Dilemma: Off label request

I WORK as a GP and a patient of mine suffering from a chronic severe neurological condition has asked me to prescribe a drug to help with fatigue and muscle spasm. I am not familiar with the drug but on checking the BNF I see that it is available as a prescription-only medicine but not licensed for use in the patient’s condition. The patient has shown me a research paper from America that he has obtained from the internet on the use of the drug for his condition, but it refers to one small study only. He discussed the drug with his consultant but she would not agree to prescribe this. He has a doctor friend who has advised him that it could help him. I am keen to help but not sure if I should prescribe.

This can be a difficult situation to manage. All doctors want to help their patients as much as possible and in this case the patient has a distressing neurological condition where treatments are limited, but the doctor is unfamiliar with the medicine in question and wants to proceed safely.

There is detailed guidance provided by the GMC on prescribing unlicensed medications which is helpful in this scenario. The GMC defines unlicensed medicines as those that are used outside the terms of their UK licence (off label) or have no licence for use in the UK. The guidance highlights that you should usually prescribe licensed medicines in accordance with the terms of their licence.

However, you may prescribe a medicine that is unlicensed when, on the basis of an assessment of the individual patient, you decide for medical reasons that it is required to meet the needs of that patient. Unlicensed medicines are commonly prescribed in some areas of medicine such as paediatrics, psychiatry and palliative care, but can be used in other areas in certain circumstances.

Such medications may be necessary where there is no other suitable licensed drug that will meet the patient’s need, or where there is a licensed medicine but it is unavailable, for example because of a temporary shortage. They may also be prescribed as part of a properly approved research project. It is important to remember to follow GMC guidance when prescribing an unlicensed medicine. It states 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.

In addition, patients (or their parents or carers) must be given sufficient information about the medicine to allow them to make an informed decision. Where a doctor decides to prescribe an unlicensed medicine when this is not routine, or if there is a suitably licensed alternative, an explanation of the reasons for doing so must be given and recorded in the patient notes.

In the above scenario, it is the patient who has requested the medication, but the doctor is unfamiliar with its use. Doctors should only prescribe medicines when they are satisfied that the drugs or treatment serve the patient’s needs. Doctors also have a duty to work within their own sphere of knowledge and competence. If the doctor is considering prescribing the medication, he should investigate the risks and benefits in detail, including discussion with the consultant to establish why he has declined to prescribe.

Under GMC guidance, the doctor will be taking full responsibility for treatment and follow up, and so would require to have sufficient knowledge of the medication to be confident that it was appropriate and safe. He would also have to be able to present sufficient evidence to justify his prescribing decision if called upon to do so for any reason.

The desire to agree to the patient’s request to help treat his condition is understandable but if there is any doubt in the doctor’s mind about the appropriateness of the prescription, he should decline. It is of course open to him to encourage the patient to seek a second opinion on the matter.

• For further guidance consult the GMC’s Prescribing and managing medicines and devices and Good MedicalPractice.

Dr Barry Parker is a medical adviser at MDDUS and editor of Insight