Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0424, written 30 Nov 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 30 Nov 2016 |
|---|---|
| Reference | 2016-0424 |
| Deceased | Marjorie Bassendine |
| Coroner | Karen Henderson |
| Coroner area | Surrey |
| Category | Care Home Health related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. MHRA 2. President, Royal College of Psychiatrists 3. Mr Jeremy Hunt, Department of Health CORONER lam Karen HENDERSON, Assistant Coroner for the coroner area of Surrey CORONER’S LEGAL POWERS | 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. INVESTIGATION and INQUEST On 9th October 2015 | commenced an investigation into the death of Marjorie Cybil Bassendine, 98 years of age. The investigation concluded at the end of the inquest on 13 October 2016. The medical cause of death given was: 4a, Cardiac Arrhythmia 1b. Long QT Syndrome ic Therapeutic drug use 2.- My conclusion was: Died from a recognised complication of necessary therapeutic agents. CIRCUMSTANCES OF THE DEATH Despite her advanced age, Mrs Bassendine was a relatively fit 98 year old lady who lived independently in a care home. On the 2" October 2015 Mrs Bassendine was eating breakfast in the dining room of her residence when she was observed by several fellow residents sitting at the same table to suddenly collapse. Despite active and prompt resuscitation by the care home staff and subsequently by the paramedics who attended, Mrs Bassendine did not recover and she was declared dead at the care home shortly thereafter. A Post mortem examination was undertaken and it was thought the cause of death was a consequence of choking by the pathologist finding food in the lungs and airways. However, during the hearing | heard no evidence that there was any choking prior to the collapse. The collapse was sudden and Mrs Bassendine appeared to die immediately. There was no further signs of life despite active and prompt resuscitation by the staff at the care home and subsequently by the paramedics who attended after a 999 call was made. Mrs Bassendine had no history of choking and was able to eat what she wanted, when she wanted. | heard evidence that Mrs Bassendine had been prescribed Olanzapine and Mirtazapine as well as Indapamide and that this combination of drugs can cause long QT syndrome. It was also noted that her dose of Mirtazapine had recently increased. In the absence of any circumstantial evidence and with direct eyewitness accounts of the nature of the collapse | concluded that it was more likely than not Mrs Bassendine’s collapse was a consequence of a cardiac arrhythmia rather than by choking and the arrhythmia was more likely than not to have arisen as a consequence of long QT syndrome from the combination of drugs she was taking to control her distressing depression, ! also heard evidence that there had been no assessment of her cardiac status including an ECG despite this combination of Olanzapine, Mirtazapine and Indapamide medication increasing the risk of developing long QT syndrome. CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise for concern. In my opinion there is a risk that future death will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: 1. To recognise use of multiple psychotropic medication has the potential to prolong the QT interval. 2. To undertake an Electrocardiogram (ECG) prior to commencing such medication. 3. To undertake regular ECG’s to ensure long QT syndrome has not developed and to help plan continuing treatment. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you and your organisation: MHRA and the Royal Colleges of Psychiatrists and General Practitioners have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of its date; | may extend that period on request. Your response must contain details of action taken or proposed to be taken, setting out the timetable for such action, Otherwise you must explain why no action is proposed. COPIES and PUBLICATION | have sent a copy of m = to the Chief Coroner and to the following Interested Persons: ees) (Son), President, Royal College of Physicians who may find it useful or of interest, | 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. DATE: 30" November 2016 SIGNED: Dr Karen Henderson
2 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.
OFFICIAL-SENSITIVE Ms Karen Henderson Assistant Coroner for the coroner area of Surrey HM Coroner’s Court Station Approach Woking Surrey GU22 7AP MHRA 151 Buckingham Palace Road London SW1W 9SZ United Kingdom www.gov.uk/mhra 20 January 2017 Dear Ms Henderson Coroners and Justice Act 2009 – Regulation 28 Report following the Inquest into the death of Mrs Marjorie Cybil BASSENDINE Thank you for your letter dated 30th November 2016, enclosing your Report under Regulation 28 following the Inquest into the death of Mrs Marjorie Cybil BASSENDINE. I can confirm that the details of your report have been added onto our Adverse Drug Reaction database, under the reference number In your report you raise concerns regarding the combination of olanzapine, mirtazapine and indapamide increasing the risk of developing long QT syndrome. 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. 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. In conclusion, all three medicines’ SmPCs already include warnings regarding the risk of QT prolongation, particularly when these medicines are used in combination with other medicines which also cause QT prolongation. On review of the warnings we consider them to be appropriate and to reflect the available data for the individual products. OFFICIAL-SENSITIVE 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. Yours sincerely, Dr Ian Hudson, Chief Executive Officer Medicines and Healthcare products Regulatory Agency 151 Buckingham Palace Road, London, SW1W 9SZ www.mhra.gov.uk
HM Coroner’s Court ROYAL COLLEGE OF
Station Approach PSYCHIATRISTS
Woking
Surrey
GU22 7AP
Letter to Dr Karen Henderson, Assistant Coroner for the coroner area of Surrey.
From Professor Sir Simon Wessely, President
Friday 13 January 2017
Dear Dr Henderson,
Re: Mrs Marjorie Sybil Bassendine (Deceased), Regulation 28 Report to
Prevent Future Deaths.
Thank you for sending me a copy of this report and I note that copies have also
been forwarded to Mr Jeremy Hunt (Department of Health) and the MHRA to
whom I have also copied this reply. May I begin by communicating my
condolences to the family of Mrs Bassendine. I note the matters of concern
detailed in your report, namely:
1. To recognise use of multiple psychotropic medication has the potential to
prolong the QT interval;
2, To undertake an Electrocardiogram (ECG) prior to commencing such
medication;
3. To undertake regular ECG’s to ensure long QT syndrome has not
developed and to help plan continuing treatment.
I also note that you think that action should be taken to prevent future deaths
and you belive that the MHRA and the Royal Colleges of Psychiatrists and
General Practitioners have the power to take such action.
Actions planned by the Royal College of Psychiatrists:
1. I shall liaise with the Chair of our Special Committee for
Psychopharmacology to publicize these matters to the members and
fellows of the RCPsych;
2. I shall liaise with the Chair of the Faculty of Old-Age Psychiatry to
determine the best way to raise these issues with old-age psychiatrists;
Royal College of Psychiatrists registered office: 21 Prescot Street, London, El 8BB UK Tek +44 (0)20 7235 2351 Fax: +44 (0)20 3701 2761
The Royal College of Psychiatrists is a charity registered in England and Wales (228636) and in Scotland (SC038369)
NO HEALTH WITHOUT MENTAL HEALTH
weww.rcpsych.ac.uk
3. We will review our continuing medical education initiatives to ensure that
this issue is comprehensively covered in RCPsych material;
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.
I hope that these endevours will help reduce the risks of further deaths of this
nature.
Kindest regards (
('A rx
Professor Sir Simon Wessely
President
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