Analysis Of 545 Cases Of Adverse Drug Reactions/Events In Children In Qingdao And The Warning Of Risk Signals

Objective:Through the comprehensive analysis of 545 cases of adverse drug reactions(ADR)in children in Qingdao,to understand the characteristics and regularities of ADR in this population,find out the important factors leading to ADR in children,and carry out the study on the relationship between ADR and drugs in children,so as to guide rational drug use in clinic,provide basis for drug safety evaluation of drug administration,and ensure the safety of drug use in children.Methods:Descriptive study was used to analysis of 545 children's ADR reports(ADR report for children aged 0-14 years reported by Shibei District and Sifang District 2012.1.1-2015.12.30),investigate the source of reports and the profession of reporting personnel,the general situation of children,the general medication situation of children,the clinical manifestations of ADR and the systemic organs involved,the evaluation of adverse reactions,prognosis and impact of ADR.Statistical analysis was made on the irrational drug use and carried out on the information concerning drug instructions for children in the report.The PRR,ROR and MHRA methods were used to data mining 545 ADR data of children.Results:1.Children under 6 years old were at high risk of ADR/ADE(72.48%);the most suspicious drugs involved were anti-infective drugs(63.21%);intravenous drip(82.14%)was the main mode of administration.Involving the system-apparatus,the main causes of ADR were skin and appendages damage,gastrointestinal system damage and systemic damage,accounting for 54.19%,17.73% and 4.76% respectively.Most ADRs occurred within 30 minutes(39.63%).2.79 cases(14.50%)of new or severe ADR/ADE were reported,with a ratio of 9.91%;children under 6 years old were the high-risk population of new and severe ADR/ADE(68.36%);intravenous drip was the most common way of administration(69.62%).Anti-infective drugs?anti-cancer drugs and central nervous system drugs were mainly used,accounting for 35.44%,18.99% and 12.66% respectively.New and severe ADR/ADE occurred in 3 days(68.35%).Most of the system and organs involved were skin and its appendages damage,systemic damage and gastrointestinal system damage,accounting for 22.33%,14.56% and 10.68% respectively.Most of the combined drugs were 1-2.3.Irrational drug use accounts for 24.03% of the total reports,it includs 6 aspects,the unsuitable usage was the most,accounting for 76.47%.The irrational use of anti-infective drugs accounts for 81.40% of the unreasonable drug use in drug category distribution.77 kinds of medicines were involved in the lack of children's application information in the manual,accounting for 51.68% of the total number of medicines involved.Most of them were anti-infective drugs and neurological drugs,14 kinds each.Among the 77 kinds of children's application information missing in the manual,without any information about children's drug use is the most common.4.The PRR method can detect up to 30 suspicious signals in the 3 data mining methods.The suspicious signals detected by ROR method and MHRA method can be detected in PRR method.There are 13 combinations of suspicious signals detected by the three methods.Reduning-shivering,Reduning-fever and Liposoluble Vitamins(I)-breathing obstruction were the new suspicious risk signals not included in the instructions.After the publication of this study,CFDA revised the instructions to increase the risk signals of fat-soluble vitamins(I)-cyanosis and fat-soluble vitamins(I)-flushing to adverse reactions.Conclusion:1.Medical staff should focus on monitoring adverse drug reactions in children under 6 years of age and within 30 minutes of medication.The high rate of ADR in intravenous drip suggests that intravenous drugs should be used cautiously in clinic.2.The serious ADR/ADE reporting rate is low,and the combined medication should not be ignored.3.Irrational use of drugs in children and lack of information on drug use in children are important factors leading to ADR in children.4.Reduning-shivering,Reduning-fever,fat-soluble vitamins(I)-breathing obstruction should be taken seriously as suspicious risk signals;All three methods can be used to detect ADR signals in children,the 3 methods can be synthetically applied in order to achieve the purpose of comprehensiveness and accuracy of evaluation.