Products for clotting factor replacement in developing countries.

Developing countries provide clotting factor replacement for hemophilia patients using one or more of the following strategies. (1) Production of domestic plasma and cryoprecipitate provides some self-sufficiency but depends heavily on the presence of an excellent blood transfusion service. The risk of transmitting donor infections is not completely obviated even with good serologic testing. (2) Domestic plasma fractionation has been achieved in a handful of emerging countries but can be expensive. Patients may distrust businessmen of their own country and may be dissatisfied with the style of product available from domestic plants. (3) Contract fractionation has been successful when the donor country is able to provide adequate amounts of well-tested plasma. Its cost is not always lower than that of imported concentrate but a degree of national self-sufficiency is retained. (4) Importation of concentrate allows a wide choice of products. The selection should focus not only on price but also on product safety, which depends upon well-validated donor testing and viral inactivation. High levels of purification are not of great importance. Successful national hemophilia programs also address organization of care, sensible dosing, and equitable distribution of resources to gain the maximum benefit from scarce resources.