Abstract
Safety of living donors is critical to the success of blood, tissue and organ transplantation. Structured and robust vigilance and surveillance systems exist as part of some national entities, but historically no global systems are in place to ensure conformity, harmonisation and the recognition of rare adverse events (AEs). The World Health Assembly has recently resolved to require AE/reaction (AE/R) reporting both nationally and globally. The World Marrow Donor Association (WMDA) is an international organisation promoting the safety of unrelated donors and progenitor cell products for use in haematopoietic progenitor cell (HPC) transplantation. To address this issue, we established a system for collecting, collating, analysing, distributing and reacting to serious adverse events and reactions (SAE/R) in unrelated HPC donors. The WMDA successfully instituted this reporting system with 203 SAE/R reported in 2011. The committee generated two rapid reports, reacting to specific SAE/R, resulting in practice changing policies. The system has a robust governance structure, formal feedback to the WMDA membership and transparent information flows to other agencies, specialist physicians and transplant programs and the general public.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$259.00 per year
only $21.58 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
WHO. Guiding Principles on Human Cell, Tissue and Organ Transplantation. Cell Tissue Bank 2010; 11: 413–419.
Leape LL . Reporting of adverse events. N Engl J Med, [Research Support, Non-U.S. Gov't] 2002; 347: 1633–1638.
Pulsipher MA, Chitphakdithai P, Logan BR, Shaw BE, Wingard JR, Lazarus HM et al. Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the NMDP. Blood 2013; 121: 197–206.
Pulsipher MA, Chitphakdithai P, Miller JP, Logan BR, King RJ, Rizzo JD et al. Adverse events among 2408 unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. Blood 2009; 113: 3604–3611.
Holig K, Kramer M, Kroschinsky F, Bornhauser M, Mengling T, Schmidt AH et al. Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors. Blood 2009; 114: 3757–3763.
Halter J, Kodera Y, Ispizua AU, Greinix HT, Schmitz N, Favre G et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009; 94: 94–101.
Nagler A, Korenstein-Ilan A, Amiel A, Avivi L . Granulocyte colony-stimulating factor generates epigenetic and genetic alterations in lymphocytes of normal volunteer donors of stem cells. Exp Hematol 2004; 32: 122–130.
Bennett CL, Evens AM, Andritsos LA, Balasubramanian L, Mai M, Fisher MJ et al. Haematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR) project. Br J Haematol 2006; 135: 642–650.
Halter JP, van Walraven SM, Worel N, Bengtsson M, Hagglund H, Nicoloso de Faveri G et al. Allogeneic hematopoietic stem cell donation: standardized assessment of donor outcome data-A WBMT consensus document. Bone Marrow Transplant 2013; 48: 220–225.
Acknowledgements
We thank the membership for their active participation in this reporting system. We also thank Florian Krouwel for his invaluable support in managing the system.
Authors contribution
All authors were active in developing the S(P)EAR reporting system and in reaction and event review. All authors were involved in the drafting of the article or critical revision for important intellectual content.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no conflict of interest.
Rights and permissions
About this article
Cite this article
Shaw, B., Chapman, J., Fechter, M. et al. Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation. Bone Marrow Transplant 48, 1506–1509 (2013). https://doi.org/10.1038/bmt.2013.104
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/bmt.2013.104
Keywords
This article is cited by
-
Basic characteristics and safety of donation in related and unrelated haematopoietic progenitor cell donors – first 10 years of prospective donor follow-up of Swiss donors
Bone Marrow Transplantation (2022)
-
Cryopreservation of unrelated donor hematopoietic stem cells: the right answer for transplantations during the COVID-19 pandemic?
Bone Marrow Transplantation (2021)
-
Inadvertent completely HLA-mismatched allogeneic unrelated bone marrow transplant: lessons learned
Bone Marrow Transplantation (2016)
-
Deferrals of volunteer stem cell donors referred for evaluation for matched-unrelated stem cell donation
Bone Marrow Transplantation (2014)