儿童的无执照和超说明书用药：医生面临诉讼风险。
Off licence and off label prescribing in children: litigation fears for physicians.
作者信息
Hill P
机构信息
Great Ormond Street Hospital for Children, Great Ormond Street, London WC1N 3JH, UK.
出版信息
Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i17-8. doi: 10.1136/adc.2004.058867.
Abstract
So-called "off label" and unlicensed prescribing refers to the use of medicines outside of the indications for which they are licensed by national regulatory bodies. Off label prescribing is quite common in children, as most drugs are developed only on the basis of trials with adults. Nevertheless, physicians and hospitals can be wary of using medicines in this way for fear of litigation if adverse events occur. Given this unsatisfactory state of affairs, regulatory bodies are beginning to request robust data from pharmaceutical companies with regard to the use of their products in children. In the meantime, off label prescribing remains acceptable if there is no suitable alternative and physicians are confident that they are using agents in accordance with the body of respected medical opinion.
摘要
所谓“超说明书用药”和未获许可的处方是指在国家监管机构批准的适应症范围之外使用药物。超说明书用药在儿童中相当常见，因为大多数药物仅在成人试验的基础上开发。然而，如果发生不良事件，医生和医院可能会因担心诉讼而对以这种方式使用药物持谨慎态度。鉴于这种不尽人意的状况，监管机构开始要求制药公司提供有关其产品在儿童中使用的可靠数据。与此同时，如果没有合适的替代药物，并且医生确信他们是根据受尊重的医学意见使用药物，那么超说明书用药仍然是可以接受的。
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