PFD report

Mr. Christopher Summerhayes · Prevention of Future Deaths report

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Issued 22 Aug 2019•South Wales Central

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
4

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
12

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised4

  1. Potential contraindication to clozapine from familial lipid disorder
    Part of recurring concern: Failure to identify clinically significant medication risksPart of recurring concern: Unreliable safety monitoring and guidance for clozapine treatment
  2. Failure to account for concomitant medications when dosing clozapine
    Part of recurring concern: Unsafe medication prescribing
  3. Failure to account for smoking cessation when managing clozapine levels
    Part of recurring concern: Unreliable medication-specific blood-level monitoring
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.6

  1. Action

    Promote polypharmacy reviews through secondary-care pharmacy and primary-care medicines-management teams.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.
  2. Action

    Provide dedicated pharmacy and specialist mental-health pharmacist support for medicines management and prescribing.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.
  3. Action

    Apply NICE-aligned physical-health monitoring arrangements for patients taking Clozapine.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    Existing medicines reconciliation, pharmacist support, NICE monitoring and promoted polypharmacy reviews address medication interaction and prescribing risks.

    Stated by Cardiff & Vale University LHBExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

Potential contraindication to clozapine from familial lipid disorder

Wider context from the report

“(1) In relation to Christopher Summerhayes, Clozapine was prescribed as a concomitant medication alongside approximately 11 other drugs including another anti-psychotic medication. Either alone or interaction with other prescribed medication, a large increase in weight occurred to >101kg (BMI 33.1) (reported side effect of clozapine) which had a ‘knock-on’ effect for his cholesterol and lipid levels and cardiovascular system. The usual dose is 200-450mg daily with the maximum dose being 900mg (BNF) which does not consider concomitant medications. Signs of prescription overdose include collapse and hallucinations which could be mistaken for unresolved symptoms of schizophrenia i.e. lack of drug efficacy encouraging dose increase. Blood levels of clozapine may rise in response to smoking cessation which Mr. Summerhayes had advised we was commencing. (2) He may have suffered from a familial lipid disorder (present in other family members) which had it been confirmed would likely to have contraindicated Clozapine. ”

Is this part of a recurring concern?

Yes — Failure to identify clinically significant medication risks; 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

Failure to account for concomitant medications when dosing clozapine

Wider context from the report

“(1) In relation to Christopher Summerhayes, Clozapine was prescribed as a concomitant medication alongside approximately 11 other drugs including another anti-psychotic medication. Either alone or interaction with other prescribed medication, a large increase in weight occurred to >101kg (BMI 33.1) (reported side effect of clozapine) which had a ‘knock-on’ effect for his cholesterol and lipid levels and cardiovascular system. The usual dose is 200-450mg daily with the maximum dose being 900mg (BNF) which does not consider concomitant medications. Signs of prescription overdose include collapse and hallucinations which could be mistaken for unresolved symptoms of schizophrenia i.e. lack of drug efficacy encouraging dose increase. Blood levels of clozapine may rise in response to smoking cessation which Mr. Summerhayes had advised we was commencing. (2) He may have suffered from a familial lipid disorder (present in other family members) which had it been confirmed would likely to have contraindicated Clozapine. ”

Is this part of a recurring concern?

Yes — Unsafe medication prescribing.

Open source report

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

Failure to account for smoking cessation when managing clozapine levels

Wider context from the report

“(1) In relation to Christopher Summerhayes, Clozapine was prescribed as a concomitant medication alongside approximately 11 other drugs including another anti-psychotic medication. Either alone or interaction with other prescribed medication, a large increase in weight occurred to >101kg (BMI 33.1) (reported side effect of clozapine) which had a ‘knock-on’ effect for his cholesterol and lipid levels and cardiovascular system. The usual dose is 200-450mg daily with the maximum dose being 900mg (BNF) which does not consider concomitant medications. Signs of prescription overdose include collapse and hallucinations which could be mistaken for unresolved symptoms of schizophrenia i.e. lack of drug efficacy encouraging dose increase. Blood levels of clozapine may rise in response to smoking cessation which Mr. Summerhayes had advised we was commencing. (2) He may have suffered from a familial lipid disorder (present in other family members) which had it been confirmed would likely to have contraindicated Clozapine. ”

Is this part of a recurring concern?

Yes — Unreliable medication-specific blood-level monitoring.

