1. Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern www.swissmedic.ch Haemovigilance international: ISTARE Swisstransfusion, 6 September 2013 Haemovigilance M. Jutzi, M.Rüesch Clinical Reviewer Haemovigilance, Swissmedic

2. 2 Aims and achievements: Basic concept for haemovigilance established Developing and maintaining a website Standard definitions for adverse reactions and events as well as for donor complications Organising annual seminars Collaboration and coordination with ISBT WP on Haemovigilance and WHO Haemovigilance now expanding beyond transfusion recipients to include clinical aspects, donor complications, biovigilance Swisstransfusion, 06.09.2013

3. 3 The IHN Database for the Surveillance of Adverse Reactions and Events in Donors and Recipients of Blood Components Aim: To provide an international tool for reporting and analysing all adverse reactions (ARs) and events (AEs) associated with the donation and transfusion of blood components, irrespective of their severity The ISTARE Working Group: C. Politis (Greece), P. Renaudier (France), C. Richardson (Greece), P. Robillard (Canada), J. Wiersum (NL) Swisstransfusion, 06.09.2013 All the ISTARE slides kindly provided by Dr.Constantina Politis, SKAE, chairperson of ISTARE Working Group

4. 4 ISTARE: Data submission and analysis Confidential online submission of annual aggregated haemovigilance data by countries (exceptionally by regions) using IHN/ISBT standard definitions ISTARE automatically provides rates and ratios of ARs for analysis of national data and produces charts comparing international data for one or more years. Swisstransfusion, 06.09.2013

5. 5 ISTARE: Data analysis and dissemination Main areas covered  Event rates, overall and by product type  Type of reaction, by severity and imputability  Distribution of types of event  Averages for global regions  Monitoring trends Data are disseminated only in anonymised form. Each country is marked in tables and diagrams by a code number. Swisstransfusion, 06.09.2013

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8. 8 ISTARE: What data are collected?

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10. 10 Swisstransfusion, 06.09.2013 STARE Pilot study 2008

11. ISTARE: Participating countries 11 Swisstransfusion, 06.09.2013

12. ISTARE: Volume of data 2006-2011 Data Units issued111’533’743 Units transfused (in 10 countries) 30’782’487 Total adverse reactions83’123 Incidence per 100,000 units issued74.5 Deaths283 Incidence per 100,000 units issued0.25 Total donor complications364’384 ISTARE 12 Swisstransfusion, 06.09.2013

13. ISTARE: % breakdown of AR, 2006-2011 13 Swisstransfusion, 06.09.2013

14. AR incidence per 100,000 units issued AR incidence per 100,000 units issued AR incidence per 100,000 units issued 100,000 units issued 14 Swisstransfusion, 06.09.2013

15. Incidence of TRALI by country, 2011 (per 100,000 units issued) 15 Swisstransfusion, 06.09.2013

16. AR by blood component, 2006-2011 AR by blood component, 2006-2011 rate per 100,000 ? 16 Swisstransfusion, 06.09.2013

17. Total ARs by severity (n=83,123) 17 Swisstransfusion, 06.09.2013

18. AR by imputability, by country, 2011 18 Swisstransfusion, 06.09.2013

19. AHTR 14 DHTR 3 Allergic reaction 26 FNHTR 3 TACO 57 TRALI 60 TAD 22 Malaria 1 Other parasitic infection 1 Bacterial infection 9 Hypotensive reaction 3 TA-GVHD2 PTP 1 Hyperkaliemia 0 Hypocalcaemia 0 Other19 UCT12 Distribution of causes of death 2006-2011 ISTARE 19 Swisstransfusion, 06.09.2013

20. AHTR 14 DHTR 3 Allergic reaction 26 FNHTR 3 TACO 57 TRALI 60 TAD 22 Malaria 1 Other parasitic infection 1 Bacterial infection 9 Hypotensive reaction 3 TA-GVHD2 PTP 1 Hyperkaliemia 0 Hypocalcaemia 0 Other19 UCT12 Distribution of causes of death 2006-2011 ISTARE 20 Swisstransfusion, 06.09.2013

21. Site of primary error Transfused with reaction Transfused without reaction Component not transfused (near misses) Total Blood unit Wrong donor group label 1212223367 Wrong recipient ID on unit 131311591157 Patient sample Wrong name on tube (including wrong patient collected) 250250734,8845,207 Transfusion ABO incompatible transfusion 251163 414 Wrong patient but ABO compatible 136382 518 Wrong product type (e.g.plasma for platelets) 90111 201 Errors-IBCT, 2006-2011 ISTARE 21 Swisstransfusion, 06.09.2013

22. Donor complications, 2006-2011 (n=364,384) Donor complications % VV Reactions 75.8 Local 20.3 Citrate 1.3 Other 2.6 Total100.0 Analysis by type Analysis by severity ISTARE 22 Swisstransfusion, 06.09.2013

23. Severe donor complications, 2011 23 Swisstransfusion, 06.09.2013

24. Conclusions The permanent web-based system enables the collection and analysis of annual data from any country that gathers detailed haemovigilance data It differs from EU and Council of Europe data collection systems in its holistic approach, aiming at the surveillance of all ARs and AEs, not just serious ones. Amongst other things, ISTARE will permit better assessment of trends Enhanced calculations capabilities are also planned The ISTARE web-based system initiates new prospects for the future of haemovigilance 24 Swisstransfusion, 06.09.2013

25. 25 Swisstransfusion, 06.09.2013 The End Merci