Brian Bicat

Me

ay Alliance Pharmaceuticals Limited
(8 Avonbridge House, Bath Road, Chippenham, Wiltshire SN15 2BB

Telephone: +44 (0) 1249 466966. Fax: +44(0) 1249 466977
e-mail: info@alliancepharmaceuticals.com
www.alliancepharmaceuticals.com

26" September 2018 Your ref: MDF-HK/2544-2017

Mr M. D. Fleming

Senior Coroner

Her Majesty's Coroner

West Yorkshire (Western) Coroner Area
City Courts

The Tyrls

Bradford BD1 1LA

Dear Mr Fleming

Brian Leonard Bicat, deceased

Report to Prevent Future Deaths

Paragraph 7, Schedule 5 of the Coroners and Justice Act 2009 and
Regulations 28 and 29 of the Coroners (investigations) Regulations 2013

Thank you for your letter of 2 August 2018.

The safety of our products is something we take extremely seriously, and we are committed
to ensuring safety information is prominent, clear and readable.

We have identified the following areas where action can and will be taken:

1. Warnings of such risk displayed on all product packaging

2. Consider more prominent labels and alerts re fire hazard on product containers

3. Consider fire warning labelling on all emollients including those below 50%
content, making clear the mechanisms of the risk

1. Warnings of such risk displayed on all product packaging

We have completed a product labelling review to improve prominence, clarity and
content as well as ensuring consistency across the Hydromol range, regardless of
paraffin content. The revised product labelling, website and promotional materials is
expected to be available throughout the remainder of 2018 and 2019.

The labelling now states:

“If this product comes into contact with dressings, clothing and bedding the fabric can
be easily ignited with a naked flame. You should keep away from fire when using this
product."

Registered Office: Avonbridge House, Bath Road, Chippenham, Wiltshire SN15 2BB Registered in England No. 3250064

rec' al

5 SS Gt er

Fa Alliance Pharmaceuticals Limited

Badd A [. [ | A N C E Avonbridge House, Bath Road, Chippenham, Wiltshire SN15 2BB
Telephone: +44 (0) 1249 466966. Fax: +44(0) 1249 466977
e-mail: info@alliancepharmaceuticals.com

www.alliancepharmaceuticals.com

We continue to work with the MHRA and PAGB to input into the labelling review. If
changes are recommended by the MHRA, we commit to further updates, in addition
to the changes we have already implemented.

2. Consider more prominent labels and alerts re fire hazard on product containers

We will undertake an assessment of the labelling throughout the remainder of this
year, this activity will review all information from this event to determine any further
opportunities for improvement of the current labelling. The assessment will be
performed by a cross functional group of experts who have knowledge and
experience of Hydromol and its use. We will implement any required changes to the
product, product labelling or promotional materials which the risk assessment
identifies. We will also apply required labelling amendments to marketed paraffin
containing products, regardless of paraffin content.

Furthermore, any proposed changes to the labelling will be reviewed by user groups
who will support us in ensuring the intended message is understandable. We are also
engaging with West Yorkshire Fire Service to ensure the mechanisms of risk are
clearly stated on our labelling.

Any and all personnel in contact with healthcare professionals and the general public
will be updated appropriately to ensure communications are in line with, and convey,
the correct message which communicates the outcome of the assessment and any
subsequent labelling changes.

3. Consider fire warning labelling on all emollients including those below 50%
content, making clear the mechanisms of the risk

We are proactively working with the MHRA and PAGB to ensure a consolidated
warning is displayed on all product packaging, across industry. And we further
commit to revisiting warnings on the product packaging, or any supporting
processes, if additional information from the MHRA, trade bodies or any other expert
groups becomes available. ,

Alliance takes this issue extremely seriously and is working proactively to address the
issues raised by the coroner. Clearly this is a tragic incident and we hope that these
actions will help to prevent future incidents from occurring.

