Prevention of Future Deaths reports · 2025

Luke Worrell

Regulation 28 report to prevent future deaths, reference 2025-0123, written 21 Feb 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report21 Feb 2025
Reference2025-0123
DeceasedLuke Worrell
CoronerAndrew Harris
Coroner areaSouth London
CategoryMental Health related deaths
Sourcejudiciary.uk record · original PDF
Responses published4

The report

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

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO:

1. MHRA
2. NHS England
3. Department of Health
4. Royal College of Psychiatrists
5. Care Quality Commission, Chief Executive

1 CORONER

I am Andrew Harris, Assistant Coroner, London South jurisdiction

2 CORONER’S LEGAL POWERS

I make this report under paragraph 7, Schedule 5, Coroners and
Justice Act 2009 and regulations 28 and 29 of the Coroners
(Investigations) Regulations 2013.

3

INQUEST

On 21st January 2022, as Senior Coroner, London Inner South, after a
Safeguarding Adults Investigation, I opened an inquest into the death
of Mr Luke Alexander Worrell, who had died in hospital aged 39 on
2nd January 2021. The inquest was concluded on 7th September 2023,
having called an expert pharmaceutical physician. On 21st September
2023 I took urgent sick leave. I resigned from my position on 31st
October 2023, after which I had no jurisdiction. On 21st September
2024, I received a request, in my new role as Assistant Coroner in
South London, to determine whether a preventing future death report
was needed. I agreed and the case was transferred on 27th November
and I was given access to the case file on 27th January 2025.
Submissions as to the need for a PFD report were filed, but in view of
the passage of time, I do not consider it fair to issue a report to those
involved with his care now in 2025, on the basis of evidence 16
months ago about a death 4 years ago. However the issues are
potentially generic and so I address my report to national
organizations.
The medical cause of death was:

1a Ruptured Oesophagus 1b Vomiting from ileus

 1c Gastro-intestinal upset from Clozapine administration
II  Treatment resistant schizophrenia, urinary tract infection

The narrative conclusion was:

He died from unintended consequences of necessary medical
treatment. There were two significant failures in care, which
contributed to his death. The first was a failure to recognize the side
effect of Clozapine on his gastro-intestinal tract. The second was the
failure to recognize the level of risk Mr Worrell presented to himself
after discharge, and in particular the failure to recognise the need for
face to face assessment by a psychiatrist in response to his
presentation on 7th and 14th December 2020, which amounted to
neglect.

4

CIRCUMSTANCES OF THE DEATH

Mr Worrell suffered from paranoid schizophrenia, dissocial personality
disorder and some learning difficulty. He spent most of his life in
hospital detention or custodial settings. He had a history of illicit
substance misuse, non- compliance with medication and non-
engagement with health services. During the Covid pandemic, he was
discharged from hospital on 28th October 2020 on oral Clozapine.
His mother, the GP and his 24 hour support service had not
contributed to discharge planning. He was assessed on the day before
discharge as having “less capacity to make informed decisions about
his follow up” and  he refused the Home Treatment Team's input post
discharge. His mother considered he was not ready for discharge; the
residential support service wanted him to remain under mental health
(MH) section on section 17 leave, as it enabled much easier recall to
hospital. This was not considered by the psychiatrist who was his
responsible  physician as its use had 'fallen out of practice' and he was
instead the subject of a community treatment order.
On 7th December he declined medication, opened his door naked
with a delusion that there was a t-shirt on his mattress touching which
would cause death and socks would kill Stevie. It was suspected that he
had bought Spice instead of food, and alcohol was found in his room,
but neither the care coordinator nor psychiatrist considered that he
needed a MH assessment, despite having demonstrated almost all
relapse indicators in his contingency and relapse plan, which required
one.
By 14th December he had persistent vomiting, stopped eating, self-
isolated with a barricade and refused medication. 111 was called as

