Department of Clinical Gerontology, Kings Health Partners Academic Health Science Centre, London, UK.
Drugs Aging. 2012 Jun 1;29(6):427-34. doi: 10.2165/11633520-000000000-00000.
The practice of off-label prescribing, i.e. prescribing drugs either for unregistered/unapproved therapeutic indications and age groups or using unregistered/unapproved doses or methods of administration, is common in older patients. This may be due to the poor representation of this group in pre-marketing clinical trials assessing therapeutic efficacy and safety of novel therapies or merely to the fact that trials in a particular indication have not been undertaken. Off-label prescribing should not be viewed as scientifically or ethically unsound when there are good clinical data to support a particular therapeutic indication. However, a number of steps should be followed in order to ensure therapeutic efficacy, reducing, at the same time, the risk of adverse drug reactions and/or medical litigation. This article discusses the current epidemiology and trends in off-label prescribing in older patients, the scientific and ethical justification of this practice, medico-legal implications, and proposed strategies for risk mitigation.
在老年患者中，标签外用药（即针对未注册/未批准的治疗适应症和年龄组开处方药物，或使用未注册/未批准的剂量或给药方法）的做法很常见。这可能是由于该人群在评估新型疗法的治疗效果和安全性的上市前临床试验中代表性不足，或者仅仅是因为在特定适应症中没有进行试验。当有充分的临床数据支持特定治疗适应症时，标签外用药不应被视为在科学或伦理上不合理。然而，为了确保治疗效果，同时降低不良反应和/或医疗诉讼的风险，应该遵循一些步骤。本文讨论了老年患者中标签外用药的当前流行病学和趋势、这种做法的科学和伦理依据、医学法律影响以及提出的风险缓解策略。
