PFD report

Linda MCLAUGHLIN · Prevention of Future Deaths report

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Issued 13 Jun 2024•Manchester 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.

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Concerns
4

Raised in this report

Recipients
1

Named on the report

Responses found
2

Of 1 recipient

Stated actions
2

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.

Report evidence summary

Concerns raised4

  1. Lack of clear guidance on discontinuing nilotinib or similar drugs when patients are in remission
    Part of recurring concern: Unreliable guidance for medication continuation and discontinuation decisions
  2. Lack of awareness and recognition of interstitial lung disease symptoms among oncologists and haematologists
  3. Delays in referral and treatment for interstitial lung disease
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

    Ask the BNF editorial team to consider listing interstitial lung disease separately in nilotinib monographs.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 14 June 2024.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.7

  1. Position

    Nilotinib’s interstitial lung disease risk is identified in product information, the BNF and the patient information leaflet.

    Stated by NHS EnglandDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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 guidance on discontinuing nilotinib or similar drugs when patients are in remission

Wider context from the report

“3. In this case the inquest was told that a decision was taken to continue with nilotinib despite being in remission. The inquest was told that there is growing evidence that some people do not need to stay on these drugs for life if in remission but there is no clear guidance for the approach to take. As a consequence patients may remain on the drug longer than necessary. ”

Is this part of a recurring concern?

Yes — Unreliable guidance for medication continuation and discontinuation decisions.

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 awareness and recognition of interstitial lung disease symptoms among oncologists and haematologists

Wider context from the report

“1. The inquest heard evidence that the complication that Mrs McLaughlin developed is rare but recognised internationally. However it is not widely known about and as a consequence of lack of awareness even amongst oncologists/haematologists it may not be recognised that a patient has symptoms of interstitial lung disease and as a consequence referral and treatment that could slow the disease progression may be delayed. ”

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

Delays in referral and treatment for interstitial lung disease

Wider context from the report

“1. The inquest heard evidence that the complication that Mrs McLaughlin developed is rare but recognised internationally. However it is not widely known about and as a consequence of lack of awareness even amongst oncologists/haematologists it may not be recognised that a patient has symptoms of interstitial lung disease and as a consequence referral and treatment that could slow the disease progression may be delayed. ”

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 to include rare complications such as interstitial lung disease in consent discussions for nilotinib

Wider context from the report

“2. The inquest was told that the consenting process for starting a patient on a drug such as nilotinib would not ordinarily include mentioning rare complications such as interstitial lung disease. The family gave evidence that in this case this is something that would have been carefully weighed in the decision to proceed with the treatment. ”

Is this part of a recurring concern?

Yes — Inadequate informed-consent processes for medical 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

Ask the BNF editorial team to consider listing interstitial lung disease separately in nilotinib monographs.

Verbatim wording from the response

“The British National Formulary (BNF) is a valuable source of information for healthcare professionals and we have noted that the BNF drug monograph for nilotinib includes the term “respiratory disorders” as a side-effect, which covers a range of respiratory side-effects, including interstitial lung disease. The publishers of the BNF are a separate organisation to the MHRA. We have reached out to the BNF editorial team and have asked them to consider including interstitial lung disease as a separate side-effect term in the nilotinib drug monograph.”

Source location

Response from MHRA
Page 4 · response
Published 14 June 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

Nilotinib’s interstitial lung disease risk is identified in product information, the BNF and the patient information leaflet.

Verbatim wording from the response

“Your Report raises the concern that it is not widely known by healthcare professionals that interstitial lung disease is a rare side effect of treatment with a tyrosine kinase inhibitor drug called nilotinib, and that the consenting process for such a drug would not usually include mentioning such rare complications.”

Source location

Response from NHS England
Page 1 · response
Published 14 June 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 MHRA are more appropriate bodies to respond to concerns about nilotinib’s side-effect information and medication regulation.

