Gor Kunj Arun, Shah Kartik N, Joshi Pranav B, Joshi Harsh M, Rana Devang A, Malhotra Supriya D
Department of Pharmacology, Smt. NHL Municipal Medical College, Ahmedabad, Gujarat, India.
Department of Neurology, Seth V.S. Hospital, Ahmedabad, Gujarat, India.
Perspect Clin Res. 2020 Jan-Mar;11(1):31-36. doi: 10.4103/picr.PICR_117_18. Epub 2019 Apr 26.
Off-label drug use refers to any use of an approved or cleared drug that is not included in that product's approved labeling or cleared indications for use. It may be in terms of indication, age group, dosage, or route of administration. Off-label drug prescriptions are common neurology practice.
The aim of the study is to evaluate the prevalence pattern of off-label drug use in neurology.
A prospective, observational, cross-sectional study was carried out in the neurology outpatient department of tertiary care teaching hospital. Data of patients above 18 years were recorded after obtaining their informed consent. The National Formulary of India (NFI) and British National Formulary (BNF) guidelines were used as tools for evaluation of the prevalence of off-label drug use.
A total of 709 drugs were recorded from the prescription data of 205 patients collected in the duration of 2 months. The results reported 145 (20.45%) and 317 (44.71%) drugs as off-label as per the NFI and BNF, respectively. Prescriptions with minimum 1 off-label drug use were 78.05% - BNF and 46.83% - NFI. The indication was one of the most common causes of drugs being off-label. Out of the total 317 off-label drug uses reported, 84 were unlicensed drug use as per the BNF. There is strong and positive correlation established between the age of the patients, number of drugs prescribed, and total off-label drugs prescribed per patient in the given study. The most common off-label drug use noted was with clonazepam and amitriptyline.
Off-label prescriptions practice is common in the field of neurology.
药品未按说明书用药是指对已批准或已获批的药物进行的任何未包含在该产品批准标签或获批使用适应症中的使用。这可能涉及适应症、年龄组、剂量或给药途径。药品未按说明书用药的处方在神经病学实践中很常见。
本研究旨在评估神经病学中未按说明书用药的流行模式。
在一家三级护理教学医院的神经内科门诊进行了一项前瞻性、观察性横断面研究。在获得18岁以上患者的知情同意后记录其数据。印度国家处方集（NFI）和英国国家处方集（BNF）指南被用作评估未按说明书用药流行情况的工具。
在2个月的时间内收集了205名患者的处方数据，共记录了709种药物。结果显示，根据NFI和BNF，分别有145种（20.45%）和317种（44.71%）药物属于未按说明书用药。至少有1种未按说明书用药的处方比例分别为：BNF为78.05%，NFI为46.83%。适应症是药物未按说明书用药的最常见原因之一。在报告的317例未按说明书用药中，根据BNF，有84例为未获许可的药物使用。在本研究中，患者年龄、处方药物数量与每位患者未按说明书用药的总数之间存在强正相关。最常见的未按说明书用药是氯硝西泮和阿米替林。
未按说明书用药的处方在神经病学领域很常见。
