Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0012, written 8 Jan 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Jan 2024 |
|---|---|
| Reference | 2024-0012 |
| Deceased | Sarah Mitchell |
| Coroner | Darren Stewart |
| Coroner area | Suffolk |
| Category | Alcohol, drug and medication related deaths |
| Organisation named | James Paget University Hospitals NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1 Rt Hon Victoria Atkins, Secretary of State for Department of Health and Social Care 2 3 4 , Chief Executive James Paget University Hospitals NHS Trust , Rosedale Surgery Lowestoft , Chief Executive NHS England 1 CORONER I am Darren STEWART OBE, HM Area Coroner for the coroner area of Suffolk 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. 3 INVESTIGATION and INQUEST On 07 October 2022 I commenced an investigation into the death of Sarah Julie MITCHELL aged 41. The investigation concluded at the end of the inquest on 27 November 2023. The conclusion of the inquest was that: Drug related The medical cause of death was confirmed as: 1a Toxicity of Multiple Drugs, including Morphine, Promethazine, Gabapentin, Fluoxetine 1b 1c 2 Fatty Liver 4 CIRCUMSTANCES OF THE DEATH Sarah Julie MITCHELL suffered from chronic back pain for over 15 years and struggled to manage this as well as the addictive effects of the pain medication she was prescribed to alleviate her pain. During the 12 years prior to her death she had made several attempts to reduce her pain medication in conjunction with her GP. The debilitating affects of her condition had also negatively impacted on her mental health and she suffered from periodic bouts of low mood and depression for which she was prescribed medication to help alleviate the symptoms. In the two years leading up to her death, Ms. MITCHELL self medicated, using dosages of her medication in excess of the prescription. She was known to hoard her prescription medication. This resulted in several overdose events where Ms. MITCHELL required ambulance attendance and hospitalisation. Following these overdose events, her GP reduced Ms. MITCHELL's prescription requiring her to attend daily to receive her medication. This would be increased to weekly following a period of compliance and due to the hardship Ms. MITCHELL experienced having to collect medication on a daily basis. On the 3rd August 2022, in the early morning (00.13 hours), Ms. MITCHELL was admitted Regulation 28 – After Inquest Document Template Updated 30/07/2021 to the James Paget University Hospital A&E Department having been involved in a Road Traffic Collision. Police had brought Ms. MITCHELL to hospital and there was a concern that she had taken an overdose of Gabapentin, one of her prescribed medications. Ms MITCHELL was discharged that morning with 14 days of medication. At the time Ms. MITCHELL was being prescribed her medication on a weekly basis due to concerns relating to her risk of overdose. In the early evening of the 3rd August 2022 (18.28 hours) Ms. MITCHELL was re-admitted to the James Paget University Hospital following a suspected overdose. She was seen by Mental Health Liaison Staff and assessed as not having suicidal ideation or intent, but having a high risk of accidental death due to overdose from self-prescribing. Ms. MITCHELL was discharged on the 4th August 2022 with a further 14 days of medication provided. The cumulative effect of the provision of 14 days medication on each of her two discharges meant she received 28 days worth of prescribed medication in less than a 48 hour period. Her weekly medication prescriptions from her GP continued meaning that Ms. MITCHELL had further opportunities to hoard her prescription medication. Ms. MITCHELL took a further overdose on the 11th August 2022 and was admitted again to the James Paget University Hospital in the late evening (23.48 hours) and she underwent a further Mental Health assessment the next day (12th August 2022) by Mental Health Liaison staff. Ms. MITCHELL expressed remorse as to her actions and she was again assessed as not having suicidal ideation or intent. She was assessed as being at high risk of accidental death from overdose. She was on weekly prescriptions for her medication at this point. A referral was made for further Mental Health Services support/treatment and at the time of her death she was pending an appointment scheduled for the following week. Ms. MITCHELL was found deceased at her residence on 22nd September 2022. Police enquiries revealed no suspicious circumstances or third party involvement. Post mortem examination found that Ms. MITCHELL had died from Multiple drug toxicity of prescribed medication. Pregabalin, a medication she was not prescribed at the time was also detected, although not at a fatal concentration. 5 CORONER’S CONCERNS During the course of the investigation my inquiries 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: (brief summary of matters of concern) The provision to Ms. MITCHELL of 28 days’ worth of prescribed medication in less than a 48-hour period (14 days’ worth of medication dispensed on each occasion she was discharged hospital on the 3rd and 4th of August 2022). This occurred at a time when, due to concerns about Ms. MITCHELL hoarding medication and taking an overdose, she was receiving weekly medication prescriptions from her GP to control this risk. The evidence heard at Inquest indicated that there was no process in place whereby accident and emergency staff could access Ms. MITCHELL’s medical records detailing the medication she was receiving and the rationale behind the dispensing regime in place. 