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

• Published in: Pharmacoepidemiology and drug safety Vol. 20; no. 2; pp. 177 - 184
• Main Authors: Alexander, G. C., Gallagher, S. A., Mascola, A., Moloney, R. M., Stafford, R. S.
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01.02.2011; Wiley Subscription Services, Inc
• Subjects: Adolescent; Adult; Aged; Antipsychotic Agents - economics; Antipsychotic Agents - therapeutic use; antipsychotics; atypical antipsychotics; Child; Drug Approval; Drug Costs; Drug Prescriptions; Drug Utilization - trends; Evidence-Based Medicine; Guideline Adherence; Health Care Surveys; Humans; Middle Aged; Off-Label Use - economics; Office Visits - trends; Practice Guidelines as Topic; Practice Patterns, Physicians' - economics; Practice Patterns, Physicians' - trends; Time Factors; treatment trends; United States; United States Food and Drug Administration; Young Adult; United States
• ISSN: 1053-8569; 1099-1557; 1099-1557
• DOI: 10.1002/pds.2082

Objective 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. Results 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. Conclusions 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.