重庆市药品经营企业新版GSP实施情况调查

Investigation on the Implementation of New Version GSP in Drug Trading Enterprises in Chongqing

目的:了解重庆市药品经营企业对新版《药品经营质量管理规范》(简称"新版GSP")的实施情况,为推进新版GSP的实施提供参考。方法:采取随机分层抽样的方法,对重庆市114家药品批发企业和270家零售药店的工作人员就被访者的基本信息,新版GSP的实施进展、实施难度、应对措施以及药品经营企业人员对新版GSP的实施意见与建议等进行问卷调查。结果与结论:有85.0%的药品批发企业和85.2%的零售药店仍处于GSP改造初期。其实施难度在药品批发企业中主要体现在冷链全程控制、库房面积、设备验证等10个方面,在零售药店中主要体现在执业药师配备、人工成本等6个方面。为了尽快推进新版GSP的贯彻实施,建议尽快调整和完善相关政策,如将医院纳入到GSP管理中来、按照企业大小及配送区域大小来规定仓库面积、引导验证机构和第三方物流的发展;另外,药品经营企业自身也要积极寻求应对措施,如调整经营范围、转变经营方式、与其他公司进行整体合并或业务合并等,以降低自身风险。

OBJECTIVE：To understand the implementation of new version Good Supply Practice（GSP）in drug trading enterprises,and to provide reference for promoting the implementation of new version GSP. METHODS：By stratified random sampling,the staff of 114 drug wholesalers and 270 retail pharmacies from Chongqing were investigated with the questionnaire in respects of general information of respondents,the progress and difficulties of the implementation of new version GSP,countermeasures,opinions of corporate personnel. RESULTS CONCLUSIONS：85.0% of drug wholesalers and 85.2% of retail pharmacies are at the early stage of new version GSP reconstruction. The difficulties of new version GSP in drug wholesalers focus on 10 aspects,such as whole cold-chain control,storage space,device validation;those of retail pharmacies focus on 6 aspects,such as licensed pharmacist allocation,labor costs. To promote the implementation of new version GSP quickly,on the one hand,the government needs to further adjust and perfect the policy,such as bringing hospitals into GSP,setting storage space according to the size of the enterprise and distribution area,guiding the development of the certification authority and the third party logistics;on the other hand,enterprises itself should also actively seek countermeasures to reduce the risk,such as adjusting the scope of business,transforming the operating mode,merging with other enterprises as a whole or business integration and so on.