儿科患者中药物的超说明书使用是药物不良反应的危险因素吗？在一家印度三级护理医院进行的前瞻性研究。

Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital.

作者信息

Saiyed Mohd Masnoon, Lalwani Tarachand, Rana Devang

机构信息

Department of Pharmacology and Clinical Pharmacy, K.B Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India.

Department of Pharmacology, Smt. N.H.L Municipal Medical College, Seth V.S General Hospital, Ellisbridge, Ahmedabad, Gujarat, India.

出版信息

Int J Risk Saf Med. 2015;27(1):45-53. doi: 10.3233/JRS-150642.

DOI:10.3233/JRS-150642

PMID:25766066

Abstract

BACKGROUND

The lack of specific medicines and labeling recommendations for the pediatric population is a long-standing problem. Using data from an observational study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that off-label status is a risk factor for ADRs.

METHODS

A prospective intensive surveillance was conducted at a pediatric ward of a public teaching hospital. Adverse events to labeled and off-label use were assessed for incidence, severity and predictors. A multivariate Cox proportional hazards regression model used to assess off-label use is a risk factor for ADR occurring.

RESULTS

Off-label and labeled use were responsible for 34 (67%) and 17 (33%) ADRs respectively. Medicines which lacked complete pediatric labeling had the greatest odds for ADRs (9.21% of medicines in this category were implicated, OR 2.84 (95% CI 1.37-7.09). Number of off-label medicines given to patient significantly increased the hazard of an ADR (hazard ratio (HR) 1.28, 95% CI 0.43-3.78, P = 0.002). Number of medicines given also significantly increased the hazard (HR 1.2, 95% CI 0.80-1.71, P < 0.001).

CONCLUSIONS

Use of off-label medicines were more likely to be implicated in an ADR than labeled medicines. This off-label use would be acceptable if evidence of potential benefits outweighs ADRs risk.

摘要

背景

缺乏针对儿科人群的特定药物及标签建议是一个长期存在的问题。我们利用一项关于儿科住院患者药物不良反应（ADR）的观察性研究数据，旨在检验标签外用药是ADR的一个风险因素这一假设。

方法

在一家公立教学医院的儿科病房进行前瞻性强化监测。评估标签用药和标签外用药的不良事件的发生率、严重程度及预测因素。使用多变量Cox比例风险回归模型评估标签外用药是否为ADR发生的风险因素。

结果

标签外用药和标签用药分别导致了34例（67%）和17例（33%）ADR。缺乏完整儿科标签的药物发生ADR的几率最高（此类药物中有9.21%涉及ADR，比值比（OR）为2.84（95%置信区间1.37 - 7.09））。给予患者的标签外用药数量显著增加了ADR的风险（风险比（HR）为1.28，95%置信区间0.43 - 3.78，P = 0.002）。用药数量也显著增加了风险（HR为1.2，95%置信区间0.80 - 1.71，P < 0.001）。