The professional liability of clinicians for off-label prescriptions

Abstract

INTRODUCTION Even if shortly, this article deals with a question that is still largely unexplored by jurisprudence and doctrine, about the professional liability of clinicians for off-label prescriptions; that’s to say the prescription of approved drugs for therapeutic indications and employments different from those they had been approved for. This work analyzes the main rules that regulate off-label prescriptions and some important elements correlated with the clinician’s professional liability, such as guilt, damages and causality connection. DISCUSSION The regulations in force say that the clinician’s prescription is fully legal only if the drug has been previously approved in the medicine data sheet for the same way of administration, dosage or therapeutic indications it has been actually prescribed to the patient (art. 3, 1st paragraph, L. 98/1998). Next to this general principle, the same law provides for some exceptions and provides for some exceptions to this general principle, giving the doctor the possibility of using an off-label drug for a therapeutic purpose different from that it had been registered, under his own responsibility and according to published scientific documents, after having informed the patient who must give his consent. It’s clear that, since we are talking about something that is borderline between treatment and clinical experimentation, the doctrine considers dangerous this practice (art. 2050 c.c.). In this perspective (dangerous practice), in the event of damage to the patient, the doctor will have to prove he had taken all the right precautionary measures to avoid it, according to such a high level of diligence proportioned to the risk for the patient an off-label prescription can follow. Obviously, the more distant is the best practice from the therapy prescribed by the doctor, even if including treatments with off-labels, the heavier should be considered the professional guilt in the presence of damage for the patient. CONCLUSIONS in wiew of the considerable diffusion of off-label prescriptions, it seem to be necessary to regulate this custom, according to the context in which the prescription occurs. This also by reason of the fact that, in the “more innovating spheres”, off-label prescriptions can be often an important opportunity that can bring about significant improvements, without forgetting that the use of off-labels exposes the patient to possible risks which must be considered by the doctor before prescribing.

Keywords

• Professional liability
• Off-label drugs
• Prescribing
• Legal consequences.