Construction And Application Of Cost Monitoring Scheme For The Quality Supervision Of Chinese Patent Medicine

Drug is a special commodity for the prevention,treatment and diagnosis of human diseases.Drug quality supervision is the necessary requirement to guarantee the safety and effectiveness of drug quality and to safeguard the physical and mental health of the people.With China’s economy and society entering a new era,the quality of the people life has improved markedly,the people’s demand for drug quality and safety has been continuously improved.At the same time,with the wide application of new and high technology,the rapid development of the medicine industry has been promoted,it also brings new opportunities and challenges to drug quality supervision.Chinese patent medicine as an important part of medicine,due to its complex composition,variety of dosage forms and limitations of quality standard,the quality and safety of Chinese patent medicine have attracted much attention,especially in recent years,there have been some cases of drug harm related to Chinese patent medicine,such as Yuxingcao Zhusheji incident,Ciwujia Zhusheji incident,Tangzhining incident,toxic capsule incident,etc.All have aroused wide concern in the whole society.The quality supervision of Chinese patent medicine has been a difficult problem,since ancient times,there has been a saying that "Pill Powder paste Dan,the Immortals are difficult to distinguish",for a long time,supervision mainly depends on social moral constraints and empirical identification,basic reference to the mode of chemical quality supervision at this stage,but the composition of Chinese patent medicine is much more complicated than that of chemical medicine,only by the existing quality standard inspection and other means can not achieve the effective supervision of the quality of Chinese patent medicine.Therefore,it is necessary to explore new ways to supervise the quality of Chinese patent medicine.This subject explores how to supervise the quality of Chinese patent medicine by monitoring the cost and price.Research and construction of quality-cost monitoring scheme for Chinese patent medicine.Through the discovery of the price inversion of the Chinese patent medicines,hope to provide problem clues for Flying Inspection,at the same time,it also provides some references for Drug Administration to strengthen the quality supervision of Chinese patent medicine.In this paper,the methods of Literature analysis,Field investigation,Expert interview,Expert consultation and Empirical research are used.By retrieving domestic and foreign literature and relevant official website data,investigation and research on the practice of Traditional Chinese Medicine Manufacturer,Provincial Food and Drug Control Institute,Provincial Food and Drug Administration.Draw up interview outline for expert interview,prepare questionnaires for expert consultation.Analysis of the current situation of the development of Chinese patent medicine,supervision problem,current situation of research on quality supervision,cost and price monitoring of Chinese patent medicines and other related areas.To discuss the new measures of quality supervision of Chinese patent medicine,construct a quality-cost monitoring scheme for Chinese patent medicine and carry on the empirical research to the scheme.Through the official website data and the literature analysis,we find that the development of Chinese patent medicine is full of opportunities and challenges,the quantity of Chinese patent medicine listed on the market is various,the number of Chinese patent medicine manufacturers is increasing year by year,the problem of quality inspection of Chinese patent medicine is still prominent,the quality supervision ofChinese patent medicine is also common,there are regulatory loopholes in the production of Chinese patent medicine,there are standard limitations of Chinese patent medicine,the phenomenon of winning the bid at very low Price in the bidding of Chinese patent medicine,the number of literature on the quality supervision of Chinese patent medicines is very small.At present,there is no research on the application of cost price monitoring in the quality supervision of Chinese patent medicine,there is no specific monitoring scheme.We first interviewed 10 experts in related fields of Chinese patent medicine,a quality-cost monitoring scheme of Chinese patent medicine with 5 first-level items and 28second-level items was initially constructed.Then using the method of expert consultation,select the representative and authoritative 20 experts in related fields of Chinese patent medicine,two rounds of expert consultation were conducted.According to expert consultation evaluation result,calculate the arithmetic mean,variation coefficient and perfect frequency of each item,select item by the method of bounds.A quality-cost monitoring scheme of Chinese patent medicine with 5 first-level items and 22second-level items was finally established.At last,we carry on the empirical research to the quality-cost monitoring scheme of Chinese patent medicine.It was found that in two of the five selected Chinese medicines,both the bid price and the market price were inverted,and there was a bid price inversion phenomenon in one.There may be a potential quality safety hazard of Chinese patent medicine with price inversion,It is suggested that the Drug Administration carry out Flying Inspection to Chinese patent medicine enterprises with price inversion varieties,focus on financial instruments,raw and auxiliary materials and extracts,pre-processing and extraction,inspection,production technology,material balance and deviation treatment,etc.to carry out special inspection and verification.The quality problems of Chinese patent medicine can not be completely solved by the existing supervision methods,we need to constantly explore new ways of administration of Chinese patent medicine.It is a new regulation idea to supervise the quality of Chinese patent medicine by monitoring the cost price,but it is also a complicated work.There is a need for national support and coordination between supervision department at all levels.We will gradually explore a practical and scientific and rational quality supervision plan for Chinese patent medicines,the quality-cost monitoring scheme of Chinese patent medicine is one of the beneficial attempts.In the future,I and other theoretical researchers and practical experts will be required to continue to study,practice and improve.