Yours sincerely

MA Bg

Peter Butterfield
Chief Executive Officer

Registered Office: Avonbridge House, Bath Road, Chippenham, Wiltshire SN15 2BB Registered in England No. 3250064

pena ied ise ba

2

of
ay

Mr M.D. Fleming

HM Senior Coroner for West Yorkshire (Western)
City Courts

The Tyrls

Bradford

BD1 1LA

Dear Mr Flemming

Brian Leonard Bicat (deceased): report to prevent further deaths
issued under Regulation 28 Coroners (Investigations) Rules 2013

We refer to the report to prevent further deaths dated 18 July 2018 (“the
Report’), issued following the inquest into the death of Mr Bicat and sent
to Bayer under cover of a letter dated 2 August 2018.

The Report indicates that, at the time of his death, Mr Bicat suffered from
leg ulcers for which he was under the care of a district nurse and
receiving daily applications of Diprobase Cream and Hydromol Ointment.
On 22 September 2017, Mr Bicat experienced severe burns as a result of
a fire inadvertently started when a flame from his cigarette lighter came
into contact with his dressing gown. Evidence given at the inquest by
West Yorkshire Fire and Rescue Service stated that the speed and
intensity of the fire had been increased by the presence of the cream and
ointment on Mr Bicat’s dressing gown and pyjamas.

We are seriously concerned to learn of the death of Mr Bicat and the fact
that his use of Diprobase Cream, together with Hydromol Ointment, may
have contributed to the intensity of the fire which caused his injuries.

The Report to Prevent Further Deaths

The Report raises various concerns in relation to the risk of fire
associated with use of paraffin based ointments and emollient creams,
including those with a paraffin content below 50%. it has been sent to a
number of Government, NHS and industry persons and bodies, including
Bayer as the manufacturer of Diprobase Cream. Bayer was not asked to
provide evidence for the purposes of the inquest and has no knowledge
of the circumstances of Mr Bicat’s death save for the information set out
in the Report.

BAYE R}

CLL

25" September 2018

Bayer ple

400 South Oak Way
Green Park
Reading

RG2 6AD

United Kingdom

Tel. +44 0118 206 3000
lars.bruening@bayer.com

www. bayer.co.uk

Bayer plc is registered
In England No.935048
Registered office:

400 South Oak Way
Green Park

Reading

RG2 6AD

Page 2 of 6

The specific concerns raised in the Report are as follows:

1.

N

10.

11.

12.

Bayer’s response to items 1-5 is provided below. We understand that

Paraffin based ointments and emollient creams which contain a low
level of paraffin pose a potential fire hazard risk;

Warnings of such risks are not displayed on all product packaging;
Consider more prominent labels and alerts re fire hazard on product

containers;

Health care professionals in both hospital and community setting
may not be aware of the potential fire hazard poised by emollient
creams which contain a low level of paraffin;

To consider fire warning labelling on all emollients including those
below 50% content, making clear the mechanisms of the risk;
Health care professionals including pharmacists to verbalize product
warnings at the point of prescription, dispensing or point of sale;
Members of the public are able to purchase such products in retail
outlets and online where verbal warnings from healthcare
professionals are not given;

Review patients with repeat prescriptions for emollients and cross
reference those that smoke. Give safety advice retrospectively and
review prescriptions;

Raise awareness with health care professionals and include paraffin
based skin products in annual continuing fire safety training;

Review information sharing of burns data between hospitals, YAS
and fire service so that incidents that didn't receive a fire service
attendance can be investigated fully;

The NHS prescribing systems (system One and Optimise) appear to
be updated by individual CCG's resulting inconsistent alerts and
warnings;

Consider a review of the current effectiveness of obtaining fire
incident reports involving paraffin based skin products since there is
currently a lack of accurate national data involving paraffin based
skin products.

other recipients of the Report will address items 6-12.

A ¥
(BAYER)

BS
E

4 E f}

Page 3 of 6

Paraffin based ointments and emollient creams which
contain a low level of paraffin pose a potential fire hazard
risk

Paraffin based skin products represent first line treatments for
patients with dry or scaly skin conditions, including psoriasis and
eczema. They are highly effective, well tolerated and easily and
conveniently applied by both patients and carers. They therefore
provide important therapies for conditions which can, when
severe, be both disabling and distressing.

Paraffin based ointments and emollient creams are not
themselves flammable. However use of products containing
paraffin which results in an accumulation of paraffin from the
ointment or cream on clothing or bedding, increases the
flammability of such fabrics in the context of environmental
hazards, such as cigarettes and cigarette lighters.

