Lean HV reporting in the UK????

[RR1]

Am I the only person in the UK who would really like MHRA and SHOT to streamline their haemovigilance reporting systems?

Why can't there be ONE system in place- this is very un-lean and becoming even more time-consuming. Additionally we have to remember another set of passwords!!!!!

[Tonyd]

Why can't there be ONE system in place?!

The short answer to that is that the MHRA and SHOT have different remits - SHOT to provide a comprehensive haemovigilance scheme with all the feedback and learning that entails, and the MHRA have a statutory duty to feed figures related to the BSQR back to Brussels every year and to check that CAPA are being performed.

SHOT reporters clamoured for years to have an electronic reporting system, then the MHRA allowed us to piggyback on to SABRE, so reporters got what they wanted.

Then they asked for electronic SHOT incident form completion, rather than the old paper forms, so we devised a new SHOT reporting database - again reporters got what they wanted. It may not be perfect, but any new system takes time to get used to and to 'shake down'.

Hopefully you will see the benefits of the new system in terms of enhanced feedback, and if you want to use a 'lean' analogy - added value :-)

[RR1]

Hi Tony, I think I mean that as SHOT is collecting such valuable information, would it not be easier to make SHOT the primary (and only!) organisation for reporting everything to. The data that MHRA require could then be included within the same questionnaire and easily extracted- and there would be a formal agreement between SHOT and MHRA for this arrangement.

[Tonyd]

Hi Rashmi

That's the kind of decision that has to be taken at DoH / Government level as it has all sorts of legal ramifications.

The UK is pretty much alone in Europe in opting for the competent authority to be other than the established national haemovigilance organisation , but that's the way of it.

[RR1]

Thanks Tony....I can feel a bit of lobbying coming on now, where do we start??!!