Research On Quality Risk Management Of Drug Distribution In Hangzhou

Drugs are special products that protect the health and safety of the public and play a big role in preventing,treating and diagnosing diseases.However,the occurrence of some drugs safety incidents in recent years has caused the public to pay more attention to drug safety.From the research and development of pharmaceuticals to the production and sales,there are many links in the middle,and the circulation field is a necessary link for connecting pharmaceutical manufacturers and drug users.The quality and safety of drugs in this link cannot be ignored.At present,research on drug quality risk management is mostly concentrated in the production field,and there are relatively few studies on quality risk management in the circulation field.Therefore,it is necessary to study the quality risks in the field of drug circulation from the perspective of risk management.This paper contains seven parts of the research on quality risk management in the field of drug circulation in Hangzhou.The first chapter is the introduction,which contains the background,purpose,significance,content and method of the research;the second chapter is the literature review.Firstly,the domestic and international research status of drug quality risk management is comprehensively discussed.Secondly,some basic concepts are defined.Finally,the concepts,processes and tools of drug quality risk management are applied to the drugs.The quality risk management theory is described in detail;the third chapter is the identification and confirmation of the quality risk in the field of drug circulation in Hangzhou.It mainly uses the literature research method,expert consultation method and questionnaire survey method to identify and confirm the quality risk of drug circulation in Hangzhou,and finally obtain the quality risk of drugs;the fourth chapter is the evaluation of quality risk factors.Through the use of quality risk management tool FMECA,the quality risk factors in the field of drug circulation in Hangzhou are quantitatively evaluated.The assessment results are 18 risk points for quality risk management tools,quality management of medical institution pharmacy managers,and traceability system.9 medium-level risk points such as the quality management system and the equipment and transportation tools to ensure the temperature of refrigerated medicines require effective control measures;the fifth chapter assigns different β weight coefficients to different evaluators from the four factors of the job position,number of years of work,education level and familiarity with the risk points of drug quality.Using weight coefficient optimizes RPN values;the sixth chapter is suggestions.From the perspective of the drug regulatory authority,it proposes to strengthen the construction of the regulatory team in the field of drug circulation,increase penalties for violations,establish a regulatory platform for information on the field of drug circulation,improve the quality management of medical institutions and drug circulation enterprises,and improve drug distribution enterprises.Responsible quality risk awareness and improvement of the quality of licensed pharmacists;the seventh chapter summarizes and forecasts this research.