Drug Safety Risk Management Research Of Our Country

As everyone knows, drugs belong to special kind of products. Though drugs can help people to prevent and treat diseases, adjust physiological functions, improve health level, they can cause injury even death to people because of their noxious and side effects. For healthcare field, the basic principle for drug use is safety and efficacy. People have searched for a best balance between safety and efficacy for several centuries in order to obtain maximum safety for improving health level and life quality continuously. With increasing attention of drug safety, people begin to attach importance to building the system of drug risk management, especially during drug production, circulation and use. Many developed countries began to introduce the concept of risk management to drug surveillance and management mechanism and build the system of risk management in order to enhance safety understanding of all the involved parties and promote efficiency of surveillance departments and trade resources. The goal of risk management is to make sure that drugs are safety and efficacy, and to guarantee public health.Drug safety risk management is a very complicated social project. Considering drug itself, we will apply risk management through the whole drug life circle. Considering external environment, when we apply risk management, we need supports and cooperation from many professionals, related enterprises, other organizations and people. Because risk management involves many surveillance processes, so we also need effective surveillance and enough resource supports. Though drug safety problems will be made by many factors, people will ask the governments for solving approaches when drug adverse reaction events happen. When people face danger, maybe they can't get the whole understanding of danger and know how to evade and keep away danger, so surveillance and management departments must carry out the responsibility of assuring drug safety and efficacy. It is very important for governments to make policies and implement surveillance. Whereas drug surveillance and management departments play a very important role in the whole system of drug management, this article will make research of drug safety risk standard system and the role and policies of drug surveillance and management departments in drug safety risk management. The results of this research will be helpful for these departments to collect, analyze, assess and utilize safety risk information, adopt measures to evade and control safety risk, give feedback of risk information to public, so departments can make the best of reducing risks or minimize risks at the same time of assuring efficacy to guarantee public health.First of all, on the base of common risk management theory, this article puts forward drug safety risk standard system. This standard system puts forward the definition, reasons of drug safety risk, and risk identification, evaluation, control and communication for the first time. This system will provides theorical support for drug safety risk management.Secondly, this article analyzed the existed aspects of drug safety risk management policy of our current drug surveillance and management departments through literature research and investigation. These analyses summarized the work that we have done in drug safety risk management and showed the problems that we are facing in drug safety risk management. The results show that there is very little time since our country introduced the theory of risk management and there aren't many practicing experiences for reference. During practical work, we still give priority to qualitative analysis and lack in in-depth research and summarization in risk management. Our society thinks public health as a very important thing and asks to build drug safety risk management system which can guarantee public health and deal with drug adverse events properly.Finally, combined with foreign experiences of drug risk management, this article provided a series steps of drug safety risk management and a policy framework of drug safety risk management according to the situation of our country. On the base of this framework, this article developed risk intervention policy research in order to provide references for future drug risk management strategy or plan for our country.