Prevention of Future Deaths reports · 2019

Christopher Summerhayes

Regulation 28 report to prevent future deaths, reference 2019-0263, written 22 Aug 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report22 Aug 2019
Reference2019-0263
DeceasedChristopher Summerhayes
CoronerSarah-Jane Richards
Coroner areaSouth Wales Central
CategoryHospital Death (Clinical Procedures and medical management) related deaths · Wales prevention of future deaths reports (2019 onwards)
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

ANNEX A 

REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS (1) 

NOTE: This form is to be used after an inquest. 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

The Chief Executive Cardiff & Vale University Health Board  

1 

CORONER 

I am Dr. Sarah-Jane Richards, HM Assistant Coroner, for the coroner area of South 
Wales Central. 

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 

On  26  September  2018  an  inquest  was  opened  was  into  the  death  of  Mr.  Christopher 
Summerhayes  otherwise  known  as  Christopher  Harrington.  Enquires  led  by  the 
Coroner’s Office focused on the medical diagnosis and prescription management of this 
29 year old man. In parallel, the family has undertaken its independent enquiries and the 
Inquest has been adjourned to allow those of the family’s concerns which are within the 
scope of the Inquest, to be addressed as best as possible.  

The family were concerned about a previous incident of acute collapse which occurred 
on 11 August 2018, 5 weeks prior to Christopher’s death. The relevance being that upon 
emergency  admission  to  the  University  Hospital  of  Wales,  Christopher  was  correctly 
diagnosed  as  suffering  from  a  pneumonia  (adenovirus  positive)  and  was  successfully 
treated. However, the family had mis-understood the cause of this collapse was due to 
cardiac  arrest  which,  had  it  been  the  case,  would  have  required  a  full  cardiac  review. 
The  family  contends  that  had  such  a  review  been  undertaken  Christopher’s  coronary 
artery  atherosclerosis  noted  at  autopsy  would  have  been  identified,  treated  and  his 
death avoided. This is subject of an investigation by the Concerns Co-ordinator, Cardiff 
and  Vale University Health Board  instigated at the request of the family. Open reading 
the medical reports provided to me, I have concluded the misunderstanding arose from 
a  note  taken  at  the  scene  of  defibrillator  use.  While  one  was  present  no  shocks  were 
administered.   

The Coroner’s investigation concluded at the end of the inquest on the 20 August 2019.  
The  medical  cause  of  death  was  1a.  Ischaemic  Heart  Disease.  The  conclusion  of  the 
“Atypical  early  onset  coronary  artery 
inquest  was  a  narrative  determination 
atherosclerosis on a background of a large number of prescribed complex medications” 

4 

CIRCUMSTANCES OF THE DEATH 

Mr.  Christopher  Summerhayes  was  found  deceased  at  his  home  address.  He  had  a 
significant  medical  history  comprising  multiple  surgical  interventions  to  treat  his  double 
scoliosis  and  treatment  resistant  schizophrenia.  His  medications  numbered  around  12 
daily. Current advice to GPs is that an excess of 5 drugs requires concomitant protectant 
medications  and  places  the  patient  at  an  increased  risk  of  hospitalisation.  Christopher 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 was prescribed the following ‘complex’ drug regime daily:  

Analgesia:             Morphine 60mg, Naproxen 1gm, Paracetamol 2-4gms and Pregabalin 
                              600mg (also anti-anxiety); 
Gastro protectant  (from Naproxen):     Omeprazole 20 mg;  
Anti-psychotic:      Aripiprazole 10mg and Clozapine 600mg - prescribed and monitored 
                              by the Community Mental Health Team (CMHT); 
Anti-anxiety:          Lorazepam up to 2mg - prescribed and monitored by CMHT 
Hyperhidrosis:       Oxybutynin 5mg  
Laxative:                Senna 28mg and Lactulose 18.6-22.2gm 
Antibiotic:               Doxycycline 200mg 
Anti-acne:              Zineryt lotion 90mls (topical application) 

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 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)  In  relation 

to  Christopher  Summerhayes,  Clozapine  was  prescribed  as  a 
concomitant  medication  alongside  approximately  11  other  drugs  including  another 
anti-psychotic  medication.  Either  alone  or  interaction  with  other  prescribed 
medication, a large increase in weight occurred to >101kg (BMI 33.1) (reported side 
effect of clozapine) which had a ‘knock-on’ effect for his cholesterol and lipid levels 
and cardiovascular system. The usual dose is 200-450mg daily with the maximum 
dose being 900mg (BNF) which does not consider concomitant medications. Signs 
of  prescription  overdose  include  collapse  and  hallucinations  which  could  be 
mistaken  for  unresolved  symptoms  of  schizophrenias  i.e.  lack  of  drug  efficacy 
encouraging  dose  increase.  Blood  levels  of  clozapine  may  rise  in  response  to 
smoking cessation which Mr. Summerhayes had advised we was commencing.  

