A survey of off-label prescribing for inpatients with mild intellectual disability and mental illness.
Off-label psych med use in adults with mild ID is common and poorly documented—audit and document every script.
01Research in Context
What this study did
The team looked at hospital records for adults with mild intellectual disability and mental illness. They wanted to know how many received psych meds for reasons not on the label.
They also checked if staff wrote down why the med was chosen and if the patient or family agreed.
What they found
Almost half of the inpatients took at least one off-label psych drug. Most of these drugs were given to calm aggression or lift mood.
Consent forms and notes explaining the choice were missing most of the time.
How this fits with other research
Heavey et al. (2000) already warned that 1990s studies backing these meds were weak. The new survey shows the habit continued into 2005.
Petrovic et al. (2016) later found the same 46 % rate of metabolic syndrome in inpatients on antipsychotics. Together the papers trace a line: off-label use stays common while health risks grow.
La Valle et al. (2025) widened the lens. Their 2025 med reviews show people with ID now average eight over-the-counter drugs each. The pill pile keeps growing, just as Hatton et al. (2005) first flagged poor tracking.
Why it matters
If you serve adults with ID, pull your med sheets today. Flag any drug without a clear target behavior and a signed consent. Add a data sheet for weight, blood sugar, and behavior. One quick audit can spark a doctor review and cut risk.
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02At a glance
03Original abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Journal of intellectual disability research : JIDR, 2005 · doi:10.1111/j.1365-2788.2005.00723.x