Analysis of unqualified results of national drug sampling in 2017-2019 based on association rules

OBJECTIVE To explore the potential information in the unqualified information of the national drug quality sampling and testing, and to provide references for the development of the national drug quality sampling and testing. METHODS By cleaning and standardizing the national drug quality sampling and testing data from 2017 to 2019, 1 816 non-conformance reports were obtained. The type, labeling production enterprise, inspection source distribution and dosage form of non-conforming drugs were analyzed through the data perspective chart function in Excel which performed a visual description. through the Apriori algorithm of SPSS modeler 18.0 software, the unqualified drug items were associated with the drug type, dosage form, labeling manufacturer, and source of inspection products, and 10 effective rules were obtained. RESULTS The national drug quality sampling and testing provided effective technical support for fighting against counterfeit and inferior drugs. The unqualified rate in Anhui, Guangxi, Jiangxi regions of traditional Chinese medicine slices and manufacturing enterprises, and the sampling areas of Jiangxi, Anhui and Hainan was higher than that of other regions. There were certain strong associations between unqualified drug items and the dosage form, the label production enterprise, the source of the inspection product. CONCLUSION it is suggested to formulate a national drug quality sampling and testing plan based on problems. Introduce credit management mechanism in penalties for counterfeit and inferior drugs, expand the application of drug quality sampling and testing results, and improve the function of the national drug quality sampling and testing platform.