Background: The information about the use of off-labeldrugs in pediatric nephrology is still lacking, which leadsto increased adverse reactions and medical disputes. Weretrospectively analyzed the use of off-label dru...Background: The information about the use of off-labeldrugs in pediatric nephrology is still lacking, which leadsto increased adverse reactions and medical disputes. Weretrospectively analyzed the use of off-label drugs in thein-patient ward of the nephrology department of NanjingChildren's Hospital, China in order to provide morecomplete information about the use of drugs for children.Methods: Proportional stratified random samplingwas applied to select patients with renal diseases aged 1month to 18 years, who were admitted to the hospital fromOctober 1, 2012 to September 30, 2013. All nephrologyrelateddrugs prescribed in the hospitalization period andtake-home drugs prescribed on discharge were recordedand evaluated as off-label drugs or not from threedifferent perspectives: person-time, prescription, anddrug category.Results: From 385 person-times of patients with 1424prescriptions, according to the ratio between off-labeldrugs and person-times, drug prescriptions, and drugproducts, the rates of off-label drugs were 40.78%, 16.64%,and 31.43%, respectively. Low-molecular-weight heparin,alfacalcidol and diltiazem were the most commonly usedoff-label drugs. Infants and younger children were thehigh-risk population of off-label drug use. The high rateoff-label nephrology-related drug use in children wasmainly related to lacking clinical research into drugs inchildren and the pace of drug label's revision, which cannotfollow the development of medical science.Conclusions: Approximaely half of pediatric patientswith renal diseases are usually prescribed with off-labelnephrology-related drugs. Analyzing the off-label conditionsfrom different perspectives may lead to various results.More clinical research into drugs for infants and youngerchildren is needed so as to update drug descriptions.展开更多
基金supported by a grant from the Jiangsu Provincial Special Program of Medical Science(BL2014007).
文摘Background: The information about the use of off-labeldrugs in pediatric nephrology is still lacking, which leadsto increased adverse reactions and medical disputes. Weretrospectively analyzed the use of off-label drugs in thein-patient ward of the nephrology department of NanjingChildren's Hospital, China in order to provide morecomplete information about the use of drugs for children.Methods: Proportional stratified random samplingwas applied to select patients with renal diseases aged 1month to 18 years, who were admitted to the hospital fromOctober 1, 2012 to September 30, 2013. All nephrologyrelateddrugs prescribed in the hospitalization period andtake-home drugs prescribed on discharge were recordedand evaluated as off-label drugs or not from threedifferent perspectives: person-time, prescription, anddrug category.Results: From 385 person-times of patients with 1424prescriptions, according to the ratio between off-labeldrugs and person-times, drug prescriptions, and drugproducts, the rates of off-label drugs were 40.78%, 16.64%,and 31.43%, respectively. Low-molecular-weight heparin,alfacalcidol and diltiazem were the most commonly usedoff-label drugs. Infants and younger children were thehigh-risk population of off-label drug use. The high rateoff-label nephrology-related drug use in children wasmainly related to lacking clinical research into drugs inchildren and the pace of drug label's revision, which cannotfollow the development of medical science.Conclusions: Approximaely half of pediatric patientswith renal diseases are usually prescribed with off-labelnephrology-related drugs. Analyzing the off-label conditionsfrom different perspectives may lead to various results.More clinical research into drugs for infants and youngerchildren is needed so as to update drug descriptions.
