Prevention of Future Deaths reports · 2023

Amanda Kramer

Regulation 28 report to prevent future deaths, reference 2023-0328, written 11 Sep 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report11 Sep 2023
Reference2023-0328
DeceasedAmanda Kramer
CoronerGraeme Irvine
Coroner areaEast London
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published3

The report

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

MRG IRVINE 
SENIOR CORONER 

EAST LONDON 

East London Coroner's Court, Queens Road Walthamstow, E17 SQP 

REGULATION 28:  REPORT TO  PREVENT FUTURE DEATHS (1) 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

1. 

, North East London Foundation Trust (NELFT), CEME 

Centre, March Way,  Rainham,  Essex, RM13 8GQ Email: 

2.  Rt Hon Steve Barclay MP, Secretary of State for Health & Social  Care, 39 

Victoria St, Westminster,  London SW1 H 0EU 

3. 

, Wood  Street Medical Centre, 6 Linford Road, 

Walthamstow, London, E17 3LA 

1 

CORONER 

I am Graeme Irvine,  senior coroner, for the coroner area of East London 

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. 
http:LLwww.legislation.gov.uklukpgal2009l25lschedu1el5lparagraphl7 
http://www.legislation.gov. ukl uksil 2013l 1629lQartl7l made 

3 

INVESTIGATION and INQUEST 

On 31 st  December 2022,  this court commenced an  investigation into the death of 
Amanda Jane Kramer aged 56 years.  The investigation concluded at the end of the 
inquest on 15th August 2023. The court returned a narrative conclusion; 

"Mrs Amanda Jane Kramer died at her home address on 31st December 2022,  she had 

1 

 
 
 
 
 
 taken  an  accidental,  fatal overdose  of Zoplicone.  Mrs Kramer had been prescribed that 
medication for approximately 18 years,  when  guidance  indicates it should be prescribed 
for the  short-term treatment of insomnia.  Those  treating Mrs Kramer had not monitored; 
whether there  was an ongoing need for her to receive  this drug,  the risks associated with 
the medication,  or whether Mrs Kramer was compliant with dosage instructions." 

Mrs Kramer's medical cause of death was determined as; 

1.a. Zopiclone Toxicity 
2.  Fatty Liver Disease 

4 

CIRCUMSTANCES OF THE DEATH 

Mrs Kramer was a 56-year-old female known to have suffered with depression since the 
1990s. She received a diagnosis of schizoaffective disorder in 2009.  Mrs Kramer also 
suffered with Arthritis and Fibromyalgia for which she was prescribed analgesia. 

Mrs Kramer was noted to  have had multiple emergency admissions to 
hospital 

. 

Mrs Kramer was found unresponsive at home on  31st December 2022. Her death was 
caused by an overdose of prescribed  hypnotic, zoplicone. 

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 as follows.  -

1.  Zoplicone is a drug licenced for the treatment of short-term  insomnia. The risks 
associated with the drug are first,  that it is a central  nervous system depressant 
and second, that patients prescribed the drug can form a dependency upon it. 

2.  Mrs Kramer was prescribed Zoplicone for 18 years. 

3.  Despite the deceased being under the care of both a GP and a secondary 

mental health trust prior to her death. No clear evidence emerged in this inquest 
that anyone had reviewed  Mrs  Kramer's use of this drug even when Mrs Kramer 
had  demonstrated a pattern of high-risk behaviour by deliberately overdosing on 
prescribed  medication. 

6 

ACTION SHOULD BE TAKEN 

In  my opinion action should  be taken to prevent future deaths and  I believe you 
[AND/OR your organisation] 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 6 November 2023  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 coov of mv reoort to the Chief Coroner and to the followinq the famil y of 

2 

 Mrs Kramer.  I have also sent it to local Director of Public Health who may find  it useful 
or of interest. 

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  he time of your response,  about 
the release or the publication of your response. 

