Intended for healthcare professionals

Rapid response to:

Letters

Off label prescribing in children

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7359.338 (Published 10 August 2002) Cite this as: BMJ 2002;325:338

Rapid Response:

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_Medic...).
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'?

Competing interests: No competing interests

09 August 2002
Theo H Fenton
Consultant Paediatrician
Mayday Hospital, Crodon CR7 7YE