PFD report

Michael Holyoake · Prevention of Future Deaths report

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Issued 27 Apr 2016•Leicester City and South Leicestershire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
3

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
14

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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Report evidence summary

Concerns raised3

  1. Highly flammable paraffin-based product with ignition risk
    Part of recurring concern: Inadequate controls for fire risks from paraffin-containing emollients
  2. Lack of fire-hazard warnings on E45 prescriptions and product packaging
    Part of recurring concern: Inadequate controls for fire risks from paraffin-containing emollientsPart of recurring concern: Inadequate product safety warnings about serious hazards
  3. Failure to communicate E45 fire hazards by GPs
    Part of recurring concern: Inadequate controls for fire risks from paraffin-containing emollients
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.12

  1. Action

    Update the British National Formulary to identify the fire risk associated with predominantly paraffin-based topical medicines.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 27 April 2016.
  2. Action

    Communicate the expanded emollient warning and related safety advice to relevant healthcare professionals, including nurses.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 27 April 2016.
  3. Action

    Take regulatory action to require similar fire-risk warnings on all emollient medicines, including aqueous-based products such as E45 Cream.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 27 April 2016.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Highly flammable paraffin-based product with ignition risk

Wider context from the report

“1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself. This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable, with the potential risk of ignition. ”

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients.

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Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of fire-hazard warnings on E45 prescriptions and product packaging

Wider context from the report

“1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself. This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable, with the potential risk of ignition. ”

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients; Inadequate product safety warnings about serious hazards.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to communicate E45 fire hazards by GPs

Wider context from the report

“1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself. This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable, with the potential risk of ignition. ”

Is this part of a recurring concern?

Yes — Inadequate controls for fire risks from paraffin-containing emollients.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Update the British National Formulary to identify the fire risk associated with predominantly paraffin-based topical medicines.

Verbatim wording from the response

“Separately the British National Formulary has been updated to make reference to this risk of fire with predominantly paraffin based topical medicines so that healthcare professionals could be alerted.”

Source location

Response from Chief Fire Officers Association and MHRA
Page 2 · response
Published 27 April 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Communicate the expanded emollient warning and related safety advice to relevant healthcare professionals, including nurses.

Verbatim wording from the response

“Aqueous-based products such as E45 Cream were not included in this review. In light of this case we will now take action to ensure all emollient medicines, including those aqueous based products such as E45 Cream carry a similar warning statement. We aim to have completed regulatory action by the end of the year and will accompany this with appropriate communications to relevant healthcare professionals including nurses to reinforce the warning and advice.”

Source location

Response from Chief Fire Officers Association and MHRA
Page 3 · response
Published 27 April 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Take regulatory action to require similar fire-risk warnings on all emollient medicines, including aqueous-based products such as E45 Cream.

Verbatim wording from the response

“Aqueous-based products such as E45 Cream were not included in this review. In light of this case we will now take action to ensure all emollient medicines, including those aqueous based products such as E45 Cream carry a similar warning statement. We aim to have completed regulatory action by the end of the year and will accompany this with appropriate communications to relevant healthcare professionals including nurses to reinforce the warning and advice.”

Source location

Response from Chief Fire Officers Association and MHRA
Page 3 · response
Published 27 April 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Issue advice to healthcare professionals explaining that paraffin-based emollients can act as accelerants when clothing or bedding becomes saturated.

Verbatim wording from the response

“The MHRA issued advice to healthcare professionals in 2008 to inform them whilst paraffin based emollients in themselves are not flammable they can act as accelerants when used in large quantities and patients' clothes or bedding become saturated with these products. A reminder article, reiterating that healthcare professionals should advise patients not to smoke or use naked flames whilst emollients are in contