3. Off-label use

By prescribing a medicine off-label, doctors have to take a special responsibility because they are prescribing something which the regulatory authority has not stated is safe and efficacious for use beyond the situations covered by the MA.

Even when the treatment was successful and, in comparison with other possible treatments, in the best interest of the patient, the doctor could be accused that their decision to use a medicine off-label was not in line with best practice and, depending on the health system, the treatment may not be reimbursed.