Analysis Of Adverse Drug Reaction Data Of Traditional Chinese Medicine In Beijing Pharmaceutical Production Enterprises (2009 - 2013)

Chinese herbal medicine, Chinese native medicine tablets, Chinese patent medicine as three forms of Chinese medicine pharmaceutical applications, play a important role in the prevention and treatment of clinical disease. Traditional Chinese medicine is widely favored for its stable quality, good curative effect and convenient use. With the widespread use of traditional Chinese medicine on the market, a series of adverse events generated by the traditional Chinese medicine is also growing concern to the community. Reporting and monitoring of adverse reactions medicine can provide reliable basis for the evaluation of Chinese medicine, Chinese medicine market consolidation, eliminate the risk of preparation, guidance for the rational use of drugs. It’s the indispensable part for the drugs re-evaluation and it’s indispensable to improve the drug risk management. How to improve the ADR reporting and monitoring work is the important issues that medical institutions, pharmaceutical enterprises and other relevant departments can not be evaded. Therefore, it is of great significance to strengthen the understanding of the status quo of the adverse drug reaction, strengthen the analysis of the reasons for the adverse reaction of traditional Chinese medicine, and put forward reasonable ways and countermeasures.This study uses the ways of data statistics, analysis and mining methods to explore more than 2 hundred thousand cases of Beijing pharmaceutical production enterprise that comes from Beijing adverse reaction center feedback. First, screening, specification, sorting, statistics. Secondly, based on the statistical results, analysis from preparations, report type, clinical manifestation, prevention measures, focusing on analysis of new or severe adverse reaction of traditional Chinese medicine, the bezoar antidotal tablet toxic ingredients safe problems and Qingkailing injection adverse situation. Thirdly, analyze the advantages and disadvantages of adverse reaction of traditional Chinese medicine preparation in reporting and monitoring, on the basis of this, put forward reasonable suggestions.Through analyzing and exploring the data of adverse drug reaction, the statistical data are obtained. The current situation of Reporting and monitoring of Chinese medicine adverse reaction:The reasons for the adverse reaction of traditional Chinese medicine are varied, involving various organs and systems. The new or serious adverse drug reaction reports and monitoring levels are low; Qingkailing injection, bezoar antidotal tablet and other preparation of traditional Chinese medicine as a whole, curative effect is better, market base is large, more good than harm, under normal and reasonable medication, a lot of adverse reaction events is can be reduced or avoided; Medical institutions and other related departments strengthen the implementation of monitoring and reporting system is an important content of drug risk management and the safety of clinical medication.The adverse reactions and drug exist at the same time, it is the inherent nature of drugs. The correct understanding of Chinese medicine and its side effects play as a warning role in promoting the rational use of medicine. In this study, some advices are put forward from the aspect of the management level, the clinical medication level and the society level:Master the incompatibility of traditional Chinese medicine; follow differentiation of symptoms and signs on the treatment; follow traditional Chinese Medicine Classics of experience, establish and improve the reporting and monitoring of adverse reactions medicine work content, facilitate the implementation of the establishment of adverse reactions medicine remedies warning system and compensation system. Medical institutions, pharmaceutical production enterprises, business enterprises, drug regulation and other related departments should popularize the knowledge of adverse reactions, improve the adverse reaction reporting and monitoring methods and processes, and strictly ensure the safety of traditional Chinese medicine.