Farmaco equivalente, sicurezza del paziente e profili di responsabilità

Abstract

A diabetic patient under oral therapy with a generic drug had a sudden indisposition and hyperglycaemia due to the consumption of a tablet of another equivalent drug product – same active principle – with evident lack of therapeutic effect. The patient herself solved the problem by interrupting the new generic drugs and taking the one normally used. The general practitioner signalled the event to the Pharmacovigilance Centre that, in turns, signalled it to the Agenzia Italiana del Farmaco (AIFA), appointed to execute the controls. The case described is paradigmatic to discuss the responsibilities of the different actors involved (general practitioner, pharmacist, AIFA, and pharmaceutical industry).