Prevention of Future Deaths reports · 2023
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 report | 11 Sep 2023 |
|---|---|
| Reference | 2023-0328 |
| Deceased | Amanda Kramer |
| Coroner | Graeme Irvine |
| Coroner area | East London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
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
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.
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
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
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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