David S. Baldwin, Nupur Tiwari and Robert Gordon Pages 3276 - 3279 ( 4 )
Pharmacological treatment forms part of much routine psychiatric practice. Many psychotropic drugs and psychotherapies are available for treating patients with mental disorders, but considerable numbers of individuals remain troubled by incapacitating symptoms even after a succession of evidence-based treatments. In this situation, many doctors consider prescribing a psychotropic medication outside the narrow terms of its market authorisation or ‘product licence’, in an attempt to optimise clinical outcomes and increase the chance of recovery. Despite expressed concerns about potential hazards and increased physician liability, many authorities agree that using a drug outside the narrow terms of its product licence can be an important part of clinical practice. This paper illustrates the nature and extent of the use of licensed drugs for unlicensed applications in psychiatric and other medical settings, indicates potential drawbacks and hazards, and makes recommendations for a suggested process when prescribing ‘off-label’, as an appropriate part of the overall management of individual patients.
Guidance, off-label, product licence, unlicensed prescribing.
University Department of Psychiatry, College Keep, 4-12 Terminus Terrace, Southampton SO14 3DT, United Kingdom.