Legal accountability on medical practice/Responsabilità medico legali nella pratica medica - La prescrizione dei farmaci off-label in ambito oncologico in Italia: valutazione da una prospettiva medico-legale / Off-label oncology prescription in Italy: a legal perspective
Keywords:
off-label prescription, medical and legal responsibilities, farmaci off-label, responsabilità medico-legaliAbstract
Con il termine off-label si definisce l’utilizzo di farmaci regolarmente registrati ma usati in maniera non conforme a quanto previsto dalla scheda tecnica autorizzata dal Ministero della Salute per gli aspetti di indicazioni, modalità e dosi di somministrazione. Attualmente l’utilizzo di farmaci fuori indicazione, in determinati casi, specie quelli più gravi, rappresenta un’importante opportunità di cura. Da un punto di vista prettamente giuridico, la responsabilità del medico derivante dalla prescrizione di farmaci off-label è una questione poco affrontata dalla dottrina e dalla giurisprudenza.
Off-label oncology prescription in Italy: a legal perspective
Any new drug is labelled for an indication, dose and route of administration by drug approval Authorities called on-label; use of a drug outside the terms of its official labelling is referred to as off-label. Currently off-label use of drugs represents an important opportunity to cure in certain cases, especially serious ones. From a legal point of view, the physician’s responsibility arising from off-label prescription of drugs, is a question poorly addressed by doctrine and jurisprudence.
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