David Riley

From Maria Caulfield 
Minister for Mental Health and Women’s Health 

39 Victoria Street 
London 
SW1H 0EU 

28 June 2024 

Our ref: PFD – 24-05-07 – RILEY 

HM Coroner Linda Lee  
Warwickshire Justice Centre 
Newbold Terrace 
Leamington Spa  
CV32 4EL 

By email:

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.   

Yours sincerely,

Ms Linda Lee 
Assistant Coroner for Warwickshire 
Warwick Justice Centre 
Newbold Terrace 
Royal Leamington Spa 
CV32 4EL 

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

8 July 2024  

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 

                                                                                                                       
 
 
 
 
 
 
  
 
 
 
 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.  

Yours sincerely,  

  
  
 
 National Medical Director

2nd Floor 
2 Redmond Place 
London 
E20 1JQ 
United Kingdom 

26 June 2024 

Ms Linda Lee 
Assistant Coroner for Warwickshire 
Warwick Justice Centre 
Newbold Terrace 
Royal Leamington Spa 
CV32 4EL 

Sent via email:

Our ref: EH-336418 

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.  

 
 
 
 
 
 
 
 
 
 
 
 
 Yours sincerely, 

Chief Executive 

                                                                                                                                 Page | 2

Glen Burley
Chief Executive
Warwick Hospital
Lakin Road
Warwick
CV34 5BW

Our ref: GWB/ci

12 July 2024

Mrs Linda Lee
Assistant Coroner for Warwickshire
Warwickshire Justice Centre
Newbold Terrace
Leamington Spa
Warwickshire
CV32 4EL

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.

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.

Yours sincerely

Chief Executive

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.

 1

2

3

4

5

6

7

8

9

Actions

Recommendation

Incident  to  be  fed back  to  UHCW
stroke team regarding the outcome of
the review.
The  incident  to  be  presented  by  the
cardiology  consultants  at  Grand
Round

Incident to be fed back to nursing staff
regarding the escalation process when
there 
in  a  patient’s
condition or change in GCS score.

is  a  change 

Remind  all  staff of  the  importance  of
clear  documentation  re  stopping  and
re-starting  of  DOACS,  and  recording
risk vs benefits of decisions.
Advise all staff that patients who have
had  their  DOAC  stopped  must  have
this 
an
appropriate  clinician  on  a  daily  basis
until the DOAC is restarted.
Recommendations 5 and 6 (above) to
the  Trust’s
be 
updated 
Oral
Anticoagulant Guideline.

incorporated 
SWH 

reviewed 

decision

01778 

into 

by 

Action to
Address
Recomme
ndation
Report  to  be
sent 
to
UHCW
Presentation
at 
Grand
round

By whom? By when?

Evidence of Progress and Completion

Evidence that will demonstrate the risk has
been reduced

Patient
Safety Team

31/10/2023

26/09/2023:
Report sent to UHCW

Cardiology
Consultant

31/10/2023 

Incident to be presented at Grand Round on 19 July 2024.

15/02/204:
Update  from  Ops  Manager:  Bespoke  Immediate  Life  Support (ILS)  sessions  have
been run across the Cardiology unit, delivered by the Resus Team and Cardiology
ACPs. The Clinical Lead continues to work hard supporting the junior nursing team
and is working with the new ward manager to ensure a robust training plan is in place
to support junior staff.

Feedback  to
Nursing staff

Clinical Lead  31/10/2023

Safety
Practice Alert

Patient
Safety Team

31/07/2024

Safety
Practice Alert

Patient
Safety Team

31/07/2024

Update
guideline

Haematolog
y lead

31/10/2024

Improve  processes  for  both  nursing
and  medical  handovers  on 
the
cardiology wards.

that  our 

future  Electronic
Ensure 
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.

Consultant to
consultant in-
person
handover.
Introduction
of 
Electronic
Patient
Record
system
(Cerner)

new

Cardiology
Operational
Manager and
Clinical Lead

31/10/2024

IT/ Innovate Late 2025

Recommendations  4  and  5  to  be
audited 
is
embedded.

to  ensure  compliance 

Clinical audit
of 
patient
records

Cardiology
medical
team

February
2026

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.