A survey of off-label prescribing for inpatients with mild intellectual disability and mental illness

St. Andrew's Hospital, Northampton, UK.
Journal of Intellectual Disability Research (Impact Factor: 2.41). 12/2005; 49(Pt 11):858-64. DOI: 10.1111/j.1365-2788.2005.00723.x
Source: PubMed


The term 'off-label prescribing' refers to the use of a drug outside the terms of its Marketing Authorisation, including prescribing for an unlicensed indication. There have been few reports about off-label prescribing in psychiatry. The aims of the study were to determine the frequency of off-label prescribing of psychotropics for inpatients with mild intellectual disability (ID) and mental illness resident in a large psychiatric hospital, the nature of the off-label clinical indications and details about patient consent and case note documentation of the off-label usage.
Cross-sectional survey of inpatients of the ID division of a charitable hospital was carried out. Interviews with consultant psychiatrists about off-label use of psychotropics were also made.
Of the 56 patients studied, 38 (67.9%) were receiving one or more psychotropic drugs and 26 (46.4%) were receiving at least one off-label psychotropic. The most frequently cited off-label indications were: reduction of aggression, arousal and behavioural disturbance (14 cases) and mood stabilization of affective disturbance (13). The principle psychotropics involved were atypical antipsychotics (17 cases) and mood stabilizers (13). Although in most instances the psychiatrist was aware the drug was being used off-label and had consulted other professionals, in only two (6%) instances had the patient been informed of the off-label usage, largely because the psychiatrist felt they lacked the capacity to understand the off-label concept. In most cases the off-label usage had not been documented in the case notes.
Off-label prescribing is common in patients with comorbid ID and mental disorder. When prescribing off-label, psychiatrists need to consider the evidence that the drug is likely to be effective for the unlicensed indication and any risks involved. 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. However, many patients with ID cannot understand the off-label concept. In some circumstances psychiatrists may find it helpful to consult other professionals before prescribing off-label. Good case note documentation of the process is important and supports the prescriber.

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    • "In relation to medication, Haw and Stubbs (2005) found that only 6% of patients with LD being prescribed off-label psychotropic medication had been informed of this fact; however, they found similar results with mental health patients without a learning disability. Arscott et al. (2000) investigating the knowledge of people with intellectual disabilities about their prescribed medication concluded that participants had insufficient understanding to give informed consent. "
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    ABSTRACT: This paper is a report of an integrative review of informed consent to healthcare interventions in people with learning disabilities. Consent to treatment lies at the heart of the relationship between patient and healthcare professional. In order for people with learning disabilities to have equity of access to health care, they need to be able to give informed consent to health interventions--or be assessed as incompetent to give consent. The British Nursing Index (BNI), CINAHL, MEDLINE, Social Care Online, ERIC and ASSIA and PsycINFO databases were searched using the search terms: Consent or informed choice or capacity or consent to treat* or consent to examin* AND Learning disab* or intellectual* disab* or mental* retard* or learning difficult* or mental* handicap*. The search was limited to papers published in English from January 1990 to March 2007. An integrative review was conducted and the data analysed thematically. Twenty-two studies were reviewed. The main themes identified were: life experience, interaction between healthcare professionals and participants, ability to consent, and psychometric variables. A consensus seemed to emerge that capacity to consent is greater in people with higher cognitive ability and verbal skills, but that the attitudes and behaviour of healthcare professionals was also a crucial factor. The findings support use of the functional approach to assessing mental capacity for the purpose of obtaining informed consent. Future research into informed consent in people with learning disabilities is needed using real life situations rather than hypothetical vignettes.
    Full-text · Article · Jan 2009 · Journal of Advanced Nursing
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