Haw, C. and Stubbs, J. (2005) A survey of the off-label use of mood stabilizers in a large psychiatric hospital. Journal of Psychopharmacology. 19(4), pp. 402-407. 0269-8811.
| Item Type: | Article |
|---|---|
| Abstract: | The term 'off-label' prescribing refers to the use of a drug outside the terms of its Marketing Authorization, including prescribing for an unlicensed indication. The aims of the study were to determine the frequency of off-label prescriptions for mood stabilizers (lithium and antiepileptics) among inpatients of a large psychiatric hospital, the nature of the off-label clinical indications in use and whether patients had been informed about the off-label usage. A cross-sectional survey of inpatients aged 18-65 years at St Andrew's Hospital, Northampton, UK and interviews with consultant psychiatrists about off-label usage of mood stabilizers were carried out. Of the 249 patients studied, 75 (30.1%) were receiving one or more mood stabilizers, of which 71 (94.7%) were off-label. The most frequently cited off-label indications for mood stabilizers were: prophylaxis of mood swings (48 cases), treatment of aggression (31), manic symptoms (10), antipsychotic augmentation in treatment-resistant schizophrenia (7) and post-traumatic stress disorder (6). Lithium was prescribed infrequently. The reasons for this are discussed. Although in most instances the psychiatrist was aware the drug was being used off-label, in less than one-third of cases had the patient been informed of this, partly because of anticipated difficulties in their understanding the off-label concept, but also because of concerns that this information could adversely affect compliance. The off-label prescription of mood stabilizers is very common in psychiatry and such usage benefits patients. When prescribing off-label, psychiatrists should consider the evidence that the drug is likely to be effective for the unlicensed indication. Where there is limited evidence of benefit, a trial of the drug, with clinical monitoring, may be indicated. Patients should be fully informed about their medication, and this includes information that the prescription is off-label. Pharmacists can assist this process. The off-label concept may be difficult for some patients to understand. |
| Uncontrolled Keywords: | off-label prescribing, unlicensed indications, mood stabilizers, anticonvulsants, mood disorders, mania, aggression, schizophrenia, survey |
| Subjects: |
R Medicine > RM Therapeutics. Pharmacology > RM138 Drug prescribing R Medicine > RM Therapeutics. Pharmacology > RM300 Drugs and their actions > RM315 Psychopharmacology |
| Creators: | Haw, Camilla and Stubbs, Jean |
| Publisher: | SAGE Publications |
| Northamptonshire and East Midlands: | Health |
| Faculties, Divisions and Institutes: |
University Faculties, Divisions and Research Centres - OLD > Faculty of Health & Society > Mental Health and Learning Disability Faculties > Faculty of Health & Society > Nursing |
| Date: | July 2005 |
| Date Type: | Publication |
| Page Range: | pp. 402-407 |
| Journal or Publication Title: | Journal of Psychopharmacology |
| Volume: | 19 |
| Number: | 4 |
| Language: | English |
| DOI: | https://doi.org/10.1177/0269881105053307 |
| ISSN: | 0269-8811 |
| Status: | Published / Disseminated |
| URI: | http://nectar.northampton.ac.uk/id/eprint/6271 |
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