Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital
Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital
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DOI：
10.1186/1741-7015-11-238
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发表时间：
2013-11-07
期刊：
影响因子：
9.3
通讯作者：
Pirmohamed, Munir
中科院分区：
文献类型：
--
作者：
Bellis, Jennifer R.;Kirkham, Jamie J.;Pirmohamed, Munir
背景：标签外和无证（OLUL）处方在儿科实践中很普遍。使用的数据从一个前瞻性队列研究的药物不良反应（ADR）在儿科住院患者，我们的目的是测试的假设，OLUL状态是一个危险因素ADRs.Methods：一个嵌套的病例对照研究进行了前瞻性队列研究。记录所有给药的详细信息，包括OLUL状态的信息。计算OLUL药物与可能或确定的ADR相关的比值比。一个多变量考克斯比例风险回归模型拟合的数据，以评估的影响，OLUL药物的使用对ADR发生的危害。与授权药物相比，OLUL药物涉及ADR的比值比（OR）为2.25（95%置信区间（CI）1.95至2.59）。许可用于儿童但给予低于最低年龄或体重的儿童的药物涉及ADR的可能性最大（该类别中19%的疗程涉及ADR，OR 3.54（95% CI 2.82至4.44））。每增加一种OLUL药物，ADR的危险性显著增加（危险比（HR）1.395%CI 1.2 - 1.3，P < 0.001）。每增加一种授权药物也会显著增加其危险性（HR 1.295% CI 1.2 ~ 1.3，P < 0.001）。结论：口服降糖药比授权药物更易发生ADR。给药的药物数量是ADR的一个风险因素，强调需要在最短时间内以最低剂量使用最少数量的药物，处方医生应持续保持警惕，以降低ADR的风险。
Background: Off-label and unlicensed (OLUL) prescribing has been prevalent in pediatric practice. Using data from a prospective cohort study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that OLUL status is a risk factor for ADRs.Methods: A nested case-control study was conducted within a prospective cohort study. Details of all medicines administered were recorded, including information about OLUL status. The odds ratio for OLUL medicines being implicated in a probable or definite ADR was calculated. A multivariate Cox proportional hazards regression model was fitted to the data to assess the influence that OLUL medicine use had on the hazard of an ADR occurring.Results: A total of 10,699 medicine courses were administered to 1,388 patients. The odds ratio (OR) of an OLUL medicine being implicated in an ADR compared with an authorized medicine was 2.25 (95% confidence interval (CI) 1.95 to 2.59). Medicines licensed in children but given to a child below the minimum age or weight had the greatest odds of being implicated in an ADR (19% of courses in this category were implicated, OR 3.54 (95% CI 2.82 to 4.44). Each additional OLUL medicine given significantly increased the hazard of an ADR (hazard ratio (HR) 1.3 95% CI 1.2 to 1.3, P < 0.001). Each additional authorized medicine given also significantly increased the hazard (HR 1.2 95% CI 1.2 to 1.3, P < 0.001).Conclusions: OLUL medicines are more likely to be implicated in an ADR than authorized medicines. The number of medicines administered is a risk factor for ADRs highlighting the need to use the lowest number of medicines, at the lowest dose for the shortest period, with continual vigilance by prescribers, in order to reduce the risk of ADRs.