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

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,

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, All the ISTARE slides kindly provided by Dr.Constantina Politis, SKAE, chairperson of ISTARE Working Group

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,

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,

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8 ISTARE: What data are collected?

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10 Swisstransfusion, STARE Pilot study 2008

ISTARE: Participating countries 11 Swisstransfusion,

ISTARE: Volume of data 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,

ISTARE: % breakdown of AR, Swisstransfusion,

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,

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

AR by blood component, AR by blood component, rate per 100,000 ? 16 Swisstransfusion,

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

AR by imputability, by country, Swisstransfusion,

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 ISTARE 19 Swisstransfusion,

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 ISTARE 20 Swisstransfusion,

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

Donor complications, (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,

Severe donor complications, Swisstransfusion,

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,

25 Swisstransfusion, The End Merci