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withdrawn carefully, and if effective the patient should be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
Recommendations for suggested
procedure when prescribing medication ‘off-label’
- 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
- Familiarise yourself with the evidence about
the proposed drug, including any possible drug interactions and
potential adverse effects.
- 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
- 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.
- 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
- 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.
- 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.
- Monitor the patient closely. Continue with
full documentation of its effectiveness and tolerance.
- If the treatment proves unsuccessful,
withdraw it, gradually if needed. Document the reason for the
withdrawal of treatment, then consider alternatives, using the same
- Consider writing up the case, to add to
knowledge about the drug and its use.