Study On Prevention And Control Strategies Of Drug Shortages

Drug shortages is a widespread problem in the world.Drug regulatory agencies in various countries or regions pay more and more attention to drug shortages.The Chinese government is also highly concerned about the problem of drug shortages.The drug administration law of the people’s Republic of China,which came into force on December 1,2019,first mentions the concept of "Drug shortages" at the legal level,and stipulates a number of countermeasures.In order to deal with the challenges brought by drug shortages,China has built a linkage mechanism between the relevant departments of the central government and between the central and local governments,and introduced a series of policies and measures,which have achieved good results in the prevention and response of drug shortages.However,the linkage mechanism to solve the drug shortages in China is not perfect,most of the policies and measures are macro level,and the specific tools and measures are not perfect.In order to ensure the accessibility of clinical medication and reduce the impact of drug shortages on disease prevention and treatment,it is necessary to further optimize and improve the working mechanism,policy measures,tools and methods to prevent and deal with drug shortages in China.This paper reviews the laws,regulations and guidelines on drug shortages in the United States,the European Union and China through literature research method,summarizes the working mechanism and core elements of preventing and responding to drug shortages in Europe and the United States,and analyzes the reference significance of the working mechanism and response measures in Europe and the United States to China from the perspective of drug supervision.At the same time,through special discussion,the necessity and feasibility of classified and graded management of drugs in short supply were discussed,and the basic working ideas of classified and graded management were put forward.Finally,based on the research results,combined with the analysis of the main causes and current situation of China’s drug shortages,this paper puts forward suggestions on further improving China’s drug shortages management mechanism and related measures,mainly including:(1)standardizing the definition of "Drug shortages";(2)unifying and improving China’s drug shortages classification management system;(3)from the perspective of drug supervision,enrich the tools and methods to solve the problem of drug shortages.