Whether you prescribe with repeats or on a one-off basis, you must make sure that suitable arrangements are in place for monitoring, follow-up and review, taking account of the patients’ needs and any risks arising from the medicines.
When you review a patient’s medicines, you should re-assess the patient’s need for unlicensed medicines (see paragraphs 67 - 70), for example antipsychotics used for the treatment of behavioural and psychological symptoms in dementia.
The term ‘unlicensed medicine’ is used to describe medicines that are used outside the terms of their UK licence or which have no licence for use in the UK.22 Unlicensed medicines are commonly used in some areas of medicine such as in paediatrics, psychiatry and palliative care. They are also used, less frequently, in other areas of medicine.
You should usually prescribe licensed medicines in accordance with the terms of their licence. However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.
Prescribing unlicensed medicines may be necessary where:
- There is no suitably licensed medicine that will meet the patient’s need. Examples include (but are not limited to), for example, where:23
- there is no licensed medicine applicable to the particular patient. For example, if the patient is a child and a medicine licensed only for adult patients would meet the needs of the child; or
- a medicine licensed to treat a condition or symptom in children would nonetheless not meet the specific assessed needs of the particular child patient, but a medicine licensed for the same condition or symptom in adults would do so; or
- the dosage specified for a licensed medicine would not meet the patient’s need; or
- the patient needs a medicine in a formulation that is not specified in an applicable licence.
- Or where a suitably licensed medicine that would meet the patient’s need is not available. This may arise where, for example, there is a temporary shortage in supply; or
- The prescribing forms part of a properly approved research project.
When prescribing an unlicensed medicine you must:
- be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
- take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so
- make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing an unlicensed medicine.
Reviewing medicines will be particularly important where:
- patients may be at risk, for example, patients who are frail or have multiple illnesses
- medicines have potentially serious or common side effects
- the patient is prescribed a controlled or other medicine that is commonly abused or misused
- the BNF or other authoritative clinical guidance recommends blood tests or other monitoring at regular intervals.
Pharmacists can help improve safety, efficacy and adherence in medicines use, for example by advising patients about their medicines and carrying out medicines reviews. This does not relieve you of your duty to ensure that your prescribing and medicines management is appropriate. You should consider and take appropriate action on information and advice from pharmacists and other healthcare professionals who have reviewed patients’ use of medicines, especially following changes to their medicines or if they report problems with tolerance, side effects or with taking medicines as directed.