Diprobase Cream, manufactured by Bayer, contains 15% white
soft paraffin and 6% liquid paraffin. It is currently regulated as a
medicinal product.

Bayer is committed to ensuring the highest standards of safety of
all of its products and, where appropriate, providing relevant
warnings about the use of such products. The Medicines and
Healthcare products Regulatory Agency (MHRA) and other
bodies have issued general warning statements informing
patients, carers and healthcare professionals of the risks posed
by naked flames to persons using emollients and we are
currently, as described below, working with the MHRA and with
the Proprietary Association of Great Britain (PAGB), the industry
association representing the consumer healthcare industry, in
order to reinforce this information. We support the development
of common warnings and information to be applied to relevant
paraffin containing ointments and emollient creams across the
industry.

Page 4 of 6

2.

Warnings of such risks are not displayed on all product
packaging

While warnings regarding the possibility that paraffin containing
products may accumulate on clothing and bedding increasing
their flammability, have been issued by the MHRA, NHS bodies
and fire services, Bayer supports the inclusion of warnings on
product packaging in order to strengthen the existing warnings
and to provide an immediate reminder of the risks to users of
emollients.

In 2017, the MHRA commenced a review of the labelling of
paraffin-containing emollients and the instructions for use
provided in relation to such products, with a view to determining
consistent warnings to apply to all such products, where
appropriate. Bayer has co-operated fully with this review, but
understands that it has not yet been completed.

The labelling and patient information provided in relation to all
medicinal products forms part of the product's marketing
authorization and must be approved by the competent regulatory
authority (the MHRA in the UK) before it is put into circulation.
MHRA has advised Bayer that it will not approve labelling
changes to emollients regulated as medicinal products until it
has completed the review referred to above.

However, Bayer is in the process of re-classifying Diprobase
Cream as a Class 1 medical device under the Medical Devices
Regulations 2002 and has conducted a conformity assessment
in accordance with such Regulations. !n compliance with the
Regulations, Bayer may apply warnings to the labelling of
medical devices without external regulatory approval. When the
re-classified product is launched in the UK (anticipated around
February 2019) Diprobase Cream will include the warning “Keep
fabric which has been in contact with this product away from
sources of fire including lit cigarettes’. The warning will be
visible on the external labelling/packaging of the product as well

Page 5 of 6

as being included in the patient information leaflet supplied with
it.

Consider more prominent labels and alerts re fire hazard on
product containers

As indicated above, Bayer supports the effective provision of
warnings to patients, carers and healthcare professionals
regarding the risk of flammability following accumulation of
paraffin containing emollients on bedding and_ clothing.
However, it is important that such warnings should convey a
consistent message when applied to relevant products. We are
therefore co-operating fully with the MHRA review, as described
above, in order to ensure that effective and appropriate
information can be provided with Bayer products and other
emollients, as soon as this has received regulatory approval.

Health care professionals in both hospital and community
setting may not be aware of the potential fire hazard poised
by emollient creams which contain a low level of paraffin

We refer to our responses above.

In addition to the measures described, Bayer operates a
consumer-facing website for Diprobase products, which includes
a warning in respect of the risk of flammability associated with
the use of Diprobase Cream. Following receipt of your letter in
relation to Mr Bicat, Bayer is in the process of updating the
content of the website to include the same warning as that which
will be included on the labelling for Diprobase Cream as a
medical device, namely “Keep fabric which has been in contact
with this product away from sources of fire including lit
cigarettes”. The updating of the website will be completed no
later than the end of October 2018.

“a
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m
BY

Gok

Page 6 of 6

5. To consider fire warning labelling on all emollients
including those below 50% content, making clear the
mechanisms of the risk

We refer to our responses above.
We hope that the information provided in this letter addresses your
concerns and reiterate our commitment to ensuring that appropriate

warnings and information are provided with all Bayer products to ensure
safe usage by patients, carers and healthcare professionals.

