title: Off-Label Prescribing by Psychiatrists: What is the Practitioner's Liability?
abstract: In psychiatry, the molecules available and the dosages recommended when a drug receives marketing authorization are not always adequate to treat patients with major behavioral disturbances. Off-label prescribing is frequent in this context, with regard to the indications and the dosages given as well as to the drug combinations used. However, if complications or death occur, the practitioner's liability may be engaged. The authors report three deaths attributed to off-label prescribing in psychiatry and which led to charges against the physicians. They review the precautions to be taken when prescribing in such conditions (no other possible treatment, existence of sound scientific evidence, consent obtained from the patient, or their legal representatives except in cases of force majeure) and the physician's liability if adverse events occur that could be attributed to off-label prescribing.
authors.affiliation: Aix-Marseille Université, 13284, Marseille, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Bartoli
authors.affiliation: Aix-Marseille Université, 13284, Marseille, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Berland-Benhaim
authors.affiliation: AP-HM, Hôpital de la Timone, Institut de Médecine Légale, 13385, Marseille, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Sastre
authors.affiliation: AP-HM, Hôpital de la Timone, Institut de Médecine Légale, 13385, Marseille, France.
authors.forename: Valerie
authors.initials: V
authors.lastname: Baillif-Couniou
authors.affiliation: X-Pertise Consulting, 42 rue Principale, 67206, Mittelhausbergen, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Kintz
authors.affiliation: Aix-Marseille Université, 13284, Marseille, France.|AP-HM, Hôpital de la Timone, Institut de Médecine Légale, 13385, Marseille, France.
authors.forename: Georges
authors.initials: G
authors.lastname: Leonetti
authors.affiliation: Aix-Marseille Université, 13284, Marseille, France.|AP-HM, Hôpital de la Timone, Institut de Médecine Légale, 13385, Marseille, France.
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Pelissier-Alicot
mesh_terms: D000328:Adult; D006801:Humans; D016365:Liability, Legal; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy; D008875:Middle Aged; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D011570:Psychiatry / Q000331:legislation & jurisprudence*
keywords: civil liability; criminal liability; forensic science; off-label prescribing; psychiatry; side effects