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The risks of unlicensed prescribing

The MDU regularly receives calls from members about their position when prescribing unlicensed or off-label drugs. Here the MDU's Dr Nicholas Norwell clarifies the situation

Q A 60-year-old patient came to see me last week having read on a health website that neuroleptic medicines could be the solution to

his long-term sleep problems. He mentioned various antipsychotic medications that are not licensed for stand-alone sleep problems, but were cited as being useful in conjunction with anti-depressants. He has been prescribed

anti-depressants with little effect on his sleep problems. How should I respond to his request?

A You can prescribe an unlicensed drug for an unlicensed indication if, in your clinical judgment, there is a need to do so. But you must take reasonable care and act in a way that is consistent with the practice of a responsible body of medical opinion.

You have a duty, under GMC guidelines, to prescribe drugs or treatments only where you are satisfied that the drugs or treatment serve the patient's needs. And you are

obliged to provide effective treatments based on the best available evidence.

You must also bear in mind the GMC's specific guidance on prescribing unlicensed medications.

First you should explain to the patient that the drugs, although they have a

product licence for certain indications, do not have a UK licence for use as hypnotics and so their use in this way would be unlicensed.

You should also make it clear what the known side-effects are but also explain that there may be other unknown problems that arise with use.

Make a full note of the conversation in the notes. If you intend to prescribe, you should satisfy yourself that there is a responsible body of medical opinion that would support your decision to use these drugs in this way. You may wish to seek clinical advice from an experienced colleague or specialist.

If you decide to go ahead with the treatment you would need to make appropriate arrangements for monitoring and reviewing the drug.

The ethical position

The MDU often receives calls similar to the above from members about their legal and ethical position when prescribing unlicensed or off label drugs. GPs are concerned about patient safety and their ethical and legal responsibilities. This is an area that can give rise to complaints and claims – for example, if patients suffer ill-effects or are damaged and later allege that they were unaware a medication was unlicensed or being used outside the terms of its licence.

There is no reason why GPs cannot prescribe an unlicensed or off-label medication, but there are a number of legal and ethical issues to bear in mind.

The MDU advises members prescribing unlicensed medicines that they should be prescribed on a patient-named basis. Doctors may wish to reassure themselves that there is a responsible body of medical opinion that would support their prescription.

It is advisable to tell patients that the medicine is unlicensed in obtaining their consent or, in the case of children who are not competent to decide for themselves, authority should be obtained from their


Patients need to be fully informed about the proposed treatment, including the options open to them and the associated risks and uncertainties. In Good Medical Practice (2006) the GMC advises (in paragraph 3) that doctors 'prescribe drugs or treatment only when they have adequate knowledge of the patient's health and are satisfied that the drugs or treatment serve the patient's needs' and to 'provide effective treatments based on the best available evidence'.

The GMC has specific advice on prescribing unlicensed medications, in Good Practice in Prescribing Medicines (2006).

In paragraphs 18, 20 and 21 it states that doctors should be satisfied that there is a sufficient evidence base for using the medicine and that an alternative medication would not better meet the patient's needs. Doctors need to explain the reason for using the drug and give sufficient information to allow patients to make an informed decision about the treatment including any known serious side-effects or adverse reactions. If the manufacturer's information is of limited help, the GMC says that the necessary information must be sought from other sources.

Doctors also need to make a contemporaneous clinical record of the reasons for their decision and the discussion with the patient, and to arrange appropriate monitoring and follow-up.

If prescribing an unlicensed vaccine, it is also worth bearing in mind it may not be covered by the vaccine damage payment scheme. In the event of a patient suffering ill-effects, the patient would not be eligible for payment under the scheme and GPs may personally face a claim for negligence.

Off-label prescribing

GPs are also sometimes asked to prescribe medications, which although licensed, are to be used outside the terms of their licence – otherwise known as off-label prescribing. This is likely to occur most often when prescribing for children, as drugs developed for adults are not always tested for children and so are only licensed for adult treatment. When prescribing off-label, the GMC's guidance states doctors must:

• Be satisfied that it would better serve

the patient's needs than an appropriately

licensed alternative.

• Be satisfied that there is a sufficient

evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help, in which case the necessary information must be sought from other sources.

• Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and follow-up treatment, or arrange for another 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 the medicine

(paragraph 20).

If you are considering prescribing an unlicensed or off-label drug and are uncertain about your ethical and legal responsibilities you may wish to contact your medical defence organisation for specific advice.

The case mentioned at the start of the article is

fictitious, but based on cases from the MDU's files. GPs with specific concerns are advised to contact their medical defence organisation for advice.

Dr Nicholas Norwell is a medicolegal adviser with the MDU

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