Adverse event reporting for cellular therapy products: Current status and future directions

Authors

Kathy Loper, Center for Cellular Therapies, AABB, Bethesda, Maryland, USA
Michele W. Sugrue, Division of Hematology/Oncology, Department of Medicine, University of Florida, Gainesville, Florida, USA
Jay S. Raval, Department of Pathology, University of New Mexico, Albuquerque, New Mexico, USA
Joseph Yossi Schwartz, Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York, USA
Kevin Land, Vitalant, Phoenix, Arkansas, USA, Department of Pathology, UT Health Sciences San Antonio, San Antonio, Texas, USA
Mickey Koh, St George's Hospital and Medical School, London, UK Health Sciences Authority, Singapore
Thilo Mengling, DKMS Gemeinnützige GmbH, Tübingen, Germany
Hildegard Greinix, Division of Hematology, Medical University Graz, Graz, Austria
Jörg P. Halter, Hematology, University Hospital Basel, Basel, Switzerland
Christina M Celluzzi, Center for Cellular Therapies, AABB, Bethesda, Maryland, USA
Maysum Chaudhri, Center for Cellular Therapies, AABB, Bethesda, Maryland, USA

Document Type

Article

Publication Date

12-1-2020

Abstract

Adverse event (AE) and adverse reaction (AR) reporting are key components of patient safety and surveillance systems. Review and analysis of this data yields opportunities for process improvement, product information and interventions, and can lead to improved patient outcomes and donor safety overall. AE and AR reporting for cellular therapy products is fragmented and not well characterized in a central reference. This review article, authored by experts from various organizations, serves to summarize the current state of reporting and offers opportunities for streamlining and coordination, as well as key reference for professionals in this field.

Recommended Citation

Loper K, Sugrue MW, Raval JS, Schwartz JY, Land K, Koh M, Mengling T, Greinix H, Halter JP, Celluzzi CM, Chaudhri M. Adverse event reporting for cellular therapy products: Current status and future directions. Transfusion. 2020 Dec;60(12):2815-2827. doi: 10.1111/trf.16062. Epub 2020 Oct 16. PMID: 33063875.