How Specials Can Deliver Value to the NHS | Página 7

The role of the prescriber – best practice GMC (General Medical Council)11
Prescribing unlicensed medicines may be necessary where:
a. There is no suitably licensed medicine that will meet the patient’s need; for example, where there is no
licensed medicine applicable to the particular patient such as:
• if the patient is a child and a medicine licensed only for adult patients would meet the needs of the child;
• 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;
• the dosage specified for a licensed medicine would not meet the patient’s need
• the patient needs a medicine in a formulation that is not specified in an applicable licence.
b. 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
c. The prescribing forms part of a properly approved research project.
When prescribing an unlicensed medicine you must:
a. be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety
and efficacy
b. 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.
c. 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.
You must give patients (or their parents or carers) sufficient information about the medicines you propose to
prescribe to allow them to make an informed decision.
Some medicines are routinely used outside the terms of their licence, such as in treating children. In
emergencies or where there is no realistic alternative treatment and such information is likely to cause distress,
it may not be practical or necessary to draw attention to ѡ