(2)  He  may  have  suffered  from  a  familial  lipid  disorder  (present  in  other  family 
members)  which  had  it  been  confirmed  would  likely  to  have  contraindicated 
Clozapine.  

6 

ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I believe you and your 
organisation have the power to take such action.  

1.  An  adverse  event  report  should  be  filed  with  the  Medicines  and  Healthcare 
products  Regulatory  Agency  in  respect  of  Clozapine  and  the  death  of  Mr. 
Summerhayes.  

2.  Where  more  than  5  medications  are  prescribed  the  drugs  be  examined  by  an 
associate  physician  or  pharmacist  for  adverse  interactions,  either  alone  or  in 
combination,  which  give  rise  to  medical  conditions  which  themselves  predict 
hospitalisation  and  shorten  longevity.  Consideration  would  be  for  automatic 
referral to an individual qualified to assess i) drug-drug interactions; ii) the risks 
posed  to  the  specific  patient  taking  into  account  age,  conditions  suffered, 
lifestyle and the length of time the drug has been prescribed; iii) dosing levels be 
‘signed-off’  by  the  qualified  individual;  and  iii)  all  prescribing  parties  and  the 
patient to be advised of the assessment outcome. 

3.  To  de-prescribe  where  appropriate  rather  than  accruing  an  increasing  list  of 
daily  medications  whereby  further  protectant  medications  are  required  to  be 
prescribed  with  the  risk  of  medication  induced  hospital  admissions  and  risk  to 
life. 

4.  Where there are two or more prescribing organisations (primary and secondary 
care) drug monitoring should be undertaken as mandated; by the responsible 
parties; and information promptly shared with all prescribers and their patients.  

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 7 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, 
namely by 25 October 2019.  I, the Coroner, may extend the period upon request. 

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 family who may find it useful or of interest. 

HeaIth Inspectorate Wales, Welsh Government; Cabinet Secretary for Health and Social 
Services; Chairman, Cwm Taf University Health Board; Medical Director of Cardiff and 
Vale Health Board. 
, South West Cardiff Community Mental Health 
Team; 
& Risk Service; 

, Concerns Co-ordinator Cardiff & Vale UHB 

, Butetown Medical Practice; 

, NWSSP Legal 

I am also under a duty to send the Chief Coroner Mr. Marcus Lucraft QC 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 

22nd August 2019 

SIGNED:                      

Dr. Sarah - Jane Richards, HM Assistant Coroner for South Wales Central 

3

Responses

1 response 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.

Response from University Health Board (PDF)
on G IG Bwrdd lechyd Prifysgol Executive Headquarters / Pencadlys Gweithredol
cy Caerdydd a'r Fro Woodland House Ty Coedtir

ol YMRU
S Cardiff and Vale Maes-y-Coed Road Ffordd Maes-y-Coed
c . 5 Cardiff Caerdydd
WALES | University Health Board = ¢piq guy CF14 4HH

Eich cyf/Your ref: 15077

Ein cyf/Our ref: LR-jb-11-7759

Welsh Health Telephone Network:

Direct Line/Llinel] uniongycho!: 02921 836010

Len Richards
Chief Executive
15 November 2019

Private & Confidential

Dr Sarah-Jane Richards

Her Majesty's Assistant Coroner
South Wales Central Coroner Area
Coroner's Office

The Old Courthouse

Courthouse Street

Pontypridd

CF37 1JW

Dear Dr Richards
Regulation 28 report — Mr Christopher Summerhayes

Thank you for your letter, dated 27 August 2019, following the inquest into Mr
Summerhayes death.

| have reviewed the points you have raised within the Regulation 28 report
which relates to the very sad death of Mr Summerhayes. My response has
been informed by colleagues within the Clinical Diagnostics and
Therapeutics, Primary Care and Intermediate Care and Mental Health Clinical
Boards. | am grateful to you for agreeing an extension to respond to you
whilst information was gathered to support our response.

| recognise that this will have been a difficult time for Mr Summerhayes family
and would wish to offer my sincere condolences on behalf of the University
Hospital Board (UHB).

