MHRA/ SHOT UK Haemovigilance Reporting guide

[Chris Robbie]

Dear Colleagues

Please find attached the final version of the Joint MHRA/ SHOT UK Haemovigilance reporting guide which describes the reporting arrangements for mandatory reporting under the BSQR to MHRA and the professionally mandated reporting of incidents to SHOT. The guide covers the use of the single reporting system and describes how to report on SABRE and also how to report on the SHOT Database.

Regards, on behalf of MHRA and SHOT

Chris

Joint UK Haemovigilance user_guide 2017.pdf

[mozza]

Thanks Chris- Can I ask for clarification on Figure 2 on the following point please? In the bottom text box, there is no option of how to proceed if the answer is no to any of the 3 questions posed. Thanks

[Chris Robbie]

Thank you for the question Mozza

You are correct, and perhaps on next review I should put a line back to Exclude - not an SAE.

To clarify, this flow diagram is one to illustrate the MHRA thought process and assessment. It is adapted from a very similar flow diagram for the reporting of SAEs in a previous guide when the SABRE and SHOT databases weren't linked. I made the changes as I didn't want reporters to go through the flow diagram and not report things which were previously described as "SHOT only" reports. For example, a WBIT is still reported on SABRE, but because it doesn't meet the criteria of a BSQR SAE, I exclude it.

Obviously a reporter can use the flow diagram to see if an event is likely to be seen as an SAE by MHRA, but I do not want reporters under-reporting to SHOT.

[mozza]

Thanks Chris, that makes sense now.