Page 19 - 2020年20期

我国医疗机构使用中间产品配制儿童小规格制剂的可行性及监

管策略研究 Δ

＊
席晓宇 ，卢梦情，黄元楷，邵 蓉（中国药科大学药品监管科学研究院，南京 211198）
#
中图分类号 R952 文献标志码 A 文章编号 1001-0408（2020）20-2445-07
DOI 10.6039/j.issn.1001-0408.2020.20.03

摘 要 目的：为提高我国儿童用药的可及性提供参考。 方法：以我国现行法律法规为基准，借鉴国外相关优秀经验及模式，分
析中间产品及医疗机构儿童小规格制剂的定义及监管属性，探讨中间产品配制儿童小规格制剂并进入医疗机构的可行性及监督
策略。结果与结论：根据临床用量和用药特点，医疗机构儿童小规格制剂可分为儿童用医疗机构制剂和儿童个性化制剂。从国外
经验、法律政策及技术条件等方面分析，医疗机构使用中间产品配制儿童小规格制剂具有一定的可行性，但同时也面临监管难执
行、质量标准不明确、使用主体与范围模糊等困境。在监管方面，中间产品配制的儿童小规格制剂进入医疗机构时，建议以中间产
品为主要质量管理对象，并同时注重对其进行质量风险管理。在进行医疗机构儿童小规格制剂的管理时，应制定医疗机构儿童小
规格制剂配制规范，编制辅料使用指南，完善制剂质量检验标准；在配制监管方面，严控式监管临床需求量大的儿童用医疗机构制
剂，宽松式监管个性化程度高的个性化制剂；在注册审批方面，应在实施注册/备案管理的同时推行技术评估；在价格制定方面，应
根据儿童用医疗机构制剂的创新程度、临床需求情况、患儿家庭经济可承受性、价格公示意见反馈等制定适宜利润率，而个性化制
剂价格可以医疗机构制剂价格为基准，参考差比价规则进行制定，同时收取药事服务费以补偿药师时间和劳动；在医保支付方面，
应根据原市售药品是否进入医保目录进行分类管理，保证儿童与成人相同的用药可及性。
关键词 儿童小规格制剂；中间产品；医疗机构；可行性；监管策略

Research on the Feasibility and Supervision Strategy of Using Intermediate Products to Prepare Children’s
Small-sized Preparations in Medical Institutions in China
XI Xiaoyu，LU Mengqing，HUANG Yuankai，SHAO Rong（Instiute of Regulatory Science for Medical Products，
China Pharmaceutical University，Nanjing 211198，China）

ABSTRACT OBJECTIVE：To provide reference for improving the availability of clinical medication for children in China.
METHODS：Based on the current laws and regulations of China，referring to the relevant excellent experience and mode of foreign
countries，the definition and regulatory attributes of intermediate products and final small-sized children’s preparations were
analyzed，and the feasible regulatory pathway of children’s medicine preparedby intermediate products entering medical institutions
were discussed. RESULTS & CONCLUSIONS：According to the clinical dosage and characteristics of medication，small-sized
preparations for children in medical institutions could be divided into preparations for children’s medical institutions and
personalized preparations for children. From the analysis of foreign experience，legal policies and technical conditions，it was
feasible for medical institutions to use intermediate products to formulate children’s small-sized preparations，but they also faced
certain difficulties as the difficulty to supervise，unclear quality standards，vague subject and scope of use，etc. In terms of
supervision，it was suggested that intermediate products should be taken as the main quality management object when children’s
small-sized preparations prepared by intermediate products entered medical institutions. Meanwhile，quality risk management should
be paid attention to it. In the management of small-sized preparations for children in medical institutions，it is necessary to
formulate the preparation specifications of small-sized preparations for children in medical institutions，prepare guidelines for the
use of excipients and improve the quality inspection standards of preparations；in the aspect of preparation supervision，the
small-sized preparations for children in medical institutions with large clinical demand are strictly controlled，and those with high
personalized degree in medical institutions are under loose supervision；in terms of registration and approval，technical evaluation
should be carried out at the same time as the implementation of registration/filing management；in terms of price setting，appropriate
profit margins should be formulated according to the innovation degree，clinical demand，children’s family affordability and public
opinion feedback of price of children’s small-sized preparations
Δ 基金项目：国家科技重大专项“重大新药创制”专项项目
in medical institutions. Indiviclualized preparations are forma-
（No.2018ZX09721-003）；中国药科大学“双一流”学科创新团队建设项
lated ased on the price of preparations inmedical institutions，
目（No.CPU2018GY39）
with reference to the differential price comparice rules. Mean-
＊副教授，硕士生导师，博士。研究方向：药物经济学与医药卫生
while，pharmaceutical service fees are charged to compensate
政策。E- mail：cpuxixiaoyu@163.com
# 通信作者：教授，博士生导师，博士。研究方向：医药政策与法 pharmacists’time and labor；in terms of medical insurance
规。电话：025-86185287。E-mail：shaorong118@163.com payment，the drugs are classified and managed according to

中国药房 2020年第31卷第20期 China Pharmacy 2020 Vol. 31 No. 20 ·2445 ·