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 March 04, 2024. I, the coroner, may extend the period. Regulation 28 – After Inquest Document Template Updated 30/07/2021 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 I have also sent it to Norfolk and Suffolk NHS Foundation Trust who may find it useful or of interest. I am also under a duty to send the Chief Coroner a copy of your response. 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 by the Chief Coroner. 9 Dated: 08/01/2024 Darren STEWART OBE HM Area Coroner for Suffolk Regulation 28 – After Inquest Document Template Updated 30/07/2021
4 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 Andrew Stephenson CBE MP Minister of State for Health and Secondary Care 39 Victoria Street London SW1H 0EU 020 7210 4850 10 April 2024 Darren Stewart OBE The Coroner’s Court and Offices Beacon House Whitehouse Road Ipswich IP1 5PB Dear Mr Stewart, Thank you for your Regulation 28 report to prevent future deaths dated 15 January about the death of Sarah Mitchell. I am replying as Minister with responsibility for health and secondary care. Firstly, I would like to say how saddened I was to read of the circumstances of Miss Mitchell’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. Thank you for the additional time provided to the department to provide a response. The report raises concerns over a lack of process in place whereby accident and emergency (A&E) staff could access Ms. Mitchell’s medical records detailing the medication she was receiving and the rationale behind the dispensing regime in place. In preparing this response, Departmental officials have made enquiries with NHS England. As I understand, the James Paget University Hospitals NHS Trust (the Trust) has provided a response which gives an update on the investigative action undertaken and assurance around the Trust’s prescribing policy. I trust their response addresses your specific concern around access to medical records for A&E staff. in his capacity as Medical Following this, I am aware that Director of NHS England too has provided a response. NHS England has provisioned a programme of work to transition records from the existing system to the new National Care Records Service (NCRS) service, which I note, by design will remove a large amount of the reported barriers to adoption within many care settings. NHS England is operationally responsible for delivering health services across the country and will carefully consider further responses provided by the Trust. I hope that as an executive non-departmental public body, sponsored by the Department of Health and Social Care, the response provided by NHS England has addressed your concern. 1 More broadly on prescribing, I refer you to the professional standards guidance from the General Medical Council which highlights that some categories of medicine may pose particular risks of serious harm or may be associated with overuse, misuse or addiction: Controlled drugs and other medicines where additional safeguards are needed - professional standards - GMC (gmc-uk.org). When prescribing, clinicians should follow relevant clinical guidance, such as drug safety updates on the risk of dependence and addiction associated with opioids. The National Institute for Health and Care Excellence has also issued relevant guidance on, “Prescribing of drugs associated with dependence and withdrawal symptoms”: Overview | Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults | Guidance | NICE. I hope this response is helpful and reassures you that concerns raised in your report have been taken very seriously. Thank you for bringing these concerns to my attention. Yours sincerely, Rt. Hon Andrew Stephenson CBE MP Minister of State Health and Secondary Care
r.!1:bj James Paget University Hospitals NHS Foundation Trust Lowestoft Road Gorleston Great Yarmouth Norfolk NR31 6LA 25th January 2024 Mr Darren Stewart, OBE HM Area Coroner for Suffolk Suffolk Coroner's Court Beacon House White House Road IPSWICH Suffolk, IP1 4PB Dear Mr Stewart RE: Regulation 28 - Report to Prevent Future Deaths I am writing to acknowledge receipt of the Regulation 28 - Report to Prevent Future Deaths, issued to the James Paget University Hospital NHS Foundation Trust (JPUH) following the inquest into the death of Ms Sarah Julie Mitchell, which was heard and closed on 27th November 2023, and received via our Legal Services Provider on 9th January 2024. I note your concerns as follows: During the course of the investigation my inquiries 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: (brief summary of matters of concern) The provision to Ms. MITCHELL of 28 days' worth of prescribed medication in Jess than a 48-hour period (14 days' worth of medication dispensed on each occasion she was discharged hospital on the 3rd and 4th of August 2022). This occurred at a time when, due to concerns about Ms. MITCHELL hoarding medication and taking an overdose, she was receiving weekly medication prescriptions