The Evaluation Index System Of The Quality Of Post-Marking Drug Safety Assessment

In recent years, the occurrence of a series of phytotoxicity events make people doubt the safety of drugs, in which, the safety issues of Injection of Traditional Chinese Medicine (ITCM) has been particularly conspicuous. In2009, the SFDA issued the notice about ITCM safety reevaluation and related guidelines, which marked the beginning of ITCM safety reevaluation in China. There are requirements clearly that the pharmaceutical production enterprise should carry out the research of drug safety post-marking. But there has not been a perfect standard and evaluation system in China, leading to the research quality of uneven, the rationality of the results could not be detected and the standardization of the evaluation study needs further investigation.The paper intends to build a set of complete evaluation index system by Delphi and AHP, it can be used to evaluate the research quality of post-marking drug reevaluation comprehensively and objectively. According to the evaluation results, analysis the deficiencies and defects of the research and take measures to promote the research of the post-marketing evaluation, so as to ensure the public safety.The results show that it is feasible to build the evaluation index system of post-marking evaluation by Donabedian’s theory and Delphi method. To give up the index not meet the three judgment dimension tolerances of full mark frequency, average and coefficient of variation. The concentrated expression:the structure index includes2second-level indexes of resource and policy, the process index include production process evaluation, evaluation of quality control, non-clinical safety study evaluation and clinical safety evaluation and the result index consist of the effect of ADR monitoring evaluation and utilization of the result of research.The result shows that using AHP method analysis the weight coefficient effectively. The study get the evaluation system includes3first-level indexes,8second-level indexes and44third-level indexes. Among them, the more important indexes of first-level indexes are the structure index and result index, which of second-level index include clinical safety evaluation, ADR monitoring and the research result utilization degree evaluation and assessment of known serious risks associated with drug use, the main performance, processing and regression of the ADR, evaluate the causal relationship of ADR and special groups of drug information of third-level index.The results show that the evaluation index system of post-marking drug reevaluation has characteristics of distinct, systematic, operability and coverage widely. On the one hand, it can be used as a basis and standards to evaluate the quality of post-marking evaluation research. On the other hand, the perfect evaluation index system can guide the adjustment of polices to some extent.