Dear Coroner,

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:

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

4 March 2024

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 information on NCRS can be found here:

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 information about SCR Additional Information can be found here:

scr. Currently, 89% of patients have an SCR with Additional Information.

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.

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 box of Fluoxetine capsules, equating to a 10 day supply. This is evidenced in the Trust's dispensing record for this patient as illustrated below: 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 SCR. This permits the Emergency Department (ED) staff to review the patient's GP records, including medication and prescriptions. 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.

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.

Following this, I am aware that in his capacity as Medical 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.

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.

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,

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