Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA.
Pharmacoepidemiol Drug Saf. 2012 Sep;21(9):997-1004. doi: 10.1002/pds.3312. Epub 2012 Jul 4.
To estimate the degree of, and level of evidence supporting, off-label antidepressant (AD) prescribing for children and adolescents compared with young adults.
Retrospective cohort study utilizing medical and pharmacy claims data from US-managed care plans, 1997-2009.
Patients aged 5-24 years, with at least one (index) AD claim during a period of continuous enrollment.
Drug-diagnosis pairs, on the basis of medical claims within 30 days pre-index or post-index AD, were grouped as (1) Food and Drug Administration (FDA)-approved or (2) off-label with one of three evidence categories based on Micromedex®2.0: favorable, inconclusive or limited-to-none (Thomson Micromedex, Greenwood Village, CO, USA).
Over the study period, 290 816 subjects met eligibility criteria: 17% 5-12 years old, 40% 13-18 years old, and 43% 19-24 years old. Sertraline was the most commonly prescribed index AD (19-23%). Psychiatrists more often prescribed the AD for children (31%) and adolescents (35%) versus young adults (17%). Only 28% of all subjects had a diagnosis consistent with an FDA-approved indication within 30 days pre-index and post-index AD. Children less than 13 years old were less likely to have had an FDA-approved indication (5-10%). Most off-label prescribing had inconclusive to no evidence supporting efficacy. The lack of evidence was especially pronounced for younger children. Trends were consistent over the study period. Increasing the time period for potential indications pre-index and post-index AD did not result in significantly reduced off-label rates.
Pediatric off-label AD prescribing occurs frequently without a strong evidence base, highlighting a need to generate additional evidence to ensure safe and effective use.
评估与年轻成年人相比，儿童和青少年的抗抑郁药（AD）处方的标签外使用程度和证据水平。
利用来自美国管理式医疗计划的医疗和药房理赔数据进行回顾性队列研究，时间为 1997 年至 2009 年。
年龄在 5-24 岁之间，在连续参保期间至少有一次（索引）AD 理赔。
根据索引 AD 前或后 30 天内的医疗理赔，将药物-诊断对（drug-diagnosis pairs）分为（1）食品和药物管理局（FDA）批准的或（2）标签外使用，并根据 Micromedex®2.0 将其分为基于三种证据类别之一：有利（favorable）、不确定（inconclusive）或有限（limited-to-none）（Thomson Micromedex，格林伍德村，CO，美国）。
在研究期间，共有 290816 名符合入选标准的患者：17%为 5-12 岁，40%为 13-18 岁，43%为 19-24 岁。舍曲林是最常被处方的索引 AD（19-23%）。与年轻成年人（17%）相比，精神科医生更常为儿童（31%）和青少年（35%）开 AD。只有 28%的患者在索引 AD 前和后 30 天内有与 FDA 批准适应症一致的诊断。13 岁以下的儿童不太可能有 FDA 批准的适应症（5-10%）。大多数标签外用药的疗效证据不确定或没有证据支持。这种缺乏证据的情况在年龄较小的儿童中尤为明显。这些趋势在整个研究期间保持一致。增加索引 AD 前和后潜在适应症的时间期限并没有显著降低标签外用药率。
儿科标签外 AD 处方的情况经常发生，而且没有强有力的证据支持，这突出表明需要生成额外的证据，以确保安全有效的使用。
