Plasma-derived medicinal products self-sufficiency from national plasma: To what extent?

Blood Transfusion

Volumn 11, Issue SUPPL. 4, 2013, Pages

  De Angelis, Vincenzo ^a   Breda, Antonio ^b  

^a UNIVERSITY HOSPITAL OF UDINE   (Italy)

^b Regional Coordinating Centre for Transfusion Activities   (Italy)

Author keywords

Clinical governance; Plasma; Plasma products; Self sufficiency

Indexed keywords

ALBUMIN; ANTITHROMBIN III; BIOLOGICAL PRODUCT; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; IMMUNOGLOBULIN; PLASMA DERIVED MEDICINAL PRODUCT; PROTHROMBIN COMPLEX; UNCLASSIFIED DRUG;

ALZHEIMER DISEASE; APHERESIS; BLOOD BANK; BLOOD COMPONENT; BLOOD DONOR; BLOOD SAMPLING; BLOOD TRANSFUSION; COST EFFECTIVENESS ANALYSIS; DRUG MANUFACTURE; DRUG MARKETING; HEALTH CARE NEED; HEMOPHILIA; HUMAN; INDEPENDENCE; ITALY; LAW; NATIONAL HEALTH SERVICE; PATIENT SAFETY; PLASMA; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; REVIEW; SELF SUFFICIENCY; VOLUNTARY PROGRAM; VOLUNTEER; WORLD HEALTH ORGANIZATION;

HUMANS; ITALY; PHARMACEUTICAL PREPARATIONS; PLASMA;

EID: 84885650055     PISSN: 17232007     EISSN: None     Source Type: Journal    
DOI: 10.2450/2013.019s     Document Type: Review

References (35)