Yours sincerely,

es

Lars Bruening
CEO, UK/ireland / Managing Director Bayer Plc

Private & Confidential

Mr Martin Fleming

HM Senior Coroner
Bradford Coroner's Court
City Courts

The Tyrls

Bradford

BD1 1LA

aa HS |

Bradford District Care

NHS Foundation Trust

Trust Headquarters
New Mill

Victoria Road
Saltaire

West Yorkshire
BD18 3LD

Tel: 01274 228300
www.bdct.nhs.uk

28 August 2018

Dear Sir

Brian Bicat (Deceased)

| am writing in response to your letter sent on 02 August 2018 regarding the Report to
Prevent Future deaths in relation to Mr Bicat.

Bradford District Care NHS Foundation Trust has taken the following actions:

1.

The Trust has produced a safety information leaflet for patients in relation to using
paraffin-based products, in particular regarding the laundering of clothing and bedding.
This leaflet has been disseminated locally across all Bradford Clinical Commissioning
Groups and Acute Trust providers and Leeds Community Services.

The Trust has produced a fire hazard poster in relation to using paraffin-based products,
which has been disseminated for display throughout clinical services areas and this has
also been communicated electronically across the organisation.

. The leaflet and poster have been uploaded onto the NHSI improvement hub website

under the heading of patient safety. Communication has been undertaken with the
Trust's lead for CCG and NHSI. Work has been undertaken to disseminate this
information nationally through NHSI.

. Awareness has been raised with all siaff within Bradford District Care Foundation Trust

and this issue is included in all fire training.

An alert has been created on our clinical records system, SystmOne. This is an
electronic icon indicating that a patient is at risk when emollient is entered into the clinical
record.

The Trust has undertaken a survey of staff's awareness of the hazards of emollients.
This survey will be undertaken six monthly and any areas of concern will be addressed
following the results

W: www.bdct.nhs.uk YW: @BDCFT

You & Your Care

7. A yearly audit will be undertaken within all community nursing services within BDCFT to
demonstrate that staff distribute the safety leaflets on initial contact of patients who are
prescribed emollients. The audit will also demonstrate that there is documented
evidence of discussion by staff with patients regarding the hazards of emollients.

8. A piece of work has been completed by the community nursing services to ensure that
all existing patients have the relevant patient information leaflet and advice has been
given by staff to patients regarding the risks of using emollients.

9. The message regarding the risks of using emollients have been shown on the Trusts
computer screens on Screen savers. This will be repeated on a bi-annual basis within
BDCFT to ensure that the risk of emollients remain paramount.

10. The fire officer for BDCFT will continue to liaise with the Fire service to ensure all teams
are updated on the most recent evidence regarding the laundering of clothes and the
ongoing hazards of emollients.

| hope that this evidence on the above will demonstrate to yourself and the family that
learning has been taken forward across the wider NHS organisation following this tragic
incident to raise awareness of the risks of using emollient creams.

Yours faithfully

Brent Kilmurray
Chief Executive
Bradford District Care Foundation Trust

a

Medicines & Healthcare products

Regulatory Agency
Mr M. D. Fleming Medicines and Healthcare products
HM Senior Coroner, West Yorkshire - Western Regulatory Agency
City Courts 10 South Colonnade
The Tyrds Canary Wharf
Bradford vende
BD1 1LA United Kingdom
+44 (0) 20 3080 6000
30" November 2018 gov.ukimhra

Dear Mr Fleming

Regulation 28 Report concerning Brian Leonard Bicat ~ Your Ref:

Thank you for your letter of August 2018 in which you asked the MHRA to provide a response to the
Regulation 28 Report to Prevent Future Deaths following the inquest into the tragic death of Brian
Leonard Bicat.

In the UK an emollient may be regulated as a medicine, a medical device or a cosmetic. One of the
emollient products referred to in your Regulation 28 Report is regulated as a medical device — Hydromol
Ointment; the other, Diprobase Cream is a medicine. This response deals with the aspects of your report
which relate to medical devices and device regulation. A response dealing with the medicine aspects will
be provided separately, in line with your request for two separate responses.

Your report listed seven matters of concern which fall within the remit of MHRA & medical device
regulation.

1. Paraffin based ointments and emollient creams which contain a low level of paraffin pose a

potential fire hazard risk

Wamings of such risks are not displayed on all product packaging

Consider more prominent labels and alerts re fire hazard on product containers

Healthcare professionals in both hospital and community setting may not be aware of the potential

for fire hazard posed by emollient creams which contain a low level of paraffin.