from her GP to control this risk. The evidence heard at Inquest indicated that there was no process in place whereby accident and emergency staff could access Ms. MITCHELL's medical records detailing the medication she was receiving and the rationale behind the dispensing regime in place. I note that, unfortunately, the JPUH was not informed or involved in the inquest and we were, therefore, unable to provide clarification regarding these concerns. However, upon receipt of the Regulation 28, an investigation into these matters of concern was commenced. Investigation Outcome Provision of Prescribed Medication I have received assurance from the Trust's Chief Pharmacist that the only medication which Ms Mitchell was given upon her first discharge, on 3rd August 2022, was one capsules, equating to a 10 day supply. This is evidenced box of in the Trust's dispensing record for this patient as illustrated below: Fluoxetine The medicines detailed on the a-Discharge Summary represent the medicines the patient was prescribed prior to admission, with any changes made in hospital, in addition to any new medication started during their inpatient stay. This information is entered onto the Trust's Electronic Prescribing and Medicines Administration (EPMA) system by the prescriber at the point of discharge. Information on pre-admission medicines is entered by the clerking doctor, when a decision to admit is made, and obtained through a variety of means, including directly from the patient, by reviewing the patient's Summary Care Review (SCR) and by reviewing SystmOne. Summary Care Record (SCR) is a national database that holds electronic records of important patient information such as current medication, allergies and details of any previous adverse reactions to medicines, created from the GP medical records. It can be seen and used by authorised staff in other areas of the health and care system involved in the patient's direct care. SystmOne is a clinical computer system used by GP practices which record patients' information securely. This information can then be shared with other clinicians at other organisations directly, or via the Emergency Department (ED) staff to review the patient's GP records, including medication and prescriptions. the SCR. This permits The Trust's EPMA system requires a duration to be added for all prescriptions, as per the legal requirements for prescriptions. This is currently defaulted to 14 days' supply for discharge prescriptions, to enable sufficient time for GPs to update their records in order to provide ongoing supplies. The actual supply given can range from 7 - 28 days, depending on what the patient brought in with them, what supplies they already have at home and what has been supplied during their inpatient stay. There is no straightforward way to get the actual quantity supplied to match the 14 days referred to in the e-Discharge Summary in the current system. In summary, thee-Discharge Summary contains a list of medication which the patient is taking on discharge, with additional information specific to medicines that have been stopped, started or amended during their inpatient stay. This list of medication therefore, does not necessarily relate to what was supplied by the JPUH. Next Steps You may be aware that the Norfolk and Waveney Acute Hospital Collaborative are in the process of procuring an Electronic Patient Record system for use across the three acute Trusts. This will remove the need for separate systems, including EPMA and e-Discharge and will eliminate the issues of data transfer between systems. It is anticipated that the new EPR system will go live in 2026. More information can be found by accessing the following link: better joined up care - EPR - (nwepr.co.uk) ED Staff Access to Medical Records Process , Assistant Medical Director for the Division of Medicine, Diagnostics and Clinical Support Services has confirmed that staff within our ED have access to both the Summary Care Record and SystmOne. It is clear that one, or both of these systems were accessed on this occasion, as Ms Mitchell's medication was included in the e-Discharge Summary. It is also noted on thee-Discharge Summary, within the Primary Care Action, to 'please only prescribe weekly prescriptions'. We would always welcome opportunities to be involved in any inquests in the future and I trust that this adequately addresses the concerns raised in the Regulation 28 Report. However, should you require any further clarification regarding this, or any other case, please do not hesitate to contact the Trust. Yours sincerely Chief Executive Enc
Darren Stewart OBE
Suffolk Coroner’s Court and Offices
Beacon House
Whitehoue Road
Ipswitch
IP1 5PB
Dear Coroner,
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
4 March 2024
Re: Regulation 28 Report to Prevent Future Deaths – Sarah Mitchell who died on
22 September 2022.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 8
January 2024 concerning the death of Sarah Mitchell on 22 September 2022. In
advance of responding to the specific concerns raised in your Report, I would like to
express my deep condolences to Sarah’s family and loved ones. NHS England are
keen to assure the family and the coroner that the concerns raised about Sarah’s care
have been listened to and reflected upon.
