MANAGEMENT OF PLASMA-DERIVED MEDICINAL PRODUCTS: SUPPLY AND TRACEABILITY ISSUES

Abstract

Background:Plasma-derived medicinal products (PDMPs) represent a particular field of pharmaceutical industry. Produced mostly from human blood, PDMPs production follows strict procedures for biological safety and traceability. It comes to albumin, immunoglobulins, coagulating fractions, antiprotease fractions as well as biological glues. Resources and procedures: Our study aimed to define PDMPs management in Morocco, as well as their biological safety procedures, while specifying constraints related to their supply and traceability. Results and discussion: Moroccan market supply by PDMPs is ensured by the National Blood Transfusion Center (NBTC) that shipments Moroccan collected plasma to the French Laboratory of Fractionation and Biotechnology (LFB). The latter produces PDMPs for the Moroccan market under an agreement signed in 1999 and PDMPs prices are fixed by a decree of the Ministry of Health. PDMPs production follows strict procedures for biological safety and traceability from blood donations collection to administration in patients, allowing their routes to be retraced in case of hemovigilance or pharmacovigilance alerts. In Morocco, only two traceability labels are provided on the primary packaging of PDMPs, unlike in some other countries where PDMPs are provided with three sticky labels, all essential for mastering products traceability. PDMPs shortages are due to insufficient amount of plasma sent to LFB, which is aggravated in case of batch recall. Conclusion:PDMPs are indicated to support critical patients, which imply mastering biological safety and traceability from production to delivery, and optimizing their supply in order to ensure their availability by emergency times.