Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0113, written 28 Feb 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 28 Feb 2025 |
|---|---|
| Reference | 2025-0113 |
| Deceased | William Green |
| Coroner | Heath Westerman |
| Coroner area | Shropshire, Telford & Wrekin |
| Category | Alcohol, drug and medication related deaths · Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | The Shrewsbury and Telford Hospital NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
HEATH WESTERMAN
H.M. ASSISTANT CORONER
FOR SHROPSHIRE,
TELFORD & WREKIN AREA
H.M. Coroner’s Service
Guildhall
Frankwell Quay
Shrewsbury
Shropshire SY3 8HB
Coroner's Office:
Email:
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. NHS England, Wellington House, 133-155 Waterloo Rd, London SE1 8UG
Email:
2.
, Chief Executive of Shrewsbury and Telford NHS Trust
1
CORONER
I am Heath Westerman, H.M. Assistant Coroner, for the coroner area of Shropshire, Telford &
Wrekin.
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 12 July 2023 Mr Ellery, H.M. Senior Coroner for Shropshire, Telford & Wrekin commenced an
investigation into the death of William Stephen GREEN
The investigation concluded at the end of the inquest on 27 February 2025
The conclusion of the inquest was:
William Stephen Green died on 9 July 2023 at The Royal Shrewsbury Hospital, Mytton Oak Road,
Shrewsbury, Shropshire. He died as the result of toxic epidermal necrolysis secondary to
Lamotrigine. This is a rare but recognised complication arising from taking Lamotrigine which was
prescribed to Mr Green for the required treatment of his then known symptoms from 5 June 2023
until its cessation on or around 8 July 2023. Those complications, however, were not counselled or
alerted to Mr Green upon his discharge from the hospital on 7 June 2023, nor was he advised on what
to look out for and what to do in such circumstances. His death was contributed to by alcohol
dependent disease.
4
CIRCUMSTANCES OF THE DEATH
Mr Green was admitted to The Royal Shrewsbury Hospital, Mytton Oak Road, Shrewsbury,
Shropshire on 5 June 2023 following a seizure probably alcohol related. He was started on
Lamotrigine an anti-epileptic at a dose of 25mg once daily. He was discharged on 7 June 2023 with a
pack of 56 Lamotrigine tablets at a dose of 25mg to be taken one daily. His compliance with taking
the Lamotrigine once in the community is not known. He was re-admitted to The Royal Shrewbury
Hospital on 5 July 2023 following a collapse and with a rash on his chest, back and upper limbs. He
was treated for sepsis secondary to viral meningitis. A treatment plan was followed which included
Lamotrigine to be administered once daily at the rate of 25mg. His condition deteriorated and on 8
July 2023 he was diagnosed with Steven Johnstone Syndrome. He died on 9 July 2023 as the result of
toxic epidermal necrolysis secondary to Lamotrigine. Contributing to his death was alcohol
dependent disease.
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 will 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) Once any patient at The Royal Shrewsbury Hospital is initiated on a new prescribed drug during
an admission, no written record is ever made anywhere by anyone including pharmacy; nurses;
doctors or consultants explaining or counselling the patient upon the possible side-effects or
complications as a result of taking a specific prescribed drug; nor is there any written record on what
to look out for and what to do in such circumstances and where they can get assistance.
(2) No provision seems to be in place to record what should happen when the patient lacks capacity
to understand such an explanation even when it is offered.
6
ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you and 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 25
April 2025. 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.
2
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 a copy to
from the Trust.
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
Heath Westerman
H.M. Assistant Coroner
Shropshire, Telford & Wrekin
28 February 2025
Send to:
3
2 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.
Mr Heath Westerman
HM Assistant Coroner
Shropshire, Telford and Wrekin
HM Coroner’s Service
Guildhall
Frankwell Quay
Shrewsbury
Shropshire
SY3 8HB
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
14 April 2025
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – William Stephen Green
who died on 9 July 2023.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 28
February 2025 concerning the death of William Stephen Green on 9 July 2023. In
advance of responding to the specific concerns raised in your Report, I would like to
express my deep condolences to William’s family and loved ones. NHS England are
keen to assure the family and the Coroner that the concerns raised about William’s
care have been listened to and reflected upon.
