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The Royal College of Psychiatrists Improving the lives of people with mental illness

CR142. Use of licensed medicines for unlicensed applications in psychiatric practice

Price: £7.50

Approved: Oct 2005

Published: Jan 2007

Status: under review

Number of pages: 32

Review by: 2009

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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, which incorporated feedback from the wider membership of the SIGP. It is recommended that unlicensed prescribing should 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 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 If the treatment proves ineffective it should be withdrawn carefully, and if effective the patient should be reviewed regularly.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.


Recommendations for suggested procedure when prescribing medication ‘off-label’


  1. Check that medicines with a product licence have either had a proper therapeutic trial or been considered, but excluded on clinical grounds (such as contraindications and risk of interactions).
  2. Familiarise yourself with the evidence about the proposed drug, including any possible drug interactions and potential adverse effects.
  3. If the medicine to be used does not have a substantial evidence-base supporting its use for the proposed indication, or if you are not sufficiently expert in this field, or have particular concerns, obtain the advice of another doctor or specialist pharmacist.
  4. Consider the risks and benefits of the proposed treatment. Particular consideration is needed with children, older patients, and in those with impaired insight and judgement. Document this.
  5. Give the patient (or his/her relative, when relevant) a full explanation, including the information that the drug will be used outside its product licence. Document this explanation.
  6. If agreement from the patient (or his/her relative, when needed) is obtained, document this approval. If a patient is unable to consent to a necessary treatment, note that it has not been possible to obtain consent.
  7. Begin a cautious trial of treatment with the medicine. In out-patients, consider sending the patient a copy of any letter sent to his/her general practitioner, summarising why this approach has been adopted.
  8. Monitor the patient closely. Continue with full documentation of its effectiveness and tolerance.
  9. If the treatment proves unsuccessful, withdraw it, gradually if needed. Document the reason for the withdrawal of treatment, then consider alternatives, using the same process.
  10. Consider writing up the case, to add to knowledge about the drug and its use.


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