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Making medicines and medical devices safer

Blood factors and immunoglobulin products

Blood products, including blood factor and immunoglobulin products, such as factors I to XIII or Anti-D (RHO) immunoglobulin, are considered medicines and suspected side effects to these products should be reported using the Yellow Card scheme.

The MHRA also regulate blood components, such as red blood cells, platelets, fresh or frozen plasma. Reporting is different for blood components compared to blood products. Blood components are reported through the Serious Adverse Blood Reactions and Events (SABRE) platform. Under the Blood Safety and Quality Regulations (2005 as amended) blood and blood component Serious Adverse Events (SAE) and Serious Adverse Reactions (SAR) are legally required to be reported to the MHRA. The Serious Hazards of Transfusion (SHOT) is the UK’s independent, professionally led haemovigilance scheme, collecting and analysing anonymised information on adverse events and reactions in blood transfusions from all healthcare organisations in the UK. The MHRA and SHOT have collaborated to improve haemovigilance reporting by producing an integrated incident reporting process through the Serious Adverse Blood Reactions and Events (SABRE) platform. All SAR and SAE incidents related to the safety and quality of blood must be reported through local hospital blood bank or blood establishment SABRE representatives. See here for more information.