 support staff and CC felt he should be taken to hospital. The GP
identified the self neglect but Mr Worrell declined to speak to him on
the phone and referred to mental health. Ambulance services were
severely stretched by Covid, and the paramedic in the early hours
inappropriately accepted that Mr Worrell did not need waking and
applied a triage assessment without consultation and made a referral
back to mental health services. He took his Clozapine on 16th and was
eating, but refused to attend the clinic. By 17th he had failed to attend
two review meetings with his psychiatrist, attendances at the clinic and
GP consultations, which persisted.
On 22nd a GP telephoned and was reassured that he was about to
attend the Clozapine clinic and lack of red flags and advised  being
taken to A&E if he worsened. His mother persuaded him to attend
the clinic with her, but he collapsed there and was taken to A&E on a
best interests basis. He was grossly dehydrated, partially conscious and
confused, with a severe metabolic alkalosis due to persistent loss of
gastric acid from vomiting, requiring intensive care. His GI tract was
dilated with a significant amount of fluid, due to an ileus from
Clozapine administration, which was not  recognised and was
continued, but probably absorbing little. His care was complicated by
postural pneumonitis, confusion preventing reinsertion of NG tube
and an arterial line being blocked. He had a coffee ground vomit on
31st December and this caused a rupture of a weakened oesophagus
and a deterioration the next day leading to a cardiac arrest, from which
resuscitation was inevitably unsuccessful. He died at 11.00 hours on
2nd January in hospital.

5 CORONER’S CONCERNS

The MATTERS OF CONCERN are as follows.  –

1. The lack of awareness by a series of clinical staff of the potential
fatal side effects of Clozapine
2. Inappropriate use of community treatment order, when there was
sufficient evidence to keep on a MHA section.

6 ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths. I
believe that the following organizations would wish to learn of the

 evidence given in the inquest about the circumstances of this death
and are in a position to mitigate or prevent future deaths. I attach my
judgment to assist them:
1. MHRA
2. NHS England
3. Department of Health
4. Royal College of Psychiatrists
5. Care Quality Commission, Chief Executive

7

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the
date of this report, namely by 17th April 2025.   I, the coroner, may
extend the period.
If you require any further information or assistance about the case,
please contact the Inner South case officer, 

:

8 COPIES and PUBLICATION

I have sent a copy of my report to the following Interested Persons:

, mother of the deceased

Oxleas NHS Foundation Trust, Medical Director
Queen Elizabeth Hospital, Woolwich, A&E Director
London Borough of Greenwich, Safeguarding Lead
Supported Living Services, Chief Executive

I am also sending this report to the Independent Panel on Deaths in
Custody, as arguably the deceased should have been in detention. 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

[DATE]                                              [SIGNED BY CORONER]
21st February 2025                              Andrew Harris, Assistant
Coroner, South London

Responses

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.

Response from Care Quality Commission (PDF)
Care Quality Commission 
Citygate 
Gallowgate 
Newcastle upon Tyne 
NE1 4PA 
Telephone: 03000 616161 
www.cqc.org.uk 

Car 

Mr Andrew Harris 
Assistant Coroner  
HM Coroner for London Inner South Coroners Court  
1 Tennis Street  
London  
SE1 1YD 

08 May 2025 

Dear Mr Harris,  

Care Quality Commission: 
Response to Regulation 28 Report to Prevent Future Deaths following the inquest into 
the death of Mr Luke Alexander Worrell.  

Thank you for your Regulation 28 Report to Prevent Future Deaths dated 21 February 
2025 about Mr Worrell's death. I am replying on behalf of the Care Quality Commission 
(CQC).  

Firstly, I would like to say how saddened I was to read of the circumstances of Mr 
Worrell’s death, and I offer my sincere condolences to his family and loved ones. Your 
report’s circumstances are concerning, and I am grateful to you for raising these 
matters.  

In the Regulation 28 Report to Prevent Future Deaths, the following concerns were 
raised to the CQC:  

1.  The lack of awareness by a series of clinical staff of the potential fatal side 

effects of Clozapine 

2.  Inappropriate use of community treatment order, when there was sufficient 

evidence to keep on a MHA section. 

