PFD report

Ian Allen · Prevention of Future Deaths report

Pin Get email alerts Request correction

Issued 17 Aug 2020•Birmingham and Solihull

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.

View original report
Concerns
6

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
10

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

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

Concerns raised6

  1. Lack of clear national guidance on clozapine monitoring frequency and blood test type
    Part of recurring concern: Unreliable medication-specific blood-level monitoringPart of recurring concern: Unreliable safety monitoring and guidance for clozapine treatment
  2. Lack of a system for escalating blood test results to the consultant
    Part of recurring concern: Failure to ensure clinical investigation results are reliably available, interpreted and acted uponPart of recurring concern: Unreliable monitoring and follow-up of clinically required laboratory tests
  3. Lack of understanding of the importance and frequency of clozapine level monitoring
    Part of recurring concern: Unreliable medication-specific blood-level monitoringPart of recurring concern: Unreliable safety monitoring and guidance for clozapine treatment
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.9

  1. Action

    Audit all patients prescribed clozapine on the identified doctor’s caseload for unconsidered anomalous results.

    Stated by Birmingham and Solihull Mental Health NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 26 October 2020.
  2. Action

    Strengthen multidisciplinary meeting focus on physical health and include clozapine in quality-improvement checks of testing and abnormal-result actions.

    Stated by Birmingham and Solihull Mental Health NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 26 October 2020.
  3. Action

    Send pharmacy reports of clozapine results above 600 to the Clozapine Lead for direct escalation to the Consultant and Divisional Pharmacist.

    Stated by Birmingham and Solihull Mental Health NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 26 October 2020.

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

  1. Position

    Routine therapeutic drug monitoring of clozapine blood levels is not required; authorised product information specifies monitoring requirements and toxicity-related exceptions.

    Stated by Department of Health and Social CareExisting 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

Lack of clear national guidance on clozapine monitoring frequency and blood test type

Wider context from the report

“4. I heard evidence at the inquest that there was a general lack of understanding about clozapine monitoring, which blood test to undertake and the general effect this drug can have on patients. I heard evidence that national guidance was required to clearly set out how frequently clozapine levels should be monitored and what type of blood test should be undertaken. ”

Is this part of a recurring concern?

Yes — Unreliable medication-specific blood-level monitoring; Unreliable safety monitoring and guidance for clozapine treatment.

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

Lack of a system for escalating blood test results to the consultant

Wider context from the report

“2. There was no system in place at the time to ensure blood test results were escalated to the consultant to ensure action was taken. ”

Is this part of a recurring concern?

Yes — Failure to ensure clinical investigation results are reliably available, interpreted and acted upon; Unreliable monitoring and follow-up of clinically required laboratory tests.

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

Lack of understanding of the importance and frequency of clozapine level monitoring

Wider context from the report

“3. There was a general lack of understanding at the inquest about the importance of monitoring clozapine levels and how frequently these levels should be monitored. ”

Is this part of a recurring concern?

Yes — Unreliable medication-specific blood-level monitoring; Unreliable safety monitoring and guidance for clozapine treatment.

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 act on high clozapine blood test results through repeat testing and dose adjustment

Wider context from the report

“1. In February 2019 a blood test result confirmed that Mr Allen had a high level of clozapine in his blood. This was not acted upon and no further blood test was taken. The clozapine dose was not adjusted as it should have been. ”

Is this part of a recurring concern?

Yes — Failure to ensure clinical investigation results are reliably available, interpreted and acted upon; Failure to obtain clinically indicated repeat investigations; Unreliable medication-specific blood-level monitoring; Unreliable safety monitoring and guidance for clozapine treatment.

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

Insufficient education of Mental Health practitioners on clozapine monitoring and level adjustment

Wider context from the report

“5. Further education is required of Mental Health practitioners on the importance of clozapine monitoring and level adjustment. ”

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

Lack of understanding of clozapine monitoring, blood test selection and drug effects

Wider context from the report

“4. I heard evidence at the inquest that there was a general lack of understanding about clozapine monitoring, which blood test to undertake and the general effect this drug can have on patients. I heard evidence that national guidance was required to clearly set out how frequently clozapine levels should be monitored and what type of blood test should be undertaken. ”

Is this part of a recurring concern?

Yes — Unreliable safety monitoring and guidance for clozapine treatment.

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

Audit all patients prescribed clozapine on the identified doctor’s caseload for unconsidered anomalous results.

Verbatim wording from the response

“We have commenced an audit of all patients prescribed Clozapine on Dr ████████’s caseload to ensure that there are no other patients for whom anomalous results have not been considered. In addition, we are in the process of issuing a practice alert to all of our Doctors reminding them of the importance of review when anomalous results are evident.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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

Strengthen multidisciplinary meeting focus on physical health and include clozapine in quality-improvement checks of testing and abnormal-result actions.

Verbatim wording from the response

“We have existing Multi-Disciplinary team meetings in place across our organisation and are now specifically strengthening the focus on physical health within these meetings utilising a quality improvement approach. This will provide an additional system for checking that periodic tests have taken place, ensuring that they are routinely acted upon when they are abnormal. Clozapine has now been added to this project to increase awareness.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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

Send pharmacy reports of clozapine results above 600 to the Clozapine Lead for direct escalation to the Consultant and Divisional Pharmacist.

