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LETTERS: S Guiton, David M Reith, and Valerie L Isitt Off label prescribing in children BMJ 2002; 325: 338 [Full text]

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Treated like a dog?

Theo H Fenton   (9 August 2002)

Off-label prescribing

Peter H.M. Brooks   (20 December 2007)

Treated like a dog? 9 August 2002
Theo H Fenton, Consultant Paediatrician Mayday Hospital, Crodon CR7 7YE Send response to journal: Re: Treated like a dog?	Before vets prescribe off-label drugs, they obtain written consent from the animal's owner. When doctors prescribe off-label drugs for children, they don't obtain written consent from their parents. Guiton asks whether doctors are less fearful than vets about litigation, or whether we simply care more about animals than we do about children. The position regarding written (as opposed to verbal)consent is made clear in the Department of Health's document: http://www.doh.gov.uk/consent/implementationguide.pdf On page 28 of the printed version (page 32 of the pdf), item 9 reminds us that the fact we've obtained a signature doesn't mean that we've got informed consent. A signature doesn't protect us, and is largely worthless. Instead, we are encouraged to document (in the patient's notes) the discussion we've had with the patient/parents. We sign our entry, but nobody else needs to. The Royal College of Paediatrics and Child has a policy about consent for off-label products(see: http://www.rcpch.ac.uk/publications/formulary_medicines/Unlicenced_Medicines.pdf). Informed consent is obtained in the same way that it is for licensed products. I don't see how asking for the parents' signature as well would show that 'we care'?
Off-label prescribing 20 December 2007
Peter H.M. Brooks, Individual South Africa,7925 Send response to journal: Re: Off-label prescribing	I see that off-label prescribing for children has been discussed. I am concerned that it is a more general problem than that. I have discovered that Seroquel, which is registered for use in schizophrenia and bipolar disorder is seldom used for these, but, instead, prescribed off-label to patients without these conditions, for its sedative and anxiolytic properties. There is some folk-wisdom amongst psychiatrists that suggests that Seroquel is good for a number of conditions, including panic disorder. Is it not a concern that patients and doctors are being exposed to this risk? The drug has not been tested on the populations being targeted, so it is unknown what the side-effects might be and unknown if it actually is effective, compared to older drugs. The manufacturer has said that it does not market or support any use other than that for which the drug is registered. This means that the psychiatrists who prescribe the drug will be personally liable for any problems that result from this use. I can't imagine that their insurers are keen on this unknown extra risk. Would it not be sensible for such off-label use to be recorded and used to set up clinical trials? Is there an statement from the BMJ on whether off-label prescribing is ethical where registered drugs exist for the condition? Competing interests: None declared