PMID: 9538473Apr 16, 1998Paper

Traceability of drugs derived from blood: regulation and pharmaco-economic implications after 24 months of application in Paris CHU

Pathologie-biologie
A Lesne-HulinE Singlas

Abstract

Since January 1, 1995, the supply, stockage, dispensing and traceability of Blood Derivative Medicinal Products (BDMP) are subject to pharmaceutical regulations. A review of 24 months' application at Necker-Enfants Malades Hospital is presented and analysed. A distinction is drawn between two categories of BDMP: 1) anti-hemophilia BDMP, factors of plasma or recombinant origin; 2) non-anti-hemophilia BDMP, covering albumin, immunoglobulins (Ig), biological glues and other clotting factors. BDMP are subject to a hospital traceability procedure. In this respect, we have constructed a tryptic nominative model prescription, though dotations are granted for only certain prescription sectors (operating room, ICU) and certain products (biological glues, albumins). A dispensing-administration form is invariably attached to each bottle. Between January 1, 1995 and December 31, 1996, 8225 dispensing procedures for BDMP were recorded, with a total cost of 52,931,586 francs (i.e. 69% anti-hemophilia products v.s. 31% non-antihemophilia products). The Factor VIII market is divided more or less equally between factors of human and recombinant origin. The risk of viral transmission is considered to be virtually nil with recombinant products, d...Continue Reading

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