Open source report

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

Failure to distinguish clozapine overdose signs from unresolved schizophrenia symptoms

Wider context from the report

“(1) In relation to Christopher Summerhayes, Clozapine was prescribed as a concomitant medication alongside approximately 11 other drugs including another anti-psychotic medication. Either alone or interaction with other prescribed medication, a large increase in weight occurred to >101kg (BMI 33.1) (reported side effect of clozapine) which had a ‘knock-on’ effect for his cholesterol and lipid levels and cardiovascular system. The usual dose is 200-450mg daily with the maximum dose being 900mg (BNF) which does not consider concomitant medications. Signs of prescription overdose include collapse and hallucinations which could be mistaken for unresolved symptoms of schizophrenia i.e. lack of drug efficacy encouraging dose increase. Blood levels of clozapine may rise in response to smoking cessation which Mr. Summerhayes had advised we was commencing. (2) He may have suffered from a familial lipid disorder (present in other family members) which had it been confirmed would likely to have contraindicated Clozapine. ”

Is this part of a recurring concern?

Yes — Failure to consider or reconsider serious alternative diagnoses; Failure to identify clinically significant medication risks; Unreliable clinical management of medication overdose and toxicity.

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

Promote polypharmacy reviews through secondary-care pharmacy and primary-care medicines-management teams.

Verbatim wording from the response

“The All Wales Medicines Strategy Group has produced a number of guidance documents to promote polypharmacy reviews. These documents can be viewed on their website which is www.awmsg.org”

Source location

2019-0263-Response-by-University-Health-Board
Page 2 · response
Published 17 October 2019

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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

Provide dedicated pharmacy and specialist mental-health pharmacist support for medicines management and prescribing.

Verbatim wording from the response

“The Pharmacy Directorate has a system in place of dedicated pharmacists aligned to clinical directorates and Clinical Boards to provide a source of support and expertise in medicines management. A specialist mental health pharmacist supports prescribing in in-patient mental health settings. The Primary Care and Intermediate Care Clinical Board has a Medicines Management and Prescribing Team who support related issues in primary care settings.”

Source location

2019-0263-Response-by-University-Health-Board
Page 2 · response
Published 17 October 2019

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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

Apply NICE-aligned physical-health monitoring arrangements for patients taking Clozapine.

Verbatim wording from the response

“Guidance from the National Institute of Health and Care Excellence (NICE) for assessing physical health of patients on Clozapine is available on their website (www.nice.org.uk) and monitoring arrangements are in place in line with this guidance.”

Source location

2019-0263-Response-by-University-Health-Board
Page 2 · response
Published 17 October 2019

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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

Operate the Medicines Management Incentive Scheme to improve recording of medicines across care settings, including staff education and retrospective recording of complex medicines.

Verbatim wording from the response

“The Primary Care and Intermediate Care team established a Medicines Management Incentive Scheme with GPs to ensure that medicines prescribed across care settings are added to the GP record so there is a complete medicines record for patients on the GP systems. The driver for this project was to promote patient safety but it has seen cost-benefits. Education is provided to staff within GP practices who are then required to identify their local process to ensure that a patient’s medication history is accurately updated prospectively. Practices have also been asked to retrospectively add certain complex medicines to the GP systems to ensure they are clearly recorded.”

Source location

2019-0263-Response-by-University-Health-Board
Page 3 · response
Published 17 October 2019

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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

Develop an interface between PARIS and PMS to improve information transfer and introduce medicines transcribing and electronic discharge using the Welsh Clinical Portal.

Verbatim wording from the response

“A project proposal is in development by Mental Health Clinical Board, Pharmacy and Information Technology to develop an interface between PARIS (patient management and information software in use in Mental Health and community services) and PMS (patient management system) to improve the transfer of information. The project aims to improve the interface between these systems and introduce Medicines Transcribing and e-Discharge to mental health wards with use of the Welsh Clinical Portal.”

Source location

2019-0263-Response-by-University-Health-Board
Page 4 · response
Published 17 October 2019

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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

Maintain the Medicines Code and its medicines-reconciliation responsibilities for doctors, pharmacy staff and other prescribers.

Verbatim wording from the response

“The UHB has a Medicines Code in place and this was updated in 2018. It contains a section on medicines reconciliation. It sets out the responsibilities of various healthcare professionals in this process, including doctors, the pharmacy team and other prescribers.”

Source location

2019-0263-Response-by-University-Health-Board
Page 2 · response
Published 17 October 2019

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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 medicines reconciliation, pharmacist support, NICE monitoring and promoted polypharmacy reviews address medication interaction and prescribing risks.

Verbatim wording from the response

“The UHB has a Medicines Code in place and this was updated in 2018. It contains a section on medicines reconciliation. It sets out the responsibilities of various healthcare professionals in this process, including doctors, the pharmacy team and other prescribers.”

Source location

2019-0263-Response-by-University-Health-Board
Page 2 · response
Published 17 October 2019

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

Mandated Clozapine monitoring, ZTAS reporting and primary-care record checks are considered sufficient for shared prescribing and information exchange.

