Off-Label Prescribing of Psychotropic Medication, 2005–2013: An Examination of Potential Influences
Abstract
Objective:
Methods:
Results:
Conclusions:
Methods
Results
Antidepressants
Classification and drugb | 2005c | 2013 |
---|---|---|
Tricyclics and tetracyclics | ||
Amoxapine | Depression | |
Clomipramine HCL | OCD | |
Amitriptyline HCL | Depression | |
Maprotiline HCL | Depression and anxiety associated with depression | Dysthymic disorder and manic-depressive illness, depressed type |
Desipramine HCL | Depression | |
Nortriptyline HCL | Depression | |
Mirtazapine | Major depressive disorder | |
Doxepin HCL | Depression or anxiety (including associated with alcoholism or with organic disease), psychotic depressive disorders, short-term management of moderate pruritus in adults with atopic dermatitis or lichen simplex chronicus | Insomnia |
Imipramine HCL, imipramine pamoate, trimipramine maleate | Depression and childhood enuresis | |
Protriptyline HCL | Depression | |
MAO inhibitors | ||
Selegiline | Major depressive disorder | |
Isocarboxazid | Major depressive disorder | |
Phenelzine sulfate | Depression | |
Tranylcypromine sulfate | Major depressive episode without melancholia | |
Newer-generation antidepressants | ||
Bupropion hydrobromide | Major depressive disorder, seasonal affective disorder, severe hepatic impairment | |
Bupropion HCL, bupropion HCL SR, bupropion HCL XL | Major depressive disorder, smoking cessation treatment | |
Trazodone HCL | Major depressive disorder | |
Nefazodone HCL | Depression | |
SSRIs | ||
Paroxetine mesylate | Major depressive disorder, OCD, panic disorder | Generalized anxiety disorder, moderate to severe vasomotor symptoms associated with menopause |
Citalopram HBR | Depression | |
Escitalopram oxalate | Major depressive disorder, generalized anxiety disorder | |
Fluvoxamine mal, fluvoxamine mal ER | OCD | Social anxiety disorder |
Paroxetine CR, paroxetine HCL, paroxetine HCL ER | Major depressive disorder, panic disorder, premenstrual dysphoric disorder | OCD, social anxiety disorder, generalized anxiety disorder, PTSD |
Fluoxetine HCL | Depression, OCD | Bulimia, panic disorder, premenstrual dysphoric disorder |
Sertraline HCL | Major depressive disorder, OCD, panic disorder, PTSD, premenstrual dysphoric disorder, social anxiety disorder | |
SNRIs | ||
Duloxetine HCL | Major depressive disorder | Diabetic peripheral neuropathic pain, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain |
Venlafaxine HCL, venlafaxine HCL ER | Major depressive disorder, generalized anxiety disorder, social anxiety disorder, panic disorder | |
Levomilnacipran HCL | Not on the market | Major depressive disorder |
Desvenlafaxine ER | Not on the market | Major depressive disorder |
SSRI/5-HT partial agonists | ||
Vortioxetine hydrobromide | Not on the market | Major depressive disorder |
Vilazodone hydrochloride | Not on the market | Major depressive disorder |
Antidepressants in combination with other drugs | ||
Perphenazine and amitriptyline | Depression | |
Amitriptyline and chlordiazepoxide | Depression | Moderate to severe depression associated with moderate to severe anxiety |
All mentions (%) | Change in mentions | Labelingb | |||||
---|---|---|---|---|---|---|---|
Diagnosisc | 2005 | 2013 | Percentage points | SE | p | 2005 | 2013 |
Psychiatric | 92.7 | 92.0 | –.7 | .0780 | <.001 | — | — |
Depressive disorders | 56.4 | 50.8 | –5.6 | .5263 | <.001 | Yes | + |
Bipolar disorders | 7.6 | 7.5 | –.1 | .0240 | No | + | |
Anxiety disorders | 16.4 | 19.8 | 3.4 | .5464 | <.001 | Yes | + |
Attention-deficit, conduct, and disruptive behavior disorders | 2.8 | 3.9 | 1.1 | .2096 | <.001 | No | No |
Schizophrenia and other psychotic disorders | 2.6 | 2.3 | –.3 | .0824 | <.001 | No | No |
Adjustment disorders | 1.3 | .9 | –.4 | .1099 | <.001 | No | No |
Personality disorders | .7 | .9 | .2 | 1.1242 | ns | No | No |
Miscellaneous disorders | .9 | .8 | –.1 | .0346 | <.01 | — | — |
