PFD report

Marjorie Cybil Bassendine · Prevention of Future Deaths report

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Issued 30 Nov 2016•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
3

Raised in this report

Recipients
3

Named on the report

Responses found
2

Of 3 recipients

Stated actions
7

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

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Report evidence summary

Concerns raised3

  1. Failure to undertake an ECG before commencing QT-prolonging medication
    Part of recurring concern: Failure to reliably detect and manage prolonged QTc syndrome
  2. Failure to undertake regular ECG monitoring during continuing treatment with multiple psychotropic medication
    Part of recurring concern: Failure to reliably detect and manage prolonged QTc syndrome
  3. Failure to recognise the QT-prolonging potential of multiple psychotropic medication
    Part of recurring concern: Failure to identify clinically significant medication risksPart of recurring concern: Failure to reliably detect and manage prolonged QTc syndrome
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.4

  1. Action

    Determine how best to raise the medication-safety concerns with old-age psychiatrists.

    Stated by Royal College of PsychiatristsStated plannedThe respondent said that this action was planned when they made their response on 19 February 2017.
  2. Action

    Publicise the medication-safety concerns to Royal College of Psychiatrists members and fellows.

    Stated by Royal College of PsychiatristsStated plannedThe respondent said that this action was planned when they made their response on 19 February 2017.
  3. Action

    Review continuing medical education initiatives to ensure comprehensive coverage of the medication-safety issue in College materials.

    Stated by Royal College of PsychiatristsStated plannedThe respondent said that this action was planned when they made their response on 19 February 2017.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    Existing product warnings appropriately address QT-prolongation risks, so no regulatory changes are currently proposed.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting 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

Failure to undertake an ECG before commencing QT-prolonging medication

Wider context from the report

“2. To undertake an Electrocardiogram (ECG) prior to commencing such medication. ”

Is this part of a recurring concern?

Yes — Failure to reliably detect and manage prolonged QTc syndrome.

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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 undertake regular ECG monitoring during continuing treatment with multiple psychotropic medication

Wider context from the report

“3. To undertake regular ECG's to ensure long QT syndrome has not developed and to help plan continuing treatment. ”

Is this part of a recurring concern?

Yes — Failure to reliably detect and manage prolonged QTc syndrome.

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 recognise the QT-prolonging potential of multiple psychotropic medication

Wider context from the report

“1. To recognise use of multiple psychotropic medication has the potential to prolong the QT interval. ”

Is this part of a recurring concern?

Yes — Failure to identify clinically significant medication risks; Failure to reliably detect and manage prolonged QTc syndrome.

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

Determine how best to raise the medication-safety concerns with old-age psychiatrists.

Verbatim wording from the response

“Actions planned by the Royal College of Psychiatrists:”

Source location

2016-0424-Response-by-RCPSYCH
Page 1 · response
Published 19 February 2017

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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

Publicise the medication-safety concerns to Royal College of Psychiatrists members and fellows.

Verbatim wording from the response

“Actions planned by the Royal College of Psychiatrists:”

Source location

2016-0424-Response-by-RCPSYCH
Page 1 · response
Published 19 February 2017

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 continuing medical education initiatives to ensure comprehensive coverage of the medication-safety issue in College materials.

Verbatim wording from the response

“3. We will review our continuing medical education initiatives to ensure that this issue is comprehensively covered in RCPsych material;”

Source location

2016-0424-Response-by-RCPSYCH
Page 2 · response
Published 19 February 2017

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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 the product information for olanzapine, mirtazapine and indapamide to assess QT-prolongation warnings.

Verbatim wording from the response

“We have reviewed the product information (Summary of Product Characteristics [SmPC] and Patient Information Leaflet) of olanzapine, mirtazapine and indapamide and are satisfied that all three contain appropriate warnings regarding the risk of QT prolongation, particularly when used with other medication that also causes QT prolongation. Details of the relevant warnings are included in Annex A.”

Source location

2016-0424-Response-by-MHRA
Page 1 · response
Published 19 February 2017

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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 product warnings appropriately address QT-prolongation risks, so no regulatory changes are currently proposed.

Verbatim wording from the response

“We have reviewed the product information (Summary of Product Characteristics [SmPC] and Patient Information Leaflet) of olanzapine, mirtazapine and indapamide and are satisfied that all three contain appropriate warnings regarding the risk of QT prolongation, particularly when used with other medication that also causes QT prolongation. Details of the relevant warnings are included in Annex A.”

Source location

2016-0424-Response-by-MHRA
Page 1 · response
Published 19 February 2017

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.3

  1. 1

    Inform the Presidents of the Royal Colleges of Physicians and General Practitioners about the College’s plans by copying them into the response letter.

    Stated by Royal College of PsychiatristsStated plannedThe respondent said that this action was planned when they made their response on 19 February 2017.
  2. 2

    Keep the issue of QT-prolongation risk under review.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 19 February 2017.
  3. 3

    Add the report details to the Adverse Drug Reaction database under a reference number.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 19 February 2017.

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

  1. 1

    Prescribing decisions for particular medicines or combinations are the responsibility of the prescribing clinician.

    Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

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

Inform the Presidents of the Royal Colleges of Physicians and General Practitioners about the College’s plans by copying them into the response letter.

Verbatim wording from the response

“4. I shall inform the Presidents of the Royal Colleges of Physicians and General Practitioners, by copy of this letter, of our plans and will be ready to work with them in any suitable joint ventures.”

Source location

2016-0424-Response-by-RCPSYCH
Page 2 · response
Published 19 February 2017

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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

Keep the issue of QT-prolongation risk under review.

Verbatim wording from the response

“Therefore we are not currently proposing any regulatory action to change these warnings. However we will keep this issue under review, and consider the need for further action or communications should the picture change.”

Source location

2016-0424-Response-by-MHRA
Page 2 · response
Published 19 February 2017

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

Add the report details to the Adverse Drug Reaction database under a reference number.

Verbatim wording from the response

“I can confirm that the details of your report have been added onto our Adverse Drug Reaction database, under the reference number ████████”

Source location

2016-0424-Response-by-MHRA
Page 1 · response
Published 19 February 2017

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

Prescribing decisions for particular medicines or combinations are the responsibility of the prescribing clinician.

Verbatim wording from the response

“Although only the indapamide SmPC specifically mentions monitoring of patients, including conducting ECG monitoring, the SmPCs for mirtazapine and olanzapine both advise the use of “caution” when prescribing in patients with known risk factors for QT prolongation including concomitant use of other medication known to cause QT prolongation. The decision to prescribe a particular medicine or combination of medicines is the responsibility of the prescribing clinician who is in the best position to consider the balance of risks and benefits for the individual patient. The MHRA cannot comment on individual prescribing decisions.”

Source location

2016-0424-Response-by-MHRA
Page 1 · response
Published 19 February 2017

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
2/3

Data last updated 7 September 2026