Source · Prevention of Future Deaths

Chand Ali

Ref: 2019-0085 Date: 7 Mar 2019 Coroner: Alison Hewitt 1 response identified · 1 indexed addressee View PDF

AI-generated concerns summaryCyclizine is routinely administered to heart failure patients without individual risk assessment, and there is no system to balance its risks against clinical need. The hospital does not monitor deaths following its use or review alternative antiemetics.

Date 7 Mar 2019

56-day deadline 2 May 2019 stated in the report

Responses identified 1 of 1

Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary

Cyclizine is routinely administered to heart failure patients without individual risk assessment, and there is no system to balance its risks against clinical need. The hospital does not monitor deaths following its use or review alternative antiemetics.

View full coroner's concerns

As stated above, cyclizine is an antiemetic which, according to the British National Formula, must be used with caution for patients suffering severe heart failure, especially if it is administered intra-venously.

The evidence revealed that cyclizine is administered to heart failure patients at St. Bartholomew’s Hospital, including those suffering severe heart failure, as the routine or standard antiemetic and without consideration of its likely effect on the individual patient in question. There is no system in place in the hospital requiring the prescriber to balance any risk to the patient arising from the use of cyclizine against the patient’s clinical need for it, in order to justify its prescription.

Further, whilst it was said that the Hospital was not aware of any pattern or trend of deaths following the administration of cyclizine, it was accepted that the actual incidence of such deaths was not, in fact, known. It was accepted that monitoring and analysis of all deaths following the recent use of cyclizine would be needed in order to establish a reliable picture.

It was also apparent from the evidence that there had been no comprehensive review of other available antiemetics in order to explore whether there exists and effective alternative antiemetic which is not subject to a caution in the British National Formula as to its use.

Responses

1 respondent

Barts Health NHS Trust

NHS Trust

Indexed date: 26 Jun 2019 PDF

AI-classified response stance Noted

AI-generated response summary

• The Trust's lead pharmacist completed a review of the evidence for cyclizine use in severe heart failure and considered alternative anti-emetic drugs. • The Trust stated it would warn all teams of the risks associated with cyclizine in heart failure patients.

View full response

Dear Ms Hewitt

RE: Chand Ali (deceased), Regulation 28 Report to Prevent Future Deaths.

In response to this regulation 28 report our lead pharmacist for Barts Heart Centre, , has undertaken an extensive review of the evidence available to support the caution highlighted in the British National Formulary for use of Cyclizine in patients with severe heart failure along with consideration of alternative anti-emetics that are available for our use.

I have enclosed report but in summary, he has identified that the evidence base for this caution is very limited and its validity to clinical practice remains questionable. He has considered the 3 alternative anti-emetic drugs commonly used in our hospital but each of these come with their own cardiac cautions and do not offer a suitable alternative to the use of cyclizine.

As instructed, we will warn all our teams of the risks of cyclizine in heart failure patients. However, it is inevitable that cyclizine will still be used in some patients with heart failure as it may be assessed as the best option in many situations.

Report sections

Investigation and inquest

I commenced an investigation into the death of Chand Ali on 14th December 2017. The investigation concluded at the end of the inquest on 28th February 2019.

Circumstances of the death

The Deceased was a 78 year old man who suffered severe, end-stage, heart failure and was diabetic. On the 7th July 2017 he attended the outpatient heart failure clinic at St Bartholomew’s Hospital for review and was found to have developed significant fluid overload and decompensated heart failure and, in consequence, at about 3pm he was admitted to Ward 6D of the hospital. Upon admission and over the following hours the Deceased was alert and responsive. At about 5.20 pm he was given an intra-venous dose of cyclizine, an antiemetic which, according to the British National Formula, must be used with caution for patients suffering severe heart failure. At about 6.45 pm he was found to have a low blood glucose level and this was treated with the provision juice and food, which he drank and ate, and the administration of glucogel. Subsequently, at about 7.20 pm, he was found to be unresponsive and his death was pronounced at 7.50 pm. On the balance of probabilities the Deceased’s death resulted from his decompensated heart failure. The possibility that the dose of cyclizine contributed to the heart failure and death cannot be ruled out but, on the evidence available, could not be said to be probable.

The medical cause of death was :

Ia Decompensated Heart Failure Ib Ischaemic Heart Disease II Chronic Renal Failure, Diabetes

My conclusion as to the death was : Natural Causes

Action should be taken

In my opinion action should be taken to prevent future deaths by addressing the concerns set out above and I believe you have the power to take such action.

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Shared signals

Report details

Reference: 2019-0085
Date of report: 7 March 2019
Coroner: Alison Hewitt

Responses identified

Responses identified 1 of 1

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 2 May 2019 (stated in the report).

Sent to

Barts Health NHS Trust

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk.

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