Delirium, dementia, and amnestic and other cognitive disorders | 1.0 | .8 | –.2 | .0693 | <.01 | No | No |
Alcohol and other substance-related disorders | .3 | .7 | .4 | 1.0935 | ns | No | No |
Disorders usually diagnosed in infancy, childhood, or adolescence | .2 | .6 | .4 | .3383 | ns | No | No |
Screening and history of mental health and substance abuse codes | .8 | .4 | –.4 | .1099 | <.001 | No | No |
Impulse control disorders not otherwise classified | .2 | .2 | .0 | .0000 | — | No | No |
Developmental disorders | .0 | .0 | .0 | .0000 | — | No | No |
Nonpsychiatric | 7.3 | 8.0 | .7 | 1.0832 | ns | — | — |
Other connective tissue disease | 1.1 | 1.9 | .8 | .2623 | ns | No | + |
Headache, including migraine | 1.1 | 1.3 | .2 | .0693 | ns | No | No |
Spondylosis, intervertebral disc disorders, and other back problems | .7 | .7 | .0 | .0000 | — | No | No |
Other nervous system disorders | .8 | .6 | –.2 | .0693 | <.01 | No | No |
Diabetes mellitus with complications | .3 | .4 | .1 | .0346 | ns | No | + |
Osteoarthritis | .0 | .3 | .3 | .1039 | ns | No | No |
Menopausal disorders | .3 | .2 | –.1 | .0346 | <.01 | No | + |
Other female genital disorders | .8 | .2 | –.6 | .1309 | <.001 | No | No |
Other aftercare | .1 | .2 | .1 | .0346 | ns | No | No |
Other gastrointestinal disorders | .1 | .2 | .1 | .0346 | ns | No | No |
Otherd | 2.0 | 1.8 | –.2 | .0693 | <.01 | — | — |
Other residual codes; unclassified | 2.0 | 2.8 | .8 | .1745 | <.01 | — | — |
Antipsychotics
Classification and drugb | 2005c | 2013 |
---|---|---|
Phenothiazine derivatives | ||
Thioridazine HCL | Schizophrenia, if there is insufficient response to other antipsychotic drugs | |
Fluphenazine HCL and fluphenazine decanoate | Manifestations of psychotic disorders; management of patients requiring prolonged parenteral neuroleptic therapy, for example, individuals with chronic schizophrenia | |
Trifluoperazine HCL | Schizophrenia and short-term treatment of generalized nonpsychotic anxiety (not as initial therapy) | |
Chlorpromazine HCL | Schizophrenia, nausea and vomiting, restlessness and apprehension before surgery, acute intermittent porphyria, adjunct in the treatment of tetanus, bipolar mania, intractable hiccups, severe behavioral problems in children ages 1–12 years, short-term treatment of hyperactivity in children | |
Perphenazine | Schizophrenia, management of manifestations of psychotic disorders, control of severe nausea and vomiting in adults | |
Antipsychotics, combined | Medications are categorized according to Uniform System of Classification (USC) coding (10). | |
Olanzapine/ fluoxetine HCL | Depressive episodes associated with bipolar disorder | Treatment-resistant depression |
Antipsychotics, other | ||
Aripiprazole | Schizophrenia, acute manic and mixed episodes associated with bipolar disorder | Treatment of schizophrenia among adults and adolescents ages 13–17 years; adjunctive treatment of major depressive disorder among adults; treatment of adults with agitation associated with schizophrenia or bipolar I disorder, manic or mixed; treatment of acute manic or mixed episodes associated with bipolar I disorder among pediatric patients ages 10–17 years; treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or adjunctive to lithium or valproate amomg adults and pediatric patients ages 10–17 years; maintenance treatment of bipolar I disorder; treatment of irritability associated with autistic disorder among pediatric patients ages 6–17 years |
Clozapine | Management of severely ill schizophrenic patients who do not respond adequately to standard drug treatment for schizophrenia; reducing the risk of recurrent suicidal behavior among patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk of reexperiencing suicidal behavior | |
Carbamazepine | Acute manic and mixed episodes associated with bipolar I disorder; epilepsy—partial, generalized and mixed types; trigeminal neuralgia | |
Iloperidone | Not on the market | Acute treatment of schizophrenia among adults |
