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Are you doing the Right Thing when Prescribing Unlicensed Medicines?

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In an ideal world, you would always prescribe medicines in line with their license. Unfortunately we don’t live in an ideal world. There may be times when an unlicensed medicine is necessary, for example when no suitable licensed medicine is available or a licensed medicine is temporarily unavailable. Commonly, unlicensed medicines are used in paediatrics, psychiatry, and palliative care.

In such circumstances, a doctor will need to take a number of factors into consideration in order to ensure that medication is appropriate and also that his or her registration is not put at risk. In this article we look at the GMC guidance on prescribing unlicensed medicines, which are designed to ensure that these two objectives are met.

What is an unlicensed medicine?

As far as the GMC guidance is concerned, an unlicensed medicine is:

- A medicine with no UK license

- A medicine being used outside the terms of its license


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Factors to consider when prescribing unlicensed medicines

A medicine should only be prescribed by a doctor when he or she has:

- Considered the patient’s exact circumstances, symptoms, and condition

- There is enough evidence to conclude that the medicine being prescribed is safe

The patient should be made fully aware of all options available, and discussions should adhere to the latest guidelines on patient consent. The decision to prescribe should be made together with the patient, with the doctor ensuring that the patient is in a position to make a fully informed decision.

However, the doctor will have to use a certain amount of judgement when deciding exactly how much to tell the patient. For example, if knowledge that a medicine is unlicensed may cause distress, it may be appropriate not to discuss its unlicensed status. It might also be appropriate to only describe in general terms why a medicine is unlicensed for the proposed treatment, especially if its use is evidenced by authoritative clinical guidance.

With all the above in mind, the doctor will also need to ensure that all questions posed by the patient, parents, or carers are answered honestly and fully.

It may also be appropriate to discuss proposed medication and treatment with others in the GP practice or healthcare environment (other doctors, carers, and healthcare professionals, for example) before medication or treatment is prescribed.

Discussions that have taken place, questions asked, answers provided, and decisions taken should be documented in the patient’s medical records.

Safeguarding registration when prescribing unlicensed medicines

Of course, doctors must take responsibility for the treatment and medicine they prescribe to patients, whether or not the medicine is licensed. However, there is no extra personal liability issues when prescribing unlicensed medicines.

Here, the GMC guidance returns to the factors that have to be considered when prescribing unlicensed medicines. Careful consideration is the key, with all decisions and prescriptions able to be justified. In this regard, there is absolutely no difference in the process of prescribing either licensed or unlicensed medicines.

See further GMC guidance about prescribingunlicensed medicines.

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