In your Report you raised the concern that Accident & Emergency Department staff
could not access Sarah’s medical records detailing the medication she was already
receiving and the rationale for her dispensing regime. Sarah was prescribed 28 days’
worth of medication within a 48-hour period, at a time where there were concerns that
she was hoarding medication and despite her history of overdose events.
Healthcare organisations use a combination of locally / regionally provided and
nationally provided information sharing systems to support patient care. A contribution
from the Shared Care Records programme would be helpful in this case to understand
what information is provided in the area where the deceased received care through
any local Shared Care Record or other local sharing agreements. You may wish to
refer to Norfolk and Waveney Integrated Care Board (ICB) on this matter as ICBs are
responsible for the delivery of Shared Care Records. This response focuses on
nationally provided services.
NHS England monitor the accesses made by organisations to the services that we
support, including the Summary Care Record application (SCRa) and the National
Care Records Service (NCRS). We publish some of this information here:
https://digital.nhs.uk/data-and-information/data-tools-and-services/tools-for-
accessing-data/deployment-and-utilisation-hub/summary-care-records-deployment-
and-utilisation.
In this case specifically, our dashboards indicate that healthcare professionals at
James Paget University Hospitals NHS Foundation Trust (“the Trust”) have been using
the Summary Care Record application and the National Care Records Service to view
Summary Care Records (among other information e.g. Demographic Information,
Child Protection - Information Sharing system, Covid Vaccination information, etc).
Accident & Emergency (A&E) staff should be among the staff groups who have access
to these records at the Trust.
For background, it is worth mentioning that, in the past, the Summary Care Record
application (SCRa) was the main method to access SCRs for the existing NHS user
base. However, NHS England have been involved in a programme of work to transfer
SCR users from the legacy SCRa service to the new National Care Records Service
(NCRS) service. This work was accelerated during 2023 and is projected to conclude
during Q2 2024. NCRS is the successor to SCRa and by design removes a large
amount of the reported barriers to adoption within many care settings. The National
Care Records Service (NCRS) provides a quick, secure way to access national patient
information to improve clinical decision making and healthcare outcomes, it is free to
use and includes additional features and services beyond the legacy SCRa product.
Further
here:
NCRS
https://digital.nhs.uk/services/national-care-records-service.
information
found
can
be
on
SCRa and NCRS both provide access to a patient’s Summary Care Record (unless
the patient has opted out). The Summary Care Record (SCR) is a national database
that holds electronic records of important patient information such as current
medications, allergies and details of any previous bad reactions to medicines, created
from GP medical records. It can be seen and used by authorised staff in other areas
of the health and care system involved in the patient's direct care. Patients are asked
for their permission to view before this information can be accessed. Further
information about SCR is available here: https://digital.nhs.uk/services/summary-care-
records-scr.
