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Sessional GPs threatened by deanery cuts

Should you prescribe unlicensed

drugs for intractable migraine?

Three GPs share their approach to a clinical problem

Case history

Mr Smith is in his 40s and has had migraine since he was a teenager. He finds triptans are the only things that work, but he is getting through a pack of six tablets every two or three weeks.

Both you and he are concerned about this, and you have referred him to a neurologist who confirmed the diagnosis, and made recommendations for preventive therapy.

Mr Smith has tried and rejected pizotifen, propranolol, amitriptyline and carbamazepine because of side-effects. The neurologist's letter suggests two other drugs, but these aren't licensed for migraine.

Dr Kavi Sharma

'It's not our policy to prescribe unlicensed drugs unless it is routine practice to do so'

My first impression is that this scenario doesn't present great difficulty. Mr Smith has a clear diagnosis of migraine, confirmed by a neurologist. The management plan for his triptans seems to be safe, effective and acceptable to the patient. The alternative ­ prescribing a prophylactic drug ­ has too many side-effects.

But Mr Smith and I are both concerned. Why should that be? Does Mr Smith think the triptans are dangerous or too expensive? Why am I concerned? Is it safety? Or is it that my partners won't be happy about the cost of the drugs?

I think I would know Mr Smith quite well by now because he has consulted many times. I suspect he wants his problem to be resolved now.

I would therefore do some preparation. Are the triptans safe? Are there any contraindications? How much does the drug cost? I would check the BNF and ask my local pharmacist.

I would also ring the neurologist and discuss whether the unlicensed drugs are likely to be effective, and whether he would be willing to prescribe them. I would explain that it is not our practice policy to prescribe unlicensed drugs unless it is routine practice to do so. I would then discuss all these factors at the next practice meeting and come to an agreement. I now have all the information I need for a consultation with Mr Smith.

During this consultation I would ask Mr Smith about his concerns and try to address them. I would also ask him how well the triptans are working, whether there are any side-effects and what the effect on his life would be if he stopped taking them.

I would then give him the choice of continuing with the triptans or trying one of the drugs the neurologist recommended. I would explain that these drugs are unlicensed and can only be prescribed by the consultant.

If he agrees to continue with the triptans I would give him 18 tablets and ask him to come back in six weeks for review.

Kavi Sharma has been a GP for 17 years in Sunderland ­ he is a GP trainer and a course organiser for Northumberland VTS

Dr Patricia Cahill

'It's reassuring that

I will be prescribing with the support of an expert'

Someone who has had migraines for as long as Mr Smith will be very experienced in their condition and may be more knowledgeable about it than their doctor. To access medication on prescription Mr Smith is likely to need to go to his GP.

Hopefully we have already explored triggers, lifestyle issues and features of a concomitant illness that could be connected to this escalation of his migraine. I would tactfully discuss them again now that the consultant has confirmed the diagnosis.

I would ask Mr Smith if he wants to try one of the two drugs the neurologist suggested. I'd explain that they are 'unlicensed' and that this means they aren't approved as medications for migraine. I would have to be sure he understands this and appreciates that, like the more conventional medication he has already tried, the drugs may not help and could have side-effects. I would record this discussion.

I am not necessarily precluded from prescribing a drug that isn't licensed for an indication, especially if it's common practice in the situation and if there is strong evidence to back it up. I'd have to make sure I know how to prescribe and monitor the drug when used for people with migraine.

It's reassuring that I will be prescribing the drug off-licence with the support and on the recommendation of an expert. Legally, however, responsibility falls to the doctor who signs the prescription, who must act in the best interest of the patient. It's possible that even the consultant was pushed into making suggestions he would not normal have done by a desperate Mr Smith.

If I am familiar with the drug but not sure how suitable it is for Mr Smith, or if I am not familiar with the drug at all, I would need to explain honestly to Mr Smith that I need to get more information before I am in a position to prescribe it.

Patricia Cahill has been a GP for nine years ­ she practises in Ipswich, Suffolk

Dr Rupal Shah

'It's surprising that the neurologist has suggested these drugs but not prescribed them'

I would want to know whether Mr Smith's migraines have been getting worse recently, or whether they have always been this frequent. If they have been more of a problem lately I

would want to know if there is an obvious explanation.

Has he been suffering from stress at home or work? Is there anything that has been worrying him recently? Has he tried avoiding foods that might trigger an attack?

I would want to be certain the neurologist had excluded any serious cause for the headaches and that Mr Smith had been investigated fully. Assuming this is the case, I would focus on optimising Mr Smith's migraine treatment.

It's important to find out more about the side-effects Mr Smith has reported with the preventive treatment we have already tried.

It's unusual to get severe adverse reactions from all of these drugs and I'd want to see whether he might be able to tolerate any of them at a lower dose. Perhaps he is just frightened of taking long-term medication.

It might also be worth phoning the drug information service to ask about the risks of taking triptans so frequently. I would also need to check that Mr Smith is using them correctly, for example that he isn't taking more than one dose of triptan for any given migraine, unless it recurs.

It's possible that Mr Smith isn't using all the tablets himself. He might be giving them to someone else, or even selling them. I might need to explore this tactfully, but it would obviously be a very difficult subject to bring up.

I'd want to discuss the unlicensed drugs with the neurologist so that I'm clear about possible side-effects and any necessary monitoring, as well as the proposed duration of treatment.

It's surprising that the neurologist has suggested these drugs but hasn't prescribed them himself or arranged follow-up. Depending on what they are and how comfortable I feel about prescribing them, I might ask him to do this.

Rupal Shah completed the VTS in 2002 ­ she is a GP in west London

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