Off-label prescriptions in Internal Medicine: difficulties involved

Abstract

INTRODUCTION Concern about off-label prescriptions, that is to say prescriptions of a drug for therapeutic indications and utilisations not approved in the medicine data sheet, is growing up more and more among hospital clinicians. AIM OF THE STUDY The aim of this work is to increase the consciousness that falling back upon off-label prescriptions has to be applied just in case of a validated therapeutic option missing, and provided that there are clinical evidences supporting the benefits reached by the patient through the assumption of that drug. Furthermore, it requires the patient involvement, in fact he has to be correctly informed and has to declare his acceptance to be treated with that kind of drug. The off-label prescription responsibility belongs to the prescribing clinician. The costs of these prescriptions can not be ascribed to the SSN (Servizio Sanitario Nazionale), unless the subjects treated are in-patients in the hospital or in a day-hospital service. METHODS a) Understanding where the therapeutic indications arise and how to use medicines, on the basis of what is reported in the Summary of Product Characteristics (SPC) following the correspondent declaration for marketing authorization. b) Showing some examples of off-label utilisation. c) Evaluating the current legislation that regulates and supports the possibility or impossibility to prescribe off-label. CONCLUSIONS It is always better to use offlabel drugs that are authorized: by Agenzia Italiana del Farmaco (AIFA), through the dynamic list of medicines included in the 648/96, by the Local Therapeutic Commission or by the Ethical Committee. The act of prescribing off-label drugs for out-patients has to be shared even with the patient's general practitioner, who is responsible for the same patient territorially, knows his medical history very well and the potential chronic therapy assumed. This is important for a proper evaluation of possible interactions and incompatibilities, and for a correct monitoring. In spite of its frequency in routine practice, off-label prescribing of medications is legal and should not be trivialised. Clinicians should be better informed about the potential legal consequences of off-label prescribing.