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Adverse event reporting for cellular therapy products: Current status and future directions
Author(s) -
Loper Kathy,
Sugrue Michele W.,
Raval Jay S.,
Schwartz Joseph Yossi,
Land Kevin,
Koh Mickey,
Mengling Thilo,
Greinix Hildegard,
Halter Jörg P.,
Celluzzi Christina M.,
Chaudhri Maysum
Publication year - 2020
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.16062
Subject(s) - adverse effect , psychological intervention , key (lock) , product (mathematics) , intensive care medicine , risk analysis (engineering) , medicine , event (particle physics) , process (computing) , business , process management , computer science , pharmacology , computer security , nursing , physics , geometry , mathematics , quantum mechanics , operating system
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.