Off-label voorschrijven verplicht vastleggen in het patiëntendossier?

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.

Conflict of interest and financial support: potential conflicts of interest have been reported for this article. ICMJE forms provided by the authors are available online along with the full text of this article.