Use of licensed medicines for unlicensed applications in psychiatric practice

Pharmacological treatment is an important component of much of psychiatric practice. Many psychotropic medications and psychological interventions are available for patients with mental health problems, but patients often remain troubled by distressing symptoms despite undergoing a series of pharmacological and psychological treatments. In this situation, doctors may wonder whether they might prescribe a medication outside the narrow terms of its market authorisation (‘product licence’) in an attempt to improve clinical outcomes. Many authorities agree that use of a drug outside the terms of its licence can be a necessary and beneficial part of clinical practice, whereas others have raised concerns about patient safety and medical liability. The Royal College of Psychiatrists first issued guidance on recommended procedures for the use of licensed medicines for unlicensed applications in psychiatric practice in 2007. In the subsequent decade, evidence on this aspect of practice has increased and other bodies have also provided guidance (e.g. General Medical Council, 2013). The Royal College of Psychiatrists’ Psychopharmacology Committee was therefore asked to consider and, if necessary, revise current College guidance and did so in consultation with representatives from the British Association for Psychopharmacology (BAP). We considered the potential benefits and risks of this aspect of clinical practice and believe that prescription of a drug outside the narrow terms of its market authorisation can be an appropriate part of overall management and in the best interests of a patient. The Committee strived to make ten balanced recommendations that it judged would be feasible to implement within current psychiatric practice.