Clozapine ODT | Management of severely ill patients with schizophrenia who do not respond adequately to standard drug treatment for schizophrenia | Reduction of the risk of recurrent suicidal behavior among patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk of reexperiencing suicidal behavior |
Ziprasidone HCL or ziprasidone mesylate | Schizophrenia, bipolar mania, intramuscular administration for acute agitation in schizophrenia | Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder, maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate |
Haloperidol or haloperidol deconate or haloperidol lactate | Schizophrenia | Severe behavior problems of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation) among children and short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance; haloperidol should be reserved for these two groups of children only after there has been no response to psychotherapy or medications other than antipsychotics; tics associated with Tourette’s disorder |
Paliperidone or paliperidone palmitate | Not on the market | Schizophrenia, schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants, schizophrenia among adolescents ages 12–17 years |
Lurasidone HCL | Not on the market | Schizophrenia |
Loxapine HCL or loxapine succinate | Schizophrenia | As an inhalation powder; for use in enrolled health care facilities only for acute treatment of schizophrenia or bipolar I disorder among adults; |
bipolar disorder, depressed phase | ||
Molindone HCL | Schizophrenia | |
Thiothixene or thiothixene HCL | Schizophrenia | |
Pimozide | Tics associated with Tourette’s disorder if patient failed to respond to standard treatment | |
Risperidone | Schizophrenia, acute manic or mixed episodes associated with bipolar I disorder as monotherapy or as adjunctive therapy with lithium or valproate | Irritability associated with autistic disorder, for example, symptoms of aggression toward others, deliberate self-injuriousness, temper tantrums, and quickly changing moods, among children and adolescents ages 5–16 years; schizophrenia among adolescents ages 13–17 years; treatment of acute episodes alone for children ages 5–16 years; monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder |
Asenapine maleate | Not on the market | Acute treatment of schizophrenia among adults; as monotherapy or adjunctive therapy, acute treatment of manic or mixed episodes associated with bipolar I disorder among adults |
Quetiapine fumarate | Bipolar mania, schizophrenia | Depressive episodes associated with bipolar disorder |
Olanzapine or olanzapine ODT or olanzapine pamoate | Schizophrenia, bipolar disorder | Agitation associated with schizophrenia and bipolar I mania; acute treatment of manic or mixed episodes with bipolar I disorder and maintenance treatment of bipolar I disorder, with special considerations in treating pediatric schizophrenia and bipolar mania |
All mentions (%) | Change in mentions | Labelingb | |||||
---|---|---|---|---|---|---|---|
Diagnosisc | 2005 | 2013 | Percentage points | SE | p | 2005 | 2013 |
Psychiatric | 98.9 | 99.0 | .0128 | <.001 | — | — | |
Depressive disorders | 5.3 | 13.6 | 8.3 | 1.5817 | <.001 | No | + |
Bipolar disorders | 26.4 | 29.8 | 3.4 | .5464 | <.001 | Yes | + |
Schizophrenia and other psychotic disorders | 34.5 | 35.5 | 1.0 | .1607 | <.001 | Yes | + |
Anxiety disorders | 5.5 | 6.2 | .7 | .1680 | <.05 | Yes | = |
Disorders usually diagnosed in infancy, childhood, or adolescence | 2.3 | 3.8 | 1.5 | .3601 | <.05 | No | + |
Attention-deficit, conduct, and disruptive behavior disorders | 5.7 | 3.0 | –2.7 | .5889 | <.001 | Yes | + |
Delirium, dementia, and amnestic and other cognitive disorders | 7.4 | 2.8 | –4.6 | .8325 | <.001 | No | No |
Personality disorders | 1.5 | 1.3 | .2 | .0693 | <.01 | No | No |
Developmental disorders | .5 | .7 | .2 | .0693 | ns | No | No |
Impulse control disorders not otherwise classified | 1.2 | .6 | –.6 | .2078 | <.01 | Yes | + |
