Donor vigilance: an international perspective

Size: px

Start display at page:

Download "Donor vigilance: an international perspective"

Andra Hunter
5 years ago
Views:

1 Donor vigilance: an international perspective Johanna (Jo) Wiersum-Osselton ISBT working party on haemovigilance International Haemovigilance Network Sanquin Blood Supply TRIP Hemovigilance and biovigilance

2 Landsteiner Photo WBDD

3 EU voluntary reporting: very basic (2013) data on serious donor reactions

4 Donor (hemo)vigilance Donor hemovigilance is the systematic monitoring of adverse reactions and incidents in the whole chain of blood donor care, with a view to improving quality and safety for blood donors. From Haemovigilance: an effective tool for improving transfusion practice, RRP de Vries, P Robillard and JC Faber (eds), Wiley, 2012.

5 International reporting Advances in knowledge Interventions Challenges

6 International reporting What EU Notify Library: didactic examples ISTARE EU Notify ISTARE Serious Reactions And events Didactic examples All levels of severity and imputability Denominators Yes No Yes Status Recommendations Reported to HV system; country aggregate data Documented in HV system or published Reported to HV system; aggregate data No No No

8 Adding hemovigilance to Notify Commonalities Human origin Guiding principles-> protection of donors and recipients Organisations and professionals Didactic Assisting countries in creating their systems NEXT STEPS Who will be the users? Align taxonomy to hemovigilance and donor vigilance definitions Editorial group members and topic expert subgroups Contributor network

9 Definitions! International Haemovigilance Network with International Society for Blood Transfusion and AABB Blood and Tissues December 2014 publication of revised classification for surveillance of complications of blood donation Publicly available on IHN/ISBT websites parties->haemovigilance->definitions Endorsement Alliance of Blood Operators European Blood Alliance

International Haemovigilance Network International Surveillance database for Transfusion Adverse Reactions and Events in donors and recipients of blood components (ISTARE) Working

10 International Haemovigilance Network International Surveillance database for Transfusion Adverse Reactions and Events in donors and recipients of blood components (ISTARE) Working Group C. Politis, Ph. Renaudier, C. Richardson, P. Robillard, J. Wiersum Aggregate data from national HV systems By blood component Severity Imputability Online data entry since 2010

11 Countries 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Total N = 107 million donations donation complications = 0.67% Donor complications : data collection in progress Other Local VVR Countries

14 (2011)

16 Analysis by type Donation complications, 2012 data (n= ) N Total Rate % N serious per 100,000 severe Haematoma % Arterial puncture % Delayed bleeding % Painful arm % Localised infection % Thrombophlebitis % VVR Immediate type % VVR Immediate type, accident % VVR Delayed type % VVR Delayed, accident % Citrate reaction % Haemolysis 0 Generalised allergic R % Air embolism % Other %

17 Severe donor complications, 2012

18 Summary Variation in rates Variation in severity assessment Not all countries can break down between complications of whole blood donation and apheresis Shows up rare complications and serious complications Limited analyses possible

20 In view of the increasing general interest in blood banks, it is hoped that this report may be of some value to those concerned with the organisation of such blood banks and may aid in anticipating some of the problems which may arise from time to time in the care and maintenance of such projects. The first consideration of the Blood Donor Service has been the care and protection of the donor; the second has been the care and prevention of spoilage of the blood obtained.

21 3,500,000 donations Distinguished local vs systemic complications Subgroup case-control study of risk factors for vasovagal reactions > young, first-time, female, low body weight, previous reaction, lower blood pressure, white-collar workers, stress Risks to donors from ammonia as a restorative: 6 cases where solution went into eye use of local anaesthetic Study of deaths and non-fatal cardiovascular events within 48 hours revealed cases of undeclared donor morbidity

22 Ask your donors! 3 premedical students and 1 volunteer 1000 donors (55% female, 17% first time, median age 42) Telephone interview 3 weeks after WB donation Did you have any general symptoms during or after your blood donation? Did you have any arm problems after your blood donation? Questions about specific symptoms/complications

