Haemovigilance international: ISTARE Swisstransfusion, 6 September 2013 Haemovigilance M. Jutzi, M. Rüesch Clinical Reviewer Haemovigilance, Swissmedic • Schweizerisches Heilmittelinstitut • Hallerstrasse 7 • CH-3000 Bern • www. swissmedic. ch
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 2
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) All the ISTARE slides kindly provided by Dr. Constantina Politis, SKAE, chairperson of ISTARE Working Group Swisstransfusion, 06. 09. 2013 3
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 4
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 5
Swisstransfusion, 06. 09. 2013 6
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ISTARE: What data are collected? 8
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STARE Pilot study 2008 Swisstransfusion, 06. 09. 2013 10
ISTARE: Participating countries Other 3 Far East & Oceania 5 Europe 17 Swisstransfusion, 06. 09. 2013 11
ISTARE: Volume of data 2006 -2011 Data Units issued Units transfused (in 10 countries) Total adverse reactions 111’ 533’ 743 30’ 782’ 487 83’ 123 Incidence per 100, 000 units issued 74. 5 Deaths 283 Incidence per 100, 000 units issued Total donor complications Swisstransfusion, 06. 09. 2013 0. 25 364’ 384 ISTARE 12
ISTARE: % breakdown of AR, 2006 -2011 40 35 30 25 All AR Serious 20 15 10 5 0 Allergic FNHTR DSTR DHTR TACO Swisstransfusion, 06. 09. 2013 TAD TRALI Others 13
AR incidence per 100, 000 units issued AR incidence per 100, 000 units issued Swisstransfusion, 06. 09. 2013 14
Incidence of TRALI by country, 2011 (per 100, 000 units issued) 2. 5 2 1. 5 1 0. 5 0 A B C D E F G J K L M O P Q R S T U V Swisstransfusion, 06. 09. 2013 15
AR by blood component, 2006 -2011 600 rate per 100, 000 500 400 ? 300 200 100 0 RBC Platelets WBD Aph Swisstransfusion, 06. 09. 2013 Plasma Others 16
Total ARs by severity (n=83, 123) Swisstransfusion, 06. 09. 2013 17
AR by imputability, by country, 2011 Swisstransfusion, 06. 09. 2013 18
Distribution of causes of death 2006 -2011 TRALI 22. 3% TAD 11. 7% TACO 25. 8% Malaria 0. 4% Other parasitic infection 0. 4% Bacterial infection Hypotensive 3. 5% reaction 1. 1% PTP 0. 7% FNHTR 1. 1% Allergic reaction 11. 7% AHTR DHTR 6. 0% 1. 1% UCT Other 4. 6% 8. 8% Swisstransfusion, 06. 09. 2013 TA-GVHD 0. 7% ISTARE 19
Distribution of causes of death 2006 -2011 Swisstransfusion, 06. 09. 2013 ISTARE 20
Errors-IBCT, 2006 -2011 Site of primary error Transfused with reaction Transfused Component not without transfused Total reaction (near misses) Blood unit Wrong donor group label 12 22 33 67 Wrong recipient ID on unit Patient sample 13 115 91 157 250 73 4, 884 5, 207 ABO incompatible transfusion Wrong patient but ABO compatible 251 163 414 136 382 518 Wrong product type (e. g. plasma 90 111 201 Wrong name on tube (including wrong patient collected) Transfusion for platelets) Swisstransfusion, 06. 09. 2013 ISTARE 21
Donor complications, 2006 -2011 (n=364, 384) Analysis by type Donor complications Analysis by severity % VV Reactions 75. 8 Local 20. 3 Citrate 1. 3 Other 2. 6 Total Moderate 13. 3% 100. 0 Mild 84. 4% Severe 2. 4% Swisstransfusion, 06. 09. 2013 ISTARE 22
Severe donor complications, 2011 Arterial puncture 0. 3% Citrate reaction 4. 9% Delayed bleeding 0. 1% Other 12. 6% VVR del - accident , 1. 4% VVR immediate 31. 3% VVR delayed 6% Painful arm 13. 2% VVR imm - accident 6. 1 % Thrombophlebitis 0. 4% Haematoma 23. 3% Swisstransfusion, 06. 09. 2013 Localised infection 0. 6% 23
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 Swisstransfusion, 06. 09. 2013 24
The End Merci Swisstransfusion, 06. 09. 2013 25
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