Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0101, written 13 Apr 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 13 Apr 2021 |
|---|---|
| Reference | 2021-0101 |
| Deceased | Ann Coles |
| Coroner | Caroline Topping |
| Coroner area | County of Surrey |
| Category | Alcohol, drug and medication related deaths · Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
IN THE SURREY CORONER’S COURT IN THE MATTER OF: ANN COLES __________________________________________________________ The Inquest Touching the Death of ANN COLES A Regulation 28 Report – Action to Prevent Future Deaths __________________________________________________________ THIS REPORT IS BEING SENT TO: • • Practitioners 1 CORONER , President of the Royal College of Physicians , President of the Royal College of General Caroline Topping, HM Assistant Coroner for the County of Surrey 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST An investigation into the death of Ann Coles was opened on the 4th April 2019. The Inquest was opened on 12th November 2019 and resumed and concluded on 16th March 2021. I concluded that Ann Coles was admitted to Frimley Park Hospital suffering with severe bilateral pneumonia and sepsis. Despite appropriate treatment she developed multi- organ failure and died on the 12th March 2019. The cause of death was: I a Multiple Organ Failure I b Sepsis I c Pneumonia II Aortic Stenosis I concluded she died of natural causes 4 CIRCUMSTANCES OF THE DEATH Ann had a tissue aortic valve replacement in 2014 having been diagnosed with severe aortic stenosis. She developed atrial fibrillation after the operation and required medication to revert to sinus rhythm. Thereafter she was prescribed amiodarone to prevent her relapsing into atrial fibrillation. She was subject to annual reviews thereafter. In March 2019 she was admitted to Frimley Park Hospital suffering with shortness of breath and found to have developed pneumonia. Despite appropriate treatment she died from multi-organ failure on the 12th March 2019. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. – The evidence showed that a potential side effect of amiodarone medication is that it can cause toxicity which effects 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. . 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe your organisation has the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 8th June 2021. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons; and Frimley Park Hospital I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 Signed: Caroline Topping Dated this 13th April 2021.
3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
PA to HM Coroner for Surrey HM Coroner’s Court Station Approach Woking Surrey GU22 7AP 3rd August 2021 Dear , Medicines & Healthcare products Regulatory Agency 10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Regulation 28 Report to Prevent Future Deaths concerning Ann Coles Thank you for your e-mail of 21 June 2021 regarding a Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Ann Coles. The report raised a matter of concern that there is no requirement for lung imaging to be undertaken when patients are prescribed amiodarone on a long term basis; the consultant cardiologist who treated Ann considered this was a glaring gap in the oversight necessary for the effects of the medication. The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health and Social Care (DHSC) with responsibility for the regulation of medicinal products in the UK. The MHRA ensures that medicines are efficacious and acceptably safe, and that any possible side effects which have been recognised to occur with use of a medicine are appropriately described in the authorised product information. This comprises the Summary of Product Characteristics (SmPC, intended for healthcare professionals), labelling, and Patient Information Leaflet (PIL, provided to patients in each medicine pack). Amiodarone is an effective medicine for the management of arrhythmia, but it is known to be associated with a number of serious unwanted effects in several organ systems including the eyes, nerves, skin, thyroid, gastrointestinal, lung, heart, and liver. The product information for amiodarone therefore contains extensive warnings and precautions for use, patients must be monitored closely during treatment, and treatment should be initiated and monitored only under hospital or specialist supervision. Additionally, due to its toxicity, the use of amiodarone is now reserved only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used. Amiodarone is available as an oral tablet and as a solution for intravenous (IV) infusion. The SmPC for both formulations describes the symptoms of pulmonary toxicity (i.e. onset of shortness of breath or non- productive cough). The incidence of pulmonary toxicity is known to be lower with IV formulations (where it is reported very rarely, affecting fewer than 1 in 10,000 patients) than for oral formulations (reported commonly, affecting between 1 in 10 and 1 in 100 patients). The SmPC for oral amiodarone notes that onset is usually slow but may be rapidly progressive and whilst the majority of cases have been reported with long term therapy, a few have occurred soon after starting treatment. The product information for oral amiodarone also suggests that consideration be given to chest X-rays before starting therapy, and if pulmonary toxicity is suspected, this should be repeated and associated with lung function testing including, where possible, measurement of transfer factor. For IV amiodarone chest X-rays are recommended only when a diagnosis of interstitial pneumonitis is suspected. The PIL reflects this information in patient-friendly language, and section 4 (side-effects) of the PIL for oral amiodarone generally instructs the user to stop treatment and see a doctor or go to a hospital straight away if they experience worsening of respiratory symptoms (which may be common). 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. 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. 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 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. The MHRA will now take forward these recommendations. For information, Ms Cole’s case has been . recorded on our adverse drug reaction database with the Yellow Card reference number I will keep you updated on progress, but in the meantime, we will continue to keep the safety of amiodarone under close review. Yours sincerely, Chief Executive Medicines and Healthcare products Regulatory Agency
