Investigation and Analysis of Off-label Drug Use in a Third Grade Class A Hospital during 2015-2016 / 中国药房

ABSTRACT

OBJECTIVE:To control the risk of off-label drug use,and to provide reference for rational drug use. METHODS:Outpatient prescriptions were selected by stratified equal proportion sampling method from a third grade class A hospital during Jun. 2015-Jun. 2016. According to the latest edition of drug instruction issued by CFDA,the off-label prescriptions were screened and analyzed statistically. According to Micromedex tools and literatures report,guidelines,off-label drug use and related severe ADR were analyzed. RESULTS:Of 3 025 outpatient prescriptions,11.2% of prescriptions(339 pieces)were considered as off-label prescriptions,including without indication(88.7%),over dose(6.0%),beyond route of administration(3.2%)and beyond adapt-to-the-crowd(2.1%). Gastroesophagedal reflux was the main diagosis(16.0%). 1.5% of off-label drug use were supported by FDA-approved labels,83.8% of them were supported by international and national guidelines,12.4% of them were supported by expert consensus,and 2.4% of them were supported by other literature report. Thirteen items of off-label drug use had been included in Micromedex,recommendation grade and evidence intensity of which varied. Eight drugs of off-label drug use were reported to result in serious ADR. CONCLUSIONS:All off-label drug use in outpatient department of this hospital is supported by evidence-based medical evidence. But the quality of evidence varies. In the practice,physicians and pharmacists should balance the benefit and risk of off-labed drug use carefully.