Off-label prescribing to children is common in primary care settings in the UK (Ekins-Daukes et al, 2005). Psychotropic drug prescribing has become a more common aspect of practice in child and adolescent psychiatry (Bramble, 1992, 2003; McNicholas, 2001), but the full extent of unlicensed prescribing in UK child and adolescent mental health services is unknown. A questionnaire survey of community child and adolescent psychiatrists in the West Midlands found that 88% of doctors reported issuing prescriptions for antidepressants and 63% for antipsychotics: it can be assumed most of these prescriptions were for unlicensed indications; two-thirds reported prescribing the unlicensed compound melatonin (Doerry & Kent, 2003).
In Germany, a retrospective study of over 1.74 million prescriptions written for 400 000 children by primary care physicians found that 13.2% were for unlicensed applications: substantial proportions of the prescriptions for antidepressants (36.6%) and antipsychotics (10.2%) were off-label (Bu"cheler et al, 2002). In Holland, a national survey of all child psychiatrists found that off-label prescribing was common (Hugtenburg et al, 2005). In the USA, a cross-sectional population-based study in three health maintenance programmes over 5 years found that the number of prescriptions of psychotropic drugs had increased dramatically between 1991 and 1995, many of them being for unlicensed applications (Zito et al, 2000). A study of adolescents consecutively admitted to a US private psychiatric hospital found that over half of them were prescribed antipsychotics, 73% of these prescriptions being for mood or anxiety disorders (Pogge et al, 2007). In Australia, a nationwide survey of general paediatricians and child and adolescent psychiatrists found that 40% reported off-label prescribing of psychotropics, including antidepressants, psychostimulants, anti-psychotics and mood stabilisers (Efron et al, 2003).
In a consensus statement, the British Association for Psychopharmacology (1997) noted that it appears reasonable to extrapolate what is known about drug treatment responses in adults to children and adolescents in the case of schizophrenia and obsessive–compulsive disorder, but that more caution is required in the case of mood and anxiety disorders. A policy statement on the use of unlicensed medicines or licensed medicines for unlicensed applications issued by the UK Royal College of Paediatrics and Child Health (2000) makes a number of clear recommendations regarding this aspect of child healthcare.
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.
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