Research On Drug Safety Monitoring System

In recent years, China’s drug safety situation is severe, and factors affecting the safety of medicines are complex and diverse. In the State Food and Drug Administration’s "Eleventh Five-Year Plan" program evaluation reports, the particular concerns include technical support system fails to meet current regulatory requirements. The monitoring system is one of the technical support systems, so in preparing the " Twelfth Five-Year Plan", recommendations were made to highlight building the technical system support. Many problems exist in China’s current monitoring system concerning the institution-building, method of monitoring technology, monitoring work related laws and regulations, the external environment of monitoring.System theory is fundamental to the paper, the drug safety monitoring system as a whole, using the literature, review, case, comparison, induction and deduction, systems analysis and other methods to analyze the elements of the system, the relationship between the elements, the relationship between system and environment. In order to make drug safety monitoring play a better role in drug safety regulation, this research will provide some proposals for improving the agency of monitoring system, clearing the legal status of the monitoring, creating monitoring methods, establishing information monitoring platform, improving the monitoring of the environment.This study suggests that drug safety monitoring as a system, its main elements are:monitoring body to monitor the regulatory norms, security incident reports, safety evaluation and analysis of information, security, signal early warning, monitoring methods.This paper studies the features of monitoring system in U.S., EU and WHO Programme for International Drug Monitoring Organization. The results show that the monitoring systems mentioned above enhance the efficiency of drug safety monitoring through a variety of ways. In particular in following aspects:monitoring system of scientific evaluation system improved; communication and enforcement of drug safety monitoring were confirmed through legal means; related guidelines to determine the person liable of drug safety monitoring; for all kinds of benefits related and sufficient drug safety and risk information communication; continue to improve the function of the database; perfect signal data mining techniques.The article studies China’s drug safety monitoring system. Results show that the drug safety monitoring of the definition is relatively narrow, but the actual monitoring scopes have been expanded. As far as the monitoring organizations are concerned, many thorny problems exist as to the insufficent personnel, arduous tasks and uncertain preparation; from the legal system’s point of view, effectiveness of drug safety monitoring regulations is weak, technical specifications and guidelines also fails to effectively compensate for existing laws shortcomings; from the reporting system’s point of view, there were also lots of issues such as omitting rate, reporting rate instability, reports incomplete, lack of information networking, lack of effective safety information communication; at last, pharmaceutical manufacturers reluctant to take the initiative to carry out drug safety monitoring,This study concludes that drug safety monitoring of the existing problems can be classified and attributed to the laws and regulations, monitoring mechanisms and monitoring technology. Mainly in the following aspects:(1) lag and imperfect relevant laws and regulations; risk management system has not been established; (2) the monitoring system is relatively backward, the monitoring function of regulatory agencies and production enterprises is imbalance, loss of pharmaceutical Advisory Committee; (3) monitoring technical defects hindered the use of information mining.This article proposes a series of measures to address these issues mentioned above. First of all, improve laws and regulations for drug safety monitoring system, develop drug safety monitoring technical guidelines, organize and instruct pharmaceutical manufacturers, medical and health institutions to develop drug risk management plans; secondly, emphasize drug safety monitoring system playing an important role in the new system; thirdly, enhance the technical capacity for drug safety monitoring; finally, speed up the construction process of monitoring information, improve the efficiency and quality of reporting, apply centralized monitoring to promoting the establishment of new monitoring mechanism basing on the combination of government guidance and pharmaceutical manufacturers’active monitoring.The article esteems that the establishment of any systems are supposed to go through the process of continuous improvement; the establishment of drug safety system must be accompanied by drug safety events’detection, treatment and evaluation, and gradually perfected.