Use of non-specific intravenous human immunoglobulins in Spanish hospitals; need for a hospital protocol

European Journal of Clinical Pharmacology

Volumn 66, Issue 6, 2010, Pages 633-641

  Ruiz Antorán, Belen ^a   Escasany, Antònia Agustí ^b   Ferraz, Antoni Vallano ^c   Carreras, Imma Danés ^b   Riba, Neus ^d   Escudero, Silvia Mateu ^e   Costa, Joan ^f   Sánchez, M Blanca Santiago ^g   Laredo, Leonor ^h   Quintana, José Antonio Durán ⁱ   Castillo, Juan Ramón ^j   Abad Santos, Francisco ^k   Herrera, Concepción Payares ^l   De Rada, Belén Sádaba Díaz ^m   Ontañón, Eugenio Gómez ⁿ  

^a HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^b HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^c HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^d HOSPITAL CLÍNIC   (Spain)

^e FUNDACIÓ PUIGVERT   (Spain)

^f HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^g HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^h HOSPITAL CLÍNICO SAN CARLOS   (Spain)

ⁱ HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^j HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^k HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^l HOSPITAL UNIVERSITARIO DE PUERTO REAL   (Spain)

^m UNIVERSITY CLINIC OF NAVARRA   (Spain)

ⁿ Clinical Pharmacology Department   (Spain)

more..

Author keywords

Compassionate use; Cost; Drug utilization study; Intravenous immunoglobulin; Off label use

Indexed keywords

IMMUNOGLOBULIN; IMMUNOLOGIC FACTOR;

ADULT; APPLICATION SITE REACTION; ARTICLE; ASTHENIA; BACKACHE; BULLOUS DERMATITIS; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; DRUG COST; DRUG DOSE REGIMEN; DRUG FEVER; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; IMMUNE DEFICIENCY; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; PRESCRIPTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; SKIN DISEASE; SPAIN; TERTIARY HEALTH CARE; VOMITING; AGED; DRUG UTILIZATION; ECONOMICS; EMPATHY; GENERAL HOSPITAL; MIDDLE AGED; STANDARD; STATISTICS;

ADULT; AGED; DRUG COSTS; DRUG UTILIZATION; EMPATHY; FEMALE; HOSPITALS, GENERAL; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC FACTORS; MALE; MIDDLE AGED; OFF-LABEL USE; PROSPECTIVE STUDIES; SPAIN;

EID: 77954941787     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-010-0800-y     Document Type: Article

References (33)

