Análise de prescrições de imunoglobulina humana endovenosa para situações clínicas não referendadas nos protocolos clínicos nacionais
Analysis of intravenous human immunoglobulin prescriptions for clinical situations not referenced in national clinical protocols
Christiane Rodrigues Spacil; Denise Bueno
Resumo
Objetivo: Avaliar para quais indicações clínicas a imunoglobulina humana está sendo utilizada, considerando ser esse um medicamento de alto custo e autorizado pelos protocolos nacionais para diagnósticos específicos. Métodos: Trata-se de um estudo transversal, retrospectivo, baseado na busca de informações através do prontuário eletrônico dos pacientes do Hospital de Clínicas de Porto Alegre no período de janeiro a dezembro de 2015. Resultados: Foram identificadas 191 prescrições, totalizando 116 pacientes que tiveram prescrita a imunoglobulina humana endovenosa (IGIV). Desses pacientes, 27 casos foram relacionados a 6 tipos de doenças autoimunes e que apresentam protocolos definidos. Esses protocolos auxiliam os profissionais da saúde quanto aos cuidados necessários de manejo medicamentoso. Os demais casos identificados não constam nas indicações previstas nos protocolos do Ministério da Saúde e representam mais de 75% dos pacientes atendidos. Não foram identificados efeitos colaterais sistêmicos ou periféricos em nenhum caso. Conclusão: Foi possível identificar para quais indicações clínicas está sendo realizada a administração de IGIV, evidenciando-se a necessidade de ampliação desse estudo para outras instituições, como forma de sinalizar a necessidade de administração desse hemoderivado devido a segurança e efetividade no tratamento.
Palavras-chave
Abstract
Objective: To evaluate clinical indications for human immunoglobulin, taking into consideration that this is a high-cost drug and authorized by national protocols for specific diagnoses. Methods: This was a cross-sectional, retrospective study based on information collected from electronic medical records of patients treated at Hospital de Clínicas of Porto Alegre from January to December 2015. Results: A total of 191 prescriptions of intravenous human immunoglobulin (IVIG) were identified, totaling 116 patients. Of these patients, 27 presented six types of autoimmune diseases that have established protocols. These protocols assist health professionals in taking all the necessary measures during medication management. The remainder of the cases identified had diseases that are not included in the indications of the protocols of the Brazilian Ministry of Health, and they accounted for more than 75% of the patients treated. No systemic or peripheral side effects were identified in any case. Conclusion: It was possible to identify the clinical indications for the prescription of IVIG, evidencing the need to replicate this study in other institutions, as a way of signaling the need to administer this blood product, considering the safety and effectiveness of the treatment.
Keywords
Referências
1. Brasil. Ministério da Saúde. Documentos e exames necessários para solicitação administrativa de medicamentos do componente especializado da assistência farmacêutica V, jun. 2015.
2. Siegel J. The product: All intravenous immunoglobulins are not equivalent. Pharmacotherapy. 2005;25(11Pt2):78S‑84S.
3. Nydegger U. (1994). Old and new views on intravenous immunoglobulin therapy. Schweizerische Medizinische Wochenschrift. 1994;124(1‑2):5‑25.
4. Antônio Eduardo Vieira dos Santos. Infusão de imunoglobulina intravenosa em crianças com imunodeficiência primária. Tese (Doutorado em Saúde da Mulher e da Criança), Instituto Fernandes Figueira, Rio de Janeiro, RJ, 2012.
5. Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med. 1991;325:110-7.
6. Nydegger UE, Mohacsi PJ, Escher R, Morell A. Clinical use of intravenous immunoglobulins. Vox Sang. 2000;78(Suppl2):191‑5. Prescrições de IGIV para situações clínicas não referendadas nos protocolos – Spacil CR & Bueno D
7. Ratko TA, Burnett D A, Foulke GE, Matuszewski KA, Sacher RA. 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.[comment]. Jama. 1995;273(23):1865‑70.
8. Anderson D, Ali K, Blanchette V, Brouwers M, Couban S, Radmoor P, Rock G. (2007). Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfusion Medicine Reviews. 2007;21(Suppl. 1):S9-S56.
9. Tellier Z, Mouthon L. Les indications therapeutiques des immunoglobulines intraveineuses. In Transfusion Clinique et Biologique. 2003;10:179‑84.
10. Brasil. Ministério da Saúde. Portaria n° 712, de 13/08/2014.
11. Glotz D, Haymann JP, Sansonetti N, Francois A, Menoyo-Calonge V, Bariety J, et al. Suppression of HLA-specific alloantibodies by high-dose intravenous immunoglobulins (IVIg). A potential tool for transplantation of immunized patients. Transplantation. 1993;56:335‑7.
12. Glotz D, Antoine C, Julia P, Suberbielle-Boissel C, Boudjeltia S, Fraoui R, et al. Desensitization and subsequent kidney transplantation of patients using intravenous immunoglobulins (IVIg). American Journal of Transplantation. 2002;2(8):758‑60.
13. Vo A, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, et al. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008;359(3):242‑51.
14. Newburger J, Takahashi M, Burns JC, Beiser AS, Chung KJ, Duffy CE, et al. The treatment of Kawasaki syndrome with intravenous gamma globulin. N Engl J Med. 1986;315(6):341-7.
15. Oates-Whitehead R, Baumer J, Haines L, Love S, Maconochie I, Gupta A, Flynn I. Intravenous immunoglobulin for the treatment of Kawasaki disease in children. Cochrane Database of Systematic Reviews (Online). 2003.(4). CD004000.
16. Sainio S, Teramo K, Kekomäki R. Prenatal treatment of severe fetomaternal alloimmune thrombocytopenia. Transfusion Medicine. 1999;9(4):321‑30.
17. Birchall JE, Murphy MF, Kaplan C, Kroll H. European collaborative study of the antenatal management of feto-maternal alloimmune thrombocytopenia. British Journal of Haematology. 2003;122(2):275‑88.
18. Alejandria MM, Lansang MA, Dans LF, Mantaring JB. Intravenous immunoglobulin for treating sepsis and septic shock. Cochrane Database of Systematic Reviews (Online : Update Software), (2). 2000. CD001090.
19. Douzinas EE, Pitaridis MT, Louris G, Andrianakis I, Katsouyanni K, Karmpaliotis D, Roussos C. Prevention of infection in multiple trauma patients by high-dose intravenous immunoglobulins. Critical Care Medicine. 2000;28(1):8‑15.
20. Matteson EL. Recent clinical trials in the rheumatic diseases. Current Opinion in Rheumatology. 1997;9(2):95‑101.
21. Pyne D, Ehrenstein M, Morris V. The therapeutic uses of intravenous immunoglobulins in autoimmune rheumatic diseases. Rheumatology. 2002;41:367-74.
22. European Agency for the Evaluation of Medicinal Products (EMEA). Core SPC for Human Normal Immunoglobulin for intravenous Administration (IVIG) [Internet]. EMEA; Core SPC for Human Normal Immunoglobulin for Intravenous Administration (IVIg) [citado 2016 fev 20]. Disponível em:http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500067337&murl=menus/document-library/document_library.jsp&mid=WC0b01ac058009a3dc&jsenabled=true
23. Knezevic-Maramica I, Kruskall MS. Intravenous immune globulins: an update for clinicians. Transfusion. 2003 Oct;43(10):1460-80. Disponível em: http://www.ncbi.nlm.nih.gov/pubmed/14507280
Submetido em:
15/06/2017
Aceito em:
21/07/2017
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