Psychotropic drugs are often prescribed for unlicensed indications in people with mental health problems and behavioural challenges arising from developmental delay or arrest. Common indications include the management of sleep disturbances, increased arousal and self-injurious behaviour, and problems related to behavioural changes resulting from epilepsy syndromes and dementing disorders.
A cross-sectional survey of psychotropic drug prescribing in in-patients with intellectual disability found that 46.4% were receiving at least one psychotropic for an unlicensed indication, most typically in an attempt to manage behavioural problems or to stabilise mood (Haw & Stubbs, 2005b).
The dearth of randomised controlled trials in this patient population means that most prescriptions are outside of product licences, although lithium is licensed for the management of aggressive or self-mutilating behaviour. Most of the common interventions are supported by retrospective case series analysis only. A review of the use of atypical antipsychotics in people with autistic-spectrum disorders reflects current thinking in the wider field of developmental neuropsychiatry and intellectual disability (Barnard et al, 2002). Uncertainties regarding diagnosis and capacity to consent, and associated physical health problems, must all be considered when formulating potential treatment approaches (British Association for Psychopharmacology, 1997) and psychotropic drug prescription is usually only one component of a multifaceted management approach.
David S. Baldwin and Nick Kosky
David Baldwin is Reader in Psychiatry in the Clinical Neuroscience Division of Southampton University’s School of Medicine (University Department of Mental Health, Royal Southants Hospital, Brintons Terrace, Southampton SO14 0YG, UK. Email: dsb1@soton.ac.uk) and Honorary Consultant Psychiatrist with the Mood Disorders Service, Hampshire Partnership Trust. He was Chair of the working group of the Royal College of Psychiatrists’ Psychopharmacology Special Interest Group (PSIG) on unlicensed applications of licensed drugs in psychiatric practice. His research interests include the clinical pharmacology of anxiety and depressive disorders. He leads a tertiary referral service for patients with chronic and severe mood and anxiety disorders. Nick Kosky is Consultant Psychiatrist and Clinical Director of Dorset Primary Care Trust. He was a member of the PSIG working group. He is interested in teaching psychopharmacology to non-medical staff and delivering high-quality prescribing. He is part of a prison mental heath in-reach team.
Anonymous (1992) Prescribing unlicensed drugs or using drugs for unlicensed indications. Drug and Therapeutics Bulletin, 30, 97–99.[Medline]
Ansani, N., Sirio, C., Smitherman, T., et al (2006) Designing a strategy to promote safe, innovative off-label use of medications. American Journal of Medical Quality, 21, 255–261.[Abstract/Free Full Text]
Barbui, C., Danese, A., Guaiana, G., et al (2002) Prescribing second-generation antipsychotics and the evolving standard of care in Italy. Pharmacopsychiatry, 35, 239–243.[CrossRef][Medline]
Barnard, L., Young, A. H., Pearson, J., et al (2002) Systematic review of the use of atypical antipsychotics in autism. Journal of Psychopharmacology, 16, 93–101.[Abstract]
Beck, S., Paton, C., Euba, R., et al (2001) Atypical antipsychotics in the elderly. International Journal of Psychiatry in Clinical Practice, 5, 257–261.[CrossRef]