Off-Label Prescribing of Psychotropic Medication, 2005-2013: An Examination of Potential Influences.

OBJECTIVE: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.