Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – David Riley who died on 10 June 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 7 May 2024 concerning the death of David Riley on 10 June 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to David’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about David’s care have been listened to and reflected upon. 

I am grateful for the further time granted to respond to your Report and I apologise for any anguish this delay may have caused to David’s family or friends. I realise that responses to Coroner Reports can form part of the important process of family and friends coming to terms with what has happened to their loved ones and appreciate this will have been an incredibly difficult time for them.

Decisions regarding pausing of DOACs Your first concern relates to the national guidance available to clinicians regarding the pausing of direct oral anticoagulants (DOACs), in this case Apixaban, and the considerations to be applied in making that decision. You have raised that the evidence at the inquest indicated that there was inconsistency around decisions taken to pause DOACs, which may ultimately put patients with atrial fibrillation at risk. It is not within NHS England’s remit to publish the relevant clinical guidance on this matter. We would refer you to the National Institute for Health and Care Excellence (NICE), who we note you have also addressed your Report to, and who have published national guidance on the use of Apixaban, which was last updated in April 2024. The guidance states that patients may need to temporarily stop taking Apixaban if they require surgery or any other invasive procedure, and this depends on the patient’s risk of having a thromboembolic event along with the bleeding risk associated with the procedure. For “procedures with a high bleeding risk, the last dose of apixaban should be taken 3 days before the procedure”. We understand from follow-up correspondence with you that David’s dose of Apixaban was paused for four days, 1-4 June 2023, and then paused again on the evening of 7 June 2023, because of further consideration about another attempt to aspirate the pericardial collection. There is also further national free-to-access guidance for clinicians via the Apixaban UK Clinical Pharmacy Association (UKCPA) Handbook: Apixaban - UKCPA Handbook National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

8 July 2024

of Perioperative Medicines (ukclinicalpharmacy.org). The guide aids clinicians to decide how to manage DOACs perioperatively, including determining the dose, the bleeding risk of the surgery / procedure and the decision on pre-operative cessation. The guide also includes post-operative advice around timings for restarting Apixaban following a procedure / surgery, dependent on the bleeding risk. The 2020 European Society of Cardiology Guidelines for the diagnosis and management of atrial fibrillation recommends continuous anticoagulation for two months post atrial fibrillation ablation, with consideration of prolonged duration in those at high risk of thromboembolism. Pericardial effusion is a recognised complication of catheter atrial fibrillation ablation. The decision whether to withhold anticoagulation for pericardiocentesis depends on several factors including:
• the size of the effusion
• its location around the heart and patient physique (which determine ease of access to the effusion and influence the risk of the procedure). The decision should be made in discussion with the individual performing the procedure. Where it is felt that temporary cessation of anticoagulation is required, this should be done for the minimum timeframe applicable. The Regional Chief Pharmacist in the Midlands has also been asked to review your Report and consider whether any learnings need to be shared across the ICBs within the Midlands region. Effective communication You also raised the concern that there was a failure to effectively communicate, recognise and act on time critical directions, including restarting the DOAC, and that this may be due to a lack of continuity of care and difficulties in accessing and updating the computerised clinical / pharmacy records. We note that your Report has also been sent to Warwick Hospital (falling under the South Warwickshire University NHS Foundation Trust), and they would be best placed to address these concerns and their local arrangements. My regional Midlands colleagues have made NHS Coventry and Warwickshire Integrated Care Board (CWICB) aware of the concerns raised in your Report, and how they relate to South Warwickshire University NHS Foundation Trust, for which they are the commissioner, and who we note you have also sent your Report to. I would also like to provide further assurances on the 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 events, such as the sad death of David, are shared across the NHS at both a national and regional level and helps us to 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.

Dear Ms Lee

I write in response to your regulation 28 report, regarding the very sad death of Mr David Riley. I would like to express my sincere condolences to Mr Riley’s family. We have reflected on the circumstances surrounding Mr Riley’s death and the concerns raised in your report, in particular decisions regarding pausing of direct oral anticoagulants (DOACs). Our guideline on venous thromboembolism in over 16s: reducing the risk of hospital- acquired deep vein thrombosis or pulmonary embolism [NG89] covers VTE risk assessment but does not specifically cover pausing of DOACs such as apixaban. It is not possible to cover all clinical circumstances in our guidelines. Nevertheless, NICE will further consider the issues raised through our guideline surveillance process to see if an update to the guideline is required. The Clinical Knowledge Summary (CKS) on anticoagulation – oral may also be relevant to this case. The CKS gives prescribing and management information for adults receiving apixaban, dabigatran, edoxaban, and rivaroxaban and covers whether apixaban should be stopped if surgery or dental treatment is required. We commission an external company, Agilio Software, to develop the CKS which are designed to summarise the evidence on the treatment of specific health conditions that present in primary care. They use a variety of sources and may include NICE guidance, if there is any that is relevant, but they use many other sources too. We publish them on our website as a source of advice and information for health professionals working in primary care, but they do not constitute NICE guidance. We will share your report with Agilio Software for their awareness. Please do let me know if you require any further information and again, I offer my sincerest condolences to Mr Riley’s family.

