title: Pharmacotherapy of schizophrenic patients: preponderance of off-label drug use.
abstract: Multiple drug class combinations are often prescribed for the treatment of schizophrenia, although antipsychotic monotherapy reflects FDA labeling and scientific justification for combinations is highly variable. This study was performed to gain current data regarding drug treatment of schizophrenia as practiced in the community and to assess the frequencies of off-label drug class combinations. 200 DSM IV-diagnosed schizophrenic patients recruited from community treatment sources participated in this cross-sectional study of community based schizophrenic patients. Drug class categories include First and Second Generation Antipsychotic drugs (FGA and SGA, respectively), mood stabilizers, antidepressants and anti-anxiety drugs. 25.5% of patients received antipsychotic monotherapy; 70% of patients received an antipsychotic and another drug class. A total of 42.5% of patients received more than one antipsychotic drug. The most common drug class combination was antipsychotic and a mood stabilizer. Stepwise linear discriminant function analysis identified the diagnosis of schizoaffective schizophrenia, history of having physically hurt someone and high scores on the General Portion of the PANSS rating scale predicted the combined use of an antipsychotic drug and a mood stabilizer. "Real world" pharmacotherapy of schizophrenia has developed its own established practice that is predominantly off-label and may have outstripped current data support. The economic implications for public sector payers are substantial as well as for the revenue of the pharmaceutical industry, whose promotion of off-label drug use is an increasingly problematic. These data are consistent with the recognition of the therapeutic limitations of both first and second generation antipsychotic drugs.
authors.affiliation: Gabriel Sciences, LLC, Cabin John, Maryland, USA. dpickar@gabrielpharma.com
authors.forename: David
authors.initials: D
authors.lastname: Pickar
authors.forename: Jessie
authors.initials: J
authors.lastname: Vinik
authors.forename: John J
authors.initials: JJ
authors.lastname: Bartko
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000494:pharmacology*; D004334:Drug Administration Schedule; D004348:Drug Labeling; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D011570:Psychiatry / Q000379:methods; D012107:Research Design; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents
references.citation: Am J Psychiatry. 2002 Jun;159(6):1035-43
references.pmid: 12042194
references.citation: N Engl J Med. 2005 Sep 22;353(12):1209-23
references.pmid: 16172203
references.citation: Psychiatr Serv. 2006 Aug;57(8):1093
references.pmid: 16870958
references.citation: Arch Gen Psychiatry. 2003 Jun;60(6):553-64
references.pmid: 12796218
references.citation: Lancet. 1995 Mar 4;345(8949):557-62
references.pmid: 7539875
references.citation: Am J Psychiatry. 2000 Sep;157(9):1379-89
references.pmid: 10964850
references.citation: N Engl J Med. 2008 Apr 3;358(14):1427-9
references.pmid: 18385495
references.citation: Am J Psychiatry. 2004 Apr;161(4):700-6
references.pmid: 15056517
references.citation: Psychiatr Serv. 2003 Jan;54(1):55-9
references.pmid: 12509667
references.citation: J Clin Psychiatry. 2003 Jun;64(6):673-9
references.pmid: 12823082
references.citation: Ann Intern Med. 2006 Aug 15;145(4):284-93
references.pmid: 16908919
references.citation: Am J Psychiatry. 1999 Aug;156(8):1138-48
references.pmid: 10450252
references.citation: Am J Psychiatry. 2007 Mar;164(3):428-36
references.pmid: 17329467
references.citation: Schizophr Res. 2006 May;84(1):90-9
references.pmid: 16631354
references.citation: Am J Psychiatry. 1991 Jun;148(6):714-26
references.pmid: 1674645
references.citation: Schizophr Bull. 2002;28(1):75-84
references.pmid: 12047024
references.citation: Neuropsychopharmacology. 2003 Jan;28(1):182-92
references.pmid: 12496955
references.citation: Arch Gen Psychiatry. 2006 Oct;63(10):1074-6
references.pmid: 17015809
references.citation: J Clin Psychiatry. 2004 May;65(5):679-85
references.pmid: 15163255
references.citation: JAMA. 2008 Apr 16;299(15):1759-61
references.pmid: 18413865
references.citation: Can J Psychiatry. 2001 May;46(4):334-9
references.pmid: 11387789
references.citation: Schizophr Res. 2007 Jan;89(1-3):91-100
references.pmid: 17070017
references.citation: FDA Consum. 2004 Jul-Aug;38(4):36-7
references.pmid: 15346583
references.citation: Br J Psychiatry. 1979 Apr;134:382-9
references.pmid: 444788
references.citation: Schizophr Bull. 1987;13(2):261-76
references.pmid: 3616518
references.citation: J Clin Psychopharmacol. 2000 Jun;20(3):357-61
references.pmid: 10831024
references.citation: Arch Gen Psychiatry. 2006 Oct;63(10):1069-72
references.pmid: 17015808
references.citation: J Clin Psychiatry. 2006 Aug;67(8):1261-5
references.pmid: 16965205
references.citation: Arch Gen Psychiatry. 2006 Oct;63(10):1079-87
references.pmid: 17015810
references.citation: Int Clin Psychopharmacol. 2006 Nov;21(6):355-62
references.pmid: 17012982
references.citation: JAMA. 2008 Apr 23;299(16):1949-51
references.pmid: 18430914
references.citation: Ann Intern Med. 2006 Aug 15;145(4):305-7
references.pmid: 16908923
references.citation: Pharmacotherapy. 2006 Mar;26(3):323-32
references.pmid: 16503712
references.citation: Psychiatr Serv. 2006 Aug;57(8):1094-101
references.pmid: 16870959
references.citation: Arch Intern Med. 2006 May 8;166(9):1021-6
references.pmid: 16682577
references.citation: J Clin Psychiatry. 1999 Jul;60(7):425-6
references.pmid: 10453794
references.citation: Psychiatr Serv. 2006 Jan;57(1):21-3
references.pmid: 16399958