Study On The Safety Of Chinese Patent Medicines For Children Based On Drug Instructions

Children determine all the possibilities of the future development of the motherland.Children are not only a bond to maintain the family,but also a key to the future development of the motherland and the nation.Whether children's physical and mental health can be guaranteed is closely related to the safety of children's medication.Due to the incomplete physiological development of children,drug safety problems occur.Traditional Chinese medicine preparations are widely used in China.At present,most of the children's medicines in China are mainly proprietary Chinese medicines.In view of the fact that the main tool for guiding safe and rational use of medicines is the drug instructions,this paper takes the information of children's medications from the instructions for selecting proprietary Chinese medicines as a starting point,and uses the theory of traditional Chinese medicine,the basic principles of pediatric medication and the relevant provisions of the manual to analyze the problems and provide suggestions in the current instructions for children's Chinese patent medicines.From a scientific point of view,reliable suggestions are provided for safe children's medications.Suggestions are provided to reduce the risks that children may have during the course of medication.The safety and rationality of children's medications are improved,with a view to further improve the drug specifications of proprietary Chinese medicines,clinical trials,rational use of proprietary Chinese medicines,research and development of children's special medicines,etc.This aspect provides a useful reference to achieve the purpose of ensuring the safety of children's medication more scientifically,reasonably and effectively.In this paper,1016 Chinese patent medicine instructions were investigated by literature research and statistical analysis.Firstly,by using the method of literature research we collected relevant literature as well as monographs,and understood the relevant domestic policies on children's drug use,the drug instructions and the existing problems of children's Chinese patent medicines.Secondly,combined with modern electronic information technology,the database of children's traditional Chinese medicine was established.SPSS22.0 was used for statistical analysis of the data,and corresponding countermeasures as well as suggestions were put forward according to the statistical analysis results and problems.A total of 1016,185 and 831 instructions for Chinese patent medicines,prescription drugs andnon-prescription drugs,respectively,were included in the survey.According to the method of administration,the majority of the instructions were for oral preparations.956 and 60 instructions for oral preparations and external preparations were included,respectively.In this study,the results showed that :(1)the information of children's drug safety was deficient in varying degrees.The rate of warning labeling was low,accounting for 8.4%,and the rate of warning labeling related to children was even less,accounting for0.5%.The rate of unclear labeling of adverse reactions was 83.3%;the rate of unclear children's proprietary Chinese medicine was 87.7%;the rate of unclear labeling of contraindication was 54.1%;and the rate of unclear labeling of children's proprietary Chinese medicine was 65.8%.There were some problems such as non-standard expression and confusion with taboos in the specific notes.The rate of labeling of children's medication was low,accounting for only 3.2%.(2)The labeling of medication guidance information was not clear,and there was no substantial content.In the usage and dosage of Chinese patent medicine for children,only 549(84%)of adult's dose were labeled.Although 836 of drug interaction items were labeled with content,827 of them had no substantial content.(3)The rate of labeling of basic information was low,the specification was not standard,the core elements were not sufficient,the rate of labeling of pharmacological and toxicological items was low(21.6%),and the rate of labeling of clinical trials was low(3.8%).There are many factors affecting the safety of children's medication.At present,there are mainly the following problems in the application of children's proprietary Chinese medicines.The quantity of children's special medicines is small;and the lack of suitable dosage form and specification for children leads to the shortage of children's special medicines.Moreover,there is unreasonable and non-standard clinical use of children's medication.In order to reduce the incidence of adverse drug reactions in children and promote the safety of Chinese patent medicines for children,this study proposes the following suggestions: firstly,to strengthen the standardization and supervision of drug instructions;secondly,to actively carry out clinical trials of children's medication;thirdly,strengthen the research and development of traditional Chinese medicine for children;fourthly,establish and perfect corresponding laws and regulations;fifthly,the adverse reaction monitoring and drugre-evaluation system should be improved.