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RRP 11-379 – HSR Study

RRP 11-379
Off-Label Use of Antipsychotics: Determinants and Impact on Patient Safety
Teresa J. Hudson, PhD PharmD
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, AR
Funding Period: July 2012 - June 2013
Antipsychotic medications remain an essential treatment for individuals with psychotic disorders but are associated with adverse effects on physical health including significant weight gain, hyperglycemia, diabetes and dyslipidemia - known collectively as metabolic side effects of second generation antipyschotics (SGAs). These problems were considered so serious that the US Food and Drug Administration required the risk of metabolic complications be included in product labeling for SGAs in 2003. Strategies focusing on primary prevention have the potential to improve safety of Veterans treated for mental health disorders and potentially decrease the budget impact associated with antipsychotic therapy.

The proposed project will leverage a data set previously obtained for a QUERI-funded short term project to: 1) Develop appropriateness criteria for identifying clinically justifiable off-label use using VA administrative data; 2) Estimate the proportion of off-label antipsychotic use that is clinically justifiable and identify factors associated with non-justifiable off-label use; 3) identify and conceptualize, in partnership with key stakeholders, QI interventions or policy approaches that are likely to be feasible, acceptable, and widely applicable across the VA.

An expert panel will be convened; the RAND appropriateness method (RAM) will be used to develop appropriateness criteria for off-label antipsychotic use. These criteria will be applied to VA administrative data and to patient medical records using CPRS as a way to examine the reliability of the criteria. The criteria will be used to develop models for specific aim 2. A stakeholder panel of clinicians and administrators will use the results from specific aim 2 and work with the investigators to help create interventions and/or policies based on the analyses from the project.

Project recently began. No project findings to report at this time.

Depending on the specific medication, antipsychotics have FDA-approval for schizophrenia, bipolar disorder, and adjunctive treatment for bipolar disorder. Our research, and that of others, has shown that a substantial proportion of antipsychotic prescribing in the VA is for non-approved indications which exposes patients to the metabolic effects of these drugs. However, in some cases, off-label prescribing of antipsychotic medications is necessary to relieve patients' suffering. In order to develop intervention strategies to reduce off-label antipsychotic prescribing, research is needed to better understand the nature and determinants of off label prescribing that is not clinically justifiable.

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Journal Articles

  1. Painter JT, Owen R, Henderson KL, Bauer MS, Mittal D, Hudson TJ. Analysis of the Appropriateness of Off-Label Antipsychotic Use for Mental Health Indications in a Veteran Population. Pharmacotherapy. 2017 Apr 1; 37(4):438-446. [view]

DRA: Substance Use Disorders, Mental, Cognitive and Behavioral Disorders
DRE: Diagnosis, Prevention
Keywords: none
MeSH Terms: none

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