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《国家组织药品集中采购和使用试点工作监测方案》要点分析
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| 篇名： | 《国家组织药品集中采购和使用试点工作监测方案》要点分析 |
| TITLE： | |
| 摘要： | 目的：为进一步评估、完善保障国家组织药品集中采购和使用试点工作顺利实施提供参考。方法：采用文献研究和调研等研究方法，对《国家组织药品集中采购和使用试点工作监测方案》的监测目的、监测内容（包括保障供应、确保使用、确保质量、控制费用四个方面的具体指标）和监测方法进行整理、归纳和分析并提出改进建议。结果与结论：监测目的是从政策指导和信息监测两方面监控采购阶段工作。在监测内容中，保障供应从生产环节和流通环节两方面设置了监测指标，其中前者包括生产库存、停复产、核心原料及辅料来源、供应及价格情况7个指标，后者包括渠道库存和回款天数2个指标；确保使用方面监测了中选药品、通用名下原研药品、通用名下其他药品、同类可替代药品4个部分，检测内容包括这些药品的月度采购价格、采购量、采购金额、累计采购量、累计采购金额、处方量；确保质量的指标包括反映药品稳定性（质量不合格药品批次和项目情况）、安全性（药品不良反应、严重药品不良反应及公众投诉举报事件情况）和有效性（换药人数及二次换药人数）的相关指标；控制费用方面主要监测中选药品、通用名下原研药品、通用名下其他药品的本月药品用量和费用，以及同比原研药品费用（针对同通用名下原研药）、同比其他药品费用和上年度医保报销比例（针对通用名下其他药品），其中药品用量以DDDs计算。监测方法采取的是国家组织药品集中采购和使用试点工作小组、“4+7”城市联合采购办公室、试点地区三级监测，固定每月报送和及时反馈监测信息的工作方式，监测信息报送主要采用规范报表格式（每月由人工填报，以电子邮件报送）和系统自动上报的形式（每日，其他试点城市与上海联合采购数据交换平台建立数据接口自动上报）。根据实际情况，笔者提出调整库存周转天数的测度标准、明确采购数量和价格监测的统计口径、区别药品制剂规格和包装规格、统一给定每个监测范围药品的DDD值等完善监测内容的建议，同时建议优化监测信息报送方式，将采购平台与医保信息互通，集成药品从生产企业经配送企业到医疗机构再到患者的供应链信息，提供跨省交易服务等，使其在国家医疗保障局药品采购管理、国家卫生健康委员会药品合理使用管理、国家药品监督管理局药品追溯管理方面发挥更大的作用。 |
| ABSTRACT： | OBJECTIVE： To provide reference for further evaluating， improving and ensuring the smooth implementation of centralized drug purchase and use pilot organized by the state. METHODS： By using the methods of literature research and investigation， monitoring purpose， monitoring contents （including supply guarantee， use guarantee， quality guarantee and cost control） and monitoring methods of Monitoring Programme for Centralized Drug Purchase and Use Pilot Projects Organized by the State were sorted， summarized and analyzed so as to put forward the suggestions. RESULTS & CONCLUSIONS： The monitoring purpose was to control the procurement phase from two aspects： policy guidance and information monitoring. In the contents of monitoring， monitoring indicators were set up for supply gurantee from two aspects of production and circulation. The former included seven indicators of production inventory， stop and resume production， source and supply and price of core raw materials and accessories， and the latter included two indicators of channel inventory and days of repayment. For use gurantee， selected drugs， original drugs in the item of generic name， other drugs in the terms of generic name and substitutable drugs of the same kind were monitored in respects of monthly purchase price， purchase quantity， purchase amount， accumulative purchase quantity， accumulative purchase amount， prescription quantity. Quality gurantee indexes included drug stability （batches and projects of unqualified drugs）， safety （ADR， severe ADR， public complaints and reporting incidents） and effectiveness （number of drug-change patients and number of secondary drug-change patients）. For cost control， the monthly drug quantity and cost of selected drugs， original drugs in the item of generic name， other drugs in the terms of generic name and substitutable drugs of the same kind were monitored； original drug cost （for original drugs in the term of same generic name）， the cost of other drugs and the reimbursement ratio of last year’s medical insurance （for other drugs in the term of generic name） were compared with the same period of the previous year， in which the drug quantity was calculated by DDDs. The monitoring methods included three-level monitoring by the national organization office for the contralized procurement and useage of pharmaceuticals， “4+7” city joint procurement office and pilot area， and regular monthly reporting and timely feedback of monitoring information. Monitoring information submission was mainly in the form of standardized report format （filling by manual in monthly， e-mail submission） and automatic system submission （every day， other pilot cities and Shanghai Joint Purchasing Data Exchange Platform established data interface for automatic submission）. According to the fact， author put forward the suggestions to improve the monitoring contents， such as adjusting the measurement standard of inventory turnover days， defining the statistical caliber of purchasing quantity and price monitoring， distinguishing the specifications of pharmaceutical preparations and packaging， defining the every drug DDD value in monitoring range， and so on. At the same time， the author suggests optimizing the reporting mode of monitoring information， interworking the purchasing platform with medical insurance information， and integrating drug supply chain information from manufacturing enterprises， distribution enterprises， medical institutions to patients， providing cross-provincial trading services， etc.， make them play a greater role in drug procurement management of the National Healthcare Security Administration， rational use management of drug by the Nation Health Commission of the People’s Republic of China， and drug traceability management of the National Medical Products Administration. |
| 期刊： | 2019年第30卷第17期 |
| 作者： | 王妍，武志昂 |
| AUTHORS： | WANG Yan，WU Zhiang |
| 关键字： | 国家组织药品集中采购和使用试点工作监测方案；药品；要点分析；改进；采购平台；采购监测 |
| KEYWORDS： | Monitoring Plan for Centralized Drug Purchase and Use Project Pilot Launched Organized by State； Drugs； Keypoint analysis； Improvement； Purchase platform； Purchase monitoring |
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