23 AEs (%) in whole-blood donors and subgroups All donors All AE Sore arm Fatigue Vasovagal reactions Men Women Repeat Bruise/ hematoma Firsttime Range between interviewers: 30-43% Newman BH et al., Transfusion 2003;43:

Complications of blood donation Complications Rates highly dependent on ascertainment method variation between centres, even with identical SOPs

24 Complications of blood donation Complications Rates highly dependent on ascertainment method variation between centres, even with identical SOPs ->reduced donor return Return within 1 year *needle-related complications, failed stab or flow problems Experience at 1st whole blood donation (2010; n=28819),

25 Needle-related complications Sorensen BS et al, Vox Sanguinis 2008; 94; : moderate and severe complications (1997 to 2003) Sorensen BS et al, Vox Sanguinis 2015: early view: 152 donors (4-6 per 100,000) moderate to severe arm pain ( ) FU questionnaire 12m 10y after donation: 88 responders 61 (78%) had persistent symptoms, 17 (19%) impact on daily life

26 Risk factors: fainting Case-control study 1860 allogeneic donors & control group from random donor population Trouern-Trend et al., Transfusion 1999; 39:

27 Risk factors (2) faints and prefaints 422,231 allogeneic whole-blood donations (9 months) Overall rate 1.43% of which 37% moderate or severe Blood volume <3500 ml OR % CI to 18-year-olds 19- to 24-year-olds compared to 25- to 65-year-olds First-time donors compared to repeat donors Gender OR % CI OR % CI OR % CI not independently predictive Wiltbank et al., Transfusion 2008; 48:

28 Interventions Theme Method Remarks Preventing vasovagal reactions Water drink (or isotonic) Applied muscle tension Social support Donor information Reduced collection volume for at-risk donors Newman 2007 and others France 2010, Ditto 2009 Hanson 2009 France 2010 Eder, 2011 Needle injury!! Avoid needle manipulation Need of evidence-based treatment methods Monitoring donor iron status Campaign for modification of apheresis connectors (preventing mix-up of saline and citrate) - Ferritin - Zinc protoporphyrin Replacement therapy Adjusting interval Collaboration between stakeholder organisations Magnussen, Goldman and others Baart 2013 Controversial! Baart 2011 Managed convergence (European Blood Alliance and other organisations)

29 Iron depletion Regular whole blood donation depletes iron stores Regular donation by apheresis also has an impact Deferral for low Hb is the most frequent reason for donor deferral Deferral reduces donor return Bryant et al. Transfusion 2012; 52: Low Hb group (age >18y) (<12.5 g/dl; n=1236) 53% female donors iron depleted or deficient (ferritin <19 ug/l) 61% of male donors iron depleted or deficient (ferritin <29 ug/l) 60 tablets 325 mg ferrous sulphate, repeated at subsequent visits Control donors (n=400) 39% donors iron depleted or deficient Offered iron replacement if iron depleted or deficient Compliance 68% Adverse gastrointestinal effects 21% 13 donors with serious medical conditions (8: GI bleeding), no malignancies or hemochromatosis.

30 Magnussen et al. Transfusion 2015 early view -Capital region of Denmark (192,288 donations) -Central department handling iron investigation and supplementation -GP referral if health history suspect (no systematic follow-up; 4 donors notified centre of leukemia, 2 bowel cancer, 1 SLE) -Tailored iron supplements for Hb-deferred donors after FBC/ferritin -including 20 tablets at supplement donations increase in Hb concentration and a reduction in the proportion of donors with low Hb concentration

based on predonation Hb Men (n=112,491) <8.4 3,607 (3.2) 683 (18.9) 97 (20.3) 428 (20.2) 114 (19.1) 44 (10.6) 8.4 5,115 (4.5) 991 (19.4) 653 (27.4) 236 (15.7) 61 (9.1) 41 (7.2) 8.5 4,058 (3.