With regards to current repeat medications in the SCR specifically, the information
includes details of all current repeat medications including the medication item
(including drug name, dosage, and formulation), dosage instructions (e.g. take one
daily), quantity prescribed and last issue date. Principally, this provides a list of those
medications prescribed by the patient’s GP Practice (but it is possible to include
information about those medications which have been prescribed elsewhere, though
this functionality is often not used for a variety of reasons). Thus, in this case, clinicians
at James Paget University Hospitals NHS Foundation Trust are likely to have had
access to information about the Morphine, Promethazine, Gabapentin and Fluoxetine
prescribed to the patient from their registered GP Practice.
Provision of medication in quantities of less than a month’s supply usually suggest
attempts are being made in General Practice to control a patient’s access to
medication (although this approach might also on some occasions be used for older
patients who are receiving medications in monitored dosage systems).
In addition, summary details about the overdose events in this patient’s clinical history
would likely be captured within a patient’s GP Summary, and as a result would be
likely to be present in this patient’s Summary Care Record with Additional Information.
Further
found here:
https://digital.nhs.uk/services/summary-care-records-scr/additional-information-in-
scr. Currently, 89% of patients have an SCR with Additional Information.
information about SCR Additional
Information can be
It is noted in the Regulation 28 letter that this patient suffered from chronic back pain
for a period of over 15 years. As a result, this patient may have had some form of
healthcare management plan e.g. emergency healthcare plan, treatment escalation
plan, etc. Details of a healthcare management plan can be shared using a local Shared
Care Record or summary details of a healthcare management plan can be shared
using the Summary Care Record. SCR also contains provision for inclusion of
information relating to a ‘Special Patient Note’ where this has been coded into the
patient’s GP record and the patient has an SCR with Additional Information. Clinical
information is best shared when these ways of working have been agreed up front
across the local healthcare economy.
There is also clear guidance from the General Medical Council (GMC) on prescribing
responsibilities for healthcare professionals. This includes:
•
• Consideration of whether a prescriber has the ‘sufficient information to
prescribe safely, for example if you have access to patient’s medical records
and can verify relevant information’.
If not a patient’s regular prescriber, prescribers should seek the patient’s
consent to contact their GP for further information.
If a patient objects to information being shared, prescribers must have
justification for prescribing without that information.
•
NHS England would refer you to James Paget University Hospitals NHS Trust for
further information on Sarah’s care and your concerns, including their prescribing
policies and we note that you have also addressed your Report to them. We
understand that the Trust has contacted the coroner to clarify some of the issues
referenced within your Report. We have been asked to be sighted on their response
and will consider this carefully once we are in receipt.
I would also like to provide further assurances on 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 preventable deaths are shared across the NHS at both
a national and regional level and helps us 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
From: To: Subject: 22/09/2022 (ROSEDALE SURGERY) RE: Prevention of Future Death Report following Inquest of Sarah Julie Mitchell DoD EXTERNAL EMAIL: Don't click any links or open attachments unless you trust the sender and know the content is safe. Click here for more information or help from Suffolk IT Dear , In our practice we have yesterday discussed the Prevention of Future Death Report regarding Sarah Mitchell in a Clinical Governance meeting. Present in the meeting were myself and 8 other doctors as well as 3 of our Health Care Practitioners. Two decisions were made: 1. The hospital does not easily have access to our clinical system, but they do have access to the Summary Care Records, which gives information about diagnosis and medication. From now on when a diagnosis of an overdose gets recorded we will add a sentence to give no more controlled medication than is needed for 48 hours, so they can contact the surgery again for a further supply after. This should be visible on the summary care record that the hospital is looking at. 2. If a patient is admitted with more than 1 overdose within a 3 month period we will change their prescription to daily until they have not to overuse or overdose on their medication. We hope that with these two new ways of working in place we might be able to bring down the chance of accidental death due to an overdose as seems to have happened in Sarah’s case. Kind regards, 1
See every Prevention of Future Deaths report matching James Paget University Hospitals NHS Foundation Trust, and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.