Prevention of Future Deaths reports · 2019

Abdeslam Benelghazi

Regulation 28 report to prevent future deaths, reference 2019-0337, written 10 Oct 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report10 Oct 2019
Reference2019-0337
DeceasedAbdeslam Benelghazi
CoronerMaria Voisin
Coroner areaAvon
CategoryAlcohol, drug and medication related deaths · Mental Health related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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.

M. E. Voisin
Her Majesty’s Senior Coroner
Area of Avon

10th October 2019 REF: 8813

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO:

The Rt Hon Matt Hancock, MP
Secretary of State for Health and Social Care

a CORONER

lam M E Voisin Senior Coroner for Area of Avon

2 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.
http://www. legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7

http://www. legislation.gov.uk/uksi/2013/1629/part/7/made

3 INVESTIGATION and INQUEST

On 10/01/2018 | commenced an investigation into the death of Abdeslam BENELGHAZI. The investigation
concluded at the end of the inquest on 9th October 2019.

The medical cause of death: 1a) combined effects of methadone, zuclopenthixol, gabapentin,
clonazepam.

The conclusion of the inquest was: Accident contributed to by neglect with a narrative which stated “As
the jury, we conclude that the inappropriate prescribing of combined medications alongside the failure
to adequately monitor and escalate concerns significantly contributed to the death of Abdeslam
Benelghazi”

4 CIRCUMSTANCES OF THE DEATH

The deceased, known as Abde throughout the inquest was a patient detained under Section 2 of the
Mental Health Act.

The medical diagnosis for Abdé being schizophrenia co-existing with mood changes known as schizo-
affective disorder. This was treated with the anti-psychotic zuclopenthixol and mood stabilizer sodium
valproate. :

The deceased was also taking gabapentin for chronic neuropathic pain and methadone to moderate,
treat and to cease his use of heroin. The last recorded time that Abde had methadone was 35mgs on 30"
November 2017.

Telephone 01275 461920
Email AvonCoronersTeam @bristol.gcsx.gov.uk Website www.avon-coroner.com
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL

In addition he was prescribed clonazepam. This prescription was started when Abde was at the Cygnet
Hospital in Weston a —7™ December 2017) when he was not initially taking methadone, the
Consultant said clonazepam and diazepam were prescribed to help with withdrawal. He was given 20mgs
of methadone at the Cygent Hospital on 5" and 6" December.

When the deceased was transferred to The Long Fox Unit at Weston General Hospital on the 7”
December 2017 his prescription.of methadone was increased and the clonazepam remained. | attach a
list of the medications prescribed and administered.

The jury found in that...

“the factors that contributed to his death include: :

i) Increasing the dosage of methadone beyond the normal limits set out in recognised guidance:
ii) Continuing clonazepam, a drug known to be associated with an increased risk of death when
taken in conjunction with opiates, without establishing the reason for the original prescription:
iii) Having taken the steps set out above, failing to.put in place an adequate pharmacological
care plan to assess, monitor and review the patient and to communicate it to relevant staff:
iv)Upon the patient presenting with signs of over sedation and/or reduced consciousness on at
least three occasions in a 48 hour period, the failure of the medical and nursing team,
notwithstanding the absence of a pharmacological care plan, to initiate any medical
investigation or intervention including enhanced physical and/or non-contact observations. And
furthermore the failure to administer naloxone”

th

Abde died on 9°" December 2017.

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. —

An expert was instructed to assist in this case rarely “+> practices in general adult
psychiatry with a special interest in the psychiatry of addition.

He agreed with the medical cause of death, that the drugs Abde was prescribed specifically methadone
with other sedative medications zuclopenthixol, gabapentin and clonazepam can cause a combined

effect of central nervous system depression and respiratory depression increasing the risk of sudden
death.

He expressed a particular concern in relation to the prescribing of clonazepam with methadone. The
reasons he gave were that clonazepam has a long half life; side effects include respiratory depression;
that one supplier of clonazepam states “concomitant use of clonazepam with opioids may result in
sedation, respiratory depression, coma and death”; that clonazepam is a means of delivering a high
equivalent dose benzodiazepine without exceeding BNF limits.

He said that in this case clonazepam may have been the drug that tipped the balance.

Telephone 01275 461920
Email AvonCoronersTeam @bristol.gesx.gov.uk Website www.avon-coroner.com
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL

ACTION SHOULD BE TAKEN

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

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report, namely by g*
December 2019. |, 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.

COPIES and PUBLICATION

| have sent a copy of my report to the chief coroner and to the following interested persons — the family
of Mr. Benelghazi and Avon & Wiltshire Mental Health NHS Trust.

| 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.