1. Farrugia A, Poulis P (2001) Intravenous immunoglobulin: regulatory perspectives on use and supply. Transfusion Med 11:63-74
2. Jolles S, Sewell WAC, Misbah SA (2005) Clinical uses of intravenous immunoglobulin. Clin Exp Immunol 142:1-11
3. Dalakas MC (2004) The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: evidence-based indications and safety profile. Pharmacol Ther 102:177-193
4. Siegel J (2005) The product: all intravenous immunoglobulins are not equivalent. Pharmacother 25:78s-84s
5. Chapel HM (1999) Safety and availability of immunoglobulin replacement therapy in relation to potentially transmissable agents. IUIS Committee on Primary Immunodeficiency Disease. International Union of Immunological Societies. Clin Exp Immunol 118(Suppl 1):29-34
6. Committee for Proprietary Medicinal Products (CPMP) (2000) Core SPC for human normal immunoglobulin for intravenous administration (IVIg). CPMP/BPWG/859/95 rev 1
7. Committee for medicinal products for human use (CHMP) (2004) Core SPC for human normal immunoglobulin for intravenous administration (IVIg). CPMP/BPWG/859/95 rev 2. EMEA, London
8. Constantine MM, Thomas W, Whitman L, Kahwash E, Dolan S, Smith S, Caudle CJ Burton E, Anderson DR (2007) Intravenous immunoglobulin utilization in the Canadian Atlantic provinces: a report of the Atlantic Collaborative Intravenous Immune Globulin Utilization Working Group. Transfusion 47:2072-2080
9. Chen C, Danekas LH, Ratko TA, Vlasses PH, Matuszewski KA (2000) A multicenter drug use surveillance of intravenous immunoglobulin utilization in US academic health centers. Ann Phamacother 34:295-299
10. Pendergrast JM, Sher GD, Callum JL (2005) Changes in intravenous immunoglobulin prescribing patterns during a period of severe product shortages, 1995-2000. Vox Sang 89:150-160
11. Darabi K, Abdel-Wanab O, Dzik WH (2006) Current usage of intravenous immune globulin and the rationale behind it: the Massachusetts General Hospital data and a review of the literature. Transfusion 46:741-753
12. Perayre M, Pastó L, Jódar R (2006) Changes in the pattern of intravenous immunoglobulin use over a 5-year period. Eur J Hosp Pharm Sci 12:67-71
13. Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios" (2006) http://sescam.jccm.es/web1/ ciudadanos/elSescam/legislacion/Ley29-2006-Farmacia.pdf. Accessed 6 Sept 2009
14. [No authors listed] (1999) Primary immunodeficiency diseases. Report of an IUIS Scientific Committee International Union of Immunological Societies. Clin Exp Immunol 118(Suppl 1):1-28
15. Ratko TA, Burnett DA, Foulke GE, Matuszewski KA, Sacher RA (1995) Recommendations for off-label use of intravenously administered immunoglobulin preparations. University Hospital Consortium Expert Panel for off-label use of polyvalent intravenously administered immunoglobulin preparations. JAMA 273:1865-1870
16. Consensus Working Group (1997) Present and future uses of IVIG. A Canadian multidisciplinary consensus building initiative. Can J Allergy Clin Immunol 5:176-208
17. The American Society of Hematology ITP Practice Guideline Panel (1997) Diagnosis and treatment of idiopathic thrombocytopenic purpura; recommendations of the American Society of Hematology. Ann Intern Med 126:319-326
18. Bril V, Allenby K, Midroni G, O'Connor PW, Vajsar J (1999) IGIV in neurology: evidence and recomendations. Can J Neurol Sci 26(2):139-152
19. Dalakas MC (1999) Intravenous immune globulin in the treatment of autoimmune neuromuscular disease: present status and practical therapeutics guidelines. Muscle Nerve 22:1479-1497
20. Fergusson D, Hutton B, Sharma M, Tinmouth A, Wilson K, Cameron DW, Hebert PC (2005) Use of intravenous immunoglobulin for treatment of neurologic conditions: a systematic review. Transfusion 45:1640-1657
21. Hughes RA, Raphaël JC, Swan AV, Doorn PA (2004) Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Database Syst Rev 1: CD002063
22. Van Schaik IN, Winer JB, De Haan R, Vermeulen M (2002) Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev 2:CD001797
23. Joint Task Force of the EFNS and the PNS (2005) European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society. J Peripher Nerv Syst 10:220-228
24. van Schaik IN, van den Berg LH, de Haan R, Vermeulen M (2005) Intravenous immunoglobulin for multifocal motor neuropathy. Cochrane Database Syst Rev 2:CD004429
25. Gray O, McDonnell GV, Forbes RB (2003) Intravenous immunoglobulins for multiple sclerosis. Cochrane Database Syst Rev 3: CD002936
26. Maddison P, Newsom-Davis J (2003) Treatment for Lambert-Eaton myasthenic syndrome. Cochrane Database Syst Rev 2:CD003279
27. Göttfried I, Seeber A, Anegg B, Rieger A, Stingl G, Volc-Platzer B (2000) Highdose intravenous immune globulins in dermatomyositis: clinical responses. Eur J Dermatol 10:29-35
28. Beck CE, Nathan PC, Parkin PC, Blanchette VS, Macarthur C (2005) Corticosteroids versus intravenous immune globulin for the treatment of acute immune thrombocytopenic purpura in children: a systematic review and meta-analysis of randomized controlled trials. J Pediatr 147:521-527
29. Jenson HB, Pollock BH (1997) Meta-analyses of the effectiveness of intravenous immune globulin for prevention and treatment of neonatal sepsis. Pediatrics 99(2):e2
30. Haque KN (2000) Intravenous immunoglobulins versus sepsis. Pediatrics 105:1173
31. Ohlsson A, Lacy J (2004) Intravenous immunoglobulin for suspected or subsequently proven infection in neonates. Cochrane Database Syst Rev 1:CD001239
32. Ohlsson A, Lacy J (2004) Intravenous immunoglobulin for preventing infection in preterm and/or low-birth-weight infants. Cochrane Database Syst Rev 1:CD000361
33. Provan D, Nockes TJC, Agrawal S, Winer J, Wood P (2008) Clinical guidelines for immunoglobulin use, 2nd ed. UK Department of Health, London. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH-085235