Study On The Drug Risk Management System In China

Drug safety is one of the vital public interests. In recent years drug safety accidents are more likely to happen in some areas in our country and several serious accidents, in particular, made very negative social effects. Although hygiene departments control the deterioration of accidents within a certain period of time,there is no way to eliminate people’s suspicion: whether or not the drug supervision departments have supervised beforehand. If they did, why their actions are ineffective?When can the drug supervision system assure the public of drug safety? There is no doubt that many problems definitely exist in the current work of drug safety risk management.Drug reform in our country is still in critical stage and the drug supervision departments also always regard drug safety risk management as their regular tasks, so they have preliminarily explored an approach of conducting drug safety risk management in a new historical situation and accumulated some valuable experience.However, with the improvement of people’s living condition and people’s pursuit of better life quality and health, consequent constant even assembled exposure of drug safety problems highlight the problems, existing in our drug safety risk management,that education is not solid, system is not sound and supervision is not strict, etc. That illustrates that the government supervision departments’ and drug enterprises’ working system and methods have some problems which are incompatible with the new situation and new tasks.The drug risk management in our country started lately, so applicability research in this field is far from able to suit the practical work and the theoretical research also lacks systematicness. Therefore, we should make use of current drug risk management experience carefully, utilize the constructive methods of drug risk management overseas, reinforce the research into the overall and forward-looking problems, solve new problems, summarize new experience, innovate while developing and establish the sound drug safety risk management system. All the tasks above are the work to be done well by the government supervision departments and drug enterprises at present and in the future long period of time.This study starts with risk management theories, reviews their origin and development, analyzes the related theories, describes the drug safety risk management connotation, principles and purposes, and analyzes the causes of drug safety risk. It also describes the development process and current management situation of drug safety risk management in America, European Union and Britain, etc. and summarizes both these countries’ experience in drug risks management and the revelations they bring to our country. Based on these, the essay designs the questionnaire to clinical medical staff, staff of drug supervision departments, drug management experts and scholars, drug salespeople, and after clustering analysis and factor analysis, the essay finds out nine major problems existing in drug risk management in our country. By referring to American Overall Risk Management Framework and ICH Q9 drugs risk management system, it illustrates the major elements of drug risk management in our country, and analyzes the responsibility subject (government departments, drug enterprises, medical institutions and patient) and their respective responsibility. The essay designs drugs risk management system combined with drug risk management process and drug risk management elements and discuss the effective operation foundation of this system. Last but not least we put forward the proposal on how to run aftermarket drug risk management system smoothly from the aspects of education,system, supervision and punishment, etc.