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Dear Linda,

Thank you for the Regulation 28 report of 7 May sent to the Department of Health and Social Care (DHSC) about the death of David Riley. I am replying as the Minister with responsibility for Patient Safety.

Firstly, I would like to say how saddened I was to read of the circumstances of Mr Riley’s death, and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention.

The report raises concerns over national guidance available to clinicians regarding the pausing of a direct oral anticoagulant (DOAC) and the considerations to be applied in making that decision and effective communication between medical staff for essential patient care.

I note that the National Institute for Health and Care Excellence (NICE) and NHS England are also recipients of this report. Departmental officials have made enquires with both organisations and the Care Quality Commissions (CQC).

I am informed that CQC’s medicines team will be contacting the Trust Chief Pharmacist to establish whether the pharmacy was informed and involved in the outcomes of the Trust investigation from a medicine management perspective. They will also be querying lessons learnt from this case and whether there are any other safety aspects to be reviewed. CQC would expect acute hospitals to follow national guidance when designing guidance/policy for staff and would expect there to be something to guide staff on pausing DOACs. CQC’s inspection team requested a copy of the guidance/policy used by staff at South Warwickshire University NHS Foundation Trust (SWFT) on 17 June 2024 for an assessment. They received this document on 19 June 2024. CQC note that the hospital’s policy was updated this month (June 2024) in response to learning from an incident. The policy has been written using up to date national guidance, however, there is no reference to pausing anticoagulation medication in the case of surgery.

SWFT had not shared details of this death with CQC. CQC inspectors requested a copy of the Root Cause Analysis on 17 June 2024 and received this on 24 June 2024. CQC will continue to monitor the Trust and will determine next steps once they have reviewed the relevant documents and made contact with the Chief Pharmacist.

CQC note there is NICE guidance for managing atrial fibrillation Recommendations | Atrial fibrillation: diagnosis and management | Guidance | NICE with a section ‘1.11 Stopping anticoagulation’. There is also further guidance available from the British Society for Haematology and the NHS on pausing DOACs: Peri-Operative Management of Anticoagulation and Antiplatelet Therapy (b-s-h.org.uk). NICE will be responding directly to your concern about national guidance on DOACs. As you will be aware, the National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body, sponsored by the DHSC. It is the independent body responsible for developing evidence-based guidelines for the National Health Service, following a rigorous process and extensive engagement with stakeholders and expert input to develop the scope of the guidelines. However, it is important to note that NICE guidelines do not override a clinician’s responsibility to make decisions appropriate to individual patients. NICE guidelines describe best practice, and the Government expects NHS commissioners to take them into account in designing services that meet the needs of their local populations.

NHS England is operationally responsible for delivering health services across the country and will be responding directly to your concerns at length. NHS England is an executive non-departmental public body, sponsored by the Department of Health and Social Care.

It is vital that lessons are learnt collectively, and changes are made to reflect where things have gone wrong, which is essential to ensure the NHS provides safe, high-quality care.   

I hope this response is helpful. Thank you for bringing these concerns to my attention.

Dear Mrs Lee, Regulation 28 report - Mr David Riley DoB 01/10/1950 DoD 10/06/2023 Thank you for your Regulation 28 report dated 7 May 2024 relating to your investigation into the death of Mr David Riley. I was sorry to read of your outstanding concerns following the 26 April inquest and hope that the following information will provide you with further reassurance. I am also grateful for the extra time granted to allow the Trust to respond. Following receipt of your report, the Trust convened a Working Group to review, and critically reappraise, the care and decision-making relating to Mr Riley in light of the concerns you raised in your report. The Group consisted of the Trust’s Chief Medical Officer and his Deputy, our Acute Medicine General Manager, our Cardiology Operational Manager, our Chief Nursing Officer and one of our Cardiology Consultants. It may be helpful to begin this response by acknowledging that the Trust has revised its view that an air embolus was a more likely cause of the stroke than a clot following a multidisciplinary discussion and review of the CT scans. In particular we have recently been given access to CT scans undertaken at University Hospitals Coventry & Warwickshire which do not show evidence of air embolus. We agree that the “pausing of the Apixaban may have increased the risk of Mr Riley suffering a stroke but it cannot be said to have caused it” and recognise that lessons can be learnt regarding the pausing of DOACs – irrespective of whether this “pausing” contributed towards Mr Riley’s stroke and death. To address your specific concerns I have, for ease of reference, repeated your concerns in bold below. The Trust’s response follows. Although the Warwick hospital conducted a Root Cause Analysis Investigation Report (RCAIR) of 6 July 2023 which indicated that the pausing of the DOAC was a lesson learned, it did not indicate what was learned. Glen Burley Chief Executive Warwick Hospital Lakin Road Warwick CV34 5BW

