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Minerva Medicolegale 2013 June;133(2):85-93

Copyright © 2013 EDIZIONI MINERVA MEDICA

language: Italian

Medical liability for off label prescription: the case of intravitreal therapy

Rosa C. 1, Depaoli M. 1, Consolandi G. 2

1 Dipartimento di Scienze della Sanità Pubblica e Pediatriche Scuola di Specializzazione in Medicina Legale Università degli Studi di Torino, Torino, Italia; 2 Dipartimento di Fisiopatologia Clinica Scuola di Specializzazione in Oculistica Università degli Studi di Torino, Torino, Italia


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On 26th September 2012 the Italian Medicines Agency (AIFA) ordered the removal of the indication for intravitreal use of bevacizumab (Avastin®) from the list of Law 648 of 1996, reigniting the debate on the issue of medical liability for off label prescription. In this paper, after a brief introduction on the age-related macular degeneration (AMD), we will examine the characteristics of the intravitreal anti-angiogenic drugs used in the wet form of the disease.
We will then try to outline the various aspects of medical liability for off label prescription. Our analysis leads us to conclude that the choice of using an off label drug ultimately rests with the physician, who, on the basis of a solid scientific knowledge and under his/her direct responsibility, may decide to treat his patient with a drug registered for different indications or routes of administration. A correct and complete information of the patient and his free consent to accept the unconventional therapy are essential. Therefore the ophthalmologist who diligently fulfills this duty to inform, relying on the international scientific literature attesting the similar efficacy and quality between the examined drugs, won’t be exposed to any medical liability in the treatment of patients affected by AMD with bevacizumab.

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