Off-Label Medication Use in the Inpatient Palliative Care Unit
Off-Label Medication Use in the Inpatient Palliative Care Unit
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DOI：
10.1016/j.jpainsymman.2017.03.014
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发表时间：
2017-07-01
影响因子：
4.7
通讯作者：
Hui, David
中科院分区：
文献类型：
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作者：
Kwon, Jung Hye;Kim, Min Ji;Hui, David
上下文尽管在姑息治疗中经常使用标签外药物，但在《美国目标》中还没有发表研究检查其使用情况。我们调查了急性姑息治疗病房（APCU）的癌症患者超说明书用药的频率。这项前瞻性观察性研究招募了一家三级癌症中心的APCU收治的连续晚期癌症患者。我们收集了从入院到出院的所有处方事件的数据，包括使用适应症。根据美国食品和药物管理局批准的适应症检查标签外使用。在201例患者中，中位生存期为10天（95%CI 7-13），85例（42%）患者在APCU中死亡。我们记录了6276例处方事件，2199例（35%）为标签外使用。在标签外处方中，最常开具的是中枢神经系统药物（n = 1606，73%）、激素和合成替代品（n = 302，14%）和自主神经药物（n = 183，8%）。氟哌啶醇（n = 720，33%）、氯丙嗪（n = 292，13%）、地塞米松（n = 280，13%）、格隆溴铵（n = 175，8%）、氢吗啡酮（n = 161，7%）和吗啡（n = 156，7%）是最常见的标签外处方。超说明书处方的最常见适应症为谵妄（n = 783，36%）和呼吸困难（n = 449，20%）。70%的超说明书处方事件有强有力的证据支持使用，19%的处方事件有中度或弱证据支持使用。APCU中三分之一的处方事件为标签外用药，大多数标签外用药具有强有力的支持性证据。我们的发现强调了在谵妄和呼吸困难管理等关键领域进行更多研究的必要性。(C)2017年美国临终关怀和姑息医学学会。爱思唯尔公司出版All rights reserved.
Context. Although off-label medications are frequently prescribed in palliative care, there are no published studies examining their use in the U.S.Objectives. We examined the frequency of off-label medication use in cancer patients admitted to an acute palliative care unit (APCU).Methods. This prospective observational study enrolled consecutive patients with advanced cancer admitted to the APCU of a tertiary care cancer center. We collected data on all prescription events, including indications for use, from admission to discharge. Off-label use was checked against the U.S. Food and Drug Administration-approved indications.Results. Among the 201 patients, median survival was 10 days (95% CI 7-13), and 85 (42%) patients died in the APCU. We documented 6276 prescription events, and 2199 (35%) were off-label. Among off-label prescriptions, central nervous system agents (n = 1606, 73%), hormones and synthetic substitutes (n = 302, 14%), and autonomic drugs (n = 183, 8%) were most commonly prescribed. Haloperidol (n = 720, 33%), chlorpromazine (n = 292, 13%), dexamethasone (n = 280, 13%), glycopyrrolate (n = 175, 8%), hydromorphone (n = 161, 7%), and morphine (n = 156, 7%) were most frequently prescribed off-label. The most common indications for off-label prescribing were delirium (n = 783, 36%) and dyspnea (n = 449, 20%). Seventy percent of all off-label prescription events had strong evidence supporting use, and 19% of prescription events had moderate or weak evidence for use.Conclusion. One-third of prescription events in the APCU were off-label, with majority of off-label use having a strong level of supporting evidence. Our findings highlight the need for more research in key areas such as delirium and dyspnea management. (C) 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.