Management of plasmapheresis in Spain.

In Spain, there is no specific regulation for plasmapheresis. At the present time, there are two decrees issued by the central government that regulate blood donation and blood banks operation. The seventeen autonomous regions have independent powers including health care. Regulation at this level is possible, but not currently in place. In 1993, 1,266,704 units of whole blood were collected in Spain. This whole blood donation was enough to cover the need for red blood cells, but not to cover the needs of plasma derivatives. It has been calculated that in order to fulfil the requirements of factor and albumin about 400,0001 of plasma are needed. In 1994, there were over 10 centres in Spain where there were ongoing plasmapheresis programmes. Other centres are preparing plasmapheresis programmes scheduled to start in 1995. Spain needs an extra amount of plasma in between 250,000 and 300,0001 to cover the needs of plasma derivatives. It is concluded that it is probably best to meet plasma derivatives requirements with plasma obtained from a plasmapheresis programme. This approach has mainly two advantages: -the plasma generated is of the best quality available in order to produce coagulation factor concentrates; -it does not produce a "by-product" that in principle is not needed and would be unethical to throw away. We believe that to achieve self-sufficiency in plasma donation throughout a plasmapheresis programme requires flexibility in the current law and a substantial investment in promotion programmes.