The national Plasma and Plasma-derived medicinal products Programme
Through the adoption of the Ministerial Decree of December 2, 2016 the first Programme was issued aiming to pursue national self-sufficiency in plasma and PDMPs. It states both principles and strategic objectives to be reached at national and regional levels in the period 2016 – 2020.
- Promotion of the rational and appropriate use of plasma and PDMPs through:
- The monitoring of the appropriate clinical use of the main PDMPs.
- The overriding use of PDMPs from national plasma as well as the support of intra- and inter-regional exchanges
- The management of surpluses and shortages of intermediate and final products.
- Development of plasma collection in the BEs and Collection units through:
- The increase of collection of plasma for fractionation, with particular regards to those Regions that show significant differences when compared to the national average;
- The adoption of measures to foster the efficiency and sustainability of plasma production
- New and more sustainable management of collection processes.
Monitoring and indicators
The objectives are annually monitored by the CNS on the basis of the following indicators:
As for appropriateness
- Standardised demand for human albumin (grams/1,000 inhabitants).
- Public demand for human albumin distributed through the pharmacies open to the public (kilograms).
- Standardised demand for antithrombin (international units / inhabitant).
- Standardised demand for polyvalent immunoglobulins (grams / 1,000 inhabitants).
- Standardised demand of fresh-frozen plasma (millilitres / 1,000 inhabitants).
As for collection
- Plasma for fractionation collected (kilograms).
- Standardised plasma for fractionation collected (kilograms /1,000 inhabitants).
- Average weight of the mono-component and multi-component units of plasmapheresis (grams).
- Average number of procedures for the plasmapheresis machine.
- Number of procedures for each plasmapheresis machine.
- Percentage of plasma units that are excluded for technical reasons on the total of units collected.
- Percentage of plasma units that are excluded for expiration on the total of units collected.
Reference standardsBlood and plasma represent precious and limited resources characterized by a strong ethical value because derived from the voluntary, responsible and unpaid donation and they can become under no circumstances source of profit, for the sake of consistency and by analogy with principle of non-commercialisation of the human body and its parts contained in the main European treaties and documents (Oviedo Convention, 1997).
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Plasma Italia is an initiative promoted by the Italian Institute of Health and by the National Blood Centre.
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