School of Business Administration, Shenyang Pharmaceutical University, Shenyang, Liaoning Province, China.
J Eval Clin Pract. 2023 Feb;29(1):181-190. doi: 10.1111/jep.13725. Epub 2022 Jun 19.
To ensure that quality medicines are available to the populace.
To provide a new perspective for drug sampling and testing using a risk-based approach globally, and provide a reference for improving the efficiency of the drug sampling and testing programme in China.
This study used a combination of theoretical analysis and problem analysis. First, we analysed the high-risk drugs that should be given attention to theoretically in the drug sampling testing programme based on the healthcare reform in China. Second, this study leveraged on data on the sampling and testing of drugs extracted from self-constructed data by the China Food and Drug Administration (CFDA). The integrated and structured data sets were used to conduct an innovative analysis that identifies the actual content of the drug sampling and testing programme and contrasts them with the theoretical content to understand the problems. This study used quantitative and qualitative approaches for data analysis.
Following analysis, we discovered that there is still a big gap between the reality of drug sampling and testing in China and the ideal state of the objective requirements of healthcare reforms. The major sources of risk are the retail pharmacies or hospital pharmacies in the distribution chain of drugs; however, the CFDA sampled mostly drugs from drug manufacturers. Additionally, the CFDA did not sample adequate essential medicines, bid-winning drugs (especially those with large price drops in centralized procurement), biological products and other high-risk drug varieties. The high-risk drugs produced by companies or enterprises with a history of noncompliance, especially bid-winning enterprises in centralized procurement, were not sampled.
We suggest that the major content of drug sampling and testing in China should focus on the link of drug utilization, varieties of drugs with large price drops in centralized procurement and bid-winning enterprises with a history of noncompliance.
确保民众能够获得高质量的药品。
为全球采用基于风险的方法进行药品抽样检测提供新视角，并为提高中国药品抽样检测计划的效率提供参考。
本研究采用理论分析与问题分析相结合的方法。首先，我们根据中国的医疗改革，从理论上分析了药品抽样检测计划中应重点关注的高风险药品。其次，本研究利用从中国国家食品药品监督管理总局（CFDA）自建数据中提取的药品抽样检测数据，采用集成和结构化数据集进行创新分析，以了解实际的药品抽样检测计划内容，并将其与理论内容进行对比，了解存在的问题。本研究采用定量和定性方法进行数据分析。
分析后发现，中国药品抽样检测的实际情况与医疗改革的客观要求之间仍存在较大差距。风险的主要来源是药品分销链中的零售药店或医院药房；然而，CFDA 主要从药品制造商处抽样。此外，CFDA 没有抽取足够的基本药物、中标药品（特别是集中采购中大幅降价的药品）、生物制品和其他高风险药品品种。没有对有违规历史的企业，特别是集中采购中标企业生产的高风险药品进行抽样。
我们建议中国药品抽样检测的主要内容应集中在药品使用环节、集中采购降价品种和有违规历史的中标企业品种。
