Off-label use of antipsychotic medications in the department of Veterans Affairs health care system.
ABSTRACT This study aimed to determine the prevalence of prescribing antipsychotics to adults without schizophrenia or bipolar disorder and to identify factors associated with such off-label use.
Patients with at least one prescription for an antipsychotic medication from the Department of Veterans Affairs (VA) during fiscal year (FY) 2007 were identified in national VA administrative databases. Rates of off-label antipsychotic use were determined along with average doses. Multivariate logistic regression models identified sociodemographic and clinical characteristics associated with off-label use.
Of the 279,778 individuals in FY 2007 who received an antipsychotic medication, 168,442 (60.2%) had no record of a diagnosis for which these drugs are approved. The most common mental illness diagnoses among patients given prescriptions for antipsychotics off label were posttraumatic stress disorder (PTSD, 41.8%), minor depression (39.5%), major depression (23.4%), and anxiety disorder (20.0%). Among VA patients with mental illness other than schizophrenia or bipolar disorder, the proportion who received prescriptions for antipsychotic medications ranged from a low of 9.1% among patients with adjustment reaction; to about 20% for those with depression, dementia, or PTSD; and to a high of 40.7% among patients with other psychoses. Doses were low, with over half of patients who received off-label quetiapine, risperidone, or first-generation antipsychotics receiving doses below those recommended for schizophrenia. In logistic regression models, patients diagnosed as having other psychosis or dementia had the highest odds of receiving an antipsychotic medication off label.
Off-label use of antipsychotic medications was common. Given that these drugs are expensive, have potentially severe side effects, and have limited evidence supporting their effectiveness for off-label usage, they should be used with greater caution.
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ABSTRACT: Background The adjunctive use of some atypical antipsychotics (AAPs) has been popular for patients with treatment-resistant depression. However, little is known about the impact of these agents on patients' Health-related quality of life (HRQoL). Objectives The objective of this study is to examine the impact of the adjunctive AAPs use on HRQoL among users of antidepressants with self-reported depression. Methods Patients with depression (ICD-9-CM: 296, 300, and 311), and to have used the given AAPs and/or antidepressants for at least a year, were identified in the Medical Expenditure Panel Survey of 2008–2011. The patients were classified into users of adjunctive AAPs (i.e., antidepressants plus AAPs) and users of antidepressants only. Adjusted multivariate linear regression analyses were conducted to examine the association between the utilization of AAPs and HRQoL measure.c Results A total of 3638 participants who met the inclusion criteria were identified (306 on AAPs vs. 3332 on antidepressants only). The study subjects were ≥18 years, predominately White (91.9%) and female (71%). The AAPs utilization was not associated with higher scores in the Physical Component Summary (PCS-12) of the Short Form Health Survey (SF-12v2) (β = 1.542, 95% CI = −0.0142 to 3.0977, P = 0.0521). Rather, it was negatively associated with the Mental Component Summary (MCS-12) scores of the SF-12v2 (β = −1.5537, 95% CI = −3.0247 to −0.0827, P = 0.0385). Conclusions The utilization of AAPs was not associated with higher scores of HRQoL. The findings of this study should underscore the need to consider other treatment options as add-on therapy for depression before resorting to AAPs.Research in Social and Administrative Pharmacy 06/2014; 11(2). DOI:10.1016/j.sapharm.2014.06.001 · 2.35 Impact Factor
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ABSTRACT: Off-label drug prescribing is very common in Psychiatry. US-Food and Drug Administration has defined off-label drug as "use of drugs for the indication, dosage form, regimen, patient or other use constraint not mentioned in the approved labeling." The objective was to evaluate off-label drug use in patients attending Outpatient Department of Psychiatry. One year prospective, cross sectional study was conducted on patients attending Psychiatry Outpatient Department. Demographic data, clinical history, and complete prescription were noted in the predesigned proforma and prescriptions were analyzed for off-label drug use as per British National Formulary-2011. A total of 250 patients were enrolled with mean age 40.36 ± 12.3 years. Most common diagnosis was major depressive disorder 101 (40.4%). A total of 980 drugs (mean 3.68 ± 1.42) were prescribed out of which 387 (39.5%) were off-label. Of 250 patients, 198 (79.2%) received at least one off-label drug. Psychopharmacological agents most frequently used in off-label manner were clonazepam 31 (12.4%), lorazepam 30 (12%), and trihexyphenidyl HCl 25 (10%). Prevalence of off-label use of these three drugs was significantly higher than other off-label drugs (P < 0.0001, P < 0.0001 and P < 0.0001 respectively). Inappropriate indication was the most common category of off-label use. There was positive and significant correlation between off-label prescribing and number of drugs (r = 0.722, P ≤ 0.000). Off-label prescribing was statistically significantly higher in 21-40 year age group, but no difference was seen in any co-morbid condition or in between any psychiatric disorder. Off-label drugs use is common in psychiatric OPD in our setup. Clonazepam, lorazepam, and trihexyphenidyl HCl were the most frequently used drugs in off-label manner.03/2015; 6(2):45-49. DOI:10.4103/0976-0105.152090
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ABSTRACT: Hair analysis is a powerful tool for retrospective drug analysis and has a wide application window. This article describes the simultaneous determination and quantification of the short-acting atypical antipsychotic drug quetiapine and its main metabolite 7-OH quetiapine in hair. A sensitive and accurate method for the determination of these two compounds was developed using high-performance liquid chromatography coupled to tandem mass spectrometry detection (LC-MS/MS). The method was applied to 10 real case samples. For five patients, a time resolved hair analysis was done. Results varied from 0.35ng/mg to 10.21ng/mg hair for quetiapine and from 0.02ng/mg to 3.19ng/mg hair for 7-OH-quetiapine.Forensic Science International 07/2014; 242C:200-203. DOI:10.1016/j.forsciint.2014.07.002 · 2.12 Impact Factor