For ease of reference, | will respond to each of the matters of concern you
have raised in turn:

e An adverse event report should be filed with the Medicines and
Healthcare products Regulatory Agency in respect of Clozapine
and the death of Mr Summerhayes.

| can confirm that the matter has been reported to the Medicines and
Healthcare products Regulatory Agency (MHRA).

Bwrdd techyd Pritysgal Caerdydd a'r Fro yw enw gweithredol Bwyrdd fechyd Lleol Prifysgol Caerdydd a'r Fro ‘ =
Cardiff and Vale University Health Board is the operational name of Cardiff and Vale University Local Health Board Fs, awe
Croesewe y Bwrod obebieeth yn Gymraeg neu Seeeneg Siemhawa byddwn yn cytethrebu & chi ym ech dewis wth Nt fydd gahebu yn Gymraeg yn creu unrhyw ced

The Board welcomes correspondence in Welsh or Enghah. We wil ensure that we wil communicate in your chosen language Comespondence m Welsh wil not lead to @ delay

| am able to advise that there is a requirement for patients taking
Clozapine to be registered with a service to monitor the medicine
during the course of their treatment with it. Additionally, when a
patient who is taking Clozapine dies or ceases to take it, the
manufacturer supplying the medication must be informed. The
monitoring service currently in place for Cardiff and Vale University
Health Board is via the Zaponex Treatment Access System (ZTAS)
which is provided by the medicine's manufacturer that we currently
use, called Leyden Delta. The necessary information was shared at
the time via ZTAS.

Where more than 5 medications are prescribed the drugs be
examined by an associate physician or pharmacist for adverse
interactions, either alone or in combination, which give rise to
medical conditions which themselves predict hospitalisation and
shorten longevity. Consideration would be for automatic referral
to an individual qualified to assess i) drug-drug interactions; ii)
the risks posed to the specific patient taking into account age,
conditions suffered, lifestyle and the length of time the drug has
been prescribed; iii) dosing levels to be ‘signed off by the
qualified individual; iv) all prescribing parties and the patient to
be advised of the assessment outcome.

The UHB has a Medicines Code in place and this was updated in
2018. It contains a section on medicines reconciliation. It sets out the
responsibilities of various healthcare professionals in this process,
including doctors, the pharmacy team and other prescribers.

The Pharmacy Directorate has a system in place of dedicated
pharmacists aligned to clinical directorates and Clinical Boards to
provide a source of support and expertise in medicines management.
A specialist mental health pharmacist supports prescribing in in-patient
mental health settings. The Primary Care and Intermediate Care
Clinical Board has a Medicines Management and Prescribing Team
who support related issues in primary care settings.

Guidance from the National Institute of Health and Care Excellence
(NICE) for assessing physical health of patients on Clozapine is
available on their website (www.nice.org.uk) and monitoring
arrangements are in place in line with this in the UHB.

The All Wales Medicines Strategy Group has produced a number of
guidance documents to promote polypharmacy reviews. These
documents can be viewed on their website which is www.awtnsg.org

Polypharmacy reviews are actively promoted to healthcare
professionals by the Pharmacy Directorate in secondary care and the
Medicines Management and Prescribing Team in primary care.

Bwrdd lechyd Prifysgol Caerdydd a’r Fro yw enw gwetthredol Bwyrdd Lechyd Lleol Prifysgot Caerdydd a'r Fro

Cardiff and Vale University Health Board Is the operationat name of Cartiff and Vate University Local Health Board

Croesaws y Burdd ohebiseth yn Gymraeg neu Seesneg Sterhawn byddwn yn cylathrebu & chu yn ech dew wth. Ni fydd gohebur yn Gymntaeg yn creu unthyw oedt

The Board welcomes correspondence in Weish or Englah. We wil ensure that we wil communicate in your chosen language Correspondence nn Welsh will not lead to 2 delay:

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Certain complex medicines are subject to formal shared care
arrangements to ensure that roles and responsibilities are clearly
defined.

