PFD report

Talia Evaniа Phillips · Prevention of Future Deaths report

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Issued 2 Sep 2023•Cornwall and Isles of Scilly

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
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
3

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 raised1

  1. Lack of guidance specifying when to test fluoxetine blood levels after palpitations
    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.1

  1. Action

    Review evidence and expert advice on monitoring fluoxetine blood levels and relevant toxicity risks.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 8 September 2023.

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

  1. Position

    The MHRA is best placed to address fluoxetine monitoring requirements because these are covered by the MHRA-agreed product characteristics.

    Stated by National Institute for Health and Care ExcellenceRedirects 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

Lack of guidance specifying when to test fluoxetine blood levels after palpitations

Wider context from the report

“During the course of the inquest I heard that guidance around the prescribing of Fluoxetine did not indicate that fluoxetine levels would should be routinely tested in a patient prescribed Fluoxetine in the event of an episode of palpitations. Such a test may have identified chronically high levels of Fluoxetine. It is requested that guidance in relation to the prescribing of Fluoxetine and management of patients on Fluoxetine should be reviewed to consider in what circumstances a blood test to establish the level of Fluoxetine in the patient's blood would be advisable. ”

Is this part of a recurring concern?

Yes — Unreliable medication-specific blood-level monitoring.

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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

Review evidence and expert advice on monitoring fluoxetine blood levels and relevant toxicity risks.

Verbatim wording from the response

“In the Matters of Concern section of the report relating to the tragic death of Talia Evania Phillips you request that guidance in relation to the prescribing of fluoxetine and management of patients on fluoxetine should be reviewed to consider in what circumstances a blood test to establish the level of fluoxetine in the patient's blood would be advisable.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 1 · response
Published 8 September 2023

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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 MHRA is best placed to address fluoxetine monitoring requirements because these are covered by the MHRA-agreed product characteristics.

Verbatim wording from the response

“We have made recommendations on the use of antidepressants in our guidelines on the treatment of anxiety and we have also published guidance on safe prescribing of antidepressants in our guideline on medicines associated with dependence or withdrawal symptoms. However, we consider that the Medicines and Healthcare products Regulatory Agency (MHRA), as the regulator of medicines, would be best placed to address concerns you have raised regarding monitoring requirements as these are covered by the summary of product characteristics (SmPC) for a drug, a document which is agreed by the MHRA. We would therefore suggest you send the regulation 28 report to the MHRA for their consideration.”

Source location

Response from National Institute for Health and Care Excellence
Page 1 · response
Published 8 September 2023

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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

Routine fluoxetine blood-level monitoring is not recommended because evidence is insufficiently robust and therapeutic plasma levels lack supporting data.

Verbatim wording from the response

“The EAG previously advised that the evidence from the analyses of Yellow Card data and published information on antidepressant drug level monitoring was not sufficiently robust to advise clinicians to routinely monitor blood levels of antidepressants for all patients on treatment. The Group recommended however that blood level monitoring of antidepressants may be helpful in certain circumstances, for example in the event of symptoms suggestive of toxicity or when concomitant medicines may act to increase antidepressant drug levels.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 1 · response
Published 8 September 2023

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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

Specific recommendations for fluoxetine blood testing are a matter for clinical guidelines because testing depends on individual patient circumstances and clinical judgment.

Verbatim wording from the response

“The approved fluoxetine SmPC contains information reflecting the currently available data on known interactions and clinical circumstances which may predispose a person to fluoxetine toxicity and describes symptoms of toxicity in overdose. The fluoxetine SmPC does not make specific recommendations on when to perform blood tests to establish the level of fluoxetine as this is a clinical judgment depending on the unique individual patient circumstances and therefore would be a matter for clinical guidelines.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 8 September 2023

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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.2

  1. 1

    Include antidepressant-use recommendations in guidelines on treating anxiety.

    Stated by National Institute for Health and Care ExcellenceStated completedThe respondent said that this action was complete when they made their response on 8 September 2023.
  2. 2

    Publish guidance on safe prescribing of antidepressants associated with dependence or withdrawal symptoms.

    Stated by National Institute for Health and Care ExcellenceStated completedThe respondent said that this action was complete when they made their response on 8 September 2023.

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 antidepressant-use recommendations in guidelines on treating anxiety.

Verbatim wording from the response

“We have made recommendations on the use of antidepressants in our guidelines on the treatment of anxiety and we have also published guidance on safe prescribing of antidepressants in our guideline on medicines associated with dependence or withdrawal symptoms. However, we consider that the Medicines and Healthcare products Regulatory Agency (MHRA), as the regulator of medicines, would be best placed to address concerns you have raised regarding monitoring requirements as these are covered by the summary of product characteristics (SmPC) for a drug, a document which is agreed by the MHRA. We would therefore suggest you send the regulation 28 report to the MHRA for their consideration.”

Source location

Response from National Institute for Health and Care Excellence
Page 1 · response
Published 8 September 2023

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

Publish guidance on safe prescribing of antidepressants associated with dependence or withdrawal symptoms.

Verbatim wording from the response

“We have made recommendations on the use of antidepressants in our guidelines on the treatment of anxiety and we have also published guidance on safe prescribing of antidepressants in our guideline on medicines associated with dependence or withdrawal symptoms. However, we consider that the Medicines and Healthcare products Regulatory Agency (MHRA), as the regulator of medicines, would be best placed to address concerns you have raised regarding monitoring requirements as these are covered by the summary of product characteristics (SmPC) for a drug, a document which is agreed by the MHRA. We would therefore suggest you send the regulation 28 report to the MHRA for their consideration.”

Source location

Response from National Institute for Health and Care Excellence
Page 1 · response
Published 8 September 2023

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