Revision and update of the position paper on the management of notifications of donors with Creutzfeldt-Jakob disease in Italy

Abstract

Notifications of blood and plasma donors who have developed Creutzfeldt-Jakob disease (CJD), and whose donations, collected in the pre-clinical phase of the disease, have entered industrial pools for the production of plasma-derived medicinal products (PDMPs), have highlighted the need to develop a technical-scientific document (position paper). This document  outlines  the prevention, management and communication measures to be adopted in such cases, and will be shared among the institutions involved: Italian Medicine Agency (AIFA), National Blood Center (CNS), Istituto Superiore di Sanità (ISS) and Ministry of Health. The first position paper on this matter titled“MANAGEMENT OF NOTIFICATIONS OF DONORS WITH CREUTZFELDT-JAKOB DISEASE (POST DONATION INFORMATION)”, was initially adopted by AIFA in December 2012 and then published in 2014¹. Current revision (ten years later) of the former Position Paper is to update available scientific evidence, and so, redefine the procedures to be followed to manage a possible precautionary quarantine (ban of use) or a possible recall of PDMPs. In particular, the document aims to define, the procedures to be followed to manage a possible precautionary ban on use or a possible withdrawal of PDMPs based on the most recent scientific evidence and international guidelines/recommendations. The goal is to minimize the potential shortage of life-saving PDMPs. Additionally, it will outline the methods and contents of the risk communication to professionals, patients, and public opinion.