Medico-legal implications of drug treatment in dementia: prescribing out of licence

AIMS AND METHOD: There is increasing evidence-based knowledge in the drug treatment of psychotic and behavioural symptoms in dementia, but drugs do not possess a formal licence for these indications. Drug companies, health authorities, NHS trusts and medical defence unions were asked for their advice on the medico-legal implications for the prescribing clinician. RESULTS: Drug companies, health authorities, medical defence unions and NHS trusts are aware of out-of-licence prescribing and leave ultimate accountability with the clinician. A suggested best practice is that of obtaining the patient's consent. CLINICAL IMPLICATIONS: Out-of-licence prescribing for psychotic and behavioural symptoms in dementia is widespread. This patient group may be unable to grant consent. The accountability of individual clinicians should be supported by more adequate medico-legal frameworks