Improved efficiency of plasmapheresis collection in Italy through licensed variations of current practice: a proposal

Background. The overall production efficiency of plasmapheresis in Italy is significantly less than that indicated by international data, but can be significantly improved by slightly increasing the amount of plasma collected for each procedure, while fully respecting the current regulations. Materials and methods. In order to compare the average plasma volumes collected by means of apheresis in Italy and other European countries, we considered data supplied by Kedrion (the only company active in Italy in the field of plasma-derived products) relating to Italy and three centres managed by Kedrion in Germany. Results. In 2014, Kedrion received about 174,000 kg of plasma collected by means of plasmapheresis in Italy, for an average unit weight including anticoagulant of 577 g, as against the approximately 97,000 kg (average unit weight including anticoagulant 783 g) produced by the three Kedrion centres in Germany. The net weight of the plasma (without anticoagulant) contained in a plasmapheresis unit of 577 g is about 520 g, whereas a maximum collected volume of 600 mL (permitted by current Italian legislation without the need for volume reintegration) would provide a plasma unit volume of 660 mL (600 mL of plasma plus about 60 mL of anticoagulant): i.e. 14% more than that currently provided by Italian Transfusion Centres. This would increase the total amount of plasma sent to Kedrion to 199,500 kg, without creating any major organisational difficulties (only a few minutes' increase in the length of the procedure) or additional costs, or increasing donor risk. Discussion. It is possible to hypothesise the following donation volumes. Women weighing 50-60 kg: 550 mL (net of anticoagulant), final unit volume about 610 mL; men, and women weighing >60 kg: 600 mL net, final unit volume about 660 mL. Using recently published data relating to the plasmapheresis centre in Verona (Italy), the cost of a litre of plasma is € 283.87 if the average unit volume (including anticoagulant) is 600 mL, and € 263.46 if it is 650 mL (i.e. a net plasma yield of 585 mL): a 7.2% cost reduction simply by increasing final unit volume by 50 mL, something that is already feasible and perfectly safe, and does not require donor volume reintegration under current Italian law.