Study On The Hierarchical Management Of Drug Circulation Quality Risk In Anhui Pharmaceutical Wholesale Enterprises

Objective: The whole society pays great attention to drug safety,which attributing to the drug safety,especially major injury events,such as "Bai Yi incident",“Qieryao”,“Xinfu”,“Houttuynia cordata injection”and“Bai Yi incide-nt”[1] and so on.The hidden dangers of drugs include the adverse reactions in the scope of the instructions and the defects in the management of the quality.The risk of drug safety will run through the use of drugs[2].The purpose of risk management is to limit known drug risk and to provide valuable data for the evaluation of drug risk and pretreatment factors[3].Drug quality risk runs through the whole life cycle of drugs,which exists in the whole process of the research,development,approval,production and marketing of the drug[4].From the practice of Pharmaceutical Administration,when it comes to drug quality management,generally we will pay attention to the quality management of raw materials,the production of drugs and the the product inspection process.Our quality management awareness after the drug factory is relatively weak as we less pay attention to the factors that may influence the quality safety of drugs in drug distribution process.To this end,drug quality management is often out of control[5].Chinese has become the world's second largest pharmaceutical distribution market,the total market share increased from 3% to 7.5%[6].We should pay attention to the development of the pharmaceutical market at the same time,establish a sense of crisis,as the drug quality risk will also be accompanied by the entire process of drug circulation The reason is that China's current risk management focus is still in the production process but not in the process of drug circulation.Through the retrieval of relevant research literature,we found that most of them are also about the risk management of pharmaceutical production enterprises,and there is little research on the quality risk in the process of drug circulation.In order to make up for the deficiency of this study,this paper studies the quality risk of the wholesale link in the process of drug circulation,and provides reference value for the quality risk management of the pharmaceutical circulation.Methods:The author of this paper will study on the classification management of drug circulation quality risk in drug wholesale enterprises by using the methods of literature search and theory review,case analysis,statistical analysis,questionnaire survey,practical observation and expert method.Results:This paper is divided into 6 parts.The first part is the introduction,which introduces the background,purpose,significance and the application value,research content,research ideas,research methods and framework of the paper[7].The second part is the theoretical basis of the thesis,which introduces the basic theory and the development of risk management theory[8].The third part is the domestic and international research situation of drug quality risk management[9].The fourth part is the current situation of drug circulation quality risk management in Anhui pharmaceutical wholesale enterprises.The fifth part is about the simple explanation of the basic procedure,the methods and the tools of the quality risk management.The sixth part is the descriptive statistical analysis of the risk classification management of drug wholesale enterprises in Anhui Province,involving the investigation methods,the basic situation of the sample,the statistical indicators of risk description,etc.The seventh part is the research on the evaluation of the risk points classification of drug wholesale enterprises in Anhui Province,including the methods of risk assessment,the selection of evaluation indicators and the evaluation criteria.The eighth part is the conclusion and the countermeasure suggestion,which involves the preliminary research results,the countermeasure suggestion,the research deficiency and the future research prospect.Conclusion:In this subject,the author tentatively carried out a preliminary methodological study on drug distribution quality risk classification management in pharmaceutical wholesale enterprises.However,drug quality risk management is a dynamic and systematic process,which requires full participation and continuous improvement to better ensure the safety and effectiv-eness of drug use.