A Study On Drug Safety Regulation

With the rapid development of our economy and society, the level of people's drug use is getting higher and higher and the consciousness of drug safety is also growing. However, on the one hand, how to strengthen drug safety regulation is imminent because the public are doubtful of the capability of government drug safety regulation owing to the events of the Vioxx and the Qieryao in recent years; on the other hand, the literature shows that the theory and method of drug safety regulation remain to be clarified and resolved. To this end, taking drug safety regulation as study objective, this paper tries to provide theory and method for drug safety regulation, provide basis and reference for government policy. This paper has important theoretical and practical significance.This paper takes the drug registration life-cycle as the main line; takes the drug registration, adverse reaction monitoring and supervision as object; takes the regulation theory, safety theory, game theory and so on as approaches. The risk signal has been picked out by adverse drug reaction data mining tools for empirical analysis. The major work and innovation are as follows.(1) The author reviews the domestic and international references of drug safety regulation from the macro, meso and micro levels; classifies the regulation theory (including the public interest theory and the interest group theory), safety theory and game theory; comprehensively analyzes the major status and problems of drug registration, ADR monitoring and supervision. The author put forward the concept of drug safety regulation, sorts out the research framework for drug safety regulation and points out that this paper should study the drug safety regulation by former or later registration and supervision according to the life cycle of drug registration.(2) The author analyzes the harmfulness of drug false application, establishes the complete information static game model between the enterprise and government, draws a conclusion that establishing the enterprise and government's responsibility investigation system is helpful to improve efficiency of drug registration, clarifies the misunderstanding that strengthening the control would hinder economic development. At last, the author suggests that responsibility investigation system, ADR monitor and drug injury compensation must be set up.(3) In order to resolve the problem that the public being lack of awareness of ADR, failed to report ADR and having different views to reward and punishment system of ADR monitoring, the author establishes incomplete information dynamic game model between government and enterprise; analyzes the influences of reward and punishment system of ADR monitoring to the utility of total society, the utility of reporter, the rate of report and the willingness of report by pure strategy equilibrium and mixed strategy equilibrium, and draws a overall conclusion that reward and punishment system based on the probability of implementation is helpful to the ADR monitoring. The author put forward suggestions that reward and punishment system is of benefit to ADR monitoring; we should not only pay attention to standards of reward and punishment system, but also pay more attention to the implementation; the value of reward and punishment should not be fixed, but should be greater than the cost which the reporter has paid or should pay.(4) Using the concept of threat in the field of military and the theory of marginal utility in the field of microeconomics, the author proposes the concept of regulation threat, establishes regulation threat mathematical and draws a conclusion that regulation threat can decrease violation of the regulations. The threat function of the frequency of penalty is more effectual than that of the amplitude of penalty. The total social utility can be increased more efficaciously by increasing the amplitude of penalty than the frequency of penalty. The amplitude and the frequency of penalty cannot be increased illimitably, and the total social utility is maximization when they increase to optimal state. The author put forward a suggestion that we should formulate our regulation focus according to different regulation stages, focus on strengthening the frequency of penalty in the early stage, focus on strengthening the amplitude of penalty in the middle stage, focus on reformation in the late stage. This study solves the problem that do we need more inspections or penalties as for government administrative regulation in one aspect of theory.(5) The author comparative analyzes the latest adverse drug reaction data mining tool in the world and jointly and independently develops computer analysis software with Proportional ADR Reporting Ratio (PRR), Reporting Odd Ratio (ROR), UK-MHRA (MHRA) and Bayesian Confidence Propagation Neural Network method (BCPNN) being of previous optimization deviation. This software has be validated and certificated by manual work and SFDA. Adverse drug reaction data mining technology can judge drug safety. We can screen and draw a strongest signal information that Clindamycin-hydrochloric acid can cause hematuria but no more serious than Cefradine by using this software to evaluate historical data. This conclusion can avoid the hurt of large groups of people. This paper's three theory conclusions can be proved to be correct and effective once again in practice by analyzing the case of Clindamycin.