NHS England
NHS / Health Body
Noted
NHS England acknowledges the coroner's concerns, notes that the BSG is updating guidance, and states they will support the implementation of any changes; they have shared the report with relevant NHS Trusts and ICBs and are monitoring reports nationally. (AI summary)
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Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Terence William Sullivan who died on 10th August 2023.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 13th March 2024 concerning the death of Terence William Sullivan on 10th August 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Terence’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Terence’s care have been listened to and reflected upon.
Your Report raised the concern that the current guidance from the National Institute for Health and Care Excellence (NICE) and the guidance from the British Society for Gastroenterology (BSG) may not reflect best practice for patients on a single anticoagulant medication (in this case Rivaroxaban) with coronary stents and requiring a therapeutic endoscopic procedure.
The British Society of Gastroenterology (BSG) and the European Society of Gastrointestinal Endoscopy issued updated guidance in 2021 on ‘Endoscopy in patients on antiplatelet and anticoagulant therapy’. This update followed “an extensive revision” and “evidence-based update”. The guidance clearly states that for patients undergoing a high-risk procedure (such as polypectomy) and taking a direct oral anticoagulants (DOAC), such as Rivaroxaban, they should take their ‘last dose 3 days before endoscopy [and] … restart DOAC 2-3 days after the procedure.’ This is clearly set out in Figure 2 of the guidance.
As part of NHS England’s review of your Report, a cardiovascular expert was also consulted. They advised that it was difficult to comment without further details of Terence’s medical history but that a conversation with a cardiologist would have been warranted in Terence’s case to agree on a strategy for the procedure and that it was possible that antiplatelet therapy with aspirin could have been given during the period that DOAC was withheld.
As your Report references, NICE and the BSG publish the relevant clinical guidance on the issues raised. This does not come under NHS England’s remit. We note that you have also addressed your Report to both organisations and refer you to their National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG
26th April 2024
responses. We have engaged with the BSG on the concerns raised and understand that they are intending to provide some updated guidance on this issue. It is our understanding that this will be a communication to all BSG members initially, followed by a published letter in a journal and formal guidelines in due course. We have asked that the BSG keep us updated on this. NHS England will support on the implementation of any changes.
NHS England has also shared your Report with the Chief Medical Officers for Worcestershire Acute Hospital Trust and Herefordshire and Worcestershire Integrated Care Board.
I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.
Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 13th March 2024 concerning the death of Terence William Sullivan on 10th August 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Terence’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Terence’s care have been listened to and reflected upon.
Your Report raised the concern that the current guidance from the National Institute for Health and Care Excellence (NICE) and the guidance from the British Society for Gastroenterology (BSG) may not reflect best practice for patients on a single anticoagulant medication (in this case Rivaroxaban) with coronary stents and requiring a therapeutic endoscopic procedure.
The British Society of Gastroenterology (BSG) and the European Society of Gastrointestinal Endoscopy issued updated guidance in 2021 on ‘Endoscopy in patients on antiplatelet and anticoagulant therapy’. This update followed “an extensive revision” and “evidence-based update”. The guidance clearly states that for patients undergoing a high-risk procedure (such as polypectomy) and taking a direct oral anticoagulants (DOAC), such as Rivaroxaban, they should take their ‘last dose 3 days before endoscopy [and] … restart DOAC 2-3 days after the procedure.’ This is clearly set out in Figure 2 of the guidance.
As part of NHS England’s review of your Report, a cardiovascular expert was also consulted. They advised that it was difficult to comment without further details of Terence’s medical history but that a conversation with a cardiologist would have been warranted in Terence’s case to agree on a strategy for the procedure and that it was possible that antiplatelet therapy with aspirin could have been given during the period that DOAC was withheld.
As your Report references, NICE and the BSG publish the relevant clinical guidance on the issues raised. This does not come under NHS England’s remit. We note that you have also addressed your Report to both organisations and refer you to their National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG
26th April 2024
responses. We have engaged with the BSG on the concerns raised and understand that they are intending to provide some updated guidance on this issue. It is our understanding that this will be a communication to all BSG members initially, followed by a published letter in a journal and formal guidelines in due course. We have asked that the BSG keep us updated on this. NHS England will support on the implementation of any changes.
NHS England has also shared your Report with the Chief Medical Officers for Worcestershire Acute Hospital Trust and Herefordshire and Worcestershire Integrated Care Board.
I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.
Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.