RC Royal College of G P General Practitioners Dr Joint Honorary Secretary Ms Caroline Topping Se 26 May 2021 Dear Ms Topping, Regulation 28 Report to Prevent Future Deaths - touching on the death of Ann Coles Thank you for your report of 13 April 2021. | am responding on behalf of the Royal College of General Practitioners as Joint Honorary Secretary to Council. Firstly, can | convey our condolences to the family and friends of Ann Coles. | was saddened to read of Ann's passing. The Royal College of General Practitioners (RCGP) is the largest membership organisation in the United Kingdom solely for GPs. It aims to encourage and maintain the highest standards of general medical practice and to act as the ‘voice’ of GPs on issues concerned with education; training; research; and clinical standards. Founded in 1952, the RCGP has just over 54.000 members who are committed to improving patient care, developing their own skills and promoting general practice as a discipline. | observe that a matter of concern from your inquest is as follows: The evidence showed that a potential side effect of amiodarone medication is that it can cause toxicity which effects 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. By way of background, a number of medications are used to control the rhythm of the heart, most commonly beta blockers and calcium channel blockers. Amiodarone is a medication that has been used for many years and whilst effective, is known to have a range of short and longer term side effects. Details can be accessed in the British National Formulary here Given these side effects it considered to be at least a second or third line drug and for this reason, would be Royal College of General Practitioners 30 Euston Square, London, NW1 2FB rcgp.org.uk Patron: HRH The Duke of Edinburgh (1972-2021) | Registered Charity Number 223106 initiated by a cardiologist or consultant physician, who would frequently then monitor the patient on a regular basis. Areview of the evidence shows that the respiratory side effects of amiodarone can be relatively frequent - about 5%, with higher doses making side effects more common (see here). The British National Formulary makes a recommendation regarding the regular assessment of thyroid function and that the patient should have a Chest X Ray prior to starting treatment with amiodarone. There is no other recommendation regarding the ongoing monitoring of lung function or a periodic chest X Ray. 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, | recommend that you request the MHRA comment upon this matter. Contact details are here. I trust that this reply is helpful and if you have any questions, please do not hesitate to contact me. Yours sincerely, k Joint a — a Council Royal College of General Practitioners Cc: Professor | i of the Royal College of Physicians
From the Registrar Dr . Royal College of Physicians 11 St Andrews Place Regent’s Park London NW1 4LE www.rcplondon.ac.uk Ms Caroline Topping HM Coroner’s Court Station Approach Woking Surrey GU22 7AP 27 May 2021 Dear Ms Topping, Re: Regulation 28 – Ann Coles Issued: Received: Responded: 13 April 2021 13 April 2021 27 May 2021 Thank you for sending your Section 28 notice to the President of the Royal College of Physicians. This reply is on behalf of the organisation following consultation with appropriate officers and partners. In particular we have consulted with three experts in the British Cardiovascular Society and British Heart Rhythm Society. Summary of 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. Details of Response Matters of Concern “The evidence showed that a potential side effect of amiodarone medication is that it can cause toxicity which effects 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”. Pulmonary toxicity is a well-recognised side effect of amiodarone and it is considered to be “common” in the British National Formulary. Guidance in October 2020, from the National Institute for Health and Care Excellence (NICE), Amiodarone – not initiated in primary care 1 is clear that this drug should have limited indications and reasserts how it should be initiated and then monitored. Re: Regulation 28 – Ann Coles Before starting treatment, patients should have a chest x-ray but there is no requirement for routine pulmonary monitoring thereafter. The emphasis is one of ongoing drug review and if pulmonary toxicity is suspected then immediate specialist review. The focus should be on shared care guidelines agreed between local hospital trusts and their primary care clinical commissioning groups. The RCP recommends adherence to such shared care guidelines and that arrangements for review of medications are in line with the recent NICE guidance (link below). https://cks.nice.org.uk/topics/atrial-fibrilaation/prescribing-information/amiodarone-not-initaited-in- primary-care/ We hope that these recommended actions will help prevent future problems of this nature. Yours Sincerely, Dr Registrar, Royal College of Physicians
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