 temperature sensor.2009年国家药品不良反应监测报告解读l 解读三：给药途径分布以 静脉注射 为主1. 静脉注射占 57.9%2. 占严重药品不良反应报告的 73.4%This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using sin
31、gle bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.2009年国家药品不良反应监测报告解读l 解读四：1. 新的、严重的报告增幅较大2. 药品不良反应监测进入平稳发展期This paper mainly introduces the design of an intelligent temperature contr
32、ol system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.问题四：l 是什么原因造成了药品出现不良反应 /事件？This paper mainly
33、 introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 tempe
34、rature sensor.三、药品不良反应与质量风险的关系事件名称 造成主要后果 原因调查结果 主要处罚结果 齐二药事件2006.513名患者死亡 工业原料 “二甘醇”假冒药用辅料 “丙二醇 ”（假药）吊销 药品生产许可证 ， 5名被告人被判处 4年至 7年不等的有期徒刑；中山三院 “属于涉案假药的销售者 ”,两家药品销售商要承担连带赔偿责任。刺五加注射液事件（完达山药业）2008.10 6名患者出现严重不良反应，其中有 3例死亡部分药品在流通环节被雨水浸泡，受到细菌污染，销售人员更换包装标签继续销售全面停产，收回药品 GMP证书；直接责任人十年内不得从事药品生产、经营活动。双黄连注射液事件
35、（乌苏里江制药）2009.2 3名患者使用涉嫌药品发生不良事件，并有 1例死亡临床表现和转归提示有外源性致病原突然入血 加强对基层医生特别是乡村医生的培训，规范抗生素和中药注射剂使用，选用中药注射剂时应注意辨证施治，严格按照药品说明书使用药品。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digita
36、l temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.造成药害事件的因素药害事件假的药用原料齐二药销售中被 污染刺五加注射液 生产时被污染注射用甲氨蝶呤 药品标准鱼腥草 7品种劣药香丹注射液医生操作不当双黄连注射液?.风险大于效益抑肽酶注射剂This paper mainly introduces the design of an intelli
37、gent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.启示1.后果很严重，处罚很严厉。2.原因很多
38、样，在原因未查明前要做好控制 。This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51
39、microcontroller and DS18B20 temperature sensor.药品不良反应的应对处理 药品不良反应监测的目的l 不仅仅是：满足客户退换货要求等服务为了完成药品不良反应的报告 l 更加是：通过监测药品不良反应来 控制质量事件风险 This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bu
40、s digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.四、药品不良反应的应对处理l 希望业务人员谨记 1、重视药品不良反应和不良事件信息，提高质量风险意识，防止药品不良反应演变为重大药害事件。2、接到客户的药品不良反应反馈，应详细了解不良反应情况（品名、规格、批号、厂家、不良反应症状，发生时间，医院名称、合并用药、用药过程等信息）
41、以后，立即报质量部。报告方式：医院的书面不良反应情况说明或 药品不良反应 /事件报告表 （医院盖章） 。3、积极配合质量部或供应商处理不良反应事件。 This paper mainly introduces the design of an intelligent temperature control system which realizes the function of temperature measurement and control by using single bus digital temperature sensor DS18B20 and single chip microcomputer. The core components of the system are AT89C51 microcontroller and DS18B20 temperature sensor.l 监测不良反应，控制质量风险！
