PFD report

ANN COLES · Prevention of Future Deaths report

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Issued 13 Apr 2021•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
2

Named on the report

Responses found
3

Of 2 recipients

Stated actions
4

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 raised1

  1. Lack of required lung imaging for patients prescribed amiodarone long term
    Part of recurring concern: Unsafe amiodarone treatment management
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 pulmonary monitoring requirements for amiodarone and obtain independent expert advice.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 13 April 2021.

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

  1. Position

    Regular chest imaging for amiodarone is not necessary because radiation and anxiety risks outweigh the benefits.

    Stated by Medicines and Healthcare products Regulatory AgencyNo action considered necessaryThe respondent said that 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

Lack of required lung imaging for patients prescribed amiodarone long term

Wider context from the report

“The evidence showed that a potential side effect of amiodarone medication is that it can cause toxicity which affects the lungs and can cause fibrotic changes. In her evidence the consultant cardiologist who treated Ann in her final illness raised the concern that there is no requirement for lung imaging to be undertaken when patients are prescribed amiodarone on a long term basis which in her view was a glaring gap in the oversight necessary for the effects of the medication. ”

Is this part of a recurring concern?

Yes — Unsafe amiodarone treatment management.

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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 pulmonary monitoring requirements for amiodarone and obtain independent expert advice.

Verbatim wording from the response

“The MHRA has conducted a review of this issue and sought independent expert advice on the matter of concern from the Commission on Human Medicines’ Pharmacovigilance Expert Advisory Group (PEAG); written advice was also sought from the CHM’s Cardiovascular, Diabetes, Renal, Respiratory and Allergy Expert Advisory Group (CDRRA EAG). The PEAG noted that the question of regular pulmonary monitoring has been well considered over many years, but the risks (especially radiation exposure from performing high-resolution computerised tomography [CT] scans) are thought likely to far exceed any benefit. The PEAG also noted that repeated chest X-rays can cause anxiety for patients.”

Source location

2021-0101-Response-from-MHRA_Published
Page 2 · response
Published 13 April 2021

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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

Regular chest imaging for amiodarone is not necessary because radiation and anxiety risks outweigh the benefits.

Verbatim wording from the response

“The MHRA has conducted a review of this issue and sought independent expert advice on the matter of concern from the Commission on Human Medicines’ Pharmacovigilance Expert Advisory Group (PEAG); written advice was also sought from the CHM’s Cardiovascular, Diabetes, Renal, Respiratory and Allergy Expert Advisory Group (CDRRA EAG). The PEAG noted that the question of regular pulmonary monitoring has been well considered over many years, but the risks (especially radiation exposure from performing high-resolution computerised tomography [CT] scans) are thought likely to far exceed any benefit. The PEAG also noted that repeated chest X-rays can cause anxiety for patients.”

Source location

2021-0101-Response-from-MHRA_Published
Page 2 · response
Published 13 April 2021

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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 NICE and local shared care guidelines are sufficient for safe amiodarone monitoring; new monitoring and reporting systems are not required.

Verbatim wording from the response

“Having reviewed the detail, the RCP would recommend that no new systems of monitoring and reporting are required for the prescription of amiodarone but that strict adherence to existing national NICE and local shared care guidelines will provide for safe and monitored practice.”

Source location

2021-0101-Response-from-Royal-College-of-Physicians-Redacted
Page 1 · response
Published 13 April 2021

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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

Medication regulation falls outside the organisation’s functions, although it guides standards and provides education.

Verbatim wording from the response

“The Royal College of General Practitioners is not a regulating organisation and especially not for medication although we do have responsibilities in guiding standards and providing education. Regulatory responsibility of medication lies with The Medicines and Healthcare products Regulatory Agency (MHRA). Given the concerns raised in your inquest, I recommend that you request the MHRA comment upon this matter. Contact details are here.”

Source location

2021-0101-Response-from-Royal-College-of-General-Practitioners-Redacted
Page 2 · response
Published 13 April 2021

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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 holds regulatory responsibility for medication and should address the concerns about amiodarone monitoring.

Verbatim wording from the response

“The Royal College of General Practitioners is not a regulating organisation and especially not for medication although we do have responsibilities in guiding standards and providing education. Regulatory responsibility of medication lies with The Medicines and Healthcare products Regulatory Agency (MHRA). Given the concerns raised in your inquest, I recommend that you request the MHRA comment upon this matter. Contact details are here.”

Source location

2021-0101-Response-from-Royal-College-of-General-Practitioners-Redacted
Page 2 · response
Published 13 April 2021

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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.3

  1. 1

    Issue healthcare-professional reminders about amiodarone risks, patient monitoring, pulmonary toxicity symptoms, and prompt reporting and investigation.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 13 April 2021.
  2. 2

    Improve the oral amiodarone patient information leaflet by clarifying pulmonary toxicity seriousness and its possible occurrence at any treatment stage.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 13 April 2021.
  3. 3

    Continue closely reviewing the safety of amiodarone.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 13 April 2021.

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

Issue healthcare-professional reminders about amiodarone risks, patient monitoring, pulmonary toxicity symptoms, and prompt reporting and investigation.

Verbatim wording from the response

“The PEAG also discussed whether additional risk minimisation measures such as a Patient Alert Card would help to inform patients of the risks of treatment and symptoms to be aware of. The PEAG considered that it would be useful to issue a reminder to healthcare professionals on the risks associated with use of amiodarone, the need for monitoring of patients, that patients should be informed of and aware of the symptoms of pulmonary toxicity, and that any such symptoms should be reported promptly (and investigated). The PEAG considered that an article in the MHRA’s monthly ‘Drug Safety Update’ bulletin may be an appropriate method to communicate these messages.”

Source location

2021-0101-Response-from-MHRA_Published
Page 2 · response
Published 13 April 2021

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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

Improve the oral amiodarone patient information leaflet by clarifying pulmonary toxicity seriousness and its possible occurrence at any treatment stage.

Verbatim wording from the response

“For these reasons, the PEAG did not consider regular chest imaging was advisable or necessary, given that patient-reported worsening of respiratory function is usually the first indicator of pulmonary toxicity. Nevertheless, the PEAG considered that there was scope for improvement in the product information, particularly with respect to the PIL on the seriousness of pulmonary toxicity and the fact this may happen at any time during treatment.”

Source location

2021-0101-Response-from-MHRA_Published
Page 2 · response
Published 13 April 2021

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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

Continue closely reviewing the safety of amiodarone.

Verbatim wording from the response

“I will keep you updated on progress, but in the meantime, we will continue to keep the safety of amiodarone under close review.”

Source location

2021-0101-Response-from-MHRA_Published
Page 2 · response
Published 13 April 2021

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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