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

Abstract

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 16.7M visits (15.5-18.2) in 2006, then declined to 14.3M 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 towards 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 4.4M visits in 1995 to 9.0M 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.

Diabetes and Cardiovascular Care Among People with Severe Mental Illness: A Literature Review

“…50,51 Specifically, ADA/APA guidelines recommend quarterly weight and BMI measurements; annual monitoring of blood pressure, fasting glucose, and waist circumference; and fasting lipids every 5 years or Bmore frequently if clinically indicated.^5 1 Unfortunately, over 10 years after publication of these diabetes screening guidelines, 70 % of people taking SGAs remain unscreened for diabetes or dyslipidemia. [52][53][54][55][56] Based on estimates that 20 % of the 19 million US adults with SMI have diabetes 26 and 70 % of them are not screened for diabetes 53,57 ; over 2 million Americans have unidentified diabetes.…”

Comparative Treatment Patterns, Resource Utilization, and Costs in Stimulant-Treated Children with ADHD Who Require Subsequent Pharmacotherapy with Atypical Antipsychotics Versus Non-Antipsychotics

“…[15][16][17] With an annual sales of more than $13 billion dollars, accounting for nearly 5% of all drug expenditures in the United States, AAPs are one of the most common and costly classes of prescription drugs. 18,19 Use of AAPs for indications not approved by the U.S. Food and Drug Administration (FDA) accounts for the majority of treatment with AAPs. 19 A recent study using data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey found that ADHD was the most common diagnosis associated with an antipsychotic prescription for children aged 2 to 18 years.…”

“…18,19 Use of AAPs for indications not approved by the U.S. Food and Drug Administration (FDA) accounts for the majority of treatment with AAPs. 19 A recent study using data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey found that ADHD was the most common diagnosis associated with an antipsychotic prescription for children aged 2 to 18 years. 15 A separate analysis of 11,700 Arkansas…”

“…Although the sponsor was involved in the design, collection, analysis, interpretation, and fact checking of information, the content of this manuscript, the ultimate interpretation, and the decision to submit it for publication in the Journal of Managed Care Pharmacy were made by all the authors independently. Preliminary results of this research were presented as a poster at the Academy of Managed Care Pharmacy 2011 Educational Conference in Atlanta, Georgia, October [19][20][21]2011.…”

Evaluation and Management of Children With Acute Mental Health or Behavioral Problems. Part II: Recognition of Clinically Challenging Mental Health Related Conditions Presenting With Medical or Uncertain Symptoms

“…36,37 Antipsychotic use, in particular, has shown large increases. 38 Especially notable is their burgeoning off-label use, [39][40][41] including in preschool-aged children. 42 -44 Given the frequency and multiple medication regimens with which psychotropic agents are being prescribed, 36 ED clinicians are likely to encounter children and adolescents taking 1 or many of these medications.…”