Study On Methods Of Adverse Drug Reaction Monitoring In Pediatric Systems

Objective:A retrospective analysis of adverse drug reactions in children in Shandong Province and an exploratory study of methods for monitoring adverse drug reactions(ADR)in pediatric systems were conducted,The purpose is to establish a set of children ADR monitoring methods suitable for medical institutions,which are powerful,repeatable and widely used,and form a standardized path for children ADR monitoring.Secondly,by raising the awareness of medical personnel about ADR and conducting research on ADR monitoring methods for children,the rate of reporting and accuracy of ADR in children will be improved,and the rate of underreporting will be reduced.Accelerate the speed of ADR identification,judgment,evaluation and correct disposal to meet the safety needs of patients and provide reference for hospital medical decision adjustment.Methods:1.Analysis of 15,727 ADR reports for children collected from Shandong ADR database in 2017,screened for high-risk drugs,high-risk groups,and follow-up orders for children's ADR.2.Designed the Children's ADR Monitoring Path and Relevant Questionnaire Forms,the questionnaire star system of Changsha Ran Xing Information Technology Co.,Ltd.was used to investigate and analyze the ADR awareness of medical staff in Qingdao Women's and Children's Hospital.3.According to the basic conditions of the patients,the basic conditions of adverse reactions,and the basic conditions of the parties and the reporters,the forms for ADR reports were designed according to the needs of the actual work,with the help of the Information Section,and the platform for reporting and monitoring ADR was established.Results:1.In 15727 children's ADR reports,9580 cases(60.86%)were male and 6147(39.05%)were female,and the ratio of male to female was 1.56:1.The original disease was mainly respiratory diseases,with 11172 cases(71.04%),followed by 823 cases of gastrointestinal disease(5.23%),625 cases(3.97%)for vaccination.There were 6,699 injection cases(42.60 %),6179 powder injection cases(39.29%),725 particles(4.61 %),and 450 tablets(2.86 %)in the drug dosage form and route that caused ADR.Among them,ADR was mainly caused by intravenous drip in children with a total of 11650 cases(74.08%),followed by oral administration of 2508 cases(15.95%).There were 17 types of drugs causing ADR,including 8913(56.67%)antibiotics,2418(15.09%)Chinese medicines and their extracts,731(4.65%)respiratory drugs,712(4.53%)biological products and 403(2.56%)antipyretic,analgesic and anti-inflammatory drugs.Among the top 20 drugs that caused ADR in children,the first one was caused by ceftriaxone sodium injection with 947 cases(6.02 %),followed by 656 cases of azithromycin for injection(4.17 %),and 608 cases(3.87 %)of Amoxicillin Sodium and Clavulanate Potassium for Injection.580 cases(3.69 %)of erythromycin lactate for injection,555(3.53 %)of azithromycin lactate for injection,526 cases(3.34 %)of Reduning injections injection.There were 5492(34.92 %)children with rash,1345(8.55 %)with nausea,914(5.81 %)with diarrhea,856(5.44 %)with abdominal pain,640(4.07 %)with itching,and 597(3.80 %)with vomiting.In addition,there were 563 cases(3.58 %),557 cases(3.54 %),and 504 cases(3.20 %)of urticaria.2.A total of 422 valid responses were collected from this questionnaire including 66 were males(15.64%)and 356 were females(84.36%).Among them,172(40.76)questionnaires were answered by nurses,138(32.70%)were physicians,20.14(20.14%)were pharmacists,16(3.79%)were health technicians,and 11(2.61%)were health managers.A survey on the awareness of the main causes of ADR in children was conducted.It was considered that 125 people(29.62%)were improperly treated,and 112(26.54%)of ADRs were caused by drug quality,and 93 people(23.04%)were considered to be drug-toxic),59 people(13.98%)who thought that the drug contained impurities caused ADR,20 people(4.74%)who caused ADR by overdosing drugs,13 people(3.08%)who did not know the cause of ADR.19 people(4.5%)of medical staff were very confident for common ADR,while 205 people(48.58%)were sure,92 people(21.80%)were unclear,89 people(21.09%)were not quite sure,and 17 people(4.03%)were not sure.3.The adverse drug reaction report card included the basic situation of the patient and the basic situation of adverse reactions.Through filling in the ADR report card online,it is conducive to real-time reporting and processing of ADR in the hospital,improving the reporting quality of ADR reports,reducing the leakage rate,contributing to the sharing of data,preventing repeated ADR reports,and improving the report quality.It could speed up the identification,judgment,evaluation and correct disposal of ADR by medical personnel to promote the standardization,proceduralization and standardization process of ADR monitoring for children,and provide more real-time,accurate and rapid guidance for children's medication.Conclusion:Medical staff should strengthen the monitoring of drug use in children,especially the monitoring of antibacterial drugs,Chinese medicines and their extracts,and respiratory drugs.The State should formulate national standards and relevant regulations for the rational use of medicines in children,improve the instructions for the use of medicines,strengthen the training of medical personnel,enhance the ADR awareness of medical personnel,improve the cognitive ability of medical staff on children's ADR,and strengthen the education and publicity of knowledge related to children's safety medication,establish the system for monitoring ADR,and promote the rational use of drugs for children.