Further information and thanks to Ian regards Danielle From: Ian Walker - Consultant [mailto:[log in to unmask]] Sent: 13 May 2016 11:14 To: Freedman Danielle (RC9) Luton & Dunstable Hospital TR Subject: FW: Urgent message from MHRA- QRISK2 Calculation errors Danielle, FYI, some clarification from MHRA below: Ian Walker Consultant in Medical Biochemistry Clinical Lead for Pathology HWWP site - please note my e-mail address is now: [log in to unmask]<mailto:[log in to unmask]> ________________________________ From: Dykes, Mike [mailto:[log in to unmask]] Sent: 13 May 2016 10:34 To: Ian Walker - Consultant Cc: Evans, Malcolm; Hallworth, Stephen Subject: RE: Urgent message from MHRA- QRISK2 Calculation errors Dear Ian, Thank you for your message. I do apologise for the delay in replying. I will forward your enquiry to colleagues who are better placed to provide you with the guidance you are seeking and ask them to respond accordingly. In the meantime, I can clarify that the issue relates to the embedding of the QRISK calculator in the software system of a single supplier to GP practices - SystemOne supplied by TPP. Our advice to GPs/clinicians is that the QRISK2 Calculator on the ClinRisk website is not affected by this issue and can be used if necessary. Therefore we have not, to date, required any message to be placed on the QRISK2 website. The issue does not relate to any other risk calculator or software system. For your information, there is now a TPP news piece<https://www.gov.uk/government/news/mhra-information-on-tpp-and-qrisk2> on the MHRA GOV.UK website, which includes a link to the alert that was sent to GPs. Kind regards, Mike. Mike Dykes Engagement Manager - Patient, Public and Stakeholder Engagement Communications Division Medicines and Healthcare Products Regulatory Agency 151 Buckingham Palace Road, London, SW1W 9SZ Telephone: 020 3080 6602 Email: [log in to unmask]<mailto:[log in to unmask]> gov.uk/mhra<https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency> Stay connected<https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency#what-we-do> From: Ian Walker - Consultant [mailto:[log in to unmask]] Sent: 12 May 2016 13:40 To: Dykes, Mike Subject: FW: Urgent message from MHRA- QRISK2 Calculation errors Dear Mr Dykes, The message which has gone out today (below) is not very helpful. As we have not been told anything about the nature of the problem, could we please have some guidance as to: * Who the 'limited group of patients' are? * Which patients might need to be re-assessed. There is no message on the QRISK2 website about this; should there be? Ian Walker Consultant in Medical Biochemistry Clinical Lead for Pathology HWWP site - please note my e-mail address is now: [log in to unmask]<mailto:[log in to unmask]> ________________________________ From: Simon Williams- Head of Communications and Policy [mailto:[log in to unmask]] On Behalf Of Simon Williams- Head of Communications and Policy Sent: 12 May 2016 13:24 To: Ian Walker - Consultant Subject: Urgent message from MHRA- QRISK2 Calculation errors QRISK(r)2 Error Calculations- Message from MHRA [https://gallery.mailchimp.com/232c278461c9a998a743e67fc/images/bc106acd-c710-4a7c-a43e-cf04b949677c.jpg]<http://heartuk.us8.list-manage1.com/track/click?u=232c278461c9a998a743e67fc&id=40b11c767b&e=1cba34a7be> Dear Colleagues, HEART UK have received the following notification from MHRA that you may wish to be aware of: "The Medicines and Healthcare products Regulatory Agency (MHRA) has been made aware of an issue involving a digital calculator used by some GPs to assess the potential risk of cardiovascular disease (CVD) in patients, which has resulted in incorrect results for some patients. The QRISK(r)2 Calculator in SystmOne, supplied by the company TPP, is a predictive algorithm used to support medical practitioners, mainly in GP practices, to help assess the potential risk of heart disease in patients, as part of their overall evaluation. This issue has resulted in incorrect results being produced for a proportion of patients. For the affected patients, the potential risk of heart disease could have been under or overstated. MHRA is working with TPP, as a matter of urgency, to make sure the identified issue is resolved and that any affected patients are identified. Clinical advice received by MHRA indicates the risk to individual patients is small and affects only a limited group of patients who should be re-evaluated at their next routine appointment. There is no reason for any immediate concern, and people should continue to take their medication. GPs have been informed and they will contact individual patients should any further action be necessary. 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