广东省药品抽检购样经费测算与路径优化  

Calculation and Optimization Path of Sampling Funds for Drug Inspection in Guangdong Province

作　　者：余燕[1] 何德金 利惠桃 刘文[2] YU Yan;HE Dejin;LI Huitao;LIU Wen(Guangdong Institute for Drug Control,Guangzhou,Guangdong,China 510180;National Institutes for Food and Drug Control,Beijing,China 100050)

机构地区：[1]广东省药品检验所,广东广州510180 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药业》2025年第9期26-30,共5页China Pharmaceuticals

摘　　要：目的为我国药品抽检购样经费的科学、合理使用提供参考。方法选取广东省21个地市(A-U市)和广东省药品检验所(V省直属单位)2020年至2022年药品任务批次数和实际支出购样数据,采用整体考虑法和实际支出成本法测算平均批次抽检购样经费(抽样成本),结合部分企业调研反馈意见分析抽样成本存在差异的原因,并提出针对性建议。结果按整体考虑法,广东省A-U市和V省直属单位可聚类为96~366元/批、445~639元/批、783~976元/批、1519~1894元/批4个组次,组间偏差为7.57倍;按实际支出成本法,可聚类为213~276元/批、379~649元/批、736~1151元/批、1654~1979元/批4个组次,组间偏差为8.61倍。2种测算方法均显示高低组次抽样成本差异显著,部分地市支出远超预算经费保障标准,而部分地市支出远未达到标准。结论建议地方药品抽检工作在国家标准模式基础上,采用加权赋分法优化经费安排,并建立相关的保障体系,以完善药品抽检购样经费管理模式。Objective To provide a reference for the scientific and rational use of sampling funds for drug inspection in China.Methods The number of drug task batches and actual sampling funds for drug inspection in 21 cities in Guangdong Province(A-U cities)and Guangdong Institute for Drug Control(directly affiliated unit of the province V,hereinafter referred to as V unit)from 2020 to 2022 were selected.The holistic approach method and actual expenditure cost method were used to calculate the average batch sampling funds for drug inspection(sampling funds).Combined with feedback from some enterprise surveys,the reasons for the differences in sampling funds were analyzed,and targeted suggestions were proposed.Results According to the holistic approach method,the A-U cities and V unit in Guangdong Province could be clustered into four groups:CNY 96-366 per batch,CNY 445-639 per batch,CNY 783-976 per batch,and CNY 1519-1894 per batch,with an inter-group deviation of 7.57 times.According to the actual expenditure cost method,those could be clustered into four groups:CNY 213-276 per batch,CNY 379-649 per batch,CNY 736-1151 per batch,and CNY 1654-1979 per batch,with an inter-group deviation of 8.61 times.Both calculation methods showed significant differences in sampling funds between high and low groups,with some cities'expenditures far exceeding the budget funding guarantee standard,while others'expenditures far fall short of the standard.Conclusion It is recommended that local drug sampling work adopt a weighted scoring method to optimize funding arrangements based on the national standard model,and establish relevant guarantee systems to improve the management mode of sampling funds for drug inspection.

关 键 词：药品抽检 抽样成本 整体考虑法 实际支出成本法 经费保障 

分 类 号：R95[医药卫生—药学]