Increasing off-label use of antipsychotic medications in the United States, 1995–2008
Article first published online: 6 JAN 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 20, Issue 2, pages 177–184, February 2011
How to Cite
Alexander, G. C., Gallagher, S. A., Mascola, A., Moloney, R. M. and Stafford, R. S. (2011), Increasing off-label use of antipsychotic medications in the United States, 1995–2008. Pharmacoepidem. Drug Safe., 20: 177–184. doi: 10.1002/pds.2082
- Issue published online: 21 JAN 2011
- Article first published online: 6 JAN 2011
- Manuscript Accepted: 8 NOV 2010
- Manuscript Revised: 22 OCT 2010
- Manuscript Received: 8 APR 2010
- treatment trends;
- atypical antipsychotics
To 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.
Antipsychotic 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.
Atypical 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. Copyright © 2011 John Wiley & Sons, Ltd.