Off-label use of second-generation antipsychotic agents among elderly nursing home residents.
OBJECTIVE
This study examined off-label and evidence-based use of second-generation antipsychotic agents among elderly nursing home residents and factors associated with off-label use.


METHODS
This study involved a retrospective, cross-sectional analysis of data from the 2004 National Nursing Home Survey (NNHS). The sample included nursing home residents 65 years and older who received second-generation antipsychotic agents. This study used an indication-based definition of off-label use established by the U.S. Food and Drug Administration (FDA). Evidence-based use included FDA-approved indications and indications for which the Agency of Healthcare Research and Quality found at least moderate strength of evidence of effectiveness. Descriptive statistics were used to examine the prevalence of off-label and evidence-based use. Multiple logistic regression was used to examine the patient and facility factors associated with off-label use of second-generation antipsychotics.


RESULTS
According to the 2004 NNHS, 308,990 (23.5%) elderly nursing home residents received at least one second-generation antipsychotic agent. Of those using second-generation antipsychotics, 86.3% received them for off-label indications and 56.9% received them for an evidence-based use. Multivariate analysis found that age (> or =75 years), self-pay for nursing home care, diagnosis of dementia, and residing in a nonprofit nursing home were positively associated with off-label use, whereas receiving Medicaid benefits was negatively associated with such use.


CONCLUSIONS
Although second-generation antipsychotics were frequently used for off-label indications, most of the usage was evidence based among elderly nursing home residents. However, the high level of non-evidence-based use combined with recent safety and efficacy data suggests an urgent need to address the evidence base for this vulnerable population.
Kamble
Pravin
P
Department of Clinical Sciences and Administration, University of Houston Texas Medical Center, Houston, TX 77030, USA.
Sherer
Jeff
J
Chen
Hua
H
Aparasu
Rajender
R
D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D003704:Dementia / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D004363:Drug Utilization / Q000706:statistics & numerical data; D019317:Evidence-Based Medicine; D005260:Female; D006707:Homes for the Aged; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D009735:Nursing Homes; D056687:Off-Label Use; D011618:Psychotic Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D014481:United States; D014486:United States Food and Drug Administration
D014150:Antipsychotic Agents