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Hot topic: Prescribing unlicensed medicines

November 2015

PillsFor clarity, in GMC guidance the term ‘unlicensed medicines’ refers to both medicines with no UK licence, and those being used outside of the terms of their licence (commonly referred to as ‘off-label’). Although there are of course differences between medicines which do not hold any UK licence and those used outside of the terms of their licence – our guidance is the same for both circumstances which is why they are grouped together in this context.

Recent debates around the Off Patent Drugs Bill have highlighted that our guidance on prescribing may be seen by some doctors as a barrier to the appropriate use of unlicensed medicines. We are keen to ensure that this is not the case and we have been working closely with the Department of Health, MHRA, NICE and others to understand the challenges faced by doctors in this area.

We recognise that unlicensed medicines are commonly used in many areas of medicine such as paediatrics, psychiatry and palliative care. This Hot Topic aims to explain our guidance and assure doctors that the GMC does not wish to prevent doctors from prescribing unlicensed medicines when clinically appropriate.

When is it appropriate to prescribe unlicensed medicines?

While you should usually prescribe licensed medicines in accordance with the terms of their licence, we recognise that there may be instances where you conclude for medical reasons that unlicensed medicines are necessary to meet your patient’s needs. This could be for a variety of reasons, for example if there is no suitable licensed treatment available, or the licensed treatment is temporarily unavailable.

What do I need to consider when prescribing unlicensed medicines?

When deciding on the best treatment for a patient you should weigh up all of the options, taking into account the evidence available. You should be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy.

Decisions should be made in collaboration with the patient by discussing the options with them and ensuring that they have sufficient information about the medicine to allow them to make an informed decision.

We expect you to use your judgement when deciding on the level of information needed. 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 to the patient in general terms, why the medicine is not licensed for the proposed use.

You must always answer questions from patients (or their parents or carers) about medicines fully and honestly. You should listen to their concerns, ask for and respect their views, and encourage them to ask questions.

You should also consider discussing the options with colleagues or experts and getting advice from them on the appropriateness of the treatment.

Am I putting my registration at risk when I prescribe unlicensed medicines?

Doctors are often worried about prescribing unlicensed medicines as we say that they must take responsibility for the prescription, but of course we expect this whether the medicine is licensed or not. You are responsible for all prescriptions you sign and your decisions and actions when supplying and administering medicines and devices (or when they authorise or instruct others to do so).

Contrary to recent suggestions, GMC guidance does not include reference to any extra personal liability in relation to prescribing unlicensed medicines.

We expect you to carefully consider any treatment that you prescribe, and we expect you to be able to justify your decisions and actions when prescribing, administering and managing medicines regardless of whether they are licensed or unlicensed.

Importantly, prescribing unlicensed medicines will not put your registration at risk any more than other areas of practice covered by our guidance.