The Application Status Of Global Trigger Tool(GTT) In Children's Adverse Drug Events

Adverse Drug Reactions/Adverse Drug Events monitoring is an important measure to improve the level of safe drug use and ensure the safety of public drug use.At present,the commonly used ADE monitoring methods at home and abroad are voluntary reports and medical record review methods are all passive monitoring afterwards.Judging the ADR/ADE trend has a lag,this limitation has resulted in a considerable number of ADEs failing to generate sufficient warnings.Some studies have shown that the potential incidence of ADE in hospitalized children is about three times that of adult hospitalized patients,but only 9.9%of children who have voluntarily reported ADR/ADE voluntarily reported in China,suggesting that children ADR/ADE should receive more attention.Medical institutions need a more effective method to identify adverse events that may cause medical harm to patients in order to quantify the severity of possible harm,and through this method to minimize the occurrence of medical-related adverse events.The global trigger tool(GTT)is an active monitoring tool for medical-related adverse events launched by the Institute for Healthcare Improvement(IHI).It has obvious active attributes compared with current monitoring methods.Over the past 10 years,GTT has been widely used at home and abroad,and a number of studies believe that it has high detection efficiency.Although GTT has been applied to adult ADE detection in China,its application in children is still rare.This study established a child ADE detection trigger based on the original GTT trigger,and applicable to local medical institutions to verified its effectiveness.Fristly,develop a pediatric trigger tool to identify adverse drug events(ADE)based on global trigger tool(GTT).METHODS Three steps were used to developthe tool,including literature review,information access and expert survey.Firstly,the databases of PubMed and CNKI were searched from January 1996 to November 2016to collect the literatures about pediatric ADE and the triggers of were screening.Then,the special guides and database of National adverse drug reaction monitoring system were checked to correct and complement the triggers.Finally,expert survey was conducted by using Delphi method.The pediatric clinicians and clinical pharmacists issued expert questionnaires to revise the triggers.RESULTS Totally 11 effective literatures were included,and 78 pediatric triggers were got from preliminary screening.After inductive arrangement and amendments,33 triggers were developed.Expert survey was conducted 2 rounds.In the first round,101 effective questionnaire were returned,and the recovery rate was 91.8%.There were 42(41.6%)experts maing amendment(fix 29 triggers,delete 1 trigger,and add 1 trigger).The M_j of experts'opinions was 3.952±0.669,K_j was 0.967±0.165,V_j was 0.0688±0.0338 and w was 0.537,P<0.001.In the second round,99 effective questionnaire were returned,and the recovery rate was 982%.There were 3 experts making amendment(fix 2 triggers).The M_j was 3.998±0.009,K_j was 0.998±0.004,V_j was 0.0025±0.0104 and w was 0.683,P<0.001.Triggers for pediatric ADE were developed including 16 laboratory test indicators,13 therapeutic drugs using and 4 clinical manifestations.Then,verify its effectiveness.METHODS:A random sample of 200 inpatient children's medical records was performed,and a component medical record review team conducted a retrospective analysis.The trigger frequency(?),positive predictive value(PPV),ADE detection rate,causality grade of ADE and related drugs,and ADE injury level were analyzed.Results:The average age of 200 patients was 6.04 years old(Med5),the average length of stay was 10.45 days(Med 58);the number of diagnosed diseases in each child was average of 1.58 species;the most common diagnoses are pneumonia,leukemia,cardiovascular,tonsillitis,and bronchitis.128 patients had a positive trigger and the?was 64%,gamma was 64%(95%CI 57%~71%),the PPV is28.42%(95%CI24%~33%),and there are 10 triggers PPV?50%.Inpatients had an ADE rate of 20.5%(95%CI 14.9%~26.1%),ADEs/100 patients 49(95%CI 42.1~55.9),and ADEs/1000 patients 46.89(95%CI 37.8~56.0).Through comparative analysis,the ADE detection rate is significantly higher than the ADE reported by the voluntary reporting system.The??PPV value,and ADE detection rate are higher than the results of multiple previous GTT-based child ADE triggers.ADE causality judgments,62.24%is certain,27.51%is probable,8.16%is possible,1.02%is unclassifiable,1.02%is unassessable.The ADE's severity level,39.80%for Level 1,56.12%for Level 2,4.08%for Level 3,and no level 4 or level 5.A total of 52 drugs involved in ADE were detected.The frequency of anti-tumor drugs was the highest(44.06%)followed by antibacterials(23.78%).Conclusion:The children's ADE triggers established in this study are well-designed and have been verified to be effective in detecting ADEs.The results of this study can be used as a GTT for children in medical institutions in China.The actual application in ADE monitoring provides the basis and reference.