Alcohol and other substance-related disorders | .7 | .5 | –.2 | .0693 | <.01 | No | No |
Adjustment disorders | .2 | .2 | .0 | .0000 | — | No | No |
Miscellaneous disorders | .4 | .2 | –.2 | .0693 | <.01 | — | — |
Nonpsychiatric | 1.1 | 1.1 | .0 | .0000 | — | — | — |
Coma, stupor, and brain damage | .0 | .3 | .3 | .1039 | ns | No | No |
Headache, including migraine | .0 | .2 | .2 | .0693 | ns | No | No |
Epilepsy, convulsions | .0 | .1 | .1 | .0346 | ns | No | No |
Spondylosis, intervertebral disc disorders, and other back problems | .0 | .1 | .1 | .0346 | ns | No | No |
Other connective tissue disease | .0 | .1 | .1 | .0346 | ns | No | No |
Parkinson's disease | .0 | .1 | .1 | .0346 | ns | No | No |
Other aftercare | .1 | .1 | .0 | .0000 | — | No | No |
Abdominal pain | .0 | .1 | .1 | .0346 | ns | No | No |
Other hereditary and degenerative nervous system conditions | .2 | .1 | –.1 | .0346 | <.01 | No | No |
Paralysis | .0 | .0 | .0 | .0000 | — | No | No |
Intracranial injury | .2 | .0 | –.2 | .0693 | <.01 | No | No |
Diabetes mellitus with complications | .1 | .0 | –.1 | .0346 | <.01 | No | No |
Nausea and vomiting | .1 | .0 | –.1 | .0346 | <.01 | Yes | + |
Other nutritional, endocrine, and metabolic disorders | .1 | .0 | –.1 | .0346 | <.01 | Yes | = |
Otherd | .2 | .1 | –.1 | .0346 | <.01 | — | — |
Other residual codes; unclassified | 1.8 | 1.0 | –.8 | .2909 | <.01 | — | — |
Anxiolytics
All mentions (%) | Change in mentions | Labelingb | |||||
---|---|---|---|---|---|---|---|
Diagnosisc | 2005 | 2013 | Percentage points | SE | p | 2005 | 2013 |
Psychiatric | 67.7 | 76.3 | 8.3 | 1.0587 | <.001 | — | — |
Anxiety disorders | 39.6 | 45.1 | 5.5 | .8839 | <.001 | Yes | + |
Depressive disorders | 14.4 | 14.4 | .0 | .0000 | — | No | No |
Bipolar disorders | 3.9 | 5.2 | 1.3 | .3121 | <.05 | No | No |
Alcohol and other substance-related disorders | 1.9 | 2.8 | .9 | .2473 | ns | Yes | + |
Schizophrenia and other psychotic disorders | 2.1 | 2.5 | .4 | .1385 | ns | No | No |
Attention-deficit, conduct, and disruptive behavior disorders | .8 | 2.2 | 1.4 | .3847 | ns | No | No |
Adjustment disorders | 1.5 | 1.3 | –.2 | .0693 | <.01 | No | No |
Personality disorders | .8 | .9 | .1 | .0346 | ns | No | No |
Delirium, dementia, and amnestic and other cognitive disorders | 1.2 | .5 | –.7 | .2424 | <.01 | No | No |
Miscellaneous mental disorders | .3 | .3 | .0 | .0000 | — | — | — |
Disorders usually diagnosed in infancy, childhood, or adolescence | .1 | .3 | .2 | .0693 | ns | No | No |
Developmental disorders | .1 | .2 | .1 | .0346 | ns | No | No |
Impulse control disorders not otherwise classified | .3 | .1 | –.2 | .0693 | <.01 | No | No |
Screening and history of mental health and substance abuse codes | .1 | .0 | –.1 | .0346 | <.01 | No | No |
Nonpsychiatric | 32.3 | 24.0 | –8.3 | 1.3339 | <.001 | — | — |
Medical examination or evaluation | 6.0 | 4.2 | –1.8 | .4321 | <.001 | Yes | + |
Allergic reactions | 4.1 | 3.5 | –.6 | .2078 | <.01 | Yes | = |
Spondylosis, intervertebral disc disorders, and other back problems | 2.5 | 1.9 | –.6*** | .2078 | <.01 | No | No |
Epilepsy, convulsions | 1.2 | 1.2 | .0 | .0000 | — | Yes | + |
Other connective tissue disease | .8 | 1.0 | .2 | .0693 | ns | Yes | = |
Conditions associated with dizziness or vertigo | .5 | .9 | .4 | .1385 | ns | No | No |
Other inflammatory condition of skin | .9 | .8 | –.1 | .0346 | <.01 | No | No |
Other skin disorders | .8 | .8 | .0 | .0000 | — | No | No |
Other aftercare | 1.3 | .7 | –.6 | .2078 | <.01 | No | No |
Sprains and strains | .9 | .7 | –.2 | .0693 | <.01 | No | No |
Otherd | 10.2 | 8.0 | –2.2 | .5281 | <.001 | — | — |
Other residual codes; unclassified | 2.8 | 3.0 | .2 | .0693 | ns | — | — |
Discussion
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Cover: Ripening Pears, by Joseph Decker, circa 1884. Oil on canvas. Gift of Ann and Mark Kington/The Kington Foundation Avalon Fund. National Gallery of Art, Washington, D.C.
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