浅谈药品电子监管码

浅谈药品电子监管码 浅谈药品电子监管码的使用 2010年6月17日，国家药品监督管理局(SFDA)发布了《关于做好基本药物全品种电子监管工作的通知》，凡生产基本药物品种的中标企业，要在2011年3月31日前加入药品电子监管网，按规定做好赋码、核注核销和企业自身预警处理的准备工作。也就是说，在继麻醉药品、精神药品、血液制品、疫苗、中药注射剂之后，307种基本药物也将全面纳入电子监管的范围。按照以上要求，我们公司的通络祛痛膏、关节止痛膏、壮骨麝香止痛膏三个品种的橡胶膏剂产品全部按期开始使用电子监管码。 1、电子监管码的原理、编码规则及赋码方式: 1.1、原理:在药品的各级包装附着监管码(从监管网平台申请)条码信息，在生产的过程中，为监管码附着药品的生产数据(如生产日期、产品批号、有效期等)，并建立产品包装各级包装之间监管码的关联关系，生产结束后将监管码的关联关系上传到国家监管网平台，对生产数据进行监管;同时企业在进行出入库业务时，扫描产品的外包装监管码，完成出入库数据上传到国家监管网平台，对出入库数据进行监管。 1.2、电子监管码编码规则:药监码使用20位编码，其中前7位(产品资源码)包含企业信息、药品名称、剂型、批准文号、包装规格等信息，方便数据存贮，可应用于物流、零售结算环节的使用。 药监码8到16位是单件产品序列号，最后4位是校验位，校验位由特殊加密算法生成。 of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 编码原则如下图: 8100021 015709021 7447 企业信息、药品名称、规格、剂型、批准文号 单件序列位 校验位 药监码分为一级药监码(药品最小销售包装)、二级药监码(药品中包装)、三级药监码(药品外层包装，如此类推)，分别用来标识最小销售包装药品、中间独立包装药品和外箱独立包装药品。 1.3、药品电子监管码赋码的几种方式 赋码方式目前共有以下几种，打印贴标、变码印刷、热转印、喷印、激光赋码等五种方式。我们公司目前使用的是打印贴标，10贴通络已准备试用变码印刷方式，届时赋码成本将会有所降低。 2、相关定义: 2.1 生产线赋码设备:为药品行业所有产品赋予一个唯一的电子监管码所使用的软件，主要实现电子监管码下载、打印、关联、导出等功能。 2.2 电子监管码:电子监管码是国家食品药品监督管理局监管平台所颁发的针对药品监管的编码，每个药品最小包装以及上级包装都有一个唯一的编码，是一串由20位的数字按照一定规定排序而生产的一维码，这个编码即电子监管码。 2.3 监管码关联关系:在产品赋码过程中，对赋予产品上的电子of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 监管码与包装上的电子监管码建立的内在联系，称为监管码关联关系。 2.4 监管码申请:企业在给产品赋码之前，需要由企业数字证书操作员向国家食品药品监督管理局的药监平台申请电子监管码，每个电子监管码的颁发需要药监平台审核审批。 2.5 生产线赋码软件管理端:生产线赋码软件用于系统管理、信息管理、任务管理以及基本数据维护管理等模块的集合，主要完成赋码软件的管理功能。 2.6 生产线驸马软件执行端:生产线赋码软件用于生产线赋码、生产过程监控、生产任务执行等模块的集合，主要是完成赋码软件的执行功能。 3、电子监管码生产过程: 药品电子监管码的实现是以依靠药监码赋码系统。整个过程包括:药监码的获取、药监码的分配、药监码的印刷或喷印、药监码的扫描、药监码及药品信息的上传及查询，实现全程核注核销。具体过程如下: 3.1 药监码的获取:包括监管码申请、监管码下载、监管码解密三个步骤; 3.2药监码的分配: 按照监管码的包装层次(3级包装或2级包装)，对解密后的监管码进行分配。 3.3药监码的印刷或喷印 3.3.1 监管码的式样 of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 根据国家药监局《监管码条码印刷技术规范》的要求，标签的样式分为以下三种，企业根据产品的包装形式分类使用。 中国药品电子监管码 8 123456 123456789 1234 样式A 样式B 样式C 3.3.2监管码标签技术要求 符合国标:GB/T 18347-2001 条码类型:Code 128C 数据类型:数字条码密度:?7mils 数据长度:20位 条码宽度及高度:?8mm 3.3.3监管码标签印刷要求 印刷空白区域尺寸: 条码两侧空白区?10倍最小模块宽度(即:10X)，其中X?0.17mm;上下空白区宽度?1mm; 印刷颜色:条码中竖条颜色为黑色，空条颜色可为白色、黄色、橙色或红色，建议的颜色搭配是黑白搭配。 3.3.4质量判定标准及判定规则 符合国标:GB/T 14258—2003. 外观检测:条码印刷无脱墨，污点，断线;条的边缘清晰，无发毛，虚晕或弯曲现象.空白区宽度不小于本“条码印刷技术规范”规of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 定的宽度。 符号一致性:Code 128C的条码符号所示的标识代码应与供人识读字符相同。 符号质量:使用具有分级检测功能的条码检测仪检测条码，符号质量等级在C(1.5)级以上。 条码赋码的要求(与EAN商品码冲突):要求监管码尽量避免同时平行出现在一个平面上，防止在进行监管码的数据采集时产生条码扫描错误。 3.4 监管码的扫描 3.4.1建立包装关系:在产品包装的过程中，通过条码数据采集设备，对每级包装内的监管码进行数据采集，并根据包装比例，完成相应的产品与外包装的监管码包装关系。 3.4.2 异常情况的处理:在包装生产过程中，系统对每个包装进行赋码，通常会出现一些异常情况需要处理，如:条码无法读取、产品取检、拼箱、非整包装封箱、更换内部包装等，流通过程中可能发生包装、标签损坏，导致更换监管码标签。 3.4.3出入库扫描:在监管网平台中称为“核注核销”，主要是将企业的入库的监管码的数据信息与出库的监管码的数据信息全部进行记录，能够详细的跟踪到药品的出入库流向。 3.5 药监码及药品信息的上传及查询 上传关联关系:生产结束后，需要将生产过程中形成的监管码的包装关系上传到监管网平台，这部分数据必须是生产结束以后，生产of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 入库之前完成上传，否则后续的出入库数据在监管网平台中都无法正常处理。 