Verbatim wording from the response

“It should be noted that NHS England does not administer the BNF, and that regulation of medication does not sit within our remit. You may wish to revert to the BNF and/or”

Source location

Response from NHS England
Page 1 · response
Published 14 June 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 MHRA is considered more appropriate to comment on guidance concerning continued tyrosine kinase inhibitor treatment after remission.

Verbatim wording from the response

“Your Report also raises that there is growing evidence that some people do not need to stay on tyrosine kinase inhibitor drugs for life once in remission, but that there is no clear guidance on this and that consequently patients may remain on the drug longer than necessary. Again, you may wish to direct this concern to the MHRA who would be more appropriate to comment. However, specialist cancer colleagues have advised that this is an issue that currently remains in evolution. A proportion of patients can stop taking the drugs once they achieve a durable molecular remission, and this is normally discussed with patients after a certain length of time, weighing the potential toxicity of ongoing treatment against the risk of recurrence. The British Society for Haematology has an extensive guideline addressing this issue.”

Source location

Response from NHS England
Page 2 · response
Published 14 June 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

Clinical practice issues, including prescribing and treatment decisions, are outside the medicines regulator’s remit.

Verbatim wording from the response

“The MHRA recognises that as the medicines’ regulator, it is not within our remit to comment on clinical practice issues. It is a healthcare professional’s responsibility to prescribe a drug based on the information contained within the SmPC and to obtain appropriate consent after counselling the patient on their individual benefits and risks with use.”

Source location

Response from MHRA
Page 3 · response
Published 14 June 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

Existing nilotinib product information adequately reflects current scientific evidence, so MHRA considers no updates necessary.

Verbatim wording from the response

“Overall, the MHRA considers that the information provided in the SmPC and PIL for nilotinib adequately reflects the current scientific evidence available and no updates are required. However, we note the concern raised about a lack of awareness of the side effect of interstitial lung disease.”

Source location

Response from MHRA
Page 4 · response
Published 14 June 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 separate BNF publisher is responsible for deciding whether to list interstitial lung disease as a distinct nilotinib side-effect term.

Verbatim wording from the response

“The British National Formulary (BNF) is a valuable source of information for healthcare professionals and we have noted that the BNF drug monograph for nilotinib includes the term “respiratory disorders” as a side-effect, which covers a range of respiratory side-effects, including interstitial lung disease. The publishers of the BNF are a separate organisation to the MHRA. We have reached out to the BNF editorial team and have asked them to consider including interstitial lung disease as a separate side-effect term in the nilotinib drug monograph.”

Source location

Response from MHRA
Page 4 · response
Published 14 June 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

Healthcare professionals are responsible for prescribing nilotinib and obtaining patient consent after discussing individual benefits and risks.

Verbatim wording from the response

“The MHRA recognises that as the medicines’ regulator, it is not within our remit to comment on clinical practice issues. It is a healthcare professional’s responsibility to prescribe a drug based on the information contained within the SmPC and to obtain appropriate consent after counselling the patient on their individual benefits and risks with use.”

Source location

Response from MHRA
Page 3 · response
Published 14 June 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

    Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group, share learning nationally and regionally, and monitor emerging trends for further action.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 14 June 2024.

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

  1. 1

    Medication regulation and administration of the BNF fall outside NHS England’s remit.

    Stated by NHS EnglandOutside remitThe respondent said that this matter was outside its role or authority.

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 Prevention of Future Deaths reports through the Regulation 28 Working Group, share learning nationally and regionally, and monitor emerging trends for further action.

Verbatim wording from the response

“I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Linda, are shared across the NHS at both a national and regional level, and helps us to pay close attention to any emerging trends that may require further review and action.”

Source location

Response from NHS England
Page 2 · response
Published 14 June 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

Medication regulation and administration of the BNF fall outside NHS England’s remit.

Verbatim wording from the response

“It should be noted that NHS England does not administer the BNF, and that regulation of medication does not sit within our remit. You may wish to revert to the BNF and/or”

Source location

Response from NHS England
Page 1 · response
Published 14 June 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
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Data last updated 7 September 2026