Analysis of Off-label Drug Use in 315 Outpatient Prescriptions
Li Lin
Abstract
Li Lin
Abstract
OBJECTIVE:To investigate off-label drug use in outpatient pharmacy of our hospital,and to promote rational drug use clinically. METHODS:During Jun. 2013,100 outpatient prescriptions were randomly collected every day;according to drug package inserts,the conformance of indication,intended population,drug dosage,DDDs,route of administration and the contraindication in the prescriptions to package inserts were compared,and those inconsistent with package inserts were regarded as off-label drug use. RESULTS:A total of 3 000 prescriptions were collected,accounting for 3.35% of all prescriptions in June. There were 315prescriptions of off-label drug use,accounting for 10.5% of included prescriptions;sorted by medication type,DDDs(57.5%),route of administration(26.7%)and intended population(6.7%)occupied the top 3 places in the list of off-label drug use;sorted by hospital department,the department of pediatric internal medicine(67.6%),dermatology department(14.9%)and otorhinolaryngology department(2.9%)occupied the top 3 places in the list of off-label use. Among them,85.7% off-label drug use was non-standard operation of medical staff;15.9% lacked of a large number of clinical data to support and evidence-based medicine;1.9% off-label drug use had multicenter and large-scale evidence-based medicine to support. CONCLUSIONS:Due to complex situation of off-label drug use,in order to protect the legitimate rights and interests of patients and hospital,improve medication safety,the hospital should build corresponding management system and normalize the off-label use program.
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OBJECTIVE:To investigate off-label drug use in outpatient pharmacy of our hospital,and to promote rational drug use clinically. METHODS:During Jun. 2013,100 outpatient prescriptions were randomly collected every day;according to drug package inserts,the conformance of indication,intended population,drug dosage,DDDs,route of administration and the contraindication in the prescriptions to package inserts were compared,and those inconsistent with package inserts were regarded as off-label drug use. RESULTS:A total of 3 000 prescriptions were collected,accounting for 3.35% of all prescriptions in June. There were 315prescriptions of off-label drug use,accounting for 10.5% of included prescriptions;sorted by medication type,DDDs(57.5%),route of administration(26.7%)and intended population(6.7%)occupied the top 3 places in the list of off-label drug use;sorted by hospital department,the department of pediatric internal medicine(67.6%),dermatology department(14.9%)and otorhinolaryngology department(2.9%)occupied the top 3 places in the list of off-label use. Among them,85.7% off-label drug use was non-standard operation of medical staff;15.9% lacked of a large number of clinical data to support and evidence-based medicine;1.9% off-label drug use had multicenter and large-scale evidence-based medicine to support. CONCLUSIONS:Due to complex situation of off-label drug use,in order to protect the legitimate rights and interests of patients and hospital,improve medication safety,the hospital should build corresponding management system and normalize the off-label use program.
Key concepts: Medicine, Medical prescription, Off-label use, Contraindication, Drug, Pharmacy, Drug Utilization Review, Outpatient clinic