对建立药品零售连锁企业药品安全管理相关法规的思考

Thought on the Establishment of Drug Safety Management Related Laws and Regulations for Pharmaceutical Retail Chain Enterprises

目的:以促进零售连锁企业药品安全管理为目标,对零售连锁企业药品安全管理相关法律法规建设进行思考。方法:通过文献研究、专家访谈探讨现有药品管理法律法规尚不完善之处,并通过问卷调查了解相关人员对连锁企业统一化管理及药学服务相关规定对药品安全管理的重要程度的态度。结果与结论:现有药品管理法律法规尚未形成专门针对药品零售连锁企业管理的法规体系,缺乏规范连锁加盟行为的管理规定等;80%以上的被调查者认为统一质量管理、统一采购管理及统一配送管理对企业药品质量安全管理十分重要,64.8%的被调查者认为零售药店开展药学服务相关规定对规范药学服务十分重要。建议以法规形式明确"药品零售连锁"的定义,建立并完善零售药店药学服务相关法规,加强和完善药品零售连锁企业加盟相关法规,鼓励制订连锁药店监督管理的地方规定。

OBJECTIVE： To consider about the relevant laws and regulations in order to promote the drug safety management of pharmaceutical retail chain enterprises. METHODS： By literature review and expert interview, the defects of the current drug management laws and regulations were discussed. The relevant persons＇ attitude towards the importance of chain enterprises unified management and pharmaceutical care relevant provisions to drug safety management were investigated through questionnaire survey. RESULTS ＆ CONCLUSIONS： Current drug management laws and regulations have some defects： such as laws and regulations for pharmaceutical retail chain enterprise have not formulated; the regulations for standardizing retail chain franchise are absent. 80% of respondents believe that unified quality management, unified purchase management and unified delivery management are very important to the safety management of drug quality; 64.8% think that related regulations that pharmaceutical care in retail drugstore is very important to standardize pharmaceutical care. It is suggested to define the meaning of ＂drug retail chain＂ in the form of laws and regulations, establish and improve the regulations for pharmaceutical care in retail drugstore, strengthen and im- prove franchise laws and regulations, and encourage development of the local regulations of chain drugstores regulation.