Unlicensed use of licensed drugs is a common feature of prescribing in general psychiatry settings. A cross-sectional survey of prescription cards for 266 psychiatric in-patients in acute wards from 14 NHS trusts found that 7.5% of 1387 prescriptions were outside the terms of the product licence: 75% of these were for indications not covered by the licence, and 25% were at doses above the recommended maximum. In all, 81 patients were prescribed at least one medicine off-label, typically for an unlicensed indication (Douglas-Hall et al, 2001). Other investigations suggest that unlicensed prescribing may be rather more common: for example, an audit of antipsychotic drug prescribing over 5 years in a secondary care NHS trust found that about 40% of prescriptions were for off-label applications (Hodgson & Belgamwar, 2006). Furthermore, a cross-sectional survey of prescriptions for mood-stabilising drugs in 249 in-patients in a tertiary care unit found that 28.5% were receiving prescriptions for unlicensed indications (Haw & Stubbs, 2005a).
The extent of unlicensed prescribing in UK psychiatric out-patient practice is uncertain, but research findings suggest that it is common in other European Union countries. A prospective evaluation of prescribing involving 209 out-patients in Italy found that over half of them were given off-label prescriptions of atypical antipsychotics (Barbui et al, 2002). A similar situation was found in a prescription review of 173 patients attending pharmacies in Austria, which revealed that two-thirds of them were receiving antipsychotics for unlicensed indications (Weiss et al, 2000). Similar practice is seen in non-European countries: for example, a prospective evaluation of prescribing of atypical antipsychotic drugs given to 73 981 combat veterans in the USA found that 42.8% of prescriptions were for unlicensed indications (Rosenheck et al, 2001).
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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