9 

[DATE]  11/09/2023 

[SIGNED BY CORONER 

3

Responses

3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Department of Health and Social Care (PDF)
The Rt Hon Dame Andrea Leadsom DBE MP 
  Parliamentary Under Secretary of State for Public Health, Start for Life and Primary Care 
39 Victoria Street 
  London 
  SW1H 0EU 

Our ref:

Mr G Irvine 
Senior Coroner  
East London Coroner’s Court 
Queens Road 
Walthamstow 
E17 8QP 

13 May 2024 

Dear Mr Irvine,  

Thank you for the Regulation 28 report to prevent future deaths of 11 September about 
the death of Mrs Amanda Jane Kramer. I am replying as Minister with responsibility 
for prescribing.       

Firstly, I would like to say how saddened I was to read of the circumstances of Mrs 
Kramer’s death and I offer my sincere condolences to her family and loved ones. The 
circumstances  your  report  describes  are  concerning  and  I  am  grateful  to  you  for 
bringing these matters to my attention. Please also accept my sincere apologies for 
the significant delay in responding to this matter. 

The report raises the following concerns: 

•  Zoplicone is a drug licensed for the treatment of short-term insomnia. The risks 
associated with the drug are first, that it is a central nervous system depressant 
and second that patients prescribed the drug can form a dependency upon it; 
•  Mrs Kramer was prescribed Zoplicone continuously for approximately 18 years; 
•  Despite  the  deceased  being  under  the  care  of  both  a  GP  and  a  secondary 
mental health trust prior to her death, no clear evidence emerged in the inquest 
that anyone had reviewed Mrs Kramer’s use of this drug even when she had 
demonstrated a pattern of high- risk behaviour by deliberately overdosing on 
prescribed medication. 

As I am sure you will be aware, GPs and other prescribers are ultimately responsible 
for their own prescribing decisions. The decision to prescribe a particular product is a 
clinical one and should be based on the patient’s medical needs. The process of 
reviewing medication is one in which the GP or responsible clinician work together 

 
 
 
 
 
 
 
 
 
  
 
 
 with the patient. It is for the GP or other responsible clinician to discuss with their 
patient to decide on the most appropriate course of treatment.  Where primary and 
secondary care are working together with one of their patients on a shared care 
basis, there needs to be clear lines of communication. 

 the then Chief Pharmaceutical Officer for England, “Good for 

NHS England is working to support prescribers in managing repeat prescribing 
generally and in particular where patients are taking medicines which can cause 
dependence. As part of their work in response to the recommendations in the report 
from 
you, good for us, good for everybody: a plan to reduce overprescribing to make 
patient care better and safer, support the NHS, and reduce carbon emissions”  the 
Royal Pharmaceutical Society has been commissioned to provide a repeat 
prescribing toolkit.  In addition, in March 2023, an action plan was published to help 
local health care providers to reduce inappropriate prescribing of high strength 
painkillers and other addiction causing medicines. 
https://www.england.nhs.uk/publication/optimising-personalised-care-for-adults-
prescribed-medicines-associated-with-dependence-or-withdrawal-symptoms/ 

I am pleased therefore to note that the concerns you have raised have been addressed 
or are in the process of being implemented following responses by Wood Street Health 
Centre’s  letter  to  you  dated  6  November  2023)  and  from  North  East  London  NHS 
Foundation Trust’s letter to you dated 20 November 2023.  

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

Best wishes, 

THE RT HON DAME ANDREA LEADSOM DBE MP
Response from North East London Foundation Trust (PDF)
PRIVATE  & CONFIDENTIAL 

Mr G Irvine 
HM Coroner 
East London Coroners Service 
124 Queens Road 
Walthamstow 
London 
E17 8QP 

Chief Executive Officer 
Trust Head Office 
West Wing 
CEME Centre 
Rainham 
Essex 
RM13 8GQ 

20th November 2023 

Dear Sir 

Re: Inquest touching upon the death of Amanda Kramer 

I refer to your Regulation 28 report, dated 11 September 2023, detailing your concerns about the 
risk of future deaths in light of the findings of this Inquest. 

I should like to extend my sincere condolences to the family of Mrs Amanda Kramer. This must 
have been an extremely difficult time and I hope that my response provides them, and you, with 
assurances that the North East London Foundation Trust (NELFT) is taking action to address the 
issues set out in your report. 

I note that your concerns are as follows: 

1. 

2. 

3. 