1. World Health Assembly and Executive Board resolutions on blood safety and availability. Geneva, World Health Organization, 2011 - www.who.int/ bloodsafety/resolutions/en/index.html. Accessed on 12/08/2013.
2. Self-sufficiency in blood and blood products based on voluntary non-remunerated blood and plasma donations. Geneva, World Health Organization, 2011. www.who.int/bloodsafety/transfusion-services/self-sufficiency/en/index. html. Accessed on 12/08/2013.
3. th, 2005. Legge 21 ottobre 2005, n. 219 "Nuova disciplina delle attività trasfusionali e della produzione nazionale degli emoderivati".
4. Grazzini G, Ceccarelli A, Calteri D, et al. Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal products manufacturing. Blood Transfus 2013; 11 (Suppl 4): s138-47.
5. Willis P, Lawler P, Ryan G, Rickard KA. Review of Australia's Plasma Fractionation Arrangements. Publisher Commonwealth of Australia, 2006.
6. van der Poel CL, Janssen MP, Behr-Gross ME. The Collection, Testing and Use of Blood and Blood Components in Europe. 2008 Report. Council of Europe, Strasbourg, May 2011. Available at http://www.edqm.eu/en/blood- transfusionreports-70.html. Accessed on 12/08/2013.
7. Robert P. Worldwide supply and demand of plasma and plasmaderived medicines. Iran J Blood Cancer 2011; 3: 111-20.
8. Farrugia A, Cassar J. Is self-sufficiency in haemotherapies a practical or necessary goal? Blood Transfus 2013; 11: 183-92.
9. O'Mahony B, Turner A. The Dublin consensus statement on vital issues relating to the collection and provision of blood components and plasma-derived medicinal products. Vox Sanguinis 2012; 102: 140-3.
10. McClelland DBL, Pirie E, Franklin IM, for the EU Optimal Use of Blood Project Partners. Manual of Optimal Blood Use. Scottish National Blood Transfusion Service Publishing; 2010. Available at www.optimalblooduse.eu/. Accessed on 12/08/2013.
11. Goodnought TL, Levy JH, Murphy MF. Concepts of blood transfusion in adults. The Lancet 2013; 381: 1845-54.
12. van der Poel CL, Janssen MP, Behr-Gross ME. Trends and Observations on the Collection, Testing and Use of Blood and Blood Components in Europe: 2001-2005 Report. Council of Europe, February 2011. Available at http://www.edqm.eu/en/blood-transfusion-reports-70.html. Accessed on 12/08/2013.
13. Burnouf T. Fractionnement plasmatique international: Etat de l'art. Transfusion Clinique et Biologique 2007; 14: 41-50. (Pubitemid 46874234)
14. Aballea P, Vieilleribiere JL. Les conditions de l'autosuffisance en produits sanguins du marché français. Inspection générale des affaires sociales publisher, RM2010-089P. November 2010.
15. Réduction de la collecte de plasma par aphérèse - 14ème législature Question écrite no 04499. Available at http://www.senat.fr/questions/base/2013/qSEQ130204499.html. Accessed on 12/08/2013.
16. Malantrucco C, Picardi F, Vitaliano E, et al. Registro Nazionale di Aferesi Produttiva (2009). Available at http://www.emaferesi.it/page7/page7. html. Accessed on 12/08/2013.
17. Breda A, Marchiori G, Pasdera A, Zorzet F. Manuale per l'Analisi dei Costi dei Servizi Immuno-Trasfusionali. Venice: Giunta Regionale del Veneto - SIC Publisher; 2004.
18. Rautonnen J. Self-sufficiency, free trade and safety. Biologicals 2010; 38: 97-9.
19. Skinner MW. WFH: Closing the global gap - achieving optimal care. Haemophilia 2012; 18 (Suppl 4): 1-12.
20. Mannucci PM, Mancuso E, Santagostino E. How we choose factor VIII to treat hemophilia. 2012; 119: 4108-14.
21. 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.
22. Iorio A, Halimeh S, Holzhauer S, et al. Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma-derived or recombinant factor VIII concentrates: a systematic review. J Thromb Haemost. 2010; 8: 1256-65.
23. Mannucci PM. Plasma-derived versus recombinant factor VIII concentrates for the treatment of haemophilia A: plasmaderived is better. Blood Transfus 2010; 8: 288-91.
24. Mannucci PM, Gringeri A, Peyvandi F, Santagostino E. Factor VIII products and inhibitor development: the SIPPET study (survey of inhibitors in plasma-product exposed toddlers) Haemophilia 2007; 13 (Suppl 5): 65-8. (Pubitemid 350253407)
25. Epstein JS. Best practices in regulation of blood and blood products. Biologicals 2012; 40: 200-4.
26. Rossi U, Heier HE, Burnouf T, et al. Stressing the need of professional and clinical education in the fields of plasma products. In: Heier HE, Burnouf T, De Angelis V, El Ekiaby M, editors. Proceedings of the ESTM residential course on "Appropriate use of plasma products". Zagreb, Croatia, 14-18 November 2012; Milano, ESTM. pp 3-9.
27. 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 Sanguinis 2012; 103: 337-42.
28. Folléa G, Behr-Gross ME. The blood supply management project of the Council of Europe - EDQM-Presented at the "Symposium on Blood Supply Management" - 1 October 2012 Strasbourg, France - Available at https://www.edqm.eu/site/blood-supply-management-session-1pdf-en-31052-2.html. Accessed on 12/08/2013.
29. Healthcare Quality Improvement Partnership. Criteria of best practice in clinical audit. Available at http://www.hqip.org.uk/. Accessed on 12/08/2013.
30. Clinical Audit Support Centre. "Clinical Audit Tools", a free resource with innovative clinical audit tools, access to lectures, online accreditation and easy-to-use discussion boards. Available at http://www.clinicalaudittools.com/. Accessed on 12/08/2013.
31. Clinical Audit Support Centre. Clinical Audit Tool - PCS Clinical Audit Tool (CAT), a population reporting enhancement to the leading GP Clinical Desktop Systems in Australian general practice. Available at http://www.clinicalaudit.com. au/. Accessed on 12/08/2013.
32. De Angelis V, Tillati S. Monitoring the appropriate use of plasma products. In: Heier HE, Burnouf T, De Angelis V, El Ekiaby M, editors. Proceedings of the ESTM residential course on "Appropriate use of plasma products". Zagreb, Croatia, 14-18 November 2012; Milano, ESTM. pp 331-6.
33. Bult J, Farrugia A. Self Sufficiency in Plasma and Plasma Derived Medicines. Iran J Blood Cancer 2011; 3: 99-106.
34. Cheraghali AM, Abolghasemi H. Improving availability and affordability of plasma-derived medicines. Biologicals 2010; 38: 81-6.
35. Heier HE. Forces shaping the pattern of consumption of plasma products in the indiustrialised world. In Heier HE, Burnouf T, De Angelis V, El Ekiaby M, editors. Proceedings of the ESTM residential course on "Appropriate use of plasma products". Zagreb, Croatia, 14-18 November 2012; Milano, ESTM. pp 287-91.