Analysis of the problems of drug sampling and testing programme under tripartite system reform in China.

ABSTRACT

RATIONALE To ensure that quality medicines are available to the populace. AIM AND OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: 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.