TRACEABILITY OF BLOOD DERIVATIVE MEDICINA L PRODUCTS - REGULATIONS AND PHARMACO-ECONOMIC IMPLICATIONS AFTER 24 MONTHS OF APPLICATION IN A PARIS TEACHING HOSPITAL

Since January 1 1995, the supply, stockage, dispensing and traceabilit y of Blood Derivative Medicinal Products (BDMP) are subject to pharmac eutical regulations. A review of 24 months' application at Necker-Enfa nts Malades Hospital is presented and analysed. A distinction is drawn between two categories of BDMP: 1) anti-hemophilia BDMP, factors of p lasma or recombinant origin; 2) non-anti-hemophilia BDMP, covering alb umin, immunoglobulins (Ig), biological glues and other clotting factor s. BDMP are subject to a hospital traceability procedure. In this resp ect, we have constructed a tryptic nominative model prescription, thou gh dotations are granted for only certain prescription sectors (operat ing room, ICU) and certain products (biological glues, albumins). A di spensing-administration form is invariably attached to each bottle. Be tween January 1, 1995 and December 31, 1996, 8225 dispensing procedure s for BDMP were recorded, with a total cost of 52,931,586 francs (i.e. 69% anti-hemophilia products vs. 31% non-antihemophilia products). Th e Factor VIII market is divided more or less equally between factors o f human and recombinant origin. The risk of viral transmission is cons idered to be virtually nil with recombinant products, despite their be ing stabilized by human albumin. The traceability rate of anti-hemophi lia factors was 100%. Albumin consumption was 182,106 g at a cost of 3 ,358,250 francs. The following indications were adopted at a Local Med icines Committee: 1) in adults: hypoalbuminemia associated with edema or ascites; 2) in children: digestive disorders leading secondarily to exsudative enteropathy and/or hypoalbuminemia. Consumption of polyval ent Ig was 69,213 g, i.e. 10,856,722 francs. These products were presc ribed in accordance with the directives of the Committee for Evaluatio n and Distribution of Technological Innovations. Consumption of specif ic Ig and biological glues may seem modest in relation to that of othe r products. BDMP expenditure appears particularly heavy here (about 26 .5 MF/year) but consensual adoption of therapeutic guidelines has enab led rationalization of prescribing conditions with the best possible c onsideration of benefit/risk vs costs ratios. Traceability and drug sa fety monitoring procedures are linked to and integrated in the more gl obal concept of Quality Assurance. Since January 1995, several withdra wals of batches have been recorded because of suspicion (or death due to) Creutzfeld-Jakob, or post-donation HIV seroconversion. In this are a, the Hospital Pharmacist acts by the establishment in real time of a permanent safety link between the patient, a prescriber, an indicatio n, a product prescribed and the product actually administered.