Do I need Informed Consent from a patient and/or their family, if I am providing off-label use of a medication? If so, what sort of information should be discussed during the informed consent process?
Yes — the patient must be informed of the off-label use of the medication and the reason for using this product off-label. As in any informed consent, all components of the informed consent must be provided to the patient including diagnosis, reason for use, risks, benefits, alternative therapies, risks if no treatment is provided, and probability of success. There should be a recording of the informed consent discussion. In a case such as SLIT, it is recommended that a patient sign the consent form as this is the best indication that the consent was obtained.
