Serious Adverse Blood Reactions & Events (SABRE)

Feedback direct to us: sabre@mhra.gsi.gov.uk

The UK Blood Safety and Quality Regulations 2005 and the EU Blood Safety Directive require that serious adverse events and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety.

From these web-pages Blood Establishments, Blood Banks/Hospital Transfusion Teams can Register and Log In to use the MHRA’s secure and confidential online reporting system.  This system allows reporters electronically to submit reports of serious adverse event or serious adverse reaction directly to the MHRA.  This new reporting system is known as SABRE – Serious Adverse Blood Reactions & Events.

Once Registered and Logged In, healthcare and blood service staff are able to draft and submit initial Notifications and subsequent Confirmations of adverse events and adverse reactions.
 
Registered reporters also have access to an online ‘Workspace’ containing a searchable library of all their reports.  Reporters will be able to save draft reports, review submitted reports, and submit a Confirmation report once their local investigation has been completed. 

SABRE does not replace existing local reporting arrangements.  If an adverse event or reaction would previously have been reported to local management or to a blood establishment, those arrangements should continue.  If information on an event or reaction would previously have been passed to SHOT (see below) that too should continue.

MHRA has produced two guidance documents:

• Background and Guidance on Reporting Serious Adverse Events and Serious Adverse Reactions (51Kb).
• SABRE – A User Guide (461Kb)

Both these documents are being widely circulated and are now available electronically on this website.

The new online reporting system has been designed to be very simple to use, and incorporates comprehensive online helptext at all stages.  However, if at any time reporters require advice or assistance beyond the helptext and guidance documents, staff in the MHRA Adverse Incident Centre will be available to provide assistance.  Enquiries may be made either by e-mail or by telephone:

sabre@mhra.gsi.gov.uk 
020 7084 3336

Reports of Serious Adverse Events and Serious Adverse Reactions should only be submitted via SABRE.  Other means of submission should only be considered if SABRE is temporarily unavailable and the report is urgent. In such cases the MHRA Adverse Incident Centre should be contacted for guidance on how to report.

In addition to satisfying the requirements of the EU Directive for reporting to MHRA, SABRE has been developed to facilitate SHOT reporting by incorporating SHOT Questionnaires. This provides a single reporting route for UK Haemovigilance. MHRA has also created a system for SHOT to review and then extract data for detailed manipulation and analysis.

Reporting to SHOT remains voluntary, but is required for compliance with HSC/2002/009 'Better Blood Transfusion' and is a standard for the Clinical Negligence Scheme for Trusts in England.  Active participation in SHOT by all hospitals was recommended by the CMO for England in his 2003 Annual report.  A number of blood safety initiatives depend on continuity of SHOT data for monitoring and evaluation and it is therefore vital that hospitals use the SABRE system to continue to report to SHOT. 

Enquiries for SHOT may be made either by e-mail or by telephone:

shot@nbs.nhs.uk
0161 251 4208