Investigation and Analysis of Off-label Drug Use in a Third Grade Class A Hospital during 2015-2016
10.6039/j.issn.1001-0408.2017.29.09
- VernacularTitle:某"三甲"医院2015-2016年超说明书用药调查分析
- Author:
Cuicui ZHANG
1
;
Lei ZHANG
;
Jin LU
Author Information
1. 中日友好医院药学部
- Keywords:
Off-label drug use;
ADR;
Risk
- From:
China Pharmacy
2017;28(29):4065-4068
- CountryChina
- Language:Chinese
-
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.