Zopiclone is a drug licenced for the treatment of short-term insomnia. The risks 
associated with the drug are first, that it is a central nervous system depressant 
and second, that patients prescribed the drug can form a dependency upon it. 

Service user was prescribed Zopiclone for 18 Years. 

Despite the deceased being under the care of both a GP and a secondary mental 
health  Trust  prior  to  her  death.  No  clear  evidence  emerged  in  this  inquest  that 
anyone had reviewed Service user’s use of this drug even when Service user had 
demonstrated  a  pattern  of  high-risk  behaviour  by  deliberately  overdosing  on 
prescribed medication. 

www.nelft.nhs.uk 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                     
        
 
 
 
 
 
 
  
 
 
   
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Following  the  sad  passing  of  Mrs  Amanda  Kramer,  a  number  of  changes  have  been 
implemented.  These include: 

1.  Patients who are initiated on Zopiclone now have a medical review of this medication 
within at least 2 weeks of the initial prescription date recorded in their care plan, whilst 
existing patients are being identified and reviewed. Senior clinical oversight has also 
been put in place to support this review for all patients prescribed this medication. The 
Trust  has  also  put  in  place  a  6  monthly  audit  process  of  this  to  help  support  this 
improvement in practice. The last of these audits was undertaken in October 2023, 
identifying  one  patient  where  a  review was  required,  but  that  all other reviews  had 
taken place. In circumstances where prescriptions remain in place for longer periods 
of time, the risks and rationale for this are discussed with patients and medical and 
care co-ordinator staff are keeping this under careful review. In support of this work, 
staff have received training on the safe prescribing and management of Z-drugs and 
Benzodiazepines and this is being arranged on a repeat basis, with the next session 
taking place on 29 November 2023. 

2.  A workstream has been established across the primary and secondary care partners 
in the North East London Integrated Care System.  This is overseeing improvements 
to the co-ordination of medication monitoring for patients receiving Benzodiazepines 
and Z-Drugs, including significant work on the co-ordination of information between 
primary and secondary care to ensure that accurate information is in place to enable 
the  effective  review  and  monitoring  of  patients  who  have  been  prescribed  such 
medication. 

3.  The  Trust  has  also  worked  with  staff  to  ensure  that  there  is  effective  handover  of 
information between teams so that responsibilities are clear. In particular, there has 
been a focus on ensuring comprehensive documentation of patient information at the 
point of handover from one team to another. The effectiveness of this is being audited, 
and in the most recent audit undertaken (a random sample of 20 patients), all records 
were  clear  and  reflected  a  comprehensive  handover  of  the  care  plan  and 
responsibilities for different professionals involved.  This includes situations in which 
prescribing is taking place within primary care. 

4.  Staffing in Crisis and Home Treatment teams has been increased, with the addition 
of extra pharmacist posts.  This will enable improved medicine reconciliation at the 
point of discharge from hospital, and ensure that prescriptions for Zopiclone amongst 
other  medication  are  effectively  monitored  and  reconciled  throughout  the  patient’s 
journey.  This increased capacity will also give more pharmacy support to work with 
individual patients at this point of transfer and transition, including work on medication 
education for both patients and prescribers that will help to address risks associated 
with these medications. 

If I can be of any further assistance or if you would like a further update on the progress made to 
address your concerns, I would be happy to provide a further update. 

Yours sincerely 

Chief Executive Office 

www.nelft.nhs.uk
Response from Wood Street Health Centre (PDF)
Private and Confidential 

  Wood Street Health Centre
   6 Linford Road
     Walthamstow
  London, E17 3LA 

. 

Mr Graeme Irvine 
His Majesty’s Senior Coroner for 
East London 
East London Coroner’s Court 
Queens Road 
London 
E17 8QP 

6 November 2023 

Dear Sir 

 response to the Regulation 28 Report to Prevent Future Deaths 

Inquest touching upon the death of Mrs Amanda Kramer 

I  write  with  reference  to  your  Regulation  28  Report  to  Prevent  Future  Deaths,  dated 

11 September 2023, issued further to the Inquest touching upon the death of Mrs Amanda 

Kramer (‘the Regulation 28 Report’). 

