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Articles   |    
Use of Administrative Data to Identify Off-Label Use of Second-Generation Antipsychotics in a Medicaid Population
Daniel M. Hartung, Pharm.D., M.P.H.; Luke Middleton, B.S.; Bentson H. McFarland, M.D., Ph.D.; Dean G. Haxby, Pharm.D.; Marian S. McDonagh, Pharm.D.; K. John McConnell, Ph.D.
Psychiatric Services 2013; doi: 10.1176/appi.ps.005482012
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Dr. Hartung, Mr. Middleton, and Dr. Haxby are with the Department of Pharmacy Practice, Oregon State University, 3303 South West Bond Ave., CHH12C, Portland, OR 97239 (e-mail: hartungd@ohsu.edu). Dr. McFarland is with the Department of Psychiatry, Dr. McDonagh is with the Department of Medical Informatics and Clinical Epidemiology, and Dr. McConnell is with the Center for Health Systems Effectiveness and the Department of Emergency Medicine, all at Oregon Health & Science University, Portland.

Copyright © 2013 by the American Psychiatric Association

Abstract

Objective  The use of second-generation antipsychotics for conditions not approved by the U.S. Food and Drug Administration (FDA) is a prevalent phenomenon with important implications. The objective of this study was to determine the accuracy of administrative claims for identifying off-label use of second-generation antipsychotics in a Medicaid population in 2009.

Methods  The authors estimated the sensitivity, specificity, positive predictive values (PPV), and negative predictive values of Medicaid claims data for detecting off-label use of second-generation antipsychotics in the electronic health records of 788 patients. Separate estimates were calculated for patients without schizophrenia and bipolar disorder, the two most long-standing FDA indications for use of second-generation antipsychotics, and for a subset of patients using a second-generation antipsychotic with indications for treatment-resistant depression.

Results  Medicaid claims determined a lack of schizophrenia and bipolar disorder in the medical record with a sensitivity of 72% and a specificity of 85%. The prevalence of identifying neither diagnosis was 83%, which was associated with a predictive ability (PPV) of 96%. Among those using a second-generation antipsychotic with an indication for treatment-resistant depression, the sensitivity, specificity, and PPV of Medicaid claims for identifying off-label use were 41%, 86%, and 87%, respectively.

Conclusions  Medicaid claims data had high predictive ability for identifying users of second-generation antipsychotics who did not have documentation of schizophrenia or bipolar disorder in the medical record. The predictive utility of the claims was diminished when the analyses were limited to patients using a second-generation antipsychotic with an indication for treatment-resistant depression.

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Figure 1 Positive predictive values (PPVs) of Medicaid claims data for identifying patients without FDA indications for use of second-generation antipsychoticsa

aThe solid line reflects claims for 788 patients with at least one fill for a second-generation antipsychotic. The dashed line reflects claims for a subset of 559 patients with at least one fill for a second-generation antipsychotic with U.S. Food and Drug Administration (FDA) indications for treatment-resistant depression. PPVs are computed on the basis of estimates of prevalence of off-label prescribing. The shaded region indicates the range of likely off-label prescribing prevalence estimates.

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Table 1Characteristics of 788 patients who used a second-generation antipsychotic in 2009
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a Days’ supply dispensed sufficient to cover 80% of year

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Table 2Concordance of Medicaid claims and medical records for identifying patients (N=788) without FDA indications for use of second-generation antipsychoticsa
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a Schizophrenia and bipolar disorder are the most long-standing U.S. Food and Drug Administration (FDA) indications for use of second-generation antipsychotics.

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Table 3Concordance of Medicaid claims and medical records for identifying patients (N=559) without FDA indications for use of olanzapine, quetiapine, and aripiprazolea
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a Schizophrenia and bipolar disorder are the most long-standing U.S. Food and Drug Administration (FDA) indications for use of second-generation antipsychotics.

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d Adjunctive treatment of depression was indicated by a prescription fill for an antidepressant within 30 days of a prescription fill for olanzapine, quetiapine, or aripiprazole.

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Table 4Use of Medicaid claims data to identify patients without FDA indications for use of second-generation antipsychotics, in percentagesa
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a FDA, U.S. Food and Drug Administration. Medicaid claims were examined for 788 patients with at least one fill for a second-generation antipsychotic, including 559 patients who used olanzapine, quetiapine, or aripiprazole.

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b Adjunctive treatment of depression was indicated by a prescription fill for an antidepressant within 30 days of a prescription fill for olanzapine, quetiapine, or aripiprazole.

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c Positive predictive values

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d Negative predictive values

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