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三级医院中开处方医生对药品未按说明书用药的认知与理解

Knowledge and perception of off-label drug use amongst prescribing physicians in a tertiary care hospital.

作者信息

Kannan S, Bahl A, Khosla P P

机构信息

Department of Health Sciences, College of Medicine, Nursing and Health Sciences, Fiji National University, Suva, Fiji.

Department of Phamacology, Subharti Medical College and Hospital, Meerut, Uttar Pradesh, India.

出版信息

Int J Risk Saf Med. 2015;27(4):219-23. doi: 10.3233/JRS-150664.

Abstract

INTRODUCTION

Off-label drug use is commonly reported in various disciplines of medicine. Considering the lacunae of studies from prescribers in the Indian subcontinent, the present study was conducted to explore their awareness and views of off-label drug use.

METHODS

A validated questionnaire was administered to interns, junior residents and faculty members who were recruited in the present study of various medical and surgical departments of Subharti Medical College, Meerut, India, a tertiary care teaching hospital. Descriptive statistics was used for analyzing the data.

RESULTS

A total of 59/85 (69%) stated that they have used a drug in an off-label manner mainly [31/85 (36.5%)] related to indications. Nearly half of the study participants (41/85, 48.2%) considered prescribing an off-label drug illegal and only 25/85 (29.3%) participants felt that they had adequate knowledge regarding the use of drugs in off-label manner. Out of the total 70 participants who answered the question related to informing parents/relatives while prescribing an off label drug, only 39/70 (55.7%) answered affirmative. Out of the remaining 31/70 (44.3%) of participants who did not inform about prescribing an off label drug, 9/31 (29%) felt that it was illegal and more than two-third (24/31, 77%) felt their knowledge on off-label drug use was insufficient. Surprisingly, 74/82 (90.2%) participants felt that a drug approved to be used in adults cannot be used in children for the same indication despite not having any alternative in pediatric age group.

CONCLUSION

We found an inadequate knowledge regarding the off-label drug use amongst the prescribers in a tertiary care medical college hospital. Many of the physicians felt such use as illegal and do not inform the patient's relatives about such acts. Considering the legal issues, clearly there exists a need to patch up this lacuna in developing countries like India.

摘要

引言

在医学的各个学科中,超说明书用药的情况屡见不鲜。鉴于印度次大陆开处方者相关研究的空白,本研究旨在探讨他们对超说明书用药的认识和看法。

方法

向印度密鲁特市苏尔哈蒂医学院(一家三级医疗教学医院)各个内科和外科部门参与本研究的实习生、初级住院医生和教员发放一份经过验证的问卷。采用描述性统计方法分析数据。

结果

共有59/85(69%)的人表示他们曾以超说明书的方式使用过药物,主要是[31/85(36.5%)]与适应证有关。近一半的研究参与者(41/85,48.2%)认为开具超说明书药物是违法的,只有25/85(29.3%)的参与者觉得他们对超说明书用药有足够的了解。在总共70名回答了关于在开具超说明书药物时是否告知父母/亲属这一问题的参与者中,只有39/70(55.7%)回答是肯定的。在其余31/70(44.3%)未告知开具超说明书药物情况的参与者中,9/31(29%)认为这是违法的,超过三分之二(24/31,77%)觉得他们对超说明书用药的知识不足。令人惊讶的是,74/82(90.2%)的参与者认为,尽管在儿童年龄组没有其他替代药物,但已批准用于成人的药物不能用于儿童相同的适应证。

结论

我们发现,在一家三级医疗医学院附属医院的开处方者中,对超说明书用药的了解不足。许多医生认为这种用药方式是违法的,并且不将此类行为告知患者亲属。考虑到法律问题,在印度这样的发展中国家显然有必要弥补这一空白。

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