Fresh frozen plasma: pharmaceutical input for the production of plasma-derived medicines

• Autor(a) principal: Adati, Marisa Coelho
• Data de Publicação: 2019
• Outros Autores: Almeida, Antônio Eugênio Castro Cardoso de, Ribeiro, Álvaro da Silva, Borges, Helena Cristina Balthazar Guedes, Issobe, Marlon Akio da Silva
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1283
• topic: Plasma Fresco Congelado; Serviços de Hemoterapia; Recuperação do Teor de Fator VIII; Frozen Fresh Plasma; Hemotherapy Services; Recovery of Factor VIII Content

Introduction: In Brazil, hemotherapy was started as a medical specialty in the 1940s in the Rio de Janeiro and São Paulo axis with the inauguration of the first Blood Bank at the Fernandes Figueira Institute. As a governmental initiative, Law n. 1,075/1950/MS, which provides for the voluntary donation of blood, was promulgated, culminating with the Law n. 10,205/2001, which regulated paragraph 4 of article 199 of the Federal Constitution, regarding collection, processing, storage, distribution and application of blood and its components. Among the components obtained in the Hemotherapy Services, we can highlight the frozen fresh plasma (FFP) that can be transfused and, when becoming a surplus of the therapy, continue to be used to produce industrialized blood products. Objective: This study intends to demonstrate the most relevant aspects regarding the recovery of factor VIII content, in the FFP units collected in 72 Hemotherapy Services visited in the country, aiming at its safe and effective use both for therapeutic use and as a pharmaceutical input in the production of blood products. Method: The methodology adopted included five steps: Elaboration and validation of the questionnaire applied; Selection of Hemotherapy Services to be visited; Analysis of quality indicators according to the Donabedian Triad; Collection, packaging and transport of FFP units; Analysis of the Factor VIII content in the FFP units collected during the technical visit during the period from 2013 to 2015. Results: Among the results obtained, it is important to highlight the concentration of factor VIII (IU/mL), in the FFP units, with the following results: mean 0.68; standard deviation 0.32; coefficient of variation 47.1%, confidence interval 0.64 to 0.71. Conclusions: factor VIII content greater than or equal to 0.70 IU/mL was found in 38.5% of FFP units, as specified in the Brazilian Pharmacopoeia, which can and should be used as a pharmaceutical input in the production of blood products. It was also found a disposal of approximately 500 million IU/mL of factor VIII, which represents 83.0% of the annual acquisition by the Ministry of Health of Concentrate of factor VIII for medical uses. Such use could generate significant savings in public coffers.