O'Brien Peggy L, Cummings Nicholas, Mark Tami L
Dr. O'Brien is with Truven Health Analytics, L.L.C., Cambridge, Massachusetts (e-mail:
Psychiatr Serv. 2017 Jun 1;68(6):549-558. doi: 10.1176/appi.ps.201500482. Epub 2017 Jan 17.
This study examined rates of psychotropic prescriptions for various on- and off-label uses in 2005 and 2013 in the context of changes in labeled indications.
The National Disease and Therapeutic Index, a survey of nationally representative office-based physicians that identifies the diagnosis attached to each prescription, was used to capture the number of psychiatric medications prescribed for a particular diagnosis in 2005 (N=4,120) and 2013 (N=4,140). Labeled indications for each year were abstracted, and the association of prescribing patterns and changes in labeled indications was evaluated.
Expanded labeling was associated with increased use of antidepressants for anxiety (an increase of 3.4 percentage points); antipsychotics for depression (8.3), bipolar disorder (3.4), and tic disorders, autism, and related disorders (1.5); and anxiolytics for anxiety disorders (5.5). Use of antidepressants for depression decreased, by 5.6 percentage points, as did use of antipsychotics (4.6) and anxiolytics (.7) for dementia-related disorders and of antipsychotics for attention-deficit and related disorders (2.7), likely reflecting black box warnings and evidence of side effects. Off-label use of antidepressants for attention deficit and related disorders and anxiolytics for bipolar disorders increased by 1.1 and 1.3 percentage points, respectively.
FDA labeling plays an important but imperfect role in influencing how providers select medications. Prescribing increases for medications with new indications. Conversely, black box warnings of potentially dangerous side effects result in decreased prescribing. However, labeled indications often lag the science, and prescribing patterns should be tracked to inform the need for more education, research, and labeling changes.
本研究在药品标签适应症变化的背景下，考察了2005年和2013年各种适应症和非适应症使用精神药物的处方率。
全国疾病与治疗指数是一项针对具有全国代表性的门诊医生的调查，可确定每张处方所附的诊断，用于获取2005年（N = 4120）和2013年（N = 4140）为特定诊断开具的精神科药物数量。提取每年的标签适应症，并评估处方模式与标签适应症变化之间的关联。
标签扩展与以下情况相关：用于焦虑症的抗抑郁药使用增加（增加3.4个百分点）；用于抑郁症（8.3）、双相情感障碍（3.4）以及抽动障碍、自闭症和相关障碍（1.5）的抗精神病药使用增加；用于焦虑症的抗焦虑药使用增加（5.5）。用于抑郁症的抗抑郁药使用减少了5.6个百分点，用于与痴呆症相关疾病的抗精神病药（4.6）和抗焦虑药（0.7）以及用于注意力缺陷和相关疾病的抗精神病药（2.7）的使用也减少了，这可能反映了黑框警告和副作用证据。用于注意力缺陷和相关疾病的抗抑郁药以及用于双相情感障碍的抗焦虑药的非适应症使用分别增加了1.1和1.3个百分点。
美国食品药品监督管理局（FDA）的标签在影响医疗服务提供者选择药物方面发挥着重要但并不完美的作用。有新适应症的药物处方量增加。相反，潜在危险副作用的黑框警告导致处方量减少。然而，标签适应症往往落后于科学，应跟踪处方模式，以便为更多教育、研究和标签变更的需求提供信息。
