Evidence map›Paper›PMID 21254289›Full record

ArticlePharmacoepidemiology and drug safety2011

Increasing off-label use of antipsychotic medications in the United States, 1995-2008.

G C Alexander, S A Gallagher, A Mascola, R M Moloney, R S Stafford

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 191 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
191citing papers in PubMed, 13 pooled it
59.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

191 citing papers in PubMed, 13 syntheses or guidelines pooled it, 427 citations in OpenAlex.

  1. Pooled it
  2. Metabolic adverse effects of off-label use of second-generation antipsychotics in the adult population: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
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  3. Bayesian Meta-analysis of Multiple Continuous Treatments with Individual Participant-Level Data: An Application to Antipsychotic Drugs.Medical decision making : an international journal of the Society for Medical Decision Making · 2019
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  14. Safer and targeted use of antipsychotics in youth: an embedded, pragmatic randomized trial.Journal of child psychology and psychiatry, and allied disciplines · 2025
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131 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

G C AlexanderDepartment of Medicine, University of Chicago Hospitals, Chicago, Illinois, USA. galexand@uchicago.edu
S A Gallagher
A Mascola
R M Moloney
R S Stafford
University of Chicago · USStanford University · US

Funding

Translating Clinical Decision Making into Systems of Care: A Mid-Career MentorK24HL086703 · NHLBI · STANFORD UNIVERSITY · PI STAFFORD, RANDALL SCOTT · 2007 to 2016
$1.5M
An RCT To Decrease Out-Of-Pocket Prescription CostsK08HS015699 · AHRQ · UNIVERSITY OF CHICAGO · PI ALEXANDER, G. CALEB · 2006 to 2010
$617k
AHRQ HHS K08 HS015699AHRQ HHS K08 HS15699AHRQ HHS R01 HS0189960NHLBI NIH HHS K24 HL086703
6 · The paper itself

Abstract

objectiveTo evaluate patterns of antipsychotic use. DESIGN, SETTING, AND MEASUREMENTS: We used nationally representative data from the IMS Health National Disease and Therapeutic Index to describe outpatient antipsychotic use. The primary outcome was the volume of visits where antipsychotics were used for specific indications (treatment visits). We also quantified use without U.S. Food and Drug Administration approval (off-label use) and off-label use with compendium data suggesting an uncertain evidence base.

resultsAntipsychotic use increased from 6.2 million (M) treatment visits (95% CI, 5.4-7.0) in 1995 to 16.7 M visits (15.5-18.2) in 2006, then declined to 14.3 M visits (13.0-15.6) by 2008. A shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). As they declined, typical medications shifted toward use in schizophrenia (30% in 1995 to 48% 2008). In contrast, use of atypical agents expanded for bipolar affective disorder (10 to 34%), remained stable for depression (12 to 14%), and declined for schizophrenia (56 to 23%). Overall, antipsychotic use for indications without FDA approval increased from 4.4 M visits in 1995 to 9.0 M in 2008. The estimated cost associated with off-label use in 2008 was US$6.0 billion.

conclusionsAtypical use has grown far beyond substitution for the now infrequently used typical agents. Antipsychotics are increasingly used for conditions where FDA approval and associated clinical evidence is less certain. Despite the value of innovation, the benefits of widening atypical antipsychotic use should be weighed against their cost, regulatory status, and incomplete nature of available evidence.

Indexed as

Off-Label UseAdolescentAdultAgedAntipsychotic AgentsChildDrug ApprovalDrug CostsDrug PrescriptionsDrug UtilizationEvidence-Based MedicineGuideline AdherenceHealth Care SurveysHumansMiddle AgedOffice VisitsAntipsychotic Agents

Identifiers

PMID21254289
PMCPMC3069498
OpenAlexW2164142166

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.