ATYPICAL ANTIPSYCHOTIC BLACK BOX WARNING AND ITS EFFECT ON NON-ANTIPSYCHOTIC PSYCHOTROPIC DRUGS IN NON-INSTITUTIONALIZED DEMENTIA PATIENTS
Author(s)
Singh RR, Nayak RSt. John's University, Jamaica, NY, USA
OBJECTIVES: In April 2005, the Food and Drug Administration (FDA) issued a black box warning (BBW) regarding the risks of using atypical antipsychotics (AAPs) for behavioral disorders in elderly patients with dementia. The objective of the present study was to investigate the impact of the BBW on the utilization of non-antipsychotic psychotropic drugs (NAPDs) such as benzodiazepines, anticonvulsants, antidepressants, and anti-dementia agents in non-institutionalized dementia population. METHODS: Medical Expenditure Panel Surveys, from year 2004 through 2007, were used in this study. Utilization rates of NAPDs pre-warning (2004-2005) and post-warning (2006-2007) were tracked over a four-year time period for both the main sample and Medicare cohorts. Chi-Square tests and multivariate logistic regression analyses were performed to examine pre-post differences in utilization rates (defined as elderly patients taking at least one medication associated with dementia) and gain insights into patterns of NAPD use with respect to demographic, insurance and other factors. RESULTS: NAPD use increased in the post-warning period for the main sample as well as the Medicare sample during the time period covered. The increase, however, was not statistically significant. Multivariate logistic regression in the main sample showed a greater likelihood of individuals receiving anti-dementia medications (Odds Ratio, OR= 1.976, p= 0.0195) and benzodiazepines (OR=3.046, p= 0.0227) in the post-warning period as compared to the pre-warning period. Similarly, dementia patients had a greater likelihood of receiving anti-dementia medications (OR= 2.229, p=0.0065) in the post-warning period as compared to the pre-warning period in the Medicare sample as well. CONCLUSIONS: The regulatory warnings and labeling changes regarding off-label use of atypical antipsychotics in dementia treatment might have resulted in spillover compensatory shift in the use of NAPD in non-institutionalized populations.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
PMH77
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Prescribing Behavior
Disease
Mental Health, Neurological Disorders