Use of licensed medicines for unlicensed applications in psychiatric practice

College Report CR142, January 2007, Royal College of Psychiatrists £ 7.50, 32 pp

Drug treatment is an essential part of much of psychiatric practice in patients from a wide age range and across many diagnostic groups. Despite the availability of many classes of psychotropic drugs, a substantial proportion of patients will remain troubled by persistent, distressing and impairing symptoms, even after a succession of licensed pharmacological treatments. In this situation, many psychiatrists will consider the prescription of psychotropic drugs outside the narrow terms of their licence, as part of an overall plan of management.

As this aspect of clinical practice in psychiatry has recently come under some scrutiny, a working group of the Special Interest Group in Psychopharmacology (SIGP) of the Royal College of Psychiatrists was convened to examine the nature and extent of the use of licensed psychotropic drugs for unlicensed applications in psychiatric practice, to consider any potential benefits and risks associated with this aspect of clinical practice, to outline when this may be an appropriate part of the management of individual patients, and to make balanced recommendations for a suggested procedure when prescribing licensed medication for unlicensed applications.

This College Report summarises the discussions and conclusions of the working group, and incorporates feedback from the wider membership of the SIGP. It is recommended that unlicensed prescribing should only occur when licensed treatments have been used or excluded on clinical grounds; and when the prescriber is familiar with any possible benefits and risks of the medication being considered, and feels confident with the proposed treatment. Whenever possible the agreement of the patient should be obtained; but if not possible, this should be noted. Prescriptions should be started cautiously, and the subsequent progress of the patient should be monitored closely. If the treatment proves ineffective it should be withdrawn carefully and if effective, the patient should be reviewed regularly. This aspect of prescribing practice may be a suitable area for review within continuous professional development peer groups and for clinical audit within mental health services.