A survey of off-label prescribing for inpatients with mild intellectual disability and mental illness
ABSTRACT 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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ABSTRACT: Forty-eight adults diagnosed with intellectual disabilities and Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified were examined with regard to psychotropic medication side effects. Participants were divided into 4 groups: no psychotropic medication group (n = 9); atypical antipsychotic medication group (n = 13); atypical antipsychotic and antiepileptic drug group (AEDs/mood stabilizers; n = 13); and a group of individuals receiving atypical antipsychotic medication, AEDs/mood stabilizers, and anxiolytics (n = 13). Those participants not currently prescribed any psychotropic medications evinced the fewest side effects. Participants prescribed psychotropic medication across multiple classes evinced more side effects. Thus, persons receiving atypical antipsychotic medication, AEDs/mood stabilizers, and anxiolytics had the greatest number of side effects. More specifically, the greatest number of side effects pertained to the CNS-Parkinsonism/Dyskinesia subscale.Journal of Mental Health Research in Intellectual Disabilities 04/2010; 3(2):85-96. DOI:10.1080/19315861003690588
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ABSTRACT: Aim. Analyze prescriptions in public hospital psychiatric practice. Methods. Psychiatric and somatic prescriptions were analyzed a given day regarding their indication, dosage, treatment duration, and prescription scheme. Consultants were individually asked for the reasons of off-label prescriptions. Results. Five thousand eighty-six lines of prescription were recorded for 495 patients, showing a total of 34% off-label prescriptions, including 43.5% for psychiatric medications and 22.7% for somatic medications. Psychiatric medications: 22.3% were off-label for indication, 13.1% for dosage, 4.5% for treatment duration, and 6.2% for prescription scheme. (off-label prescriptions for indication: 12.1% without clonazepam - which delivery have been restricted by the end of 2011). Somatic medications: respectively 4.5%, 14.9%, 4.8% and 12.5%. Conclusions. Percentage of off-label prescriptions for indication of psychiatric medications was clearly less than percentages published in the literature (other percentages are new). While most of off-label prescriptions were made in accordance with clinical reports in the literature, some others were not.Thérapie 11/2013; 68(6). DOI:10.2515/therapie/2013054 · 0.40 Impact Factor
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ABSTRACT: Psychotropic drugs are a cornerstone in the treatment of psychopathology and/or behavioral problems in children with intellectual disability (ID), despite concerns about efficacy and safety. Studies on the prevalence of psychotropic drug use have mainly been focused on adults with ID or children without ID. Therefore the aim of this cross sectional study was to assess the prevalence and characteristics of psychotropic drug use in children with mild ID who were institutionalized in specialized inpatient treatment facilities in The Netherlands. Demographic data, psychiatric diagnoses, the nature of the behavioral problems, level of intellectual functioning, and medication data were extracted from medical records using a standardized data collection form. Adjusted relative risks (ARR) for the association between patient characteristics and psychotropic drug use were estimated with Cox regression analysis. Of the 472 included children, 29.4% (n=139) used any psychotropic drug, of which 15.3% (n=72) used antipsychotics (mainly risperidone), and 14.8% (n=70) used psychostimulants (mainly methylphenidate). Age, sex, and behavioral problems were associated with psychotropic drug use. Boys had a 1.7 (95%CI 1.1-2.4) higher probability of using psychotropic drugs, compared to girls adjusted for age and behavioral problems. Having any behavioral problem was associated with psychotropic drug use with an ARR of 2.1 (95%CI 1.3-3.3), adjusted for sex and age. The high prevalence of psychotropic drug use in children with ID is worrisome because of the lack of evidence of effectiveness (especially for behavioral problems) at this young age, and the potential of adverse drug reactions.Research in developmental disabilities 07/2013; 34(10):3159-3167. DOI:10.1016/j.ridd.2013.06.009 · 4.41 Impact Factor