In response to the individual points raised: 

1.  The Care Quality Commission (CQC) recognises the serious concerns arising 
from the lack of awareness among some clinical staff regarding the potentially 
fatal side effects of Clozapine. As the regulator of health and social care in 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 England, we are committed to supporting safe, high-quality care for people 
receiving treatment with Clozapine, both in inpatient settings and in the 
community. 

Clozapine remains an essential treatment for individuals with mental health 
conditions such as treatment-resistant schizophrenia; however, its use carries 
significant risks, including agranulocytosis, myocarditis, and gastrointestinal 
hypomotility, which require stringent monitoring and management. To ensure 
high standards of care, the assessment of Clozapine use, including through 
community Clozapine clinics and the monitoring of Clozapine related concerns, is 
conducted by our mental health inspectors within the CQC integrated 
assessment and inspection teams. These teams are further supported by our 
team of specialist medicines inspectors and our mental health senior specialists. 

In addition, our medicines inspection team delivers targeted Clozapine training 
and awareness sessions for our mental health inspectors across our integrated 
assessment and inspection teams. These are delivered through dedicated face-
to-face training sessions and development days to strengthen the knowledge and 
vigilance of our integrated assessment and inspection teams. 

Our dedicated mental health senior specialists support our integrated 
assessment and inspection teams in monitoring intelligence and assessing 
providers. This includes evaluating the safe and lawful use of Clozapine.  

Furthermore, the CQC medicines inspection team maintains regular engagement 
with the Health Services Safety Investigation Body (HSSIB), particularly in 
relation to investigations into Clozapine-related deaths in inpatient settings. 
Learning from these investigations is incorporated into our regulatory approach, 
enhancing our understanding of the safe use of Clozapine in inpatient and 
community settings. 

2.  The CQC is concerned by instances of the inappropriate use of Community 

Treatment Orders (CTOs), particularly where there is sufficient clinical and legal 
justification to maintain a person on a detention under the Mental Health Act 
(1983). The inappropriate application of CTOs can compromise both the safety of 
the individual and the effectiveness of their care and treatment. 

As the independent regulator of health and social care in England, we expect 
providers to ensure that all decisions relating to the use of the Mental Health Act, 
including transitions to CTOs, are based on clear clinical evidence, follow legal 
frameworks, and prioritise the individual’s rights and wellbeing. 

To support this, the CQC has a team of dedicated Mental Health Act Reviewers 
who work alongside our integrated assessment and inspection teams. These 
specialists provide expert advice and oversight in assessing the use and 
application of the Mental Health Act across both inpatient and community mental 
health services, including the use of CTOs. 

During the CQC assessment processes, our reviewers assess whether decisions 
regarding CTOs are legally compliant, clinically justified, and in the best interests 
of the person receiving care. They also monitor how well providers involve 

 
 
 
 
 
 
 
 
 
 
 individuals, carers, and advocates in the decision-making process, and whether 
services uphold people’s rights under the Act. 

Where we identify inappropriate use of CTOs or concerns about compliance with 
the Mental Health Act, we can undertake additional monitoring, engagement and 
regulatory action as necessary to drive improvement and hold providers to 
account. We aim to ensure that all people receiving care under the Mental Health 
Act are treated lawfully, safely, and with dignity and respect. 

All system partners in the health and social care sector must recognise the potentially 
fatal side effects of Clozapine. Failure to monitor and manage these risks can lead to 
avoidable harm or death. Equally, the appropriate use of Community Treatment Orders 
is critical to ensuring individuals receive necessary treatment while maintaining 
oversight and safeguarding their rights. Collaborative awareness and accountability 
across services help provide safe, person-centred care and uphold the standards we 
are committed to as a sector. 

The safety of people using mental health services remains a top priority for the CQC, 
and we will continue to take action where standards fall short to ensure that providers 
deliver safe, effective, and person-centred care.  