10/10/2019

Signature.
M E Voisin-Sénior Coroner Area of Avon

Telephone 01275 461920
Email AvonCoronersTeam@bristol.gcsx.gov.uk Website www.avon-coroner.com
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL

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 Department of Health and Social Care (PDF)
dor From Nadine Dorries MP

D epartm ent Parliamentary Under Secretary of State for Mental Health,

Suicide Prevention and Patient Safety
of Health &

i 39 Victoria Street
Social Care a Street
SW1H 0EU

020 7210 4850

Your Reference: 8813
Our Reference: PFD-1193673

Mrs Maria Eileen Voisin
HM Senior Coroner, Avon
HM Coroner's Court

The Courthouse

Old Weston Road

Flax Bourton BS48 1UL

om ‘January 2020

Thank you for your correspondence of 10 October 2019 to Matt Hancock about the death
of Abdeslam Benelghazi. | am replying as Minister with responsibility for mental health
services and patient safety and | am grateful for the additional time in which to do so.

Firstly, | would like to say how very saddened | was to read of the circumstances of Mr
Benelghazi’s death and | extend my deepest sympathies to his family and loved ones.

We must do all we can to learn from regrettable incidents such as these, especially when
they involve vulnerable individuals detained under the Mental Health Act, to ensure the
safety of health services and prevent future deaths. | am clear that the Avon and Wiltshire
Mental Health Partnership NHS Trust must take forward the learning from this inquest in
order to avoid another such tragic death.

In considering the concerns in your report, Departmental officials sought the advice of the
Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute
for Health and Care Excellence (NICE).

In relation to the prescribing of methadone beyond the normal limits and the continuing
administration of clonazepam, a drug known to be associated with an increased risk of
death when taken with opioids, | am advised as follows.

The increased risk of respiratory depression, coma and death when benzodiazepines and
opioids are used together is known and changes to the product information highlighting
these risks was recommended following an EU review in 2018. Wording for inclusion in
the product information for both benzodiazepines and opioid medicines was published that
year",

The MHRA has reviewed all licences for clonazepam and methadone and noted that not
all marketing authorisation holders (MAH) have applied the appropriate amendments. The
MHRA is therefore contacting the MAH holders to request updates to the product
information and the outstanding changes are expected to be implemented within three to
six months.

In reviewing the product information for methadone, the MHRA has noted that several
products contain information regarding respiratory depression and state that due to the
slow accumulation of methadone in the tissues, respiratory depression may not be fully
apparent for a week or two. The MHRA agrees that this important information should be
included in all methadone products and has committed to working with MAH holders to
update the product information within the timeframe above.

In addition, the MHRA will remind healthcare professionals of the risks of respiratory
depression when benzodiazepines and opioids are co-prescribed via an article in its Drug
Safety Update early this year.

The MHRA has added this case to its Yellow Card database (reference number ADR
24445672). The Yellow Card Scheme is the UK system for collecting and monitoring
information on suspected adverse drug reactions (ADRs). The purpose of the Scheme,
run by the MHRA, is to provide an early warning that the safety of a product may require
further investigation.

As with all safety concerns, the MHRA will keep this particular issue under review and will
update product information further if necessary.

Prescribing decisions are made by clinicians who are responsible for taking into
consideration the dosage of medication prescribed and the combination of medicines
administered.

Prior to offering treatment, healthcare professionals are expected to carefully consider
information on the likely benefits of a treatment and balance these against possible
adverse side effects, interactions and contraindications before making decisions
appropriate to the circumstances of the individual (in consultation with them, and/or their
families and carers/guardian).

Sources of information include the British National Formulary (BNF?) and, as already
mentioned, a drug’s summary of product characteristics (SmPCs). SmPCs contain
information regarding the administration of medicines, and issues such as adverse side
effects, contraindications and special warnings. SmPCs are available on the electronic

https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h /Advice from CMDh/CMDh_ 372 2018 RevO 02 2014
8.pdf

2 https://onf.nice.org.uk/?utm_source=evidence_bnf redirect&utm medium=(other)&utm_campaign=old_site_ redirect

Medicines Compendium website? which contains up-to-date, easily accessible information
about medicines licensed for use in the UK.

The NICE website hosts the BNF, which is a joint publication of the British Medical
Association and the Royal Pharmaceutical Society. The BNF provides prescribers,
pharmacists, and other healthcare professionals with up-to-date information about the
selection, prescribing, dispensing and administration of medicines. A further source of
advice is the General Medical Council's prescribing guidance’.

