Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Anesth Analg. 2012 Nov;115(5):1148-54. doi: 10.1213/ANE.0b013e3182501b04. Epub 2012 Mar 26.
Many drugs used for anesthesia and analgesia in children are administered "off-label." We undertook an audit of drugs commonly used for pediatric anesthesia to determine which drugs have United States Food and Drug Administration (FDA) labeling for pediatric use, which drugs are age-restricted, and which have no labeling for pediatric use.
We identified drugs administered during anesthesia to pediatric patients from the operating room pharmacy. FDA approval and indications were determined by using the Thomson Micromedex® online database. Drugs without FDA approval for pediatric use were further examined for strength of evidence and strength of recommendation for their listed indications in the database. We then examined the rate of off-label drug administration to patients younger than the age of 18 years between July 1, 2010, and August 31, 2011.
One hundred six drugs were identified. Thirty-six (34%) were not FDA-labeled for use in any pediatric age group, 40 (38%) were FDA-labeled for use in all pediatric age groups, and 30 (28%) were FDA-labeled for use in only specific age groups. Drugs were administered off-label in 73.4% of cases. Of those not labeled for any pediatric age group, some were among the most commonly used drugs in pediatric anesthesia, including neostigmine, hydromorphone, and dopamine.
Many drugs used for children during anesthesia continue to lack FDA labeling for pediatric use. Off-label use of these drugs is an accepted practice that is considered superior to the alternative of withholding needed medications. Studies are still needed to determine the safety and efficacy of drugs that lack FDA labeling for this vulnerable patient population.
许多用于儿童麻醉和镇痛的药物都是“超说明书使用”的。我们对常用于小儿麻醉的药物进行了审核，以确定哪些药物有美国食品和药物管理局（FDA）批准用于儿科，哪些药物有年龄限制，哪些药物没有用于儿科的标签。
我们从手术室药房确定了在麻醉期间给予儿科患者的药物。通过使用 Thomson Micromedex®在线数据库来确定 FDA 的批准和适应证。对于没有 FDA 批准用于儿科的药物，我们进一步检查了数据库中列出的适应证的证据强度和推荐强度。然后，我们检查了在 2010 年 7 月 1 日至 2011 年 8 月 31 日期间，给年龄小于 18 岁的患者使用超说明书药物的比率。
确定了 106 种药物。其中 36 种（34%）没有 FDA 标签批准用于任何儿科年龄组，40 种（38%）是 FDA 标签批准用于所有儿科年龄组，30 种（28%）是 FDA 标签批准用于特定年龄组。73.4%的病例中使用了超说明书药物。在没有任何儿科年龄组标签的药物中，有些是小儿麻醉中最常用的药物之一，包括新斯的明、氢吗啡酮和多巴胺。
许多用于儿童麻醉的药物继续缺乏 FDA 批准用于儿科。对这些药物的超说明书使用是一种被接受的做法，被认为优于拒绝给有需要的患儿使用这些药物。仍需要研究来确定缺乏 FDA 标签的药物在这个脆弱的患者群体中的安全性和疗效。