Internally, the CQC incorporates information from incidents, notifications, and 
Regulation 28 Prevention of Future Deaths reports into its ongoing monitoring and 
assessment planning. Our internal Specific Incidents Guidance process evaluates 
whether incidents indicate avoidable harm or breaches of fundamental standards. 
Where necessary, further enquiries are made, and the CQC may undertake targeted or 
unannounced inspections. If risks are confirmed, regulatory actions such as requirement 
notices or enforcement measures may be taken to ensure compliance and drive 
improvements in care. 

The Care Quality Commission’s local integrated assessment and inspection teams 
actively monitor Oxleas NHS Foundation Trust and Lewisham and Greenwich NHS 
Trust through continuous engagement and risk-based assessments. This includes 
gathering intelligence from various sources such as patient feedback, incident reports, 
and partner organisations. Regular meetings with the trusts and attendance at key 
committees, like Oxleas’ mortality surveillance committee, allow the CQC to review 
performance, address concerns, and seek assurance on improved care quality and 
safety. In addition to this local monitoring, the CQC has committed to a national review 
of adult community mental health services across England, following the 2024 Section 
48 special review of Nottinghamshire Healthcare NHS Foundation Trust. This work 
includes inspections of services such as community-based mental health services for 
adults of working age and mental health crisis services and health-based places of 
safety to identify gaps in care quality, patient and public safety, and staff experience. 
The review will assess both individual trust services and provide a broader national 
overview of community mental health service provision. 

We are grateful for the information you have shared. It is invaluable in helping us 
monitor the quality of care provided across services and ensure that providers meet the 
standards expected under the Health and Social Care Act (2008) and the associated 
Regulated Activities Regulations (2014). We appreciate the coroner raising these 

 
 
 
 
 
 
 
 
 
 concerns with us. We will continue to monitor the trusts and any information we receive 
in line with our internal processes and methodology. If you have any further queries, 
please do not hesitate to contact us. 

Yours sincerely,  

Deputy Director Operations 
Care Quality Commission – London & East of England Network
Response from Dhsc (PDF)
Parliamentary Under-Secretary of State for  
Patient Safety, Women’s Health and Mental Health  

39 Victoria Street  
London  
SW1H 0EU  

25 April 2025  

Our ref: 

Mr Andrew Harris  
Assistant Coroner  
London Inner South Coroners Court 
1 Tennis Street 
London 
SE1 1YD 

By Email: 

Dear Mr Harris,    

Thank you for your Regulation 28 report of 21 February 2025 sent to the Secretary of State 
about the death of Luke Alexander Worrell. I am replying as the Minister with responsibility 
for patient safety and mental health.  

Firstly, I would like to say how saddened I was to read of the circumstances of Mr Worrell’s 
death, and I offer my sincere condolences to his family and loved ones. The circumstances 
your  report  describes  are  deeply  concerning  and  I  am  grateful  to  you  for  bringing  these 
matters to my attention.  

Your report raises concerns over levels of awareness of clinical staff around the potentially 
fatal side effects of clozapine and the use of a Community Treatment Order (CTO) to support 
Mr Worrell when there may have been sufficient evidence to detain Mr Worrell under the 
Mental Health Act.  

I note that you have also addressed these matters of concern to NHS England, the Medicines 
and  Healthcare  Products  Regulatory Agency  (MHRA), the  Royal College  of  Psychiatrists, 
and  the  Care  Quality  Commission.  I  look  forward  to  working  together  with  these  bodies 
where appropriate to avoid a repetition of the tragic events of this case.  

I  understand  your  concern  that  clinical  staff  administering  clozapine  need  to  have  a  firm 
understanding of the drug’s potential side effects. I am aware that the Chief Executive of 
Medicines and Health Care products Regulatory Agency has provided a response to your 
report, which sets out the protocols it has in place to ensure clinicians are aware of the side 
effects of clozapine. This includes ensuring that the special warnings and precautions for 
use  section  of  the  Summary  of  Product  Characteristics  (SmPC)  for  clozapine  includes 
information on the medicine’s anticholinergic effects and ensuring that labelling and Patient 
Information Leaflets accurately reflect the risk of gastrointestinal disorders.   