In addition, healthcare professionals are expected to take account of NICE guidelines that
offer advice on clinical care based on evidence of best practice. In 2014, NICE published
Psychosis and schizophrenia in adults: prevention and management (CG178°), that
includes recommendations on when to offer psychotic medication and how to initiate and
monitor its use. NICE published technology appraisal guidance Methadone and
buprenorphine for the management of opioid dependence (TA114®) in 2007, that
recommends the treatments as options for maintenance therapy in the management of
opioid dependence and highlights the potential risks, including of respiratory depression
and interactions with other drugs. There are also NICE guidelines that make
recommendations on the use of clonazepam’ and gabapentin®.

In summary, a healthcare professional is expected to consider the patient’s circumstances
and the possible benefits and risks before making an informed decision about what
treatment might be appropriate for them.

In relation to the finding by the inquest jury of a failure to adequately monitor Mr
Benelghazi and to identify signs of over sedation, the General Medical Council’s (GMC)
Good practice in prescribing and managing medicines and devices, is clear that
prescribers must make sure that suitable arrangements are in place for monitoring, follow-
up and review, taking into account the patients’ needs and any risk arising from the
medicines. This is particularly important where the medicines prescribed have potentially
serious or common side effects.

The Nursing and Midwifery Council (NMC) is responsible for the standards of education of
undergraduate nurses and works to ensure that registered nurses have the knowledge and
skills they need to deliver high-quality, safe care on a consistent basis. The NMC’s Future

3 https:/Awww.medicines.org.uk/eme

4 https://www.gmc-uk.org/ethical-guidance/ethical-quidance-for-doctors/prescribing-and-managing-medicines-and-
devices

5 https://www.nice.org.uk/quidance/cg178/chapter/1-Recommendations#first-episode-psychosis-2

§ https:/Avww.nice.org.uk/quidance/ta114

7 https:/Awww.nice.org.uk/guidance/cg137

§ httos:/Avww.nice.org.uk/quidance/cg173

5 hitps:/Awww.gme-uk.org/ethical-quidance/ethical-quidance-for-doctors/prescribing-and-managing-medicines-and-
devices/reviewing-medicines

:
:

Nurse: Standards of proficiency for registered nurses’ specifies the knowledge and skills
that registered nurses must demonstrate when caring for people of all ages and across all
care settings.

It is expected that a registered nurse should be able to demonstrate the knowledge and
ability to respond proactively and promptly to signs of deterioration or distress in mental,
physical, cognitive and behavioural health and use this knowledge to make sound clinical
decisions and contribute to a comprehensive clinical plan that is compliant with the
employer's policy on monitoring and observing patients.

In response to changes to the National Early Warning Score (NEWS) parameters’, Health
Education England (HEE) is working in partnership with NHS England and NHS
Improvement and others, to support learning needs for the health and care workforce.
Learning resources have either been developed, are in development or are being planned
for staff working in secondary care, primary care, ambulance settings and mental health
settings. The resources consist of a number of case studies covering presentations
common to particular care settings. In response to your report, HEE advises that it will
ensure the development of a specific case study to cover opioid use and over sedation
when it develops the early warning score learning resource for mental health settings.

| am further advised that HEE is providing education and training opportunities for mental
health practitioners through the development of related competency frameworks and
teaching initiatives. HEE is working with health system stakeholders, subject matter
experts and people with lived experience, to develop guidance, endorsed by the Royal
Pharmaceutical Society, that sets out additional guidance, support, resources and learning
materials specifically related to prescribing in mental health.

On medicine safety more generally, the Government is committed to supporting the work
of the Medicine Safety Improvement Programme’?, led by NHS England and NHS
Improvement, which aims to increase safety across the medication pathway. The
programme will bring together a variety of projects to support medicine safety, from
improvements to technology and the roll out of electronic prescribing, to improved training
for health and care professionals in the safe use of medicines.

The Government recognises the need to modernise the Mental Health Act 1983 to ensure
it is used in a fair and just way and that people are not detained any more than is
necessary. We want to make sure that people subject to the Act receive better care, that
they have a much greater say in that care and that they are treated with the dignity and
respect they deserve. We will publish a White Paper in early 2020, which will set out the
Government's response to Sir Simon Wessely’s Independent Review of the Mental Health
Act. We will consult publicly on our proposals and will bring forward a Bill to amend the
Act when Parliamentary time allows.

10 https:/Avww.nmc.org.uk/globalassets/sitedocuments/education-standards/future-nurse-proficiencies.pdf

‘| https:/Awww.rcplondon.ac.uk/projects/outputs/national-early-waming-score-news-2

*? htips://improvement.nhs.uk/resources/national-medicines-safety-programme/

i

Finally, | have asked Departmental officials to bring the matters of concern in your report to
the attention of NHS England and NHS Improvement, the Care Quality Commission and
the Healthcare Safety Investigation Branch.

| hope this response is helpful. Thank you for bringing these concerns to my attention.

"\ ic SS, \ |
ade

rs NADINE DORRIES ~

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