Management of notifications of donors with Creutzfeldt-Jakob disease (post-donation information).

Abstract

Recent notifications of blood and plasma donors who have developed Creutzfeldt-Jakob disease (CJD), whose donations collected during the pre-clinical phase of the disease have entered into industrial pools for the manufacturing of plasma-derived medicinal products, highlighted the institutional need for a position paper on the preventive measures, management and communication regarding these cases. As a consequence a document was jointly produced and agreed by the Italian Medicine Agency (AIFA), the Italian National Blood Centre (CNS) and the National Institute of Health (ISS). At its meeting on September 25th, 2012 the National Council of Health unanimously expressed a positive opinion on this document, resulting in its full approval also by the Ministry of Health (MoH). On the basis of the most recent scientific evidence and international guidelines and recommendations, the position paper is intended to define the procedures to be followed in order to manage a possible precautionary quarantine (ban of use) or a possible recall of plasma-derived medicinal products. It is also intended to define the method and content of risk communications to healthcare professionals, patients and general population. Current legislations and international recommendations do not provide for the adoption of restrictive measures in the case of sporadic, genetic or iatrogenic CJD, whereas they do recommend precautionary lots recall in case of a diagnosis of variant CJD. Reference must be made to the following legislation and guidance documents: “Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components”1, transposed with Decree of the Ministry of Health of March 3rd, 2005 “Protocols for determining the suitability of donors of blood and blood components”2. Committee for Medicinal Products for Human Use (CHMP) Position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. European Medicines Agency (EMA). London, 23 June 20113. Guidance for Industry. Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by Blood and Blood Products, May 2010 Food and Drug Administration (FDA)4. This position paper was prepared on the basis of current scientific knowledge, taking into account the above-mentioned legislation and guidelines, and shall be subject to review if new scientific evidence becomes available.