 
  
  
  
   
  
  
 
   
  
  
  
  
  
  
 In  its  response,  the  MHRA  has  considered  the  evidence  provided  in  your  report  and 
acknowledges  the  concerns  relating  to  the  level  of  awareness  of  clinical  staff  around  the 
potentially  fatal  side  effects  of  clozapine.  Whilst  the  MHRA  is  unable  to  comment  on  the 
specific clinical decisions made in Mr Worrell’s case, the MHRA is currently reviewing the 
product  information  for clozapine  which  will  carefully  consider the  information provided  to 
healthcare  professionals,  patients  and  their  families  and  carers  and  whether  this  can  be 
improved to provide greater clarity on the side effects of clozapine.  The MHRA will engage 
with stakeholders to ensure the regulatory documents for clozapine meet the needs of both 
patients and prescribers. I understand this review is expected to be completed this year and 
that the MHRA will inform you of the outcome.   

I am aware that the National Medical Director of NHS England has written to you setting out 
the additional measures that have been taken to ensure responsible clinicians are aware of 
the potentially fatal side effects of clozapine. These include ongoing work to raise awareness 
in the health community around the potential risks of clozapine.  

I understand your concerns around whether the use of a CTO was the appropriate course 
of action for Mr Worrell’s treatment, as opposed to detaining him under the Mental Health 
Act.  Whilst  I  am  unable  to  comment  on  the  specific  decision  made  by  the  psychiatrist  to 
place Mr Worrell under a CTO, the CTO should not have been a barrier to providing better 
support Mr Worrell.  

CTOs  are  a  form  of  supervised  community  treatment  where  an  individual  can  be  quickly 
recalled  to  hospital  to  be  detained  and  treated.  CTOs  are  intended  to  maintain  ongoing 
contact with mental health services to provide support and help prevent relapse. In certain 
circumstances,  patients  subject  to  a  CTO  may  be  recalled  to  hospital  under  the  Mental 
Health Act. Under section 17E of the Act, a patient can be recalled to hospital if they require 
medical treatment in hospital for their mental disorder and there would be a risk of harm to 
the  health  or  safety  of  the  patient  or  to  other  persons  if  the  patient  were  not  recalled  to 
hospital for that purpose.  

I am aware that the National Medical Director has advised that, in cases like Mr Worrell’s, 
inpatient mental health teams still have the option to use section 17 to recall individuals to 
hospital. He has also advised that clear guidance is available within the Mental Health Act 
Code of Practice1 for responsible clinicians to make decisions on guardianship, section 17 
leave,  and  CTOs.  This  guidance  outlines  circumstances  for  clinicians  to  consider  when 
making decisions on whether a CTO or section 17 leave would be the most suitable course 
of action for a patient.   

This  guidance  states  that  section  17  leave  is  only  suitable  for  short-term  absences  from 
inpatient services for a fixed period or purpose. Section 17 may also be suitable in the longer-
term (for more than seven consecutive days) where the clinical team wish to see how the 
individual manages outside of hospital before making a decision to discharge. For patients 
who  are  able  to  live  in  the  community,  a  CTO  should  be  considered  a  better option  than 
longer-term leave for the management of their care. Where longer-term leave is considered 
under section 17 (for more than seven consecutive days), the responsible clinician must first 

1 Code of practice: Mental Health Act 1983 - GOV.UK  

 
  
  
  
  
  
