PFD report

Mr Luke Alexander Worrell · Prevention of Future Deaths report

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Issued 21 Feb 2025•London South

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
2

Raised in this report

Recipients
5

Named on the report

Responses found
4

Of 5 recipients

Stated actions
13

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised2

  1. Lack of clinical staff awareness of Clozapine's potential fatal side effects
    Part of recurring concern: Failure to identify clinically significant medication risksPart of recurring concern: Unreliable clinician management of medication side effectsPart of recurring concern: Unreliable safety monitoring and guidance for clozapine treatment
  2. Inappropriate use of community treatment orders where sufficient evidence supports retention on a Mental Health Act section
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.5

  1. Action

    Raised clinician awareness of clozapine side effects by communicating associated risks to mental health chief pharmacists and health communities.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 7 March 2025.
  2. Action

    Introduce additional professional oversight of decisions to make, vary, suspend, recall, revoke and discharge patients from Community Treatment Orders.

    Stated by Department of Health and Social CareStated in progressThe respondent said that this action was in progress when they made their response on 7 March 2025.
  3. Action

    Engage relevant stakeholders during the clozapine product-information review to ensure regulatory documents meet patients’ and prescribers’ needs.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 7 March 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    The information provided does not enable assessment of whether discharge onto a community treatment order was appropriate rather than detention or Section 17 leave.

    Stated by NHS EnglandUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of clinical staff awareness of Clozapine's potential fatal side effects

Wider context from the report

“1. The lack of awareness by a series of clinical staff of the potential fatal side effects of Clozapine ”

Is this part of a recurring concern?

Yes — Failure to identify clinically significant medication risks; Unreliable clinician management of medication side effects; Unreliable safety monitoring and guidance for clozapine treatment.

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Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Inappropriate use of community treatment orders where sufficient evidence supports retention on a Mental Health Act section

Wider context from the report

“2. Inappropriate use of community treatment order, when there was sufficient evidence to keep on a MHA section. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Raised clinician awareness of clozapine side effects by communicating associated risks to mental health chief pharmacists and health communities.

Verbatim wording from the response

“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.”

Source location

Response from NHS England
Page 1 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Introduce additional professional oversight of decisions to make, vary, suspend, recall, revoke and discharge patients from Community Treatment Orders.

Verbatim wording from the response

“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 benefiting from the framework they provide.”

Source location

Response from DHSC
Page 3 · response
Published 7 March 2025

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Engage relevant stakeholders during the clozapine product-information review to ensure regulatory documents meet patients’ and prescribers’ needs.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review clozapine product information and consider whether warnings for healthcare professionals, patients and carers can be clarified.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Deploy Mental Health Act Reviewers to advise and oversee assessment of Mental Health Act decisions, including the lawful and clinically justified use of Community Treatment Orders.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 2 · response
Published 7 March 2025

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The information provided does not enable assessment of whether discharge onto a community treatment order was appropriate rather than detention or Section 17 leave.

Verbatim wording from the response

“NHS England are unable to comment on whether there was sufficient evidence for the responsible clinician to keep Luke under a mental health section or 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.”

Source location

Response from NHS England
Page 2 · response
Published 7 March 2025

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing Mental Health Act guidance and recall powers provide clinicians with sufficient arrangements to manage CTO patients and determine appropriate care.

Verbatim wording from the response

“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.”

Source location

Response from DHSC
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Commenting on clinical decisions in specific cases, including those concerning clozapine, is outside the respondent’s remit.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 2 · response
Published 7 March 2025

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.8

  1. 1

    Discuss Reports to Prevent Future Deaths through a national working group and share resulting learning across NHS national and regional services.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 7 March 2025.
  2. 2

    Inform the coroner of the outcome of the clozapine product-information review.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 7 March 2025.
  3. 3

    Use incident, notification and Prevention of Future Deaths information in ongoing monitoring and assessment planning through the Internal Specific Incidents Guidance process.

    Stated by Care Quality CommissionStated completedThe respondent said that this action was complete when they made their response on 7 March 2025.
  4. 4

    Engage regularly with HSSIB on Clozapine-related death investigations and incorporate investigation learning into the regulatory approach.

    Stated by Care Quality CommissionStated completedThe respondent said that this action was complete when they made their response on 7 March 2025.
  5. 5

    Deliver targeted Clozapine training and awareness sessions to mental health inspectors through face-to-face training and development days.

    Stated by Care Quality CommissionStated completedThe respondent said that this action was complete when they made their response on 7 March 2025.
  6. 6

    Undertake a national review of adult community mental health services, including inspections of community, crisis and health-based places-of-safety services.

    Stated by Care Quality CommissionStated plannedThe respondent said that this action was planned when they made their response on 7 March 2025.
  7. 7

    Provide specialist support to inspection teams for intelligence monitoring and assessment of providers’ safe and lawful Clozapine use.

    Stated by Care Quality CommissionStated completedThe respondent said that this action was complete when they made their response on 7 March 2025.
  8. 8

    Conduct Clozapine assessments and monitor Clozapine-related concerns through integrated mental health and specialist medicines inspection teams.

    Stated by Care Quality CommissionStated completedThe respondent said that this action was complete when they made their response on 7 March 2025.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Discuss Reports to Prevent Future Deaths through a national working group and share resulting learning across NHS national and regional services.

Verbatim wording from the response

“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.”

Source location

Response from NHS England
Page 3 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Inform the coroner of the outcome of the clozapine product-information review.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Use incident, notification and Prevention of Future Deaths information in ongoing monitoring and assessment planning through the Internal Specific Incidents Guidance process.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 3 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Engage regularly with HSSIB on Clozapine-related death investigations and incorporate investigation learning into the regulatory approach.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Deliver targeted Clozapine training and awareness sessions to mental health inspectors through face-to-face training and development days.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Undertake a national review of adult community mental health services, including inspections of community, crisis and health-based places-of-safety services.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 3 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Provide specialist support to inspection teams for intelligence monitoring and assessment of providers’ safe and lawful Clozapine use.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 2 · response
Published 7 March 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Conduct Clozapine assessments and monitor Clozapine-related concerns through integrated mental health and specialist medicines inspection teams.

Verbatim wording from the response

“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.”

Source location

Response from Care Quality Commission
Page 2 · response
Published 7 March 2025

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
4/5

Data last updated 7 September 2026