Prevention of Future Deaths reports · 2019
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 report | 22 Aug 2019 |
|---|---|
| Reference | 2019-0263 |
| Deceased | Christopher Summerhayes |
| Coroner | Sarah-Jane Richards |
| Coroner area | South Wales Central |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Wales prevention of future deaths reports (2019 onwards) |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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
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.
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: Aa POSip, ‘ Oe ‘oS D> ‘Op, ¢ “says 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" Ltt % e Lp, O51, oe e 6 oo On % sae 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 An soa, aYYs 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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