Plasma and plasma-derived medicinal product self-sufficiency: The Italian case

Blood Transfusion

Volumn 11, Issue SUPPL. 4, 2013, Pages

  Calizzani, Gabriele ^a   Profili, Samantha ^a   Candura, Fabio ^a   Lanzoni, Monica ^a,b   Vaglio, Stefania ^a,c   Cannata, Livia ^a   Catalano, Liviana ^a   Chianese, Rosa ^d   Liumbruno, Giancarlo M ^e   Grazzini, Giuliano ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^c SAPIENZA UNIVERSITY OF ROME   (Italy)

^d Ospedale di Ivrea   (Italy)

^e SAN GIOVANNI CALIBITA FATEBENEFRATELLI HOSPITAL   (Italy)

Author keywords

Plasma; Plasma fractionation; Plasma derived medicinal products; Self sufficiency; Voluntary non remunerated blood donation

Indexed keywords

ALBUMIN; ANTITHROMBIN; BLOOD CLOTTING FACTOR 8 CONCENTRATE; BLOOD CLOTTING FACTOR 9 CONCENTRATE; IMMUNOGLOBULIN; PROTHROMBIN COMPLEX;

BLOOD COMPONENT THERAPY; BLOOD TRANSFUSION; GEOGRAPHIC DISTRIBUTION; HEALTH CARE UTILIZATION; HUMAN; ITALY; NATIONAL HEALTH SERVICE; PLASMA TRANSFUSION; RESOURCE MANAGEMENT; REVIEW;

HUMANS; ITALY; PHARMACEUTICAL PREPARATIONS; PLASMA;

EID: 84885670125     PISSN: 17232007     EISSN: None     Source Type: Journal    
DOI: 10.2450/2013.018s     Document Type: Review

References (38)