  
 
 consider  whether  the  patient  should  be  discharged  on  a  CTO  instead.  Any  decision  to 
authorise section 17 leave for more than seven days on a second occasion should be fully 
documented, including why a CTO discharge is not appropriate. 
Through the Mental Health Bill, which is currently making its way through Parliament, we are 
introducing  further professional oversight  in decisions  regarding  the  use  and  operation of 
CTOs. The community clinician (the approved clinician who is responsible for overseeing 
the patient’s care as a community patient) will be involved in decision making in addition to 
the hospital-based responsible clinician. This includes the decision to make a person subject 
to a CTO, to vary or suspend conditions made under a CTO, to recall to hospital a patient 
subject to a CTO, to revoke a CTO after a patient has been recalled, and to discharge the 
patient from the CTO.  This will help ensure better join up between inpatient and community 
clinical  teams  and  make  sure  that  patients  subject  to  a  CTO  are  benefitting  from  the 
framework they provide.      

I agree with the point your report raises around the importance of involving the patient, family 
and carers, and clinicians in communities when planning and supporting an individual to be 
discharged  from  hospital.  Statutory  guidance  on  discharge  from  mental  health  inpatient 
settings 2  should  be  referred  to  by  responsible  clinicians  to  ensure  that  decisions  on 
discharge  are  firmly  centred  around  patients  and  their  chosen  carers  and  that  they  are 
actively involved throughout the process with appropriate input from relevant professionals 
involved in their ongoing care.   

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

Yours sincerely,   

2 Discharge from mental health inpatient settings - GOV.UK
Response from Mhra (PDF)
10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Mr Andrew Harris 
Assistant Coroner  
London South Jurisdiction 
By Email: 

Reference: 

10 March 2025 

Dear Mr Harris, 

Regulation 28 Report relating to the death of Luke Alexander Worrell 

Thank you for your Regulation 28 report relating to the death of Mr Luke Alexander Worrell 
which was received on 20th February 2025. I would like to offer my sincere condolences to 
Mr Worrell’s family on their tragic loss. 

I understand from your report that Mr Worrell’s death resulted from ruptured oesophagus, 
vomiting from ileus and gastro-intestinal upset associated with clozapine treatment. Your 
report identified the following matters of concern relating to clozapine:  

1.  There was lack of awareness by a series of clinical staff of the potential fatal side 

effects of clozapine. 

2.  There was an inappropriate use of community treatment order, when there was 

sufficient evidence to keep the patient on a Mental Health Act section. 

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency 
of the Department of Health and Social Care with responsibility for the regulation of 
medicinal products in the UK. We ensure that medicines are efficacious and acceptably safe, 
and that information to aid the safe use of a medicine, including possible side effects are 
appropriately described in the authorised product information. This comprises the Summary 
of Product Characteristics (SmPC, intended for healthcare professionals), labelling, and 
Patient Information Leaflet (PIL, provided to patients in each medicine pack). The product 
information can support discussions between healthcare professionals and patients. The PIL 
is not intended to replace the discussion with prescribers about the benefits and risks of 
treatments. 

 
 
 
 
 
 
 
 
 
 
 
 
 The current special warnings and precautions for use section of the SmPC for clozapine 
states within the sub-section relating to anticholinergic effects that,  

“Clozaril has been associated with varying degrees of impairment of intestinal 
peristalsis, ranging from constipation to intestinal obstruction, faecal 
impaction, paralytic ileus, megacolon and intestinal infarction ischaemia (see 
section 4.8). On rare occasions these cases have been fatal. Particular care 
is necessary in patients who are receiving concomitant medications known to 
cause constipation (especially those with anticholinergic properties such as 
some antipsychotics, antidepressants and antiparkinsonian treatments), have 
a history of colonic disease or a history of lower abdominal surgery as these 
may exacerbate the situation. It is vital that constipation is recognised and 
actively treated.”  

Gastrointestinal disorders are also described in the undesirable effects section of the SmPC 
of clozapine, which lists constipation, intestinal obstruction and paralytic ileus as possible 
adverse reactions to the treatment with clozapine. In addition, the contraindication section 
states that clozapine is contraindicated in patients with paralytic ileus. Similar messages can 
be found in the current PIL for clozapine. 

