Recurring concern

Unsafe amiodarone treatment management

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First reported 28 Jul 2015•Latest report 20 Mar 2022

Definition

What this concern includes

Includes failures of controls specifically dedicated to safe amiodarone treatment, including early-treatment monitoring, toxicity surveillance, dose adjustment, prescribing, review and response to abnormal findings.

Not included

Excludes medication-management failures involving other medicines unless the report explicitly ties them to amiodarone treatment.
Excludes generic medication monitoring, prescribing or documentation deficiencies that are not specifically dedicated to amiodarone safety.
Excludes unrelated clinical deterioration, treatment delays or adverse outcomes where no amiodarone-management control failure is identified.

Reports: 3
Individual concerns: 4
Date range: 2015–2022
Stated actions: 2

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Cwm Taf Morgannwg University Local Health Board1

Northern General Hospital1

Royal College of General Practitioners1

Royal College of Physicians1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

20 Mar2022
South Wales Central
Concerns raised1
1. Failure to implement Amiodarone dose down-titration
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.

No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

Mr. Donald Vernon Compton · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Donald Vernon Compton, aged 87, was admitted to hospital after developing Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis and Covid-19, and died on 14 February 2021. The principal concerns were prescribing and dispensing errors involving Co-trimoxazole despite a known trimethoprim allergy, including failures by hospital staff and a GP to identify the risk. A separate medication error involving excessive amiodarone dosing was also identified.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Failure to implement Amiodarone dose down-titration
Wider context from the report
“Prescribing and dispensing errors 1. At the time, the All Wales electronic prescribing tool (eDAL) permitted prescribers to avoid reading the section concerning known allergies; 2. The commonly prescribed antibiotic Co-trimoxazole comprises two constituent drugs trimethoprim and sulfamethoxazole. Allergies were not noted as Co-trimoxazole but to the constituent drug, trimethoprim. 3. Prescribing hospital doctors; overseeing pharmacist; and ward nurses all failed to pick up on this discharge prescribing and dispensing error suggesting drug safety on discharge is an area for scrutiny and input to ensure a similar error is avoided a patient safety is maximised. 4. That the Torbay GP also made an error in prescribing Co-trimoxazole to Mr. Compton in the knowledge he was allergic to trimethoprim indicates the lack of specific knowledge about this antibiotic and its constituent elements. It may also reflect a more general lack of knowledge about constituent components of commonly prescribed drugs. 5. A different prescribing error was made in respect of this same patient whilst under the care of RGH. The down titration of Amiodarone was overlooked resulting in too high a dose being administered over several days. ”
Source location
Mr. Donald Vernon Compton · Prevention of Future Deaths report
Page 2 · concerns
Open source report
13 Apr2021
Surrey
Concerns raised1
1. Lack of required lung imaging for patients prescribed amiodarone long term
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 1
1. Action
  Review pulmonary monitoring requirements for amiodarone and obtain independent expert advice.
  Stated by Medicines and Healthcare products Regulatory AgencyStated completed
Respondent positions 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 necessary
1. Position
  Existing NICE and local shared care guidelines are sufficient for safe amiodarone monitoring; new monitoring and reporting systems are not required.
  Stated by Royal College of PhysiciansExisting arrangements considered sufficient
2. Position
  Medication regulation falls outside the organisation’s functions, although it guides standards and provides education.
  Stated by Royal College of General PractitionersOutside remit
3. Position
  The MHRA holds regulatory responsibility for medication and should address the concerns about amiodarone monitoring.
  Stated by Royal College of General PractitionersRedirects responsibility
AI-generated summary