1. WHO Expert Group. Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD). Vox Sang 2012; 103: 337-42.
2. th, 2005. Legge 21 ottobre 2005, n. 219 recante la "Nuova disciplina delle attività trasfusionali e della produzione nazionale degli emoderivati". Available at: http://www.centronazionalesangue. it/content/legge-21-ottobre-2005-2-219. Accessed on 30/08/2013.
3. th, 2011. Decreto del Ministero della Salute 20 gennaio 2011: "Programma di autosufficienza nazionale del sangue e dei suoi prodotti per l'anno 2010". Available at: http://www.centronazionalesangue.it/sites/default/files/dm-20.01. 2011-programma-nazionale-autosufficienza-2010.pdf. Accessed on 30/08/2013.
4. st, 2011. Decreto del Ministero della Salute 7 ottobre 2011: "Programma di autosufficienza nazionale del sangue e dei suoi prodotti, per l'anno 2011". Available at: http://www.centronazionalesangue.it/sites/default/files/d.m.-7. 10.11-programma-nazionale-autosufficienza-2011-gu-22.11.11. pdf. Accessed on 30/08/2013.
5. th, 2012. Decreto del Ministro della Salute del 4 settembre 2012. Programma di autosufficienza nazionale del sangue e dei suoi prodotti per l'anno 2012. Available at: http://www.centronazionalesangue.it/sites/default/files/ programmazione-autosuff-2012-0.pdf. Accessed on 30/08/2013.
6. rd, 2008. Decreto legislativo 20 dicembre 2007, n. 261. Revisione del decreto legislativo 19 agosto 2005, n. 191, recante attuazione della direttiva 2002/98/CE che stabilisce norme di qualità e di sicurezza per la raccolta, il controllo, la lavorazione, la conservazione e la distribuzione del sangue umano e dei suoi componenti. Available at: http://www. centronazionalesangue. it/sites/default/files/DECLEG20DIC2007.pdf. Accessed on 30/08/2013.
7. Calizzani G, Vaglio S, Profili S, et al. The evolution of the regulatory framework for the plasma and plasma-derived medicinal products system in Italy. Blood Transfus 2013; 11 (Suppl 4): s6-12.
8. Farrugia A, Evers T, Falcou PF, et al. Plasma fractionation issues. Biologicals 2009; 37: 88-93.
9. World Federation of Haemophilia. Contract Fractionation third edition. Available at: http://www1.wfh.org/publication/files/pdf-1225.pdf. Accessed on 27/08/2013.
10. World Health Organization. Information sheet, Plasma contract fractionation program. Available at: http://www.who. int/bloodproducts/ publications/en/Information%20Sheet%20 PLASMA.pdf. Accessed on 27/08/2013.
11. Grazzini G. Clinical appropriateness of blood component transfusion: regulatory requirements and standards set by the Scientific Society in Italy. Blood Transfus 2008; 6: 186-90.
12. Lanzoni M, Biffoli C, Candura, et al. Plasma-derived medicinal products in Italy: information sources and flows. Blood Transfus 2013; 11 (Suppl 4): s13-7.
13. Grazzini G, Rossi G, Rafanelli D, et al. Quality control of recovered plasma for fractionation: an extensive Italian study. Transfusion 2008; 48: 1459-68.
14. Vaglio S, Calizzani G, Lanzoni M, et al. The demand for human albumin in Italy. Blood Transfus 2013; 11 (Suppl 4): s26-32.
15. Candura F, Lanzoni M, Calizzani G, et al. The demand for polyvalent immunoglobulins in Italy. Blood Transfus 2013; 11 (Suppl 4): s45-54.
16. Liumbruno GM, Franchini M, Lanzoni M, et al. Clinical use and the Italian demand for antithrombin. Blood Transfus 2013; 11 (Suppl 4): s86-93.
17. Mannucci PM. Plasma-derived versus recombinant factor VIII concentrates for the treatment of haemophilia A: plasmaderived is better. Blood Transfus 2010; 8: 288-91.
18. Franchini M. Plasma-derived versus recombinant factor VIII concentrates for the treatment of haemophilia A: recombinant is better. Blood Transfus 2010; 8: 292-6.
19. Calizzani G, Arcieri R. Clinical and organisational aspects of haemophilia care: the patients' view. Blood Transfus 2012; 10: 110-1.
20. Gringeri A. Factor VIII safety: plasma-derived versus recombinant products. Blood Transfus 2011; 9: 366-70.
21. Iorio A, Puccetti P, Makris M. Clotting factor concentrate switching and inhibitor development in hemophilia A. Blood 2012; 120: 720-7.
22. Calizzani G, Profili S, Candura F, et al. The demand for factor VIII and for factor IX in Italy and the toll fractionation product surplus management. Blood Transfus 2013; 11 (Suppl 4): s64-76.
23. Burnouf T. Modern plasma fractionation. Transfus Med Rev 2007; 21: 101-17. (Pubitemid 46482990)
24. Franchini M, Liumbruno GM, Vaglio S, et al. Clinical use and the Italian demand for prothrombin complex. Blood Transfus 2013; 11 (Suppl 4): s94-100.
25. Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion 1999; 39: 1160-8.
26. Velati C, Romanò L, Fomiatti L, et al; SIMTI Research Group. Impact of nucleic acid testing for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus on the safety of blood supply in Italy: a 6-year survey. Transfusion 2008; 48: 2205-13.
27. Rodgers GM. Prothrombin complex concentrates in emergency bleeding disorders. Am J Hematol 2012; 87: 898-902.
28. Farrugia A. International movement of plasma and plasma contracting. Dev Biol 2005; 120: 85-96. (Pubitemid 41717503)
29. CHMP Position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. European Medicines Agency. London, 23 June 2011. EMA/CHMP/BWP/303353/2010. Available at: http://www.ema.europa.eu/docs/en- GB/document-library/Position-statement/2011/06/WC500108071.pdf. Accessed on 16/07/2013.
30. Guidance for Industry. Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products, May 2010. Food and Drug Administration. Available at: http://www.fda.gov/downloads/ BiologicsBloodVaccines/GuidanceComplianceR egulatoryInformation/Guidances/ UCM213415.pdf. Accessed on 27/08/2013.
31. Calizzani G, Vaglio S, Vetrugno V, et al. Management of notifications of donors with Creutzfeldt-Jakob disease (post-donation information). Blood Transfus 2013; DOI 10.2450/2013.0035-13.
32. Boulis A, Goold S, Ubel PA. Responding to the immunoglobulin shortage: a case study. J Health Polit Policy Law 2002; 27: 977-99. (Pubitemid 36135089)
33. CBS & Plasma Protein Products: All you ever wanted to know. Canadian Blood Services. Available at: http://www.transfusionmedicine.ca/sites/ transfusionmedicine/files/events/Fraction%20process%20CBS%20overview%20-%20 resident%20seminar%202012.pdf. Accessed on 13/08/2013.
34. Grazzini G, Ceccarelli A, Calteri D, et al. Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing. Blood Transfus 2013; 11 (Suppl 4): s138-47.
35. Lanzoni M, Candura F, Calizzani G, et al. Public expenditure for plasma-derived and recombinant medicinal products in Italy. Blood Transfus 2013; 11 (Suppl 4): s110-7.
36. Petrini C. Production of plasma-derived medicinal products: ethical implications for blood donation and donors. Blood Transfus 2013; DOI 10.2450/2013.0167-12.
37. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Council of Europe. Oviedo, 04/04/1997. Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm. Accessed on 13/08/2013.
38. Petrini C. Is my blood mine? Some comments on the Convention on Human Rights and Biomedicine. Blood Transfus 2013; 11: 321-3.