Your Report raises the concern that there is no written record explaining or counselling
patients on the side-effects, and what to do if side-effects are experienced, when a
patient at The Royal Shrewsbury Hospital is initiated on a new prescribed drug during
an admission. Your Report also raises that there is no provision in place for patients
who lack capacity to understand an explanation of the side-effects of prescribed drugs,
even when this may be offered. In William’s case, he was prescribed an anti-epileptic
and seizure drug called Lamotrigine between 5 June 2023 and 8 July 2023.
My response to the Coroner has been aided by engagement with NHS England’s
National Clinical Director
two experienced Clinical
for Prescribing and
Pharmacologists.
When administering a new prescribed drug to patients, there should be shared
decision-making and potential risks or complications relevant to the patient should be
verbally discussed with them, even if very rare. The counselling of patients on their
medications, including documenting a record of these discussions (or a lack of
capacity to engage with such discussion) is a matter of professional duty and is
described by both professional and organisational regulatory bodies.
It is not standard practice in hospitals to document or record if a patient has been
counselled about the risk of medicines, apart from in certain circumstances where
consent is required (e.g., completing an Acknowledgement of Risk form for the
prescription of isotretinoin) or to provide written information on the risk.
However, NHS England will take your concern about counselling, and keeping a
written record of such counselling, to an appropriate forum for further discussion and
consideration of any actions we need to take.
It should also be noted that, on discharge from hospital, patients will be provided with
the ‘original pack’ medication, and these will contain the Patient Information Leaflet
(PIL) which outlines the risks and side-effects. In the case of Lamotrigine, the PIL
states:
‘A small number of people taking Lamotrigine get an allergic reaction or potentially life-
threatening skin reaction, which may develop into more serious problems if they are
not treated. These can include Stevens-Johnson syndrome (SJS), toxic epidermal
necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS). You need to know the symptoms to look out for while you are taking
Lamotrigine Tablets. This risk may be associated with a variant in genes in people
from Asian origin (mainly Han Chinese and Thai). If you are of such origin and have
been tested previously carrying this genetic variant (HLA-B* 1502), discuss this with
your doctor before taking Lamotrigine Tablets.’
Your Report does not mention whether William was given the original pack medication
on discharge from hospital.
Regarding the capacity of patients, there is clear NHS guidance on how to proceed
with treatment when someone may lack capacity. There is also legislation (The Mental
Capacity Act 2005), which provides a framework for decision-making on behalf of
people who lack capacity. We would expect Trusts to have their own local policies on
the administration of new medications, and most Trusts’ Medicine Policies will contain
guidance on counselling patients. However, as above, they may not direct that this
counselling needs to be recorded in the patient’s notes, as this is not standard practice.
NHS England has also engaged with NHS Shropshire, Telford and Wrekin Integrated
Care Board (ICB), the responsible commissioner for services delivered by Shrewsbury
and Telford Hospital NHS Trust, on the concerns raised in your Report. We are
advised that the Trust have developed a Safety Improvement Plan, with actions
including:
• A Working Group to review patient counselling and informed consent regarding
medications being prescribed in hospital
• Learning from William’s case to be used to deliver training to junior doctors
• A new Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis (severe muco-
cutaneous reactions usually caused by certain medicines) pathway to be
developed and published within the Trust.
I would also like to provide further assurances on the 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 events, such as the sad death of
William, are shared across the NHS at both a national and regional level and helps us
to 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
Royal Shrewsbury Hospital
Mytton Oak Road
Shrewsbury
Shropshire
SY3 8XQ
Mr Heath Westerman, Assistant Coroner
HM Coroners Service
Shirehall
Abbey Foregate
Shrewsbury
Shropshire SY2 6ND
Tel: 01743 261000 ext. 2580
22nd April 2025
Dear Mr Westman,
Thank you for your letter dated 28th February 2025 issued under Regulation 28: Report to
prevent future deaths, in relation to the risks you identified through the inquest examining the
death of the late William Stephen Green.
