Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing

Background. In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993-2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement. Materials and methods. In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account. Results. The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study. Discussion. Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability

The Chikungunya epidemic in Italy and its repercussion on the blood system

BACKGROUND: The Chikungunya virus (CHIKV) is transmitted by Aedes mosquitoes and recently caused a massive epidemic on La R\ue9union Island, in the Indian Ocean. Between July and September 2007 it caused the first autochthonous epidemic outbreak in Europe, in the Region of Emilia-Romagna in the north-east of Italy. MATERIALS AND METHODS: After the first reports of an unusually high number of patients with a febrile illness of unknown origin in two contiguous villages, an outbreak investigation was carried out to identify the primary source of infection, the modes of transmission and the dynamics of the epidemic. An active surveillance system was also implemented. Laboratory diagnosis was performed through serology and polymerase chain reaction (PCR) analysis. Blood donation was discontinued in the areas involved from September to October 2007 and specific precautionary blood safety and self-sufficiency measures were adopted by the regional health and blood authorities and the National Blood Centre. An estimate method to early assess the risk of viraemic blood donations by asymptomatic donors was developed, as a tool for "pragmatic" risk assessment and management, aiming at providing a reliable order of magnitude of the mean risk of CHIKV transmission through blood transfusion. RESULTS: Two hundred and seventeen cases of CHIKV infection were identified between 4th July and 28th September. The disease was fairly mild in most of the cases. The precautionary measures adopted in the blood system caused a considerable reduction of the collection of blood components and of the delivery of plasma to the pharmaceutical industry for contract manufacturing. The estimated risk of CHIKV transmission through blood transfusion peaked in the third week of August. CONCLUSION: ACHIKV epidemic poses considerable problems for public health authorities, who not only need good routine programmes of vector control and epidemiological surveillance but also local and national emergency plans to sustain the blood supply, so as to promptly deal with the potentially severe effects of an epidemic outbreak, especially when affected areas locally require a significant blood inventory and at the same time represent a critical resource for other areas depending on external supplies of blood components