ANN COLES · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Ann Coles was admitted to Frimley Park Hospital in March 2019 with pneumonia and later developed multi-organ failure, dying on 12 March 2019. The principal concern was that long-term amiodarone can cause lung toxicity and fibrotic changes, while there was no requirement for lung imaging to monitor patients prescribed the medication long term.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
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. ”
Source location
ANN COLES · Prevention of Future Deaths report
Page 2 · concerns
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
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
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
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
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 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
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 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
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 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
Open published response
28 Jul2015
South Yorkshire (Eastern)
Concerns raised2
1. Failure to ensure adequate monitoring during the first twelve months of Amiodarone treatment
2. Lack of protocols or guidance for monitoring patients prescribed Amiodarone
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 1
1. Action
  Maintain and revise the shared-care protocol defining amiodarone monitoring responsibilities and required liver, thyroid, respiratory and toxicity testing.
  Stated by Sheffield Teaching Hospitals NHS Foundation TrustStated completed
Respondent positions 1
1. Position
  An appropriate amiodarone protocol existed, covered monitoring and GP communication, and was followed during the inpatient stay.
  Stated by Sheffield Teaching Hospitals NHS Foundation TrustDisputes the concern
AI-generated summary

William Arthur Bows · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

William Arthur Bows, an 85-year-old man, was admitted with increasing shortness of breath, deteriorated despite supportive treatment, and died on 15 January while investigations were ongoing. Concerns were raised about the lack of protocols and guidance for monitoring patients prescribed amiodarone, including liver function, thyroid function, and respiratory difficulties, particularly during the first year of treatment.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Failure to ensure adequate monitoring during the first twelve months of Amiodarone treatment
Wider context from the report
“(2) With regard to the development of Amiodarone toxicity, I heard evidence that should this complication develop it usually does so within the first twelve months or so of commencing this drug and linked with (1) above, there was nothing before me to suggest primary care providers, or indeed secondary care prescribers, were taking steps to ensure there was adequate monitoring during this period. ”
Source location
William Arthur Bows · Prevention of Future Deaths report
Page 1 · concerns
Open source report
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Lack of protocols or guidance for monitoring patients prescribed Amiodarone
Wider context from the report
“(1) There was no evidence of any protocols in place or guidance for advising primary care providers of the need to closely monitor patients who have been prescribed Amiodarone, particularly in relation to liver function tests, thyroid tests and respiratory difficulties. ”
Source location
William Arthur Bows · Prevention of Future Deaths report
Page 1 · concerns
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
Maintain and revise the shared-care protocol defining amiodarone monitoring responsibilities and required liver, thyroid, respiratory and toxicity testing.

Verbatim wording from the response
“I am pleased to reassure you that there is and was an appropriate policy in place. The Shared Care Protocol for Amiodarone was initially developed in Sheffield in 2007 by the cardiology team in conjunction with the then Sheffield PCT. It has been revised several times since, so that it was the third edition that was current at the time of the prescription (Appendix 1). It was subsequently revised further in 2014, a version developed by Dr Sheridan, Consultant Cardiologist, STHFT and Richard Crosby, Head of Primary Care Clinical Support, NHS West and South Yorkshire and Bassetlaw CSU.”

Source location
2015-0301-Response-by-Sheffield-Teaching-Hospitals-NHS-Trust
Page 1 · response
Published 28 July 2015
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
An appropriate amiodarone protocol existed, covered monitoring and GP communication, and was followed during the inpatient stay.

Verbatim wording from the response
“I am pleased to reassure you that there is and was an appropriate policy in place. The Shared Care Protocol for Amiodarone was initially developed in Sheffield in 2007 by the cardiology team in conjunction with the then Sheffield PCT. It has been revised several times since, so that it was the third edition that was current at the time of the prescription (Appendix 1). It was subsequently revised further in 2014, a version developed by Dr Sheridan, Consultant Cardiologist, STHFT and Richard Crosby, Head of Primary Care Clinical Support, NHS West and South Yorkshire and Bassetlaw CSU.”

Source location
2015-0301-Response-by-Sheffield-Teaching-Hospitals-NHS-Trust
Page 1 · response
Published 28 July 2015
Open published response

Data last updated 7 September 2026

What this concern includes

Not included

Reports over time

Concerns raised1

Failure to implement Amiodarone dose down-titration

Concerns raised1

Lack of required lung imaging for patients prescribed amiodarone long term

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.4

Concerns raised2

Failure to ensure adequate monitoring during the first twelve months of Amiodarone treatment

Lack of protocols or guidance for monitoring patients prescribed Amiodarone

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1

Actions described in response 1

Respondent positions 4

Actions described in response 1

Respondent positions 1