Prevention of Future Deaths reports · 2019

Maureen Milton

Regulation 28 report to prevent future deaths, reference 2019-0396, written 22 Nov 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report22 Nov 2019
Reference2019-0396
DeceasedMaureen Milton
CoronerMargaret Jones
Coroner areaStaffordshire (South)
CategoryOther related deaths
Sourcejudiciary.uk record · original PDF
Responses published3

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.

| | REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO:

1. RT HON MATT HANCOCK MP SECRETARY OF STATE FOR HEALTH
AND SOCIAL CARE

THE CHIEF EXECUTIVE — NATIONAL INSTITUTE FOR HEALTH AND
CARE EXCELLENCE

. DUNCAN SELBIE, CHIEF EXECUTIVE PUBLIC HEALTH ENGLAND

. THE CHIEF EXECUTIVE, BRITISH MEDICAL ASSOCIATION

THE CHIEF EXECUTIVE, CARE QUALITY COMMISION

_ THE MANAGER TRENT AND DOVE SOCIAL HOUSING

N

Oanhw

CORONER

| am Mrs Margaret Joy Jones assistant coroner for the coroner area of Staffordshire
South.

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 22.08.2019 | commenced an investigation into the death of MAUREEN MILTON
AGED 74. The investigation concluded at the end of the inquest on 20.11.2019. The
conclusion of the inquest was ACCIDENTAL DEATH, with the medical cause of
death recorded as “1a Burns”.

CIRCUMSTANCES OF THE DEATH

The deceased was 74 years of age, she had poor mobility and was something‘of a
recluse. She was known to be a very heavy smoker. Carers had identified that she
was at risk of fire and consequently a safeguarding referral had been made in July
2019. On the 25"" July 2019 she refused to have her smoke alarm linked to her first
call alarm. At 0911 hours on the 18" August 2019 Staffordshire Fire and Rescue
were called to her flat in Burton upon Trent by neighbours. On arrival they were
confronted with a smoke-filled property. The deceased was recovered from the
lounge and pronounced dead at the scene. Fire investigations identified the source
of the fire to be a cooks (long) match used to attempt to light a cigarette coming into
contact with clothing (probably a nightdress) worn by the deceased whilst she sat in
an armchair in the lounge of the property. There was evidence of petrol based
emollient cream which she was likely to have used and which probably soaked her
clothing. This would have acted as an accelerant to the fire. Toxicology identified 4
low level of carboxyhaemoglobin and the cause of death was burns. ‘

wy

CORONER'S CONCERNS ores

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. —

Evidence given by fire investigators was that they are increasingly attending fires
involving (mostly) the elderly where there is evidence of petrol based emollient
cream in use. The petrol base is found in a significant number of prescribed creams
and creams (such as moisturisers) which are readily available over the counter.
This cream impregnates clothing and is not washed away during a normal washing
programme. In the event of a fire the victim is rapidly engulfed by flames with little
chance of survival. The cause of death is generally burns, not inhalation of smoke.
The concern is the lack of awareness of this problem by medical professionals,
carers, victims and their families. It is felt appropriate heighten awareness of this
growing problem amongst health professionals and others who work in the field of
prescribing such creams and those caring for patients using petrol based
emollients.

i

ACTION SHOULD BE TAKEN

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

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this
report, namely by 17.01.2020 I, 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: (family member), a West Midland Fire
Service, and Staffordshire Fire Service

| 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.

22.11.2019 SIGNED BY CORONER ares

Margaret J Jones M4,

LHM Senior Coroner

Staffordshire (South)

Coroner’s Office

No 1 Staffordshire Place
Stafford

ST16 2LP

Tel No: 01785 276127
Fax No: 01785 276128

www.staffordshire.gov.uk
sscor@staffordshire.gov.uk

Responses

3 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.

Response from Department of Health and Social Care (PDF)
e From Nadine Dorries MP

Pari tary Under Secretary of State for Mental Health,

Department amen Sulide Prevention | and Patient Safety
of Health &

H 39 Victoria Street

Social Care ‘ctor Siveet

SW1H OEU

Your Ref: AAH/RE152021 020 7270 4850

Our Ref: PFD-1197497

Mrs Margaret J Jones

HM Assistant Coroner, Staffordshire (South)
1 Staffordshire Place

Stafford

ST16 2LP

Daw Ms, Yes

Thank you for your correspondence of 22 November 2019 to Matt Hancock about the
death of Mrs Maureen Milton. | am replying as Minister with responsibility for patient
safety.

2 | 5& January 2020

Firstly, | would like to say how saddened | was to read of the tragic circumstances of Mrs
Milton's death. | offer my sincere condolences to Mrs Milton’s family and loved ones.

In preparing the response to your report, Departmental officials have taken advice from the
Medicines and Healthcare products Regulatory Authority (MHRA) which is an executive
agency of the Department of Health and Social Care and is responsible for ensuring that
medicines and medical devices available in the UK meet applicable standards of safety,
quality and efficacy.

The matters of concern in your report are that there is a lack of awareness among
healthcare professionals, patients and their carers, of the fire risk associated with the use
of paraffin-based emollient creams; and that paraffin is found in a number of prescribed
creams as well as creams such as moisturisers that are readily available over the counter.

