PFD report

Thomas Paul Arthur JACKSON · Prevention of Future Deaths report

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Issued 13 Nov 2018•Staffordshire 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.

View original report
Concerns
11

Raised in this report

Recipients
2

Named on the report

Responses found
1

Of 2 recipients

Stated actions
0

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

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

Concerns raised11

  1. Failure of staff to recognise Clozapine significance, side-effects and warning signs of deterioration
    Part of recurring concern: Failure to identify clinically significant medication risksPart of recurring concern: Unreliable safety monitoring and guidance for clozapine treatment
  2. Lack of national policy for regular clozapine blood plasma-level testing
    Part of recurring concern: Unreliable medication-specific blood-level monitoringPart of recurring concern: Unreliable safety monitoring and guidance for clozapine treatment
  3. Unclear lone-working procedures for entering patients’ rooms
    Part of recurring concern: Unreliable safety arrangements for lone workers
Responses linked to these concerns

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

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

  1. Position

    The MHRA is responsible for medicine safety and will assess whether therapeutic drug monitoring supports safer clozapine use.

    Stated by Nicola BlackwoodRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking 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

Failure of staff to recognise Clozapine significance, side-effects and warning signs of deterioration

Wider context from the report

“(3) It is clear that Clozapine is a beneficial drug for many patients and that a large number of patients in the care of the Trust do receive this drug. However it appears that many staff are not aware of the significance of this medication particularly when considering potential side-effects and warning signs of deterioration. ”

Is this part of a recurring concern?

Yes — Failure to identify clinically significant medication risks; 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 national policy for regular clozapine blood plasma-level testing

Wider context from the report

“It is well known that Clozapine is a potentially dangerous drug which needs to be carefully monitored. Monitoring is for both whole blood to look at infection markers and for blood plasma to cheek on Clozapine levels. Since this death the Trust involves has established a policy for the regular checking of blood plasma levels for patients in receipt of Clozapine. However it appears that this is a local policy and that there is no national policy for these checks to be carried out. I wonder if there should be a direction for all trusts to carryout blood plasma tests on patients receiving Clozapine on a regular basis perhaps at least six monthly or yearly. ”

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

Unclear lone-working procedures for entering patients’ rooms

Wider context from the report

“(5) I wonder if there needs to be a review of any lone-working policy or procedure with particular reference as to when to enter patients’ rooms. ”

Is this part of a recurring concern?

Yes — Unreliable safety arrangements for lone workers.

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

Poor recording of ward rounds or multi-disciplinary team meetings

Wider context from the report

“(2) It is apparent that patients do benefit from regular ‘ward rounds’ or ‘multi-disciplinary team meetings’ (there are a variety of titles) and, apart from the record of these meetings being very poor at times, there is a concern about the conduct of these meetings. In particular there appears to be on occasions inadequate consideration of the history in preparation for the meeting, failure of attendance of all appropriate personnel at such meetings and concern about the patient being able properly to participate. ”

Is this part of a recurring concern?

Yes — Unsafe operation of multidisciplinary clinical meetings.

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

Inadequate patient participation in clinical meetings

Wider context from the report

“(2) It is apparent that patients do benefit from regular ‘ward rounds’ or ‘multi-disciplinary team meetings’ (there are a variety of titles) and, apart from the record of these meetings being very poor at times, there is a concern about the conduct of these meetings. In particular there appears to be on occasions inadequate consideration of the history in preparation for the meeting, failure of attendance of all appropriate personnel at such meetings and concern about the patient being able properly to participate. ”

Is this part of a recurring concern?

Yes — Unsafe operation of multidisciplinary clinical meetings.

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

Difficulty disclosing significant patient documents during the Inquest process

Wider context from the report

“(6) It is well known that it is important for lessons to be learnt following serious incidents. The SIR procedure is a significant part of this. I understand there have been some changes since the time of Tom’s death but the SIR carried out in this matter contained a number of significant inaccuracies which can affect the validity of the process. Additionally although the records for patients who are in hospital for a long period of time can become voluminous there has also been some difficulty in disclosure of significant documents during the Inquest process. ”

Is this part of a recurring concern?

Yes — Unreliable disclosure of relevant evidence in formal proceedings.

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

Unavailability of standard treatment and Clozapine smoking-risk information for patients and families

Wider context from the report

“(4) I would not wish for patients or their families to be overloaded with paperwork but I wonder if there could be a simple leaflet available to patients and family members covering standard information about treatment generally but including matters such as the dangers of patients smoking whilst they are receiving Clozapine. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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 of appropriate personnel to attend clinical meetings

Wider context from the report

“(2) It is apparent that patients do benefit from regular ‘ward rounds’ or ‘multi-disciplinary team meetings’ (there are a variety of titles) and, apart from the record of these meetings being very poor at times, there is a concern about the conduct of these meetings. In particular there appears to be on occasions inadequate consideration of the history in preparation for the meeting, failure of attendance of all appropriate personnel at such meetings and concern about the patient being able properly to participate. ”

Is this part of a recurring concern?

Yes — Unsafe operation of multidisciplinary clinical meetings.

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

Poor record keeping affecting continuity of care

Wider context from the report

“(1) During the hearing it was noted that on a number of occasions record keeping was poor. This can make continuity of care difficult and it can lead to matters being missed. I wonder if the Trust can take any action to improve this. ”

Is this part of a recurring concern?

Yes — Incomplete, inaccurate or unavailable clinical and care records.

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

Inadequate consideration of patient history before clinical meetings

Wider context from the report

“(2) It is apparent that patients do benefit from regular ‘ward rounds’ or ‘multi-disciplinary team meetings’ (there are a variety of titles) and, apart from the record of these meetings being very poor at times, there is a concern about the conduct of these meetings. In particular there appears to be on occasions inadequate consideration of the history in preparation for the meeting, failure of attendance of all appropriate personnel at such meetings and concern about the patient being able properly to participate. ”

Is this part of a recurring concern?

Yes — Failure to incorporate relevant clinical history and diagnoses into care decisions; Unsafe operation of multidisciplinary clinical meetings.

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

Inaccuracies in serious incident reviews affecting process validity

Wider context from the report

“(6) It is well known that it is important for lessons to be learnt following serious incidents. The SIR procedure is a significant part of this. I understand there have been some changes since the time of Tom’s death but the SIR carried out in this matter contained a number of significant inaccuracies which can affect the validity of the process. Additionally although the records for patients who are in hospital for a long period of time can become voluminous there has also been some difficulty in disclosure of significant documents during the Inquest process. ”

Is this part of a recurring concern?

Yes — Inadequate safety incident investigations; Unreliable accuracy of safety-review findings and conclusions; Unreliable formal safety-incident management processes.

Open source report

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 MHRA is responsible for medicine safety and will assess whether therapeutic drug monitoring supports safer clozapine use.

Verbatim wording from the response

“As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the safety of medicines and medical devices. The MHRA seeks independent advice from the Commission on Human Medicines (CHM) which advises on whether the overall balance of benefits and risks of medicines is favourable at the time of licensing and remains so thereafter.”

Source location

Response from DHSC
Page 2 · response
Published 12 April 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

The NICE guideline surveillance team will consider whether guidance on clozapine plasma-level monitoring requires updating.

Verbatim wording from the response

“I am informed that clinical guideline CG178 is to undergo a surveillance review to check whether it needs to be updated and given the concerns you raise, the issue of monitoring blood plasma levels in people taking clozapine (or other antipsychotics) has been logged for the consideration of the guideline surveillance team undertaking the review process.”

Source location

Response from DHSC
Page 2 · response
Published 12 April 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

Data last updated 7 September 2026