Verbatim wording from the response

“I am able to advise that there is a requirement for patients taking Clozapine to be registered with a service to monitor the medicine during the course of their treatment with it. Additionally, when a patient who is taking Clozapine dies or ceases to take it, the manufacturer supplying the medication must be informed. The monitoring service currently in place for Cardiff and Vale University Health Board is via the Zaponex Treatment Access System (ZTAS) which is provided by the medicine’s manufacturer that we currently use, called Leyden Delta. The necessary information was shared at the time via ZTAS.”

Source location

2019-0263-Response-by-University-Health-Board
Page 2 · response
Published 17 October 2019

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.6

  1. 1

    Develop and apply pathway-specific criteria to guide appropriate deprescribing.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.
  2. 2

    Monitor records of patients prescribed Clozapine in secondary care to check interfaces with primary care.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.
  3. 3

    Include learning from the death in a forthcoming Patient Safety and Quality Department newsletter.

    Stated by Cardiff & Vale University LHBStated plannedThe respondent said that this action was planned when they made their response on 17 October 2019.
  4. 4

    Report the Clozapine-related death to the Medicines and Healthcare products Regulatory Agency.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.
  5. 5

    Operate formal shared-care arrangements for complex medicines to define roles and responsibilities.

    Stated by Cardiff & Vale University LHBStated completedThe respondent said that this action was complete when they made their response on 17 October 2019.
  6. 6

    Share the Regulation 28 report and response with Clinical Boards and the Medication Safety Executive Group.

    Stated by Cardiff & Vale University LHBStated plannedThe respondent said that this action was planned when they made their response on 17 October 2019.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    Existing polypharmacy guidance and pathway-specific criteria are considered sufficient to support deprescribing where clinically appropriate.

    Stated by Cardiff & Vale University LHBExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

Develop and apply pathway-specific criteria to guide appropriate deprescribing.

Verbatim wording from the response

“• To de-prescribe where appropriate rather than accruing an increasing list of daily medications whereby further protectant medications are required to be prescribed with the risk of medication induced hospital admissions and risk to life.”

Source location

2019-0263-Response-by-University-Health-Board
Page 3 · response
Published 17 October 2019

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

Monitor records of patients prescribed Clozapine in secondary care to check interfaces with primary care.

Verbatim wording from the response

“Prescribing in relation to Clozapine is undertaken as mandated. The process is in place via ZTAS as outlined previously. The Primary Care and Intermediate Care Clinical Board maintains a list of over 300 patients who are currently prescribed Clozapine within the UHB. The team actively checks systems in GP surgeries to monitor the records of all patients who are known to have Clozapine prescribed in secondary care to ensure an interface with primary care.”

Source location

2019-0263-Response-by-University-Health-Board
Page 3 · response
Published 17 October 2019

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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

Include learning from the death in a forthcoming Patient Safety and Quality Department newsletter.

Verbatim wording from the response

“Your findings at Mr Summerhayes’ inquest are of relevance to all Clinical Boards in the UHB. A copy of your Regulation 28 report and my response will be shared with the Clinical Boards and Medication Safety Executive Group. The Patient Safety and Quality Department will include the learning from Mr Summerhayes’ sad death in a forthcoming newsletter.”

Source location

2019-0263-Response-by-University-Health-Board
Page 4 · response
Published 17 October 2019

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

Report the Clozapine-related death to the Medicines and Healthcare products Regulatory Agency.

Verbatim wording from the response

“• An adverse event report should be filed with the Medicines and Healthcare products Regulatory Agency in respect of Clozapine and the death of Mr Summerhayes.”

Source location

2019-0263-Response-by-University-Health-Board
Page 1 · response
Published 17 October 2019

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

Operate formal shared-care arrangements for complex medicines to define roles and responsibilities.

Verbatim wording from the response

“Certain complex medicines are subject to formal shared care arrangements to ensure that roles and responsibilities are clearly defined.”

Source location

2019-0263-Response-by-University-Health-Board
Page 3 · response
Published 17 October 2019

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

Share the Regulation 28 report and response with Clinical Boards and the Medication Safety Executive Group.

Verbatim wording from the response

“Your findings at Mr Summerhayes’ inquest are of relevance to all Clinical Boards in the UHB. A copy of your Regulation 28 report and my response will be shared with the Clinical Boards and Medication Safety Executive Group. The Patient Safety and Quality Department will include the learning from Mr Summerhayes’ sad death in a forthcoming newsletter.”

Source location

2019-0263-Response-by-University-Health-Board
Page 4 · response
Published 17 October 2019

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

Existing polypharmacy guidance and pathway-specific criteria are considered sufficient to support deprescribing where clinically appropriate.

Verbatim wording from the response

“Principles for de-prescribing are embedded within the aforementioned documents available regarding polypharmacy reviews at www.awmsg.org”

Source location

2019-0263-Response-by-University-Health-Board
Page 3 · response
Published 17 October 2019

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

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Data last updated 7 September 2026