Verbatim wording from the response

“There is a system in place whereby anomalous results received are escalated to the Consultant, for example, via the Multi-Disciplinary Team meeting, the administrative staff in receipt of paper results or by junior medical staff who have checked electronic investigations; however on this occasion it appears that this failed. We have therefore put in place an additional control whereby our Information Team will send a report to the pharmacy Clozapine Lead of any results >600 so that these can be escalated directly to the Consultant and the Divisional Pharmacist so that appropriate action can be taken. This will include discussion and action where appropriate at the Multi-Disciplinary Team meeting.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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 clozapine education for junior doctors through the postgraduate medical education programme, using learning from the regulation 28 report.

Verbatim wording from the response

“In addition, we are working with our Post Graduate Medical Education training programme to utilise the learning from the regulation 28 report in the training of junior doctors on the use of clozapine and the importance of acting upon abnormal results where it is deemed necessary.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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 additional clozapine training to pharmacists to promote consistent advice and rapid responses.

Verbatim wording from the response

“This guidance will be approved in November 2020 and once this has been completed, this will be disseminated round the Trust as a reminder to other staff to ensure that they are complying with the updated guidance. We have already provided all pharmacists with some additional training on Clozapine so we have more consistent advice and can respond quickly where necessary.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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 and update the Trust clozapine guidelines following the investigation into Mr Allen’s death.

Verbatim wording from the response

“As you may be aware from the Mr ████████s evidence at inquest; the Trust is currently in the process of reviewing and updating the Trust Clozapine guidelines following the investigation carried out into Mr Allen’s death. We understand that on 26 August 2020, in response to the Prevention of Future death reports from the Coroner there has now been an update in the MHRA guidance in relation to clozapine.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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

Issue a practice alert to doctors reminding them to review anomalous clozapine results.

Verbatim wording from the response

“We have commenced an audit of all patients prescribed Clozapine on Dr ████████’s caseload to ensure that there are no other patients for whom anomalous results have not been considered. In addition, we are in the process of issuing a practice alert to all of our Doctors reminding them of the importance of review when anomalous results are evident.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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

Draft and send a clozapine safety alert to clinicians to support immediate action where necessary.

Verbatim wording from the response

“In addition, as we set out in response to your first point, further education will be built into the Post Graduate Medical Education programme to address any gaps in knowledge on clozapine. A safety alert is also being drafted and sent to all clinicians so that immediate action can be taken where necessary.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 3 · response
Published 26 October 2020

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

Disseminate the approved updated clozapine guidance across the Trust as a staff reminder.

Verbatim wording from the response

“This guidance will be approved in November 2020 and once this has been completed, this will be disseminated round the Trust as a reminder to other staff to ensure that they are complying with the updated guidance. We have already provided all pharmacists with some additional training on Clozapine so we have more consistent advice and can respond quickly where necessary.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

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

Routine therapeutic drug monitoring of clozapine blood levels is not required; authorised product information specifies monitoring requirements and toxicity-related exceptions.

Verbatim wording from the response

“The patient monitoring requirements for clozapine include the measurement of clinical parameters such as regular full blood counts; blood pressure; electrocardiograms; hepatic enzymes; blood sugar, lipids and weight. Therapeutic drug monitoring of blood plasma levels is not currently required under the terms of the clozapine marketing authorisation.”

Source location

2020-0161-Response-from-Dept-Health-and-Social-Care_Redacted.pdf
Page 2 · response
Published 26 October 2020

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

NICE guideline 178 does not require updating because clozapine toxicity risks are detailed in the BNF and authorised product information.

Verbatim wording from the response

“NICE advises that while it is recognised that the current recommendations in the NICE guideline may not fully take account of the adverse effects and risks of toxicity associated with the use of clozapine, these are specified in detail in the British National Formulary⁷ and, as already explained, the SmPC for prescribers which contains advice on interactions that can influence blood levels of clozapine.”

Source location

2020-0161-Response-from-Dept-Health-and-Social-Care_Redacted.pdf
Page 3 · response
Published 26 October 2020

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.1

  1. 1

    Obtain approval for the updated Trust clozapine guidelines.

    Stated by Birmingham and Solihull Mental Health NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 26 October 2020.

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

Obtain approval for the updated Trust clozapine guidelines.

Verbatim wording from the response

“The new guidelines published by MHRA are in fact similar to the current Trust guidance, although the wording of the monitoring level will be altered from ‘may be useful’ to ‘must be carried out when attempting to determine adequate dose during initiation, to establish recent adherence, managing tolerability problems, managing drug on drug interactions or change in smoking status, when using higher doses and when there is a systemic infection’.”

Source location

2020-0161-Response-from-Birmingham-and-Solihull-Mental-Health-Trust_Redacted.pdf
Page 2 · response
Published 26 October 2020

Open published response
Back to top

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

Data last updated 7 September 2026