Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015
Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015
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DOI：
10.1542/peds.2019-0896
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发表时间：
2019-10-01
期刊：
影响因子：
8
通讯作者：
Horton, Daniel B.
中科院分区：
文献类型：
--
作者：
Hoon, Divya;Taylor, Matthew T.;Horton, Daniel B.
背景：儿童超说明书用药很常见，而且有潜在危害。在大多数先前的标签外使用研究中，作者研究了住院儿童、特定药物类别或非美国环境。我们对美国流动环境中儿童的超说明书全身用药订单的频率、趋势和原因进行了分析。方法：利用对诊所医生进行的全国代表性调查（全国门诊医疗调查，2006-2015），我们研究了年龄 = 1 种超说明书全身药物的儿童的超说明书用药订单，其就诊率为 18.5%（95% 置信区间：17.7%-19.3%），通常（74.6%）是因为未经批准的情况。超说明书订购在新生儿中最常见（83%），在青少年中绝对常见（1000 次就诊中有 322 次订购）。标签外用药与女性、专科医生、多药治疗和慢性病有关。标签外订单的比例和原因因年龄而异。标签外订单的相对和绝对率随着时间的推移而上升。在常见类别中，抗组胺药和几种精神药物的超说明书订单随着时间的推移而增加，而几类抗生素的超说明书订单则稳定或下降。结论：尽管最近努力增加儿童的证据和药物批准，但美国诊所的医生还是以越来越高的比例为儿童订购了超适应症全身药物，最常见的是针对未经批准的病症。这些发现可以帮助为有关儿童有效、安全使用药物的教育、研究和政策提供信息。在这项研究中，我们使用 2006 年至 2015 年全国代表性的调查数据，研究了美国门诊儿童的标签外全身用药订单模式。
BACKGROUND: Off-label drug use in children is common and potentially harmful. In most previous off-label use research, authors studied hospitalized children, specific drug classes, or non-US settings. We characterized frequencies, trends, and reasons for off-label systemic drug orders for children in ambulatory US settings. METHODS: Using nationally representative surveys of office-based physicians (National Ambulatory Medical Care Surveys, 2006-2015), we studied off-label orders of systemic drugs for children age = 1 off-label systemic drug at 18.5% (95% confidence interval: 17.7%-19.3%) of visits, usually (74.6%) because of unapproved conditions. Off-label ordering was most common proportionally in neonates (83%) and in absolute terms among adolescents (322 orders out of 1000 visits). Off-label ordering was associated with female sex, subspecialists, polypharmacy, and chronic conditions. Rates and reasons for off-label orders varied considerably by age. Relative and absolute rates of off-label orders rose over time. Among common classes, off-label orders for antihistamines and several psychotropics increased over time, whereas off-label orders for several classes of antibiotics were stable or declined. CONCLUSIONS: US office-based physicians have ordered systemic drugs off label for children at increasing rates, most often for unapproved conditions, despite recent efforts to increase evidence and drug approvals for children. These findings can help inform education, research, and policies around effective, safe use of medications in children.Using nationally representative survey data from 2006 to 2015, in this study, we examined patterns of off-label systemic drug orders for children in ambulatory US settings.