Prevention of Future Deaths reports · 2021

Ethel Beaumont

Regulation 28 report to prevent future deaths, reference 2021-0377, written 9 Nov 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report9 Nov 2021
Reference2021-0377
DeceasedEthel Beaumont
CoronerLorna Skinner QC
Coroner areaCambridgeshire and Peterborough
CategoryHospital Death (Clinical Procedures and medical management) related deaths · Community health care · Alcohol, drug and medication related deaths
Sourcejudiciary.uk record · original PDF
Responses publishednone published

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

1.  NORTH WEST ANGLIA NHS FOUNDATION TRUST 
2.  CAMBRIDGESHIRE & PETERBOROUGH CLINICAL COMMISSIONING GROUP 
3.  DEPARTMENT FOR HEALTH & SOCIAL CARE 
1.  CORONER 

I  am  Miss  Lorna  Skinner  QC,  Assistant  Coroner  for  the  coroner  area  of 

Cambridgeshire and Peterborough. 

2.  CORONER’S LEGAL POWERS 

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 
2009  and  Regulations  28  and  29  of  the  Coroners  (Investigations)  Regulations 
2013. 
Coroners and Justice Act 2009 (legislation.gov.uk) 
The Coroners (Investigations) Regulations 2013 (legislation.gov.uk) 

3. 

INVESTIGATION and INQUEST 

On  21  May  2020  I  commenced  an  investigation  into  the  death  of  Ethel  Ann 
Beaumont, who died on 11 May 2020 aged 69 years. The investigation concluded 
at  the  end  of  the  inquest  on  Thursday  29  April  2021.  The  conclusion  of  the 
inquest was: 

Medical Cause of Death – 1a liver failure 1b nitrofurantoin induced liver injury 1c 
colorectal fistula 2 atrial fibrillation, chronic obstructive pulmonary disease 

Conclusion – From liver injury caused by taking nitrofurantoin as prescribed from 
28 February 2020 onwards. 

4.  CIRCUMSTANCES OF THE DEATH 

At  the  time  of  her  death,  Ethel  Beaumont  had  been  scheduled  for  a  subtotal 
colectomy.  On  28  February  2020  her  GP  had  prescribed  nitrofurantoin  100mg 
twice  daily  for  7  days  following  advice  from  the  registrar  at  Hinchingbrooke 
Hospital.  On  Consultant  review  in  flexible  cystoscopy  clinic  on  6  March  2020, 
Ethel  was  asked  to  continue  the  nitrofurantoin  for  a  further  two  months,  but 
advised not to take it for more than three. Accordingly, a prescription for 100mg 
once  daily  for  28  days  was  issued.  Ethel  attended  clinic  on  17  March  2020, 
agreed  to  go  ahead  with  surgery  and  blood  tests  were  taken  on  that  day.  The 

 following  day  –  showing  a  raised  alanine 
results  were  reported  the 
aminotransferase, or ALT level, of 134. The “normal” range is between 5 and 33. 
The potential effects of nitrofurantoin on liver function were not appreciated. It 
was  anticipated  that  further  liver  function  tests  would  be  taken  at  a  pre-
operative  assessment  on  6  April  2020.  When  Ethel  attended  for  her  pre-
operative  assessment  her  eyes  were  yellow  and  she  reported  having  been 
jaundiced  for  the  last  two  days.  Blood  tests  were  taken  and  within  2  hours  of 
returning  home,  Ethel  was  recalled  to  Hinchingbrooke  hospital  and  admitted 
with suspected drug induced liver injury. She was transferred to Addenbrooke’s 
for liver biopsies on 13 April and from there admitted to the Arthur Rank Hospice 
in Shelford on 7 May, where she died on 11 May 2020. 
The pathologist, Dr 
, concluded in his report that Ethel’s drug induced liver 
injury was caused by the nitrofurantoin she had been taking, and was a rare but 
known adverse effect of long-term0 nitrofurantoin therapy. 
In  order  to  assist  me  to  investigate  Ethel’s  death,  I  heard  expert  evidence, 
including from Dr 
As  a  result  of  the  evidence  I  heard  from  Dr 
,  and  in  particular  her  careful 
synthesis of various studies, I accepted that drug induced liver injury secondary 
to  nitrofurantoin  is  an  extremely  rare  event  –  the  risk  of  severe  hepatoxicity 
remains at probably less than 1 per 3000 patients to whom it is prescribed. I also 
accepted  that  it  is  not  predictable,  so  no  testing  pre-treatment  could  have 
identified  that  Ethel  was  at  increased  risk  for  this  complication.  I  also  accepted 
that  there  was  no  failure  by  Ethel’s  medical  practitioners  to  appropriately 
monitor her nitrofurantoin as she was on it for such a short period, and the plan 
for surgery would likely result in her being able to stop taking it. 
I did, however, conclude that the abnormal blood test result, which had shown a 
significantly  raised  ALT,  should  have  been  followed  up  in  a  timely  manner,  and 
that a repeat should have been ordered with 7 days of 17 March. Had this been 
done,  it  would,  on  the  balance  of  probabilities,  have  more  than  minimally 
reduced the chance of death occurring. 

 a consultant hepatologist. 

5.  CORONER’S CONCERNS 

During  the  course  of  the  inquest  the  evidence  revealed  matters  giving  rise  to 
concern. In my opinion there is a risk that future deaths could occur unless action 
is taken. In the circumstances it is my statutory duty to report to you. 

The MATTERS OF CONCERN ARE that there is a lack of clarity between hospital 
and  primary  care  as  to  which  of  them  should  be  responsible  for  monitoring 
where  a  GP  is  prescribing  an  antibiotic  on  the  request  of  the  hospital  that  a 
patient  is  attending  regularly  for  review.  I  am  concerned  that  these  pathways 

 should be clarified and that there remains a risk of future death at present. 

6.  ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I believe you 
have the power to take such action. 

7. 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this 
report, namely by 05 January 2022. I, the Coroner, may extend the period. 

Your  response  must  contain  details  of  action  taken  or  proposed  to  be  taken, 
setting out the timetable for action. Otherwise, you must explain why no action 
is proposed. 

8.  COPIES and PUBLICATION 

I  have  sent  a  copy  of  my  report  to  the  Chief  Coroner  and  to  the  following 
Interested Persons: 

(1) 
(2)  Dr 

I am also under a duty to send a copy of your response to the Chief Coroner and 
all Interested Persons who in my opinion should receive it. 

I may also send a copy of your response to any other person who I believe may 
find it useful or of interest. 

The  Chief  Coroner  may  publish  either  or  both  in  a  complete  or  redacted  or 
summary form. He may send a copy of this report to any person who he believes 
may find it useful or of interest. 

You may make representations to me, the Coroner, at the time of your response, 
about the release or the publication of your response. 

9. 

09 November 2021

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