In October 2017, we published an article in our bulletin Drug Safety Update which was 
distributed to healthcare professionals reminding of the potential fatal risks of intestinal 
obstruction, faecal impaction, and paralytic ileus. This information is also highlighted in the 
British National Formulary. 

We have considered the evidence provided and the circumstances leading to Mr Worrell’s 
death and acknowledge that your concerns relate to lack of awareness of clinical staff of the 
potentially fatal side effects of clozapine, and clinical decisions. Unfortunately, we cannot 
directly address these points, as it is not within our remit to comment on the clinical decisions 
in specific cases.  

We continuously review the safety of medicines on the UK market and take appropriate 
regulatory action as required. Currently, we are reviewing the product information for 
clozapine. As part of this review, we will be giving careful consideration to the information 
which is provided to healthcare professionals, patients and their families and carers, and 
whether this can be improved to provide greater clarity. We intend to engage with relevant 
stakeholders during this process to ensure the regulatory documents meet the needs of 
patients and prescribers. It is anticipated that this review of clozapine will be completed this 
year, and we will inform you of the outcome. 

Should you have any further questions, please do not hesitate to contact my office at 
Executive.Office@mhra.gov.uk. 

Yours sincerely 

Chief Executive  
Medicines and Healthcare products Regulatory Agency 
E:
Response from NHS England (PDF)
Mr Andrew Harris  
HM Assistant Coroner  
London Inner South  
Southwark Coroner’s Court  
1 Tennis Street 
London SE1 1YD 

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 – Luke Alexander Worrell 
who died on 2 January 2021  

Thank  you  for  your  Report  to  Prevent  Future  Deaths  (hereafter  “Report”)  dated  20 
February 2025 concerning the death of Luke Alexander Worrell on 2 January 2021. In 
advance of responding to the specific concerns raised in your Report, I would like to 
express  my  deep  condolences  to  Luke’s  family  and  loved  ones.  NHS  England  are 
keen to assure the family and the Coroner that the concerns raised about Luke’s care 
have been listened to and reflected upon.   

Your Report raises concerns that there is a lack of awareness amongst clinical staff of 
the potential side effects of Clozapine, and that Luke was subject to the inappropriate 
use of a community treatment order. 

Side effects of Clozapine 

NHS  England  has  undertaken  considerable  work  to  highlight  to  clinicians  and 
colleagues the importance of keeping people safe from the side effects of Clozapine, 
which are well-recognised.  

The  risks  and  side-effects  of  Clozapine  are  listed  in  the  British  National  Formulary 
(BNF), last updated on 26 February 2025, and the Summary of Product Characteristics 
on the Electronic Medicines Compendium (EMC), last updated on 13 February 2024. 
The  BNF  and  EMC  are  both  information  resources  for  medications  that  healthcare 
professionals would be expected to make reference to.  

In October 2022, updates were made to the Specialist Pharmacy Service website page 
on  Clozapine  (see  https://www.sps.nhs.uk/articles/managing-constipation-in-people-
taking-clozapine/) to specifically highlight the risks of constipation and fatal cases of 
intestinal obstruction, faecal impaction, and paralytic ileus.  

In  February  2022,  NHS  England’s  National  Specialty  Advisor  for  Mental  Health 
Pharmacy  wrote  to  all  Mental  Health  Chief  Pharmacists,  asking  them  to  raise 
awareness about the potential risks of Clozapine across their health community.  

                                                                                                                       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Prior  to  this,  in  October  2017,  the  Medicines  and  Healthcare  products  Regulatory 
Agency (MHRA) issued a medicines safety bulletin highlighting the risks of fatalities 
related to bowel problems associated with Clozapine: https://www.gov.uk/drug-safety-
update/clozapine-reminder-of-potentially-fatal-risk-of-intestinal-obstruction-faecal-
impaction-and-paralytic-ileus.  

