北京市药品电子监管码实施现状分析  

Analysis of the Implementation Status of Drug Electronic Supervision Code in Beijing

作　　者：莫美 温灵犀 翟文文[1] 隗丽[1] 侯成波[1] 董玲[1] 

机构地区：[1]北京中医药大学中药学院,北京100102 [2]北京市食品药品监督管理局,北京100053

出　　处：《中国药房》2015年第4期448-450,共3页China Pharmacy

基　　金：北京中医药大学创新团队发展计划资助项目(No.2011-CXTD-13)

摘　　要：目的:了解北京市药品生产企业电子监管码的赋码情况,为相关部门制订全品种覆盖时间提供参考。方法:采用实地调研、问卷调查、座谈会相结合的方式,对北京市部分相关药品生产企业进行调研,研究企业赋码率、生产线改造完成率、成本投入等情况,分析其电子监管码的实施现状。结果与结论:通过对问卷数据的统计可知,北京市药品生产企业药品平均已赋码率达56.8%,企业生产线改造平均完成率达74.3%,企业改造生产线平均增加投入为39.2万元/条。从整体上看,北京市药品生产企业电子监管码的实施情况良好,能实现全品种监管的目标,但在实际运行中仍存在全品种赋码的准备时间不足、企业权利及义务不明确等问题。建议相关部门给企业至少6个月的准备时间,以期更全面地完成北京市药品生产企业的药品赋码指标。OBJECTIVE：To understand the coding system conditions of drug electronic supervision code in pharmaceutical en- terprises in Beijing, and provide references on regulating the covering time of all the species for the relevant departments. METH- ODS：Field investigations, questionnaires, and lectures were conducted to investigate part of the pharmaceutical enterprises in Bei- jing, research the ratio of coding, the completion ratio of the production lines transformation and the cost of input, and analyze the present circumstance of electronic supervision code. RESULTS ＆ CONCLUSIONS ： The questionnaire statistics showed the average ratio of coding was 56.8% in pharmaceutical enterprises in Beijing, the average completion ratio of the transformation of produc- tion lines stood at 74.3% and the average cost of the transformation of production line increased to 392 000 yuan per piece. General- ly speaking, the drug electronic supervision code in pharmaceutical enterprises goes well in Beijing and it can achieve the goal of variety regulation. However, it still exists problems, like lack of preparation time in the coding of all the species, the uncertain rights and obligations of enterprises. It is suggested that the relevant departments had better leave six months preparation time at least to the pharmaceutical enterprises, so as to achieve a more comprehensive coding index of pharmaceutical enterprises in Beijing.

关 键 词：电子监管码 生产企业 成本投入 建议 

分 类 号：R95[医药卫生—药学]