Discipline, Palliative & Supportive Services, Flinders University, Adelaide, Australia.
Palliat Med. 2013 Apr;27(4):320-8. doi: 10.1177/0269216312464263. Epub 2012 Nov 5.
Regulatory bodies including the European Medicines Agency register medications (formulation, route of administration) for specific clinical indications. Once registered, prescription is at clinicians' discretion. Off-label use is beyond the registered use. While off-label prescribing may, at times, be appropriate, efficacy and toxicity data are often lacking.
The aim of this study was to document off-label use policies (including disclosure and consent) in Australian palliative care units and current practices by palliative care clinicians.
A national, cross-sectional survey was conducted online following an invitation letter. The survey asked clinicians their most frequent off-label medication/indication dyads and unit policies. Dyads were classified into unregistered, off-label and on-label, and for the latter, whether medications were nationally subsidised.
SETTING/PARTICIPANTS: All Australian palliative medicine Fellows and advanced trainees.
Overall, 105 clinicians responded (53% response rate). The majority did not have policies on off-label medications, and documented consent rarely. In all, 236 medication/indication dyads for 36 medications were noted: 45 dyads (19%) were for two unregistered medications, 118 dyads (50%) were for 26 off-label medications and 73 dyads (31%) were for 12 on-label medications.
Off-label prescribing with its clinical, legal and ethical implications is common yet poorly recognised by clinicians. A distinction needs to be made between where quality evidence exists but registration has not been updated by the pharmaceutical sponsor and the evidence has not been generated. Further research is required to quantify any iatrogenic harm from off-label prescribing in palliative care.
包括欧洲药品管理局在内的监管机构会对特定临床适应证的药物（制剂、给药途径）进行注册。一经注册，处方权便由临床医生掌握。超适应证用药是指超出已注册适应证的用药。虽然超适应证用药有时可能是合适的，但往往缺乏疗效和毒性数据。
本研究旨在记录澳大利亚姑息治疗病房的超适应证用药政策（包括披露和同意），以及姑息治疗临床医生的当前实践。
在一封邀请信发出后，我们进行了一项全国性的、横断面的在线调查。该调查询问了临床医生他们最常使用的超适应证药物/适应证对，以及病房的政策。将药物对分为未注册、超适应证和适应证，并对后者，是否有药物获得国家补贴。
地点/参与者：所有澳大利亚姑息医学研究员和高级培训生。
共有 105 名临床医生（53%的回应率）做出了回应。大多数病房没有超适应证药物政策，且很少有书面同意。总共记录了 36 种药物的 236 种药物/适应证对：45 对（19%）是两种未注册药物，118 对（50%）是 26 种超适应证药物，73 对（31%）是 12 种适应证药物。
超适应证用药及其带来的临床、法律和伦理影响很常见，但临床医生对此认识不足。需要区分存在质量证据但药品赞助商尚未更新注册信息与尚未生成证据这两种情况。需要进一步研究来量化姑息治疗中超适应证用药带来的任何医源性危害。
