门急诊输液药房注射制剂追溯体系现存问题及对策分析

Problem and Countermeasure Analysis of Traceability System of Injection Preparation in Outpatient and Emergency Infusion Pharmacy

目的为完善我国药品追溯体系提供参考。方法以上海交通大学医学院附属上海儿童医学中心为样本医院,系统分析其门急诊输液药房供应的注射制剂药品追溯码的标注情况,结合供应具体情况,探讨完善我国注射制剂追溯体系的对策及提出建议。结果样本医院门急诊输液药房供应药品共178种,以抗感染药物居多;现有药品中,21种药品(11. 80%)未标注药品追溯码。目前,我国药品追溯码的标注形式主要有5种,其中,以"中国药品电子监管码"和"码上放心追溯码"为主,但标注及查询方式不统一,仅2种药品在最小单位瓶身标签上印制有二维码。结论我国现有注射制剂的追溯体系存在一定漏洞,需系统制订药品追溯及监管体系。

Objective To provide references for improving the drug traceability system in China. Methods Shanghai Children’s Medical Center was taken as a sample. The labeling of traceability codes of drugs supplied in the outpatient and emergency infusion pharmacies in the sample hospital was systematically analyzed,and the countermeasures and suggestions for improving the traceability system of injection preparations in China were discussed based on the specific situation of drug supply. Results A total of 178 kinds of drugs were supplied in the outpatient and emergency infusion pharmacies in the sample hospital,most of which were anti-infective drugs. Among the existing drugs,21 kinds of drugs( 11. 80%) were not marked with a drug traceability code. At present,China’s drug traceability code is mainly marked in 5 forms. Among them,the ″China Drug Electronic Regulatory Code″ and ″Reassurance Traceability Code″ are the main types,but the labeling and query methods are not uniform. Only 2 drugs had the two-dimensional codes printed on the label of the smallest unit bottle. Conclusion There are some loopholes in the current traceability system of injection preparations in China. It is necessary to systematically establish the traceability and supervision system of injection preparations in China.