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[Should it be mandatory to document off-label prescription in the patient's medical file?]
Teun van Gelder1,2, Frouke M Engelaer1
1LUMC, afd. Interne Geneeskunde, Leiden.
Abstract:
When patients are treated with a drug that is not registered for the intended indication the prescriber must inform the patient on the benefits and risks of this off-label prescription. In the patient file the prescriber should make a note that the patient was informed. In daily practice prescribers are reluctant to do this, with the motivation that informing patients on benefits and risks of pharmacotherapy is done for all drug treatments, and that this is not different for off-label prescriptions.
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