NHS England are also aware that the Royal College of Psychiatrists are undertaking 
some work around raising awareness of Clozapine risks.  

Inappropriate use of a community treatment order, where there was sufficient 
evidence for a Mental Health Act section  

NHS England are unable to comment on whether there was sufficient evidence for the 
responsible clinician to keep Luke under mental health section on Section 17 (S17) 
leave, rather than discharging him onto a community treatment order (CTO), based on 
the  information  provided  in  your  Report,  but  this  is  an  available  option  to  inpatient 
mental health teams.   

The  Mental  Health  Act  1983  Code  of  Practice  provides  clear  guidance  on  deciding 
between guardianship, S17 leave and a CTO. S17 leave is “primarily intended to allow 
a patient detained under the Act to be temporarily absent from hospital where further 
in-patient treatment as a detained patient is still thought to be necessary. It is clearly 
suitable for short-term absences for a fixed period or specific purpose e.g., to allow 
visits to family and to trial living more independently” (see Chapter 31.4 of the Code of 
Practice). The Code of Practice states that a “Leave of absence may be useful in the 
longer term (more than seven consecutive days) where the clinical team wish to see 
how the patient manages outside hospital before making the decision to discharge. 
Leave for a longer period should also be for a specific purpose or a fixed period, and 
not  normally  more  than  one  month.  For  most  patients  who  are  able  to  live  in  the 
community, a CTO should be considered a better option than longer-term leave for the 
ongoing management of their care. Reflecting this, whenever considering longer-term 
leave  for  a  patient  (that  is,  for more  than  seven  consecutive  days),  the  responsible 
clinician  must  first  consider  whether  the  patient  should  be  discharged  onto  a  CTO 
instead.  Any decision to  authorise  section  17  leave  for more  than seven  days  on  a 
second occasion should be fully documented, including why a CTO or discharge is not 
appropriate” (see 31.5).  

CTOs are a form of supervised community treatment where someone can be quickly 
recalled to hospital to be detained and treated. They are intended to maintain ongoing 
contact  with mental  health  services  to  provide  support  and help  prevent  relapse.  In 
certain circumstances, patients subject to a CTO may be recalled to hospital under the 
Mental Health Act. Under section 17E, the patient can be recalled to hospital if they 
require medical treatment in hospital for their mental disorder and there would be a 
risk of harm to the health or safety of the patient or to other persons if the patient were 
not recalled to hospital for that purpose. 

Your Report also highlights the importance of involving the patient, family, carers and 
clinicians  in  the  community  when  planning  and  supporting  an  individual  to  be 
discharged from hospital. Statutory guidance (

 
 
 settings - GOV.UK) reaffirms this point, stating that services must “ensure that people 
and their chosen carers (including those with parental responsibility for children and 
young  people)  are  the  centre  of  discharge  planning  and  are  actively  involved 
throughout  the  process,  with  appropriate  input  from  relevant  professionals  and 
services  involved  in  their  ongoing  care”.  NHS  England  guidance  (NHS  England  » 
Acute  inpatient  mental  health  care  for  adults  and  older  adults)  provides  further 
guidance on joint and effective discharge planning.  

A  reformed  Mental  Health  Act  is  currently  being  scrutinised  by  parliament.  The  Bill 
strengthens the protocol around discharging individuals from detention under Part 2 
of  the  Act  so  that,  where  currently  a  patient’s  responsible  clinician  can  unilaterally 
decide to discharge a Part 2 or unrestricted Part 3 patient from hospital, under the Bill 
they will be required to consult with another clinical professional. A similar protocol will 
apply  to  people  under  guardianship  and  community  treatment  orders,  where  the 
detaining  authority  will  need  to  consult  with  another.  The  Bill  further  strengthens 
professional oversight in decisions regarding the use and operation of CTOs, where 
the community clinician (the approved clinician who is responsible for overseeing the 
patient’s care as a community patient) will be involved in decision making in addition 
to the hospital-based responsible clinician. 

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 Luke, 
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

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