The MHRA advises that it most recently communicated information about the risk of
severe and fatal burns with paraffin-containing and paraffin-free emollients in December
2018 through a press release and an article in Drug Safety Update’. These
communications resulted from an in-depth review of this issue by the MHRA’s independent
expert advisory committee, the Commission on Human Medicines (CHM).

Following that review, the MHRA has convened a stakeholder group that includes
representatives from the fire service, healthcare professionals and their representative

bodies, organisations that provide guidance to health and social care workers, patient
representatives and organisations that speak for relevant patient populations such as the
National Eczema Society. The stakeholder group is designing and optimising sustainable
training and educational resources for healthcare professionals and the public and their
method of distribution and access, to ensure these are impactful and maintain long-term
awareness of the risk of emollient creams.

| am advised that the group has met twice, most recently on 10 December 2019, and is
working towards producing a toolkit of resources for patients, their carers’, healthcare
professionals, health organisations and healthcare professional educators. The
Government welcomes pians by the MHRA to officially launch the toolkit in 2020. This will
be accompanied by a MHRA press release and stakeholders will propagate the key
messages through their networks at the same time.

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

Ved

NADINE DORRIES
Response from Nice (PDF)
N | C National institute for 10 Spring Gardens
Health and Care Excellence London
SWI1A 2BU

United Kingdom

+44 (0)300 323 0140
9 December 2019

Mrs Margaret Joy Jones
HM Assistant Coroner
Staffordshire South
Coroner’s Office

No 1 Staffordshire Place
Stafford

S$T16 2LP

HM CORONER'S OFFICE
STAFFORDSHIRE SOUTH

1 1 DEC 201

Our ref: EH-303143

Dear Mrs Jones,

| write in response to your correspondence, dated 22 November 2019, regarding the tragic
death of Maureen Milton. We have considered the circumstances surrounding Ms Milton’s
death, and the concerns raised in your report — that there needs to be heightened
awareness amongst health professionals, patients and carers about petro!-based emollients
being flammable.

We do not consider that tnere is any action required from NICE on this issue.

NICE does not have a role in overseeing the safety of medicines and medical products, or in
ensuring appropriate warnings on the labels of such products. In the UK, this Is the
responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). In
addition, NICE does not have a role in running safety awareness or educational campaigns
aimed at professionals or patients and carers. The responsibility for this would rest with
organisations such as the MHRA and other healthcare regulators, professional bodies and
voluntary organisations and charities.

Prescribers are expected to refer to a medicine's clinical and safety information to help
inform prescribing decisions made with patients. This includes being familiar with guidance
within the British National Formulary (BNF). This expectation is set out in the General
Medical Council's publication on ‘Good practice in prescribing and managing medicines and
devices’, within the section titled: Keeping up to date and prescribing safely.

The British National Formulary (BNF) provides prescribers and other healthcare
professionais with information about the appropriate selection, prescribing, administration
and monitoring of medicines. The BNF is a joint publication of the British Medical Association
and the Royal Pharmaceutical Society. It is accessible from the NICE website. The BNF
contains information on emollient and barrier preparations which includes advice from the

www.nice.org.uk | nice@nice.org.uk

MHRA/Commission on Human Medicines (CHM) (dated December 2018) warning about the
risk of severe and fatal burns with paraffin-containing and paraffin-free emollients. The BNF
also contains cautionary and advisory labels regarding individual emollient products that
warn, for example, where such products are flammable.

It's not clear whether Ms Milton was using an emollient for dry skin or a specific health
condition such as eczema. The NICE website features clinical knowledge summaries (CKS)
which are concise summaries of current evidence and best practice for primary care
professionals, such as GPs. The CKS advice on eczema — atopic includes the following
information: “People who need to use large quantities (more than 100 g) of any paraffin-
based product should regularly change clothing, bedding, or dressings which become
impregnated with the product and keep away from naked flames, as there is a risk of

fire [ABPI, 2016a]”.

We consider that appropriate information and warnings are available to prescribers
regarding the risks of fire associated with the use of paraffin-based emollient products, and
that there is nothing specifically NICE can do to add to this. As explained above, an
awareness or educational campaign for professionals, patients or carers on this important
issue would not fall within our role.

Yours sincerely, -~

Sir Andrew Dillon
Chief Executive
Response from Public Health England (PDF)
Public Health
England

Protecting and improving the nation’s health

Public Accountability Unit Tel: 020 8327 6920
Wellington House
133-155 Waterloo Road www.gov.uk/phe

London SE1 8UG
By email and recorded delivery

sscor@staffordshire.gov.uk
Our ref: 28/11/ab/911

7 January 2020

Dear Ms Jones
Re: Coroners Investigation
Thank you for sending the attached report for PHE’s consideration.

Under the Coroners and Justice Act 2009 please find below Public Health England's
response in relation to the investigation of the death of Maureen Milton.

We have reviewed the report and Public Health England have no comments to add
as the report refers to the risks of petroleum-based emollients/skin creams which
have been implicated in fire deaths prescribed to the elderly, as they act as an
additional fuel.

As the skin creams are medicines, the Medical and Healthcare products Regulatory
Agency (MHRA) would be better placed to respond on this occasion.

Please do not hesitate to contact PHE should we be of any further assistance in this
matter.

Yo ert

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