Date Published: March 9, 2020
Publisher: Sociedade Brasileira para o Desenvolvimento da Pesquisa em Cirurgia
Author(s): Joan Roselló-Catafau, Arnau Panisello-Roselló, Gianfranco Pasut, Miquel Navasa, Jacques Pirenne, René Adam.
Solid organ transplantation is a very complex process, in which the storage of the graft in a preservation solution is mandatory in order to extend ischemic times and contain further damage. The condition in which the organ is transplanted is critical for the outcome of the organ recipient. The recent emergence of generic versions of organ preservation solutions (solutions with the same composition and under the same legislation as the original versions, but with different brands) compelled us to study whether the standards are maintained when comparing the original and its generic counterpart. Along these lines, we discuss and comment on some aspects concerning this issue of general interest in the organ transplantation field.
The use of generic preservation solutions (GPS) is increasing and, as has happened in other fields such as in the case of immunosuppressants, their efficacies vary. With this in mind, it seems reasonable that the concerns about the efficacy of GPS should be addressed in the context of regulatory requirements for quality and for composition in clinical studies to guarantee the best clinical practice in organ transplantation
We address several concerns regarding the use of generic preservation solutions, which could affect the quality of graft preservation and transplant outcomes. Our common goal is to guarantee the best clinical practice in organ transplantation to ensure good clinical outcome in organ recipients.