Research On The Current Situation And Influencing Factors Of Adverse Drug Reactions/Events Of Children In A Western Province In 2015-2018

Objective:Medicine is a kind of chemical substance used to prevent and treat people’s diseases and regulate people’s physiological functions purposefully.It is an indispensable special commodity in our daily life.However,medicine is like a double-edged sword around us.In ancient China,there was a saying that "Shennong tasted hundreds of herbs and encountered seventy poisons a day".On the one hand,drugs can cure diseases and maintain people’s health,on the other hand,they can also have harmful effects unrelated to the purpose of drug use,which is the common saying that "drugs have three poisons".In recent years,the events of Houttuynia cordata injection,clindamycin phosphate injection,methotrexate and Longdan Xiegan pill have attracted more and more public attention.Through understanding the occurrence of ADR/E of children aged 0-14 in a western province from 2015 to 2018,and analyzing the influencing factors of children’s serious ADR/E,this study hopes to provide reference for improving the quality of ADR/E report,strengthening the monitoring of children’s ADR/E,guiding children to use drugs reasonably and ensuring the safety of children’s drug use.Method:By using the method of literature analysis,this paper analyzes the current situation of children’s drug use and the monitoring of adverse drug reactions of children at home and abroad.Using the method of on-the-spot investigation,we went to a Provincial Institute of drug supervision and inspection for practical investigation to understand the specific process of reporting,evaluation and feedback of ADR/E reports.All ADR/E reports of 0-14-year-old children in a province from 2015 to 2018 were retrieved and collected through the national ADR/E monitoring platform.According to the guiding principles for the collection and reporting of individual adverse drug reactions,effective reports were screened,drug names were standardized according to the general name of Chinese drugs in 2014,standardized drugs were classified according to the national formulary of China(2010 Edition),and systems/organs and major clinical symptoms involved in ADR/E were classified according to the WHO glossary of adverse drug reactions.Microsoft excel 2010 software was used to input,sort out and count the annual number,regional distribution,results of ADR/E,age and gender of children,source of report,occupation of reporter,combination drug,drug category,route of administration,drug dosage form,involved system/organ and main clinical symptoms.The related drugs,involved systems/organs and administration routes of new and severe ADR/E in children were compared and analyzed.Spss21.0 software was used to analyze the influencing factors of severe ADR/E in children by univariate and multivariate analysis.Result:The quality of children’s ADR/E reports in this province is uneven,with invalid reports,inaccurate information,simple description of adverse events and irregular description of clinical symptoms.By eliminating invalid reports,standardizing drug names,classifying drug types,classifying involved systems/organs and clinical symptoms,233 cases of invalid ADR/E reports were eliminated,and 14427 drug names and 15315 clinical symptoms were standardized.The number of children’s ADR/E increased year by year.The number of ADR/E in Central China was the highest.The number of ADR/E in boys was more than that in girls.The incidence of ADR/E was different in different age groups.The number of reports from medical institutions is the largest,while that of manufacturing enterprises is less.Doctors are the main reporter of ADR/E,and the proportion of pharmacists’ reports is decreasing year by year.The number of ADR/E caused by single drug and combination of two drugs was more.Anti microbial drugs,Chinese patent medicines and digestive system drugs are the main drugs causing adverse reactions in children.Intravenous administration,oral administration and intramuscular injection were the main routes of ADR/E in children.The most involved drug formulation is injection.The top three involved systems/organs were skin and its appendages damage,systemic damage and digestive system damage.The main adverse reactions were recovery and improvement.There are 2936 new and serious ADR/E in the province,468 of them are serious ADR/E,the ratio of male to female is 1.38:1.The drugs involved are mainly anti microbial drugs,and cephalosporins are the most.Traditional Chinese medicine injection is the most new and serious ADR/E in children.Intravenous drip is the main way to cause new and serious ADR/E in children.The involved systems/organs were mainly damaged by skin and accessories and systemic damage.The cure or improvement rate of severe ADR/E reached 83.33%,and most of the children with severe ADR/E were better.By single factor analysis,we found that the difference between children’s serious ADR/E and general ADR/E was statistically significant(P < 0.05)in age,drug category,drug combination,previous ADR/E history,family ADR/E history,and previous history.The incidence of children’s serious ADR/E was statistically significant(P < 0.05)in drug category,drug combination,previous ADR/E history,and previous history.In the aspect of drug category,the use of biological products is more likely to cause serious ADR/E than proprietary Chinese medicine.In the aspect of drug combination,children with three drugs are more likely to have serious ADR/E than those with single drugs.Children with a previous ADR/E history and a previous history have a higher risk of serious ADR/E.Conclusion:We should strengthen the audit of ADR/E report,improve the quality of ADR/E report from the authenticity of ADR/E report,drug name and the standardization of ADR/E description.Focus on the safety of drug use and ADR/E monitoring in young children.To play the role of clinical pharmacists in children’s ADR/E monitoring.Strengthen the responsibility of the first person responsible for drug safety in drug manufacturing enterprises.Reduce intravenous administration of drugs to children,pay special attention to the monitoring of drug use in combination with cephalosporins,traditional Chinese medicine injections and biological products.Strengthen the monitoring of new and severe ADR/E in children.Pay attention to observe the function changes of skin and appendages.To reduce the occurrence of severe ADR/E,reduce the impact of severe ADR/E on children.