伴随药品追溯码在药品采购、医保及工伤保险等领域持续推进，我国药品追溯体系迎来全面升级，彰显 了国家通过数字化手段筑牢药品安全防线的决心，为构建全链条监管体系提供了技术支撑。不过，我国 在用药安全方面依然存在短板弱项。例如，仿制药上市前监管较为严格，上市后存在多头管理、协同不 足的问题，若企业对原料药和辅料、包装材料来源、生产工艺、生产场地等关键要素进行变更，很容易 导致监管出现盲区。对于创新药、仿制药、孤儿药等不同类型药品，尚未形成精细分类与分级管理的科 学体系。对具有较高临床风险的特殊药品，监管设计仍显粗放，这类药物剂量或血药浓度发生微小变化 即可能导致治疗失败或严重不良反应，贸然进行临床厂牌与规格替换存在较大风险。 2017年，世界卫生组织在德国波恩发布"全球患者安全挑战——用药安全"，旨在未来几年内将所有国家 严重的、可避免的药物相关伤害减少50%。许多国家和地区积极响应并探索实践。例如，欧盟通过《反 伪造药品指令》，建立了高度集中的欧洲药品验证系统，各成员国国家系统与中央数据库对接，形成一 体化网络。又如，在高风险药物窄治疗指数药物（NTIDs）管理方面，芬兰构建了NTIDs全流程监管体 系，通过"立 ...

Core Viewpoint - The National Healthcare Security Administration (NHSA) is conducting a nationwide special rectification of medical insurance fund management, focusing on issues related to "abnormal drug traceability codes" and illegal resale of "returned drugs" [1][2]. Group 1: Regulatory Actions - The NHSA, in collaboration with various government departments, has initiated a three-phase comprehensive investigation into designated medical institutions suspected of selling "returned drugs" [1]. - The first phase of the investigation has been completed, with the second phase scheduled for deployment in August 2025, and a concentrated action planned from October to December [1]. - The NHSA has collected a total of 39.885 billion drug traceability codes since the nationwide implementation of drug traceability code collection began in 2024 [1]. Group 2: Drug Traceability System - The drug traceability code serves as a unique "electronic ID" for each box of medication, ensuring that each drug can only be sold once; repeated scans may indicate counterfeit or "returned drugs" [2]. - The NHSA has implemented a policy where medical insurance funds will refuse payment for drugs that are not scanned or show repeated scans, thereby enhancing drug regulation efficiency [2]. - As of July 1, 2025, designated medical institutions are required to scan drugs during the sales process to facilitate medical insurance fund settlement [2]. Group 3: Public Engagement and Compliance - A societal consensus has emerged around the principle of "verify the code before buying, scan the code before selling," with approximately 5 million consumers checking drug authenticity daily [3]. - The NHSA aims to strengthen the use of drug traceability codes for regulatory purposes and will collaborate with relevant departments to combat the resale of "returned drugs" comprehensively [3]. - The NHSA has advised that any anomalies in scanning should lead to the rejection of goods, and evidence should be collected for reporting to authorities, with penalties for those involved in the sale of "returned drugs" [2].

业内专家表示，搭建医保药品线上追溯体系，是药品追溯制度建设过程中重要的一环，第三方线上买药 平台的数字化服务为药品智慧监管注入新动能。 （文章来源：广州日报） 据悉，建立药品追溯体系，是有效实现药品"来源可查、去向可追、责任可究"，保障公众用药安全的重 要手段。"年初起，我们便协同监管部门探索建设医保药品线上追溯体系，通过行业联动及大数据精准 识别，助力智慧监管。"美团医药健康医保业务负责人介绍，在实际走访调研中发现，药店数字化发展 水平不同，特别是中小药店，存在信息基础设施薄弱问题。 为助力药品追溯体系建设并减轻药店负担，美团医药健康推出了双轨制解决方案。一方面，针对大型连 锁药店，美团提供标准化API接口，支持一次对接全国复用。目前，该解决方案已与漱玉平民大药房、 海王星辰健康药房等头部连锁品牌完成总部对接。另一方面，针对中小连锁药店，美团医药健康在商家 后台开设了扫码功能，通过平台技术升级，前置封装20多项合规监管信息，在线上医保药品订单出库结 算时，可快速完成信息采集工作。"每个扫码动作减少1分钟，日积月累就意味着药店运营成本的释 放。"该负责人表示，希望通过免费开放技术服务，最大程度降低药店系统开发 ...

下一步，乌苏市市场监管局将持续深入推进药品经营环节"清源"行动，不断加大监管力度，巩固整治成 果，建立健全长效机制，切实保障药品质量安全，打好"监管﹢普法"组合拳，组织药店从业人员开展法 规培训，实现辖区药店培训全覆盖，为人民群众用药安全保驾护航。 （杜志锋、王林、孙紫玮） 推进会上，该局持续推出整治举措，在加强药品经营环节执法检查和监督抽查的同时，向127家药品经 营企业明确此次行动以"源头严防、过程严管、风险严控"为原则，以打击非法渠道购销药品、制售假劣 药品、违规网售药品等违法违规行为为重点，全面排查药品经营环节风险隐患。一是严管药品网络销售 企业，加大线上巡查力度。二是严查非法渠道购销，联合相关部门重点核查医保高值药品、原研药品及 老年病常用药品，坚决杜绝从非法渠道购进药品。三是严控特殊管理药品，加强对高风险药品的监管， 严防流弊。四是严处执业药师"挂证"行为，聚焦处方药销售，督促执业药师在岗履职、审方签字。五是 严促药品经营企业全品种扫码追溯，持续推进药品追溯体系建设。六是严打违规使用医保基金违法行 为，坚决杜绝销售医保回流药。并督促药品经营企业在检查过程中发现问题隐患整改情况、下发《责令 整改通知 ...