PFD report

Jessica de Souza · Prevention of Future Deaths report

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Issued 16 Jul 2024•Surrey

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
1

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
6

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 raised1

  1. Failure to ensure aripiprazole monotherapy is effective for prophylaxis against both bipolar polarities
    Part of recurring concern: Unsafe medication prescribing
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

    Discuss long-term bipolar disorder treatment across both polarities with NICE topic experts.

    Stated by National Institute for Health and Care ExcellenceStated plannedThe respondent said that this action was planned when they made their response on 1 August 2024.
  2. Action

    Review new evidence that could affect NICE’s long-term bipolar disorder treatment recommendations.

    Stated by National Institute for Health and Care ExcellenceStated plannedThe respondent said that this action was planned when they made their response on 1 August 2024.
  3. Action

    Monitor emerging bipolar-disorder management information and consider adding appropriate detail in a future BNF update.

    Stated by BNF PublicationsStated in progressThe respondent said that this action was in progress when they made their response on 1 August 2024.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    The content of the BNF and BMJ Best Practice is outside NICE’s responsibility, so NICE cannot comment on it.

    Stated by National Institute for Health and Care ExcellenceOutside remitThe respondent said that this matter was outside its role or authority.

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 ensure aripiprazole monotherapy is effective for prophylaxis against both bipolar polarities

Wider context from the report

“i. The treating psychiatrists gave evidence that, following the acute manic episode, Jessica was prescribed aripiprazole as a maintenance prophylactic drug to control both polarities of bipolar disorder. ii. The clinicians relied on the BNF and the BMJ Best Practice Bipolar Disorder in Adults to support their decision to prescribe aripiprazole as prophylaxis for both polarities as a monotherapy. iii. Nice Guidance on Bipolar Disorder [CG185] suggests aripiprazole may be considered as a maintenance treatment to prevent relapse in bipolar disorder. iv. The BMJ refers to aripiprazole being used as a monotherapy to treat bipolar disorder, though does advise that it is more effective in preventing mania than depression. v. The court appointed psychiatric expert gave evidence that aripiprazole is not effective as a prophylaxis in relation to the depressive polarity in bipolar and that as a result Jessica was not protected from a depressive relapse. vi. The expert considered that the guidance relied on may have been misleading for the clinicians. ”

Is this part of a recurring concern?

Yes — Unsafe medication prescribing.

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

Discuss long-term bipolar disorder treatment across both polarities with NICE topic experts.

Verbatim wording from the response

“Our senior clinical advisers acknowledge that the guideline does not explicitly consider the 2 polarities of bipolar disorder in long-term treatment. We will discuss this area with our topic experts and review any new evidence that could impact on our recommendations, updating them if necessary.”

Source location

Response from NICE
Page 2 · response
Published 1 August 2024

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 new evidence that could affect NICE’s long-term bipolar disorder treatment recommendations.

Verbatim wording from the response

“Our senior clinical advisers acknowledge that the guideline does not explicitly consider the 2 polarities of bipolar disorder in long-term treatment. We will discuss this area with our topic experts and review any new evidence that could impact on our recommendations, updating them if necessary.”

Source location

Response from NICE
Page 2 · response
Published 1 August 2024

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 emerging bipolar-disorder management information and consider adding appropriate detail in a future BNF update.

Verbatim wording from the response

“As we do for all BNF content, we will continue to monitor for additional sources of information around the management of bipolar disorder, and consider whether we need to include further”

Source location

Response from Royal Pharmaceutical Society
Page 1 · response
Published 1 August 2024

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

Update the bipolar disorder topic to discuss guideline differences and incorporate the NICE guideline in greater detail.

Verbatim wording from the response

“In updates since 2022, the topic discusses in more detail the differences between guidelines, and incorporates the NICE guideline in greater detail but there has been no substantive change to the content that is relevant to the report. In keeping with our processes, we will continue to review and update this topic with subject matter experts and will incorporate new evidence into the content as appropriate.”

Source location

Response from BMJ Group
Page 3 · response
Published 1 August 2024

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

Continue reviewing and updating the bipolar disorder topic with subject matter experts and incorporating new evidence as appropriate.

Verbatim wording from the response

“In updates since 2022, the topic discusses in more detail the differences between guidelines, and incorporates the NICE guideline in greater detail but there has been no substantive change to the content that is relevant to the report. In keeping with our processes, we will continue to review and update this topic with subject matter experts and will incorporate new evidence into the content as appropriate.”

Source location

Response from BMJ Group
Page 3 · response
Published 1 August 2024

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 content of the BNF and BMJ Best Practice is outside NICE’s responsibility, so NICE cannot comment on it.

Verbatim wording from the response

“The BNF is a joint publication of the British Medical Association and the Royal Pharmaceutical Society. NICE hold the licence to make this resource available on the NICE website to health professionals working in the UK, but we are not responsible for the content.”

Source location

Response from NICE
Page 1 · response
Published 1 August 2024

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 BNF and BMJ Best Practice publishers are best placed to respond to concerns about their content.

Verbatim wording from the response

“I note that you have sent your report to those parties, and they are best placed to respond to your comments on their content.”

Source location

Response from NICE
Page 1 · response
Published 1 August 2024

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 BNF guidance was not misleading because it did not recommend aripiprazole for prophylaxis of bipolar depression and advised specialist input.

Verbatim wording from the response

“The matter of concern that directly references the BNF states that the clinicians relied on the BNF (and the BMJ Best Practice Bipolar Disorder in Adults) to support their decision to prescribe aripiprazole as prophylaxis for both polarities as a monotherapy. In Summer 2022, when aripiprazole was first prescribed to Ms De Souza, the aripiprazole drug monograph in BNF included one indication that was relevant to the management of bipolar disorder – that is the treatment and recurrence prevention of mania. The indication reflected, and continues to reflect, the licensed use of oral aripiprazole in licensed product information and is unchanged in current BNF content. The BNF does not include information on the use of aripiprazole as prophylaxis for bipolar depression.”

Source location

Response from Royal Pharmaceutical Society
Page 1 · response
Published 1 August 2024

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

Selection and management of bipolar treatment remain the treating clinicians’ responsibility because they know the patient’s full clinical context.

Verbatim wording from the response

“The BMJ Best Practice ‘Bipolar Disorder in Adults’ topic, at the time (and still does) discusses the complex nature of bipolar disorder and the many factors to consider and monitor during treatment. It outlines the different phases in terms of acute mania, acute depression and patients with mixed features, as well as maintenance treatment, and the differing treatment options and considerations during each phase. It is the duty of the treating doctor to take all of this into account when deciding on treatments.”

Source location

Response from BMJ Group
Page 2 · response
Published 1 August 2024

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

    Review the BMJ Best Practice content likely available during the patient’s 2022 admission.

    Stated by BMJ Publishing Group Limited (BMJ GroupStated completedThe respondent said that this action was complete when they made their response on 1 August 2024.

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 the BMJ Best Practice content likely available during the patient’s 2022 admission.

Verbatim wording from the response

“First of all, we would like to make clear that BMJ Best Practice is an online clinical decision support tool (https://bestpractice.bmj.com/) to be used as a source of reference material by medical professionals. The clinical content on BMJ Best Practice is live and can be updated at any time in response to changes in the evidence landscape - and in line with our processes. We have reviewed the content that is (according to our internal records) likely to have been online at the time of Miss de Souza’s hospital admission in Summer 2022.”

Source location

Response from BMJ Group
Page 1 · response
Published 1 August 2024

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
3/3

Data last updated 7 September 2026