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.