Pharmacotherapeutic management of advanced therapy medicinal products

Autores de IIS La Fe

• José Luis Poveda Andrés

  Autor

• Maria Jose Ruiz Caldes

  Autor

• Javier García Pellicer

  Autor

• Eduardo López Briz

  Autor

• Juan Eduardo Megías Vericat

  Autor

• María Tordera Baviera

  Autor

• Silvia Valero Garcia

  Autor

Participantes ajenos a IIS La Fe

• Jose Carreras-Soler, Maria
• Clopes-Estela, Ana
• Flores-Moreno, Sandra
• Giraldez-Quiroga, Miriam
• Lozano-Blazquez, Ana

Grupos

• Farmacogenética

Abstract

Advanced therapy medicinal products have emerged in recent years as new pharmacotherapeutic strategies. In this context, hospital pharmacy services have had to adapt to the new challenges posed by the inclusion of advanced therapies in their roster of services against the background of the complex pharmacotherapeutic process patients typically go through. All the activities carried out in the hospital pharmacy services must abide by the rules established in the Spanish legislation and ensure both the quality of the different drugs they manage and the safety of every single patient. Advanced therapy medicinal products are associated certain peculiarities, including the need to select and evaluate potential candidates to receive them; recourse to financing mechanisms based on risk sharing; and their extreme fragility, which means that the personnel in charge of handling them must be properly trained to maintain their viability and that special storage conditions, involving temperatures below 180 degrees C in the case of chimeric antigen receptor T cell therapies, must be maintained. In addition, use of advanced therapy medicinal products in the clinical setting has made it necessary for scientific societies to produce consensus documents recognizing the pivotal role of hospital pharmacists as indispensable members of the multidisciplinary healthcare team and ensuring the same traceability, conservation, custody and pharmacotherapeutical monitoring standards imposed on other drugs to provide for adequate pharmaceutical care. Scientific societies have also highlighted the importance of intensifying clinical research, an essential requirement for the safe incorporation of new therapeutic targets. The present document is intended to describe the challenges pharmacists may face when using advanced therapy medicinal products at the different stages or processes in the patient's clinical journey.

Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Keywords

• Adoptive cellular immunotherapy; CAR-T cell therapy; Gene therapy; Cryopreservation; Patient outcomes assessment