3.6 实现全程核注核销。 全程核注核销是指药品入库时，需要扫描药品包装上的监管码，并将入库药品监管码上传至监管网平台，为核注。反之，出库同样操作，为核销。 生产企业操作，申请监管码->赋码->上传激活->出库核销。 经营企业操作，入库核注->出库核销。 全程核注核销形成药品生产、流通、使用的闭环监管，监管网在此基础上为政府部门提供监管功能。 4、需要投入的资源: 电子监管码的使用也需要相当多的资源投入。人力、物力、财力是都不可少的。主要有以下方面: 4.1、目前公司有三条外包生产线，就需要安装三套电子监管码赋码系统，每套赋码系统都需要配电脑服务器、打码机、扫描枪等配套设备。当然，有些设备是可以共用的。 4.2、电子监管码的使用需在原有的生产线上增加几道工序，人员需要增加，可以想到劳动效率必然会降低。同时，电子监管码的获取、上传等其它工序，以及日常维护、维修等都需要相应的人员和费用投入。 4.3、赋码系统的软件购入及维护使用每年还得有相当的投入。 5、使用过程中存在的问题: of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 公司使用电子监管码二年多以来，总体来说效果还是相当好的，但也存在一定的问题，主要表现为以下几个方面: 5.1、2013年6月份以来，有多起经销公司投诉，公司产品电子监管码入库扫描信息与公司产品实际包装不一致。经查此问题的形成是因为今年3月份赋码系统软件升级时没有将公司产品的正确关联关系上报。此问题在8月初已得到解决。 5.2、公司成品出库时偶尔会出现产品关联关系丢失的情况。此问题的形成大概在两个方面:一是包装车间生产过程中漏扫，做入库扫描时又没有及时发现，二是赋码系统软件存在一定的漏洞，在正确入库上传后信息丢失。 5.3、赋码系统硬件设备配置较低，操作过程中易出现故障。目前公司已购置新设备进行了必要的替换。 6、今后工作中需要改进和提高的地方: 6.1、赋码过程的操作需规范管理 加强监控码的下载、解压、打印、关联、扫描各步骤的规范操作，必须有记录，有人复核。确保无误后方可结束任务。 6.2、增加入库扫描工序 现入库扫描工序、数据上传工序皆由包装车间完成，这样的操作管理不利于问题的及早发现。 6.3、赋码系统增加自检功能 赋码系统增加对比自检功能，如果生成数据与扫描数据不一致系统将有提醒功能，问题不解决将无法进行下一步任务。 of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP. 6.4、赋码系统软件的稳定性有待进一步提高。 从出现的问题来看，赋码系统软件还是存在可靠性不高的问题。需联络爱创将所出现的问题进行系统分析。 6.5、赋码系统硬件维护需加强 赋码系统所用电脑、打印机、扫码器等硬件需要专业人员定期维护，以保证其可靠性。 7、电子监管码的发展方向 7.1、如何实现与企业原有ERP管理系统无缝对接，是目前亟需解决的问题。 7.2、加强药品电子监管网的维护与运行。药品电子监管网正在尝试将各企业上传的信息分散到各地药监局的服务器上以缩减压力。 7.3、2015年年底前完成药品制剂全品种电子监管，完成全国所有零售药店电子监管的实施工作。 7.4、按照卫生部的总体部署，将开展医疗机构电子监管工作。 7.5、适时启动高风险医疗器械电子监管试点工作，并探索原料药实施电子监管。 药品电子监管码的使用是国家政策大的方向，其覆盖的领域会越来越广，要求也会越来越高。所以在今后的工作中大家都有必要加强这方面的学习，让各个环节尽可能少地出现问题，进一步提高赋码系统的效率。 生产部:祝跃兵 2013年9月2日 of cases required: name number (?) cerebral infarction 10 20 20 brain hemorrhage following subarachnoid hemorrhage intracranial and intraspinal tumors 10 10 10 brain vascular malformation of encephalitis meningitis in 5 central nervous system demyelinating disease 5 Disc 3 5 brain parasite disease brain, spinal trauma 3 (IX) Neural electrophysiology 2 months 1. Rotary objective: indications of nerve electrophysiological examination methods and points for attention. Be familiar with: the clinical significance of the findings. 2. basic requirements for learning type and number required: number of species (?) EEG reading 30 reading 30 evoked EMG 20 (10) neuropathic 1 month 1. Rotary objective: indications of peripheral nerve and muscle biopsy. About: specimen materials as well as common the main pathology of peripheral nervous system and muscle disease. 2. basic requirements for learning type and number required: number of species (?) nerve biopsy 2 muscle biopsies 34, written at the end of training with a certain level of literature review and case report v, reference books and IA Jianping. Neurology. Beijing Medical University Press. 2004 Rowland LP.