Prescribing unlicensed medicines
In this guidance, the term ‘unlicensed medicine’ is used to describe medicines, which are used outside the terms of their UK licence or that have no licence for use in the UK.33 Unlicensed medicines are commonly used in some areas of medicine, such as in paediatrics, psychiatry and palliative care. They are also used, albeit less frequently, in other areas of medicine.
MHRA guidance on the lawful supply and use of unlicensed medicines is set out in the MHRA publication ‘The supply of unlicensed medicinal products (“specials”)’, MHRA Guidance Note 14.
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 in the following instances.
- There is no suitably licensed medicine that will meet the patient’s need. Examples include – but are not limited to – where:34
- 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
- a medicine licensed to treat a condition or symptom in children would nonetheless not meet the specific assessed needs of the particular child, 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. 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.
c. The prescribing forms part of a properly approved research project.
d. There is a serious risk to public health and the MHRA has temporarily authorised the sale or supply of an unlicensed medicine, such as a vaccine or treatment, in response.35
e. A prescription only medicine that is unlicensed in Northern Ireland has been supplied under the Northern Ireland MHRA Authorised Route (NIMAR).36
We cannot foresee every circumstance in which it may be necessary to prescribe an unlicensed medicine to meet a particular patient’s assessed needs. If you are in any doubt, consult the MHRA or seek legal advice.
Regulation 174 of the Human Medicines Regulations 2012 allows the MHRA (the licensing authority) to permit a temporary authorisation for the supply of an unlicensed medicinal product for use in response to specific types of public health threat. This includes the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation.
The Department of Health and Social Care will be publishing guidance on NIMAR.
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 make sure that arrangements are in place 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.
Information for patients about the licence for their medicines
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, for example 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 the licence. In other cases, where prescribing unlicensed medicines is supported by authoritative clinical guidance, it may be sufficient to describe in general terms why the medicine is not licensed for the proposed use or patient population.37 In the case of a medicine supplied under NIMAR, it’s not usually necessary to draw attention to it being unlicensed in Northern Ireland. This is because the medicine will be licensed in Great Britain and have met the MHRA’s requirements for safety, quality and efficacy. You must always answer questions from patients, or their parents or carers, about medicines fully and honestly.
The Medicines for Children leaflets on unlicensed medicines, produced by the Royal College of Paediatrics and Child Health/Neonatal and Paediatric Pharmacists Group Standing Committee on Medicines, may be helpful in explaining to children and parents why such practice is common in caring for children. The British Pain Society publishes ‘Using medicines beyond licence: Information for patients’.
If you intend to prescribe unlicensed medicines where it’s not routine or if there are suitably licensed alternatives available, you should explain this to the patient, and give your reasons for doing so.
