Research on the Feasibility and Supervision Strategy of Using Intermediate Products to Prepare Children ’s Small- sized Preparations in Medical Institutions in China
- VernacularTitle: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
- Author:
Xiaoyu XI
1
;
Mengqing LU
1
;
Yuankai HUANG
1
;
Rong SHAO
1
Author Information
1. Instiute of Regulatory Science for Medical Products，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
Children’s small-sized preparations;
Intermediate products;
Medical institution;
Feasibility;
Supervision strategy
- From:
China Pharmacy
2020;31(20):2445-2451
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To provide reference for improving th e 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 wa s 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 in medical institutions. Indiviclualized preparations are forma- lated ased on the price of preparations inmedical institutions ， with reference to the differential price comparice rules. Mean- while，pharmaceutical service fees are charged to compensate pharmacists’time and labor ；in terms of medical insurancepayment，the drugs are classified and managed according to whether they are included in the medical insurance list ，so as to ensure the same drug availability for children and adults .