To consider fire waning labelling on ail emollients including those below 50% content, making

clear the mechanism of the risk

6. Healthcare professionals including pharmacists to verbalise product warnings at the point of
prescription, dispensing or point of sale.

7, Members of the public are able to purchase such products in retail outlets and online where verbal
warnings from healthcare professionals are not given.

PON

a

Medical devices must be CE marked before they are placed on the market in the UK and throughout the
EU. MHRA’s expectation is that, when CE marking and placing a medical device on the market,
manufacturers will have evaluated the potential risks that could occur, including that of fire.

CE se Dig

=

The CE mark demonstrates that the medical device is fit for its stated intended purpose and meets
legislation relating to satety. This requires the manutacturer to demonstrate their medicai device meets
the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment.
Additionally, higher risk medical devices require certification from a third party conformity assessment body
(‘Notified Body”) located in the EU prior to being placed on the market. MHRA is responsible for the
oversight of UK Notified Bodies and has a post-market role in investigating reported safety issues.

Emollients may fall into any of the risk classes according to their constituents and mode of action. The
paraffin content of these products varies over a wide range, also, from as little as 5% in some cases, and
has no bearing on whether the product is classed as a device or as a medicine. The classification
difference is due to their mode of action.

In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks
associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency
(NPSA) in 2007. This reminder was in the form of a “One Liner” which was published in issue 56. Since,
at that time, as no adverse incident reports had been received, it was not considered necessary to issue
any further communication.

However, in addition, we have written to manufacturers to raise awareness of this potential risk. This
highlighted the need for the risk of fire to be included in their product risk analysis and ensuring warnings
of the potential risk were placed either on packaging or included in the device’s instructions for use. We
have previously issued warnings regarding the dangers around smoking and bed fires (MDA/2013/073).

No reports of adverse events, injuries or fatalities were reported to MHRA regarding devices until 2017.
At this point it was noted that there are differences in the labelling between products regulated as devices
and medicines.

Working in collaboration with colleagues in the medicines regulatory part of the Agency in Spring 2017
MHRA Devices wrote to UK manufacturers of Class | medical devices (the lowest risk category) directly
and asked them to undertake a review of their products. In addition, we asked the UK Notified Bodies to
ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification
medical devices.

We also brought the issue to the notice of European regulatory colleagues to highlight the dangers
internationally. All European Competent Authorities were asked to share the letter mentioned above to
with Notified Bodies they oversee to ensure coverage of all manufacturers with products in the European
market.

The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs). The
latter are individuals in each NHS Trust in England who ensure safety information is made available to
relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers
to users within the care community.

In response to more recent evidence regarding the risk with emollient products paraffin, including a number
of fatalities reported since 2017 (many of which were historical), MHRA is reviewing the available evidence
regarding the risk for a wider range of paraffin-containing medicines and devices and has convened an ad
hoc Expert Group to advise on the appropriate regulatory action for both medicines and medical devices.

The Expert Group met for the first time on 7 September 2018 and will meet again on Friday 30 November
2018 when it is expected to deliver its final recommendations for regulatory action to protect public health.

Each of the seven matters of concern raised in your report within MHRA’s remit is being put to the group
for consideration and advice. In making its recommendations, the ad hoc Group will consider evidence
from five Coroners Regulation 28 reports including those for Pauline Taylor (Regulation 28 Report by
Assistant Coroner Mary Burke, West Yorkshire Western District; Ref: HK/1067-2015) and Brian Bicat; data
on additional possible cases reported by ten Fire and Rescue Services across the UK; the results of

flammability tests conducted by West Yorkshire Fire and Rescue Service and Anglia Ruskin University;
data irom ine internationai Burn injury Database, as well as data provided by the companies which market
emollients in the UK.

| will write to you following the ad hoc Expert Group's meeting on 30" November 2018, to inform you of its
recommendations and the regulatory action we will take to protect public health.

Yours Sincerely,
\ \h ag
oe
Dr lan Hudson

Chief Executive
Medicines and Healthcare products Regulatory Agency