31 Hb previous donation /visit, mmol/l* n (%) Prevalence of Hb deferral, n (%) (total) M. Baart, Transfusion 2015 early view Prevalence of Hb deferral, n (%) (per time interval ) Interval < 3 months Interval 3-6 months Ongoing study: effect of preemptive adjustment of donation interval based on predonation Hb Men (n=112,491) <8.4 3,607 (3.2) 683 (18.9) 97 (20.3) 428 (20.2) 114 (19.1) 44 (10.6) 8.4 5,115 (4.5) 991 (19.4) 653 (27.4) 236 (15.7) 61 (9.1) 41 (7.2) 8.5 4,058 (3.6) 605 (14.9) 392 (21.7) 159 (12.7) 37 (6.6) 17 (3.8) 8.6 4,501 (4.0) 490 (10.9) 322 (16.5) 125 (9.0) 22 (3.6) 21 (3.7) >8.6 95,210 (84.6) 1,799 (1.9) 1,079 (3.0) 454 (1.6) 165 (1.0) 101 (0.7) Women (n=108,455) <7.8 6,658 (6.1) 1,683 (25.3) 3 (15.0) 1,156 (27.9) 362 (23.8) 162 (16.8) 7.8 8,208(7.6) 1,737 (21.2) 41 (32.5) 1,179 (26.2) 285 (16.0) 132 (9.3) 7.9 6,490 (6.0) 1,022 (15.7) 21 (25.3) 790 (19.3) 171 (11.7) 100 (8.6) 8.0 6,499 (6.0) 798 (12.3) 24 (22.2) 561 (14.7) 121 (8.8) 92 (7.7) >8.0 80,600 (74.3) 3,057 (3.8) 82 (7.4) 2,171 (4.7) 489 (2.7) 315 (2.1)

32 WHO decision, January 2015 The Executive Board, having considered the report by the Secretariat on blood and other medical products of human origin (MPHO), noted that several medical products of human origin, which are intended for human clinical application, have significant commonalities in terms of sharing some characteristics inherent in their human origin; recognized that protection of the donor is a prerequisite in order to meet the needs of patients for access to safe medical products of human origin safety issues for donors and recipients; protect the fundamental human rights of donors; standards to guarantee quality and safety of medical products of human origin and to ensure traceability, vigilance, surveillance and equitable access to these products REQUESTED that the Director-General convene consultations with Member States and international partners, to support the development of global consensus on guiding ethical principles for the donation and management of the mentioned medical products of human origin; good governance mechanisms; and common tools to ensure quality, safety and traceability, as well as equitable access and availability, as applicable, to result in a document to be submitted to the Seventieth World Health Assembly for its consideration

33 Why do we need donor vigilance? The goals of management of young blood donors are to provide an excellent experience for the donor at every step in the donation process minimize the duration of the total donation process minimize vasovagal reaction/complication rates protect against donor injury in those who sustain a reaction maximize donor retention. B. Newman Management of young blood donors Transfus Med Hemother 2014;41:

34 Many unanswered questions o o o o o o o Lower iron stores associated with reduced cardiovascular events or is it the healthy donor effect? Health consequences of low iron stores Frequent automated donation demineralisation? Question from donors do frequent donations weaken my immunity? Repeated vaccination (off label use) Stem cell donation donor follow up Living organ donation

35 Increasing focus on donors

36 Increasing focus on donors

37 A vision Capture of complication data according to common definitions and minimum set of parameters Denominator data Comparisons between blood centres Comparisons between countries Developing and evaluating interventions Improvements for donors Don t wait for the perfect definitions and data!

38 Acknowledgements All blood donors ISTARE Working group Constantina Politis, Clive Richardson, Philippe Renaudier, Pierre Robillard, Jan Jorgensen (retired), Danielle Rebibo (retired) IHN Peter Tomasulo, Jean-Claude Faber, Erica Wood, all board members Sanquin Tanneke Marijt, Arlinke Bokhorst, Wim de Kort, all colleagues ISBT Mindy Goldman, Kevin Land, Barbee Whitaker Haemovigilance working party donor subgroup

Adverse reactions and adverse events in blood donors: an international approach to the standardisation of classification

Adverse reactions and adverse events in blood donors: an international approach to the standardisation of classification Johanna (Jo) Wiersum-Osselton ISBT working party on haemovigilance International