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Abstract

Aim: To describe trends in off-label antipsychotic use among Texas Medicaid adults and examine whether demographic and clinical characteristics were associated with off-label use. Methods: Three diagnostic groups (i.e. no diagnosis, on label and off-label) were created based on mental health disorder diagnoses and related antipsychotic prescriptions. Results: During 2013–2016, the prevalence of off-label antipsychotic use decreased from 22.5% to 17.4% and the proportions of no mental health diagnosis remained stable (7.3–9.4%). Patients aged ≥25 years and second-generation antipsychotic users had significantly lower odds of receiving antipsychotics off-label or with no diagnosis. Conclusion: Compared with previous Medicaid database studies, the proportions of off-label antipsychotic use and antipsychotic use with no concurrent psychiatric diagnosis were notably lower.

Supplementary Material

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References

Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Stafford RS. Regulating off-label drug use–rethinking the role of the FDA. N. Engl. J. Med. 358(14), 1427–1429 (2008).
2.
Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch. Intern. Med. 166(9), 1021–1026 (2006).
3.
Vijay A, Becker JE, Ross JS. Patterns and predictors of off-label prescription of psychiatric drugs. PLoS ONE 13(7), e0198363 (2018).
4.
Olfson M, King M, Schoenbaum M. Antipsychotic treatment of adults in the United States. J. Clin. Psychiatry 76(10), 1346–1353 (2015).
•• A recent national study described the patterns of antipsychotic recipients and found 76.8% of antipsychotic-treated adults (20–64 years) had no mental disorder diagnosis.
5.
Chen H, Reeves JH, Fincham JE, Kennedy WK, Dorfman JH, Martin BC. Off-label use of antidepressant, anticonvulsant, and antipsychotic medications among Georgia Medicaid enrollees in 2001. J. Clin. Psychiatry 67(6), 972–982 (2006).
6.
Leslie DL, Rosenheck R. Off-label use of antipsychotic medications in Medicaid. Am. J. Manag. Care 18(3), e109–e117 (2012).
•• A multistate Medicaid study indicated 49.0% of adults received off-label prescriptions in 2003.
7.
Leslie DL, Mohamed S, Rosenheck RA. Off-label use of antipsychotic medications in the department of Veterans Affairs health care system. Psychiatr. Serv. 60(9), 1175–1181 (2009).
8.
Painter JT, Owen R, Henderson KL, Bauer MS, Mittal D, Hudson TJ. Analysis of the appropriateness of off-label antipsychotic use for mental health indications in a veteran population. Pharmacotherapy 37(4), 438–446 (2017).
9.
Carbon M, Kane JM, Leucht S, Correll CU. Tardive dyskinesia risk with first- and second-generation antipsychotics in comparative randomized controlled trials: a meta-analysis. World Psychiatry 17(3), 330–340 (2018).
10.
De Hert M, Detraux J, Van Winkel R, Yu W, Correll CU. Metabolic and cardiovascular adverse effects associated with antipsychotic drugs. Nature Rev. Endocrinol. 8(2), 114–126 (2012).
11.
Sernyak MJ, Leslie DL, Alarcon RD, Losonczy MF, Rosenheck R. Association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia. Am. J. Psychiatry 159(4), 561–566 (2002).
12.
Maher AR, Theodore G. Summary of the comparative effectiveness review on off-label use of atypical antipsychotics. J. Manag. Care Pharm. 18(5 Suppl. B), S1–S20 (2012).
13.
Alexander GC, Gallagher SA, Mascola A, Moloney RM, Stafford RS. Increasing off-label use of antipsychotic medications in the United States, 1995–2008. Pharmacoepidemiol. Drug Saf. 20(2), 177–184 (2011).
•• A retrospective analysis indicated the prevalent off-label antipsychotic use and a shift occurred between first-generation antipsychotic and second-generation antipsychotics (SGA) during 1995–2008.
14.
Citrome L, Kalsekar I, Guo Z, Laubmeier K, Hebden T. Diagnoses associated with use of atypical antipsychotics in a commercial health plan: a claims database analysis. Clin. Ther. 35(12), 1867–1875 (2013).
• A recent study using Optum data investigated off-label use among SGA recipients with commercial insurance.
15.
Rhee TG, Rosenheck RA. Initiation of new psychotropic prescriptions without a psychiatric diagnosis among US adults: rates, correlates, and national trends from 2006 to 2015. Health Serv. Res. 54(1), 139–148 (2019).
16.
Olfson M, Blanco C, Liu S-M, Wang S, Correll CU. National trends in the office-based treatment of children, adolescents, and adults with antipsychotics. Arch. Gen. Psychiatry 69(12), 1247–1256 (2012).
17.
Olfson M, King M, Schoenbaum M. Treatment of young people with antipsychotic medications in the United States. JAMA Psychiatry 72(9), 867–874 (2015).
18.
Anderson SL, Vande Griend JP. Quetiapine for insomnia: a review of the literature. Am. J. Health Syst. Pharm. 71(5), 394–402 (2014).
19.
Maglione M, Maher AR, Hu J et al. Off-label use of atypical antipsychotics: an update. Agency for Healthcare Research and Quality (US), MD, USA (2011).
•• A latest Agency for Healthcare Research and Quality guidelines for off-label SGA use.
20.
Yang M, Barner JC, Lawson KA et al. Antipsychotic medication utilization trends among Texas veterans: 1997–2002. Ann. Pharmacother. 42(9), 1229–1238 (2008).
21.
Crystal S, Olfson M, Huang C, Pincus H, Gerhard T. Broadened use of atypical antipsychotics: safety, effectiveness, and policy challenges: expanded use of these medications, frequently off-label, has often outstripped the evidence base for the diverse range of patients who are treated with them. Health Aff. (Millwood) 28(Suppl. 1), w770–w781 (2009).
22.
Leslie DL, Rosenheck RA. Benchmarking the quality of schizophrenia pharmacotherapy: a comparison of the Department of Veterans Affairs and the private sector. J. Ment. Health Policy Econ. 6(3), 113–121 (2003).
23.
Gelenberg AJ, Freeman MP, Markowitz JC et al. Practice guideline for the treatment of patients with major depressive disorder third edition. Am. J. Psychiatry 167(10), 1 (2010).
24.
Nelson JC, Papakostas GI. Atypical antipsychotic augmentation in major depressive disorder: a meta-analysis of placebo-controlled randomized trials. Am. J. Psychiatry 166(9), 980–991 (2009).
25.
Locke A, Kirst N, Shultz CG. Diagnosis and management of generalized anxiety disorder and panic disorder in adults. Am. Fam. Physician 91(9), 617–624 (2015).
26.
Hyman SL, Levy SE, Myers SM. Identification, evaluation, and management of children with autism spectrum disorder. Pediatrics 145(1), 1–64 (2020).
27.
Chung W, Jiang S-F, Paksarian D et al. Trends in the prevalence and incidence of attention-deficit/hyperactivity disorder among adults and children of different racial and ethnic groups. JAMA Network Open 2(11), e1914344 (2019).
28.
Driessen J, Baik SH, Zhang Y. Trends in off-label use of second-generation antipsychotics in the Medicare population from 2006 to 2012. Psychiatr. Serv. 67(8), 898–903 (2016).