Adverse outcomes and substances of human origin: Cases from the NOTIFY Library
ISBT Education. Petrisli E. Jun 3, 2018; 218842 Topic: Safety and adverse events
Dr. Evangelia Petrisli
Dr. Evangelia Petrisli
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After viewing this presentation the participant will be able to:
- Gain insight into the adverse outcomes from the Notify Library records
- Discuss cases of adverse outcomes in the Notify database
Background: Blood components, corneas, hematopoietic progenitor cells (HPC), kidneys and gametes can improve, and often, save lives. They can be grouped under the term “Medical Products of Human Origin” (MPHO), since they require a human donor and share exposure to risk from breaches of ethical and safety standards, for example the risk of disease transmission. Lessons learned from the adverse occurrences (AO) associated with such human-derived products should be shared as widely as possible in order to maximize donor and recipient safety.
Aims: The Notify Library ( is a joint global initiative, co-sponsored by the World Health Organization (WHO) and the Italian National Transplant Centre (CNT), that supports the sharing of published vigilance information for teaching purposes and for greater public transparency on the clinical use of MPHO in the settings of transplantation, transfusion and assisted reproduction.
Methods: Since 2012, AO identified primarily by literature review and associated with MPHO are collected and analyzed by dedicated editorial groups of international experts in the Notify Library. Categories of occurrences that are analyzed include transmitted infections, malignancies, donor reactions, clinical complications and process-related incidents. In order to facilitate a structured database search, all cases have been classified according to an AO type (Harm to a recipient, Harm to a donor, Harm to a fetus or offspring, Risk of harm) and an MPHO type (Organs, Blood, Cells, Tissues, etc.) taxonomy. The experts have reviewed cases to identify alerting signals, latency, frequency and methods of confirmation of imputability. Blood experts joined the editorial groups in 2015 and since then haemovigilance records are also incorporated in the database.
Results: The Notify Library contains 2,457 references linked to 1,558 didactic cases: 596 organs, 331 blood/blood products, 290 cells, 259 tissues, 69 reproductive tissues and cells, 9 derived medicinal products, 4 other. Of the 331 reports of AO associated with blood/blood products, 57% are related to red blood cell transfusion, 21% to platelets, 11% to plasma, 7% to whole blood, 1% to granulocytes, and the remainder are not specified. Of the 88% of blood reports that have been classified under Harm to recipient, 49% of reports are immunological in nature, including delayed hemolytic transfusion reactions (DHTR, 33%), acute hemolytic transfusion reactions (AHTR, 28%), delayed serologic transfusion reaction (DSTR, 15%), transfusion related acute lung injury (TRALI, 13%), allergic reactions (7%) and other (4%) (Whitaker, Immunohematology, 2017). Of the 91 cases of infection transmission, 49% are bacterial, 35% viral, 12% parasitic, 2% fungal and 2% prion. Of the 283 records of AO associated with HPC (46% marrow, 44% apheresis, 8% cord blood, 2% source not specified), 42% have been classified under Harm to a recipient, 50% under Harm to a donor and 8% under Risk of harm.
Summary / Conclusions: In conclusion, the NOTIFY Library is an important resource for the collection and description of AO in transplantation, transfusion and assisted reproduction. The Library aims to support clinicians, competent authorities, potential donors and recipients to better understand and reduce the risks associated with the donation and clinical application of MPHO.
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