Prescrizione dei medicinali: aspetti normativi

Medications must be approved by AIFA or EMEA before they are allowed to be marketed in Italy. Once a drug is on the market, physicians may use it to achieve therapeutic goals other than those for which the drug was originally approved: this is referred to as off-label prescribing. Off-label prescribing has become an ubiquitous part of mainstream medical practice and it’s particularly common in oncology, paediatrics, and infectious disease. In Italy this practice is regulated by a specific normative who underlines the criteria for off-label prescription and gives a positive list of accepted in-hospital off-label uses. This article examines the Italian regulatory context concerning the prescription of off-label, from the so called “legge Di Bella” to the dispositions of “legge finanziaria 2007” and the most recent “legge finanziaria 2008”. Its aim is to help the physician to understand his responsibilities and limitations in drug off-label use.