The Primary Care and Intermediate Care team established a
Medicines Management Incentive Scheme with GPs to ensure that
medicines prescribed across care settings are added to the GP record
so there is a complete medicines record for patients on the GP
systems. The driver for this project was to promote patient safety but it
has seen cost-benefits. Education is provided to staff within GP
practices who are then required to identify their local process to ensure
that a patient's medication history is accurately updated prospectively.
Practices have also been asked to retrospectively add certain complex
medicines to the GP systems to ensure they are clearly recorded.

To de-prescribe where appropriate rather than accruing an
increasing list of daily medications whereby further protectant
medications are required to be prescribed with the risk of
medication induced hospital admissions and risk to life.

Principles for de-prescribing are embedded within the aforementioned
documents available regarding polypharmacy reviews at

WWww.awmsq.org

The Primary Care and Intermediate Care team has also developed
criteria to stop various medicines in a number of patient pathways of
care. The criteria are designed to guide healthcare professionals in
de-prescribing processes. An example of where this may be used is in
relation to analgesia that has been subject to long-term use.

Where there are two or more prescribing organisations (primary
and secondary care) drug monitoring should be undertaken as
mandated; by the responsible parties; and the information
promptly shared with all prescribers and their patients.

Prescribing in relation to Clozapine is undertaken as mandated. The
process is in place via ZTAS as outlined previously. The Primary Care
and Intermediate Care Clinical Board maintains a list of over 300
patients who are currently prescribed Clozapine within the UHB. The
team actively checks systems in GP surgeries to monitor the records
of all patients who are known to have Clozapine prescribed in
secondary care to ensure an interface with primary care.

The Medicines Management Incentive Scheme that | referred to earlier
was designed to ensure there is an accurate record of a patient's
medication within the GP's records and all practices in the Cardiff and
Vale UHB area are currently participating in this Scheme.

Bwrdd Lechyd Prifysgol Caerdydd a'r Fro yw enw gweithredo! Bwyrdd Iechyd Lleo! Prifysgol Caerdydd a'r Fro
Cardiff and Vale University Health Board Is the operational name of Cardiff and Vale University Local Health Board

Croesaws y Bwrdd ohebveeth yn Gymraeg neu Seesneg Sicrhewn byddwn yn cyfathreby d chi yn exch dewss iath Ny fyod gohebu yn Gymraeg yn creu unthyw ced
The Board welcomes correspondence in Welsh of Engtah We wil ensure thet we will communicate im your chosen language Carespondence n Welsh wil not lead fo 0 delay"

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A project proposal is in development by Mental Health Clinical Board,
Pharmacy and Information Technology to develop an_ interface
between PARIS (patient management and information software in use
in Mental Health and community services) and PMS (patient
management system) to improve the transfer of information. The
project aims to improve the interface between these systems and
introduce Medicines Transcribing and e-Discharge to mental health
wards with use of the Welsh Clinical Portal.

Your findings at Mr Summerhayes inquest are of relevance to all Clinical
Boards in the UHB. A copy of your Regulation 28 report and my response
will be shared with the Clinical Boards and Medication Safety Executive
Group. The Patient Safety and Quality Department will include the learning
from Mr Summerhayes sad death in a forthcoming newsletter.

| hope that the information set out in this letter provides you with the
assurance that the Health Board has fully considered the issues raised as a
consequence of Mr Summerhayes death, and has taken appropriate action in
response.

Yours sincerely
[7 Jpn. » ae

Martin Driscoll

Deputy Chief Executive
on behalf of

Len Richards

Chief Executive

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Bwrdd techyd Prifysgol Caerdydd a'r Fro yw enw gwerthredol Bwyrdd lechyd Lleol Prifysgol Caentydd a'r Fro cs <
Cardiff ond Vale University Health Board Is the operational name of Cardiff and Vale University Local Health Board say

Croesews y Bwrekd ohebieeth yn Gymraeg neu Sresneg Sicrhawn byddwn yn cytathrebu & chi yn exch dewns ech Nt fydd gohebu yn Gymreeg yn creu unrhyw edt
The Board wetcomes correspondence in Welsh or Enghsh. We mal ensure that we wil communicate 1 your chosen fenguage Correspondence # Welsh wil not lead to 2 delay”

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