The Trust is committed to being environmentally friendly, therefore where possible we use 100% recycled paper. This paper has been made using no harmful chemicals in the manufacturing process. Although the decisions to stop, restart and then stop again Mr Riley’s Apixaban were not, in themselves, wrong, they highlighted insufficient documentation in Mr Riley’s medical notes. There was no note to say that Apixaban had been stopped, when it should restart, and no related note explaining this decision in the context of risks vs benefits. The Trust will address this as follows:  By reminding all staff, via a Safety Practice Alert, and at a Grand Round meeting in July, of the importance of documenting in a patient’s medical records when a DOAC is stopped or restarted. Those same communications will reemphasise the importance of recording the risk vs benefits analysis behind such decisions, and also that patients who have had their DOAC stopped must have this decision reviewed by an appropriate clinician on a daily basis until the DOAC is restarted.  The two points above will be incorporated into the Trust’s updated SWH 01778 Oral Anticoagulant Guideline and will be subject to a future audit to check compliance has been embedded. The only further action was limited to the incident being presented at the Grand Round, but this had not taken place at the time of the inquest, some 9 months after publication of the RCAIR. I can only apologise that, over a year after his death, Mr Riley’s case has still not been presented at the Trust’s Grand Round. His case will be presented by one of our Cardiology consultants to Grand Round on 19 July – and will incorporate the learning from the concerns you have raised in your Regulation 28 report. Grand Round is an “open to all staff” learning forum – held weekly both in person and online
– and there are always a large number topics vying for attention. This, combined with staff availability, means that there can sometimes be a significant time lag between an incident occurring and the learning being shared. That said, the delay in this particular instance is unacceptable, and we have asked our Medical Education Co-ordinator (who manages the programme) to ensure that priority slots are given to those cases where a formal investigation recommends that a case be discussed at Grand Round. Decisions regarding pausing of Direct Oral Anticoagulants (DOAC). It was not clear if there is national guidance available to clinicians regarding the pausing of DOACs and the considerations to be applied in making that decision. If there is such guidance, it is not widely understood or on the evidence given, followed consistently from hospital to hospital or within different teams. The inconsistency of approach appears from the evidence to increase the risk of misunderstanding and to put patients with atrial fibrillation at risk. National guidance is available in The British Journal of Haematology’s Guideline: Peri- operative management of anticoagulation and antiplatelet therapy. In addition, the Trust has its own Oral Anticoagulant Guide  SWH 01778 Oral Anticoagulant Guideline

The Trust is committed to being environmentally friendly, therefore where possible we use 100% recycled paper. This paper has been made using no harmful chemicals in the manufacturing process. This guideline has now been updated to include a link to the UK Clinical Pharmacy Association’s Handbook of Perioperative Medicines which provides national guidance re perioperative medicine. The Trust’s haematology lead advised the Working Group that, despite guidance and resources being available to staff, there has been a tendency to ask the haematology department for case-by-case advice. Whilst this will remain an import resource we intend to further update our Oral Anticoagulant Guideline to provide clearer guidance. Effective communication From the evidence, there was a failure to effectively communicate, recognise and act on directions that were time critical, such as restarting the DOAC as directed. It does not appear that there was any consideration as to the timing of the pericardiocentesis to ensure that the DOAC was paused for a short a time as possible. The evidence suggested that this may be due to lack of continuity of care and the difficulties in the way in which computerised clinical/pharmacy records are updated and accessed. Clear communication between medical staff is essential to patient care. Whilst some of the above points are covered in actions set out above, to ensure clear documentation of decision-making, the Trust will also:  work towards a dedicated consultant to consultant in person handover, with nursing handovers managed separately. This work will be led by the Cardiology Operational Manager and Clinical Lead. Of note, a medical handover sheet is now being used on the ward, separately to nursing handover and managed by the Physicians Associate and Doctors in Training.  Seek to ensure that our future Electronic Patient Record system (Cerner) better highlights information around pausing medication and that medical staff are aware of that functionality as the training in Cerner rolls out. We are aware that it affords more functionality in highlighting temporary stops/prompts for review, than our current system. I am grateful that your Regulation 28 Report provided us with a further opportunity to consider and improve our care to patients prescribed DOACs. The latest position on all of the actions arising from both our RCA Investigation and the further review arising from your Regulation 28 Report can be found at the foot of this letter. I hope that this provides you with the assurance that you require but if, having read this letter, you have outstanding concerns, please do not hesitate to contact me.