I write to provide details of the steps that we have taken and plan to address the issues
highlighted in your letter.
1. Once any patient at The Royal Shrewsbury Hospital is initiated on a new prescribed drug
during an admission, no written record is ever made anywhere by anyone including
pharmacy; nurses; doctors or consultants explaining or counselling the patient upon the
possible side-effects or complications as a result of taking a specific prescribed drug; nor
is there any written record on what to look out for and what to do in such circumstances
and where they can get assistance.
2. No provision seems to be in place to record what should happen when the patient lacks
capacity to understand such an explanation even when it is offered.
Record of counselling
The counselling of a patient in hospital should be undertaken by the medical staff on prescribing
the medication, by the nursing staff and pharmacy staff in preparation for discharge. All
professions have a role in drug counselling, our pharmacists are the specialists in medication
and counselling and have access to additional resources and referral services.
Pharmacy led counselling/documentation:
• The current medication counselling standard operating procedure (SOP) only requests a
memo is entered into the eScript software (the pharmacy drug management system) if
there is concern a patient does not fully understand the explanation of the new
medication. This SOP is being updated to require all counselling episodes to be
documented. This will be fully implemented by the end of May 2025.
• A referral to the community-based support services (see below) will also require
documented evidence on eScript.
• A new patient medication leaflet has been designed and is being introduced to help
provide further patient information. This leaflet will signpost patients to the NHS drug
information website that has patient directed information on many of the drugs
prescribed, including specific information on high-risk drugs and immediate actions to
take for serious side-effects. This leaflet will be available by September 2025; it has been
drafted and is currently being taken through the trust accessibility and governance
processes.
o The community services outlined below will supplement the patient information
leaflet for those patients where the leaflet is not adequate.
Nurse led counselling:
• The nursing staff have a role in providing information especially around the time of
discharge. The printed discharge summaries will be adapted with the NHS drug website
highlighted to aid this counselling process.
• When a patient is discharged from a non-inpatient area, the patient information leaflet will
be available to give to patients as they are counselled.
Informed consent/counselling when prescribing a new medication:
Treating clinicians have a duty and responsibility to ensure patients are aware of any material
risk associated with planned treatment, this includes significant side effects of medication.
• All senior doctors have statutory training which include safe prescribing. This case will be
incorporated into this training as a learning example, highlighting the importance of
adequate counselling, the importance of documenting the process and reminding them of
the support available for patients who may not immediately understand. The training is
delivered by the trust pharmacists.
Ongoing support and counselling
Not all patients may be able to fully understand and comprehend the new medications started in
hospital for a variety of reasons. It is also recognised that some medications are high risk, they
have potentially serious implications of not complying with the medication or have potentially
serious complications (anti-epilepsy medication is included in this list).
Once a patient has been discharged from hospital, there are two Integrated Care System (ICS)
led services that patients can be referred to for ongoing support and monitoring. The Discharge
Medication Service (DMS) and the Structured Medication Review (SMR) service.
The DMS is a service where patients identified in the acute care setting who require additional
support in relation to their medication management can be referred by the pharmacy team. The
hospital ward staff, doctors or nurses can highlight patients of concern to pharmacy to trigger a
referral. The general referral criteria are: Admitted patients only, patients initiated on a high-risk
medication or patients who have been identified with compliance concerns. The referral is
directed to the patients nominated community pharmacist who will provide counselling and
additional support in a less stressful environment.
The SMR is a service where referral is to the GP or the PCN pharmacist for a full medication
review. This service is to review patient compliance and provide further information/education
and counselling. There will also be a review of all the medications to ensure they are
appropriate and optimised. The pharmacy team at SaTH would initiate a referral to this service.
Following the death of Mr Green and as a result of the internal investigation, a multi-disciplinary
working group has been set up to address the concerns raised and ensure appropriate actions
are developed, implemented and embedded in future care.
Thank you for bringing your concerns to my attention. I hope that you are assured that I have
taken them seriously, investigated then appropriately and we are putting in place systems and
processes to reduce future harm. If I can provide any further information, please do not hesitate
to contact me at the above address.
Yours sincerely
Chief Executive Officer
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