Research On The Monitoring Of Adverse Drug Reactions In China Under The Pharmacovigilance System

On August 26,2019,the revised version of the "Pharmaceutical Administration Law of the People’s Republic of China" was voted and adopted on December 1,2019.The "Pharmaceutical Administration Law" introduced the pharmacovigilance for the first time,marking the state’s formal inclusion of the pharmacovigilance system in drug supervision.The monitoring of adverse drug reactions in China started in the 1980s.Through a series of legislation and improvements,the current monitoring system of adverse drug reactions has been completed and stabilized.At present,there are still some problems in the construction of pharmacovigilance in China.For example: limited to passive collection of adverse drug reactions,drug risk signals,and underutilization of pharmacovigilance data.In this paper,by querying the literature on pharmacovigilance and related data,comparing the differences between the existing pharmacovigilance systems,relevant legislation,and government agencies in China and Europe and the United States,we find that China’s pharmacovigilance system places more emphasis on supervision and ignore risk control.Mainly manifested in: the imperfect pharmacovigilance system;insufficient attention to the full life cycle risk control of drugs;the pharmacovigilance responsibilities of drug marketing license holders have not been strictly implemented;the initiative to collect and report mechanisms needs to be established;In order to better understand the progress of domestic pharmacovigilance,this paper takes a certain area of Shanghai as a representative and collected reports of adverse drug reactions in that area from 2008 to 2018.Through statistical analysis,it was found that the reports of adverse drug reactions in China’s pharmacovigilance system were single-sourced,the proportion of serious adverse drug reactions was very small,and the drug was used unreasonably.At the same time,this article further reanalyzes the data of severe adverse drug reactions in the region from 2008 to 2018.Through analysis,it was found that serious adverse drug reactions in the area were related to some drug varieties and routes of administration,and there were problems with the number and quality of reported adverse drug reactions.This article puts forward a series of suggestions based on related issues,such as: improving the construction of the pharmacovigilance system,improving the quality of adverse drug reaction reports,paying attention to rational personalized medicine,rationally using antibiotics,reducing the use of injections,and increasing compensation for serious adverse drug reactions.China’s current adverse drug reaction monitoring system is still effective,and the construction of future pharmacovigilance systems should focus on the production and use of drugs to improve the monitoring system of adverse drug reactions in China.Suggestions and prospects are put forward by consulting literature,comparing the difference of pharmacovigilance system at home and abroad,analyzing the data of adverse drug reactions,aiming at the construction of adverse drug reaction system at the grass-roots level,the training of medical workers,promoting the reporting of the holders of marketing license,improving the release of adverse drug reactions information,building the active collection system of adverse drug reactions,establishing the compensation system of adverse drug reactions,etc: to strengthen the pharmacovigilance system,to promote the legislation of pharmacovigilance,to improve the establishment of pharmacovigilance organizations and personnel,to improve the mechanism of pharmacovigilance information release;to strengthen risk control,to strictly implement the pharmacovigilance responsibilities of drug listing license holders,to strengthen the training of medical personnel in pharmacovigilance;to strengthen the publicity of rational drug use,to reduce adverse drug reactions;to accelerate the establishment of compensation mechanism for adverse drug reactions.