On  behalf  of  the 

  Practice  (‘the  Practice’),  I  would  like  to  extend  my  deepest 

condolences  to  Mrs  Kramer’s  family.  I  would  like  to  reassure  them  that  the  Practice  has 

taken  the  Coroner’s  findings  seriously  and  has  taken  steps  to  address  any  deficiencies, 

which are set out in this response.  

The Coroner’s concerns 

‘1.  Zopiclone  is  a  drug  licenced  for  the  treatment  of  short-term  insomnia.  The  risks 

associated with the drug are first, that it is a central nervous system depressant and 

second, that patients prescribed the drug can form a dependency upon it. 

2. Mrs Kramer was prescribed Zopiclone for 18 years. 

3.  Despite  the  deceased  being  under  the  care  of  both  a  GP  and  a  secondary  care 

mental health trust prior to her death. No clear evidence emerged in this inquest that 

 
        
   
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 anyone  had  reviewed  Mrs  Kramer’s  use  of  this  drug  even  when  Mrs  Kramer  has 

demonstrated  a  pattern  of  high-risk  behaviour  by  deliberately  overdoing  on 

prescribed medication.’ 

The Practice’s response 

To address the Coroner’s concerns, the Practice has taken the following steps: 

1.  All patients being prescribed with Zopiclone or Zolpidem have been identified via an 

audit,  enclosed  with  this  response  as  Exhibit  1;  the  Practice  is  in  the  process  of 

reviewing their medication – the progress of this can be demonstrated in the re-audit, 

undertaken in October 2023 (Exhibit 2). The goal is for each patient to have a plan in 

place to reduce and eventually stop the medication or change it to a safer alternative. 

Notification letters of these actions and patient leaflets will be sent to all patients on 

Zopiclone  and  Zolpidem.  The  completed  plans  have  been  coded  onto  the  patients’ 

notes  on  the  EMIS  computer  system  for  both  healthcare  professionals  and 

administrators  to  be  aware  of  the  care  plan  and  not  deviate  from  it.  Patient  alert 

system  notification  has  also  been  put  in  place  for  all  these  patients  as  an 

identification  for  other  healthcare  providers  both  in  the  out  of  hours  service  and 

hospital trusts. 

2.  Where possible, all patients on Zopiclone or Zolpidem will have a medication review 

every  4  weeks;  such  review  will  focus  on  reducing  the  regimen  of  their  medication, 

depending on withdrawal symptoms, level of risk and support structure. 

3.  All prescriptions of Zopiclone and Zolpidem have been reviewed to ensure they are 

acute, rather than repeat prescriptions; this will be a policy for new requests as well. 

This will also provide opportunities for more frequent reviews and discussion on how 

the withdrawal plan is being achieved with the patient. All quantities on prescription 

are reduced to a maximum 2-week supply. 

4.  The  dosage  instructions  now  state  on  the  prescription  that  the  medication  is  to  be 

used on a ‘as required’ basis, not regularly; and to reduce the dosage down and stop 

when  appropriate,  so  to  remind  the  patient  and  the  community  pharmacist  of  the 

withdrawal  plan.  All  local  community  pharmacists  have  been  informed  of  the 

Practice’s plan and the shared goal of reducing these prescriptions and to work with 

the Practice to achieve it. 

5.  For  the  patients  who  are  under  a  shared  care  arrangement,  the  Practice  will 

implement a joint care policy with their secondary care provider. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 6.  The  Practice  has  prepared  a  new  policy  for  prescribing  Zopiclone  and  Zolpidem 

under shared care arrangements – this is enclosed with this response as Exhibit 3. 

The  audit  (Exhibit  1)  and  re-audit  (Exhibit  2)  demonstrate  that  these  changes  have  been 

already implemented at the Practice; a total of 69 patients on either Zopiclone or Zolpidem 

have  had  their  medications  stopped  as  of  19  October  2023,  the  date  the  re-audit  was 

completed,  compared  to  18  patients  who  were  stopped  following  the  first  audit  in  March 

2023. 

I  trust  that  that  this  response  provides  reassurance  that  the  Practice  has  taken  action  to 

address the matters raised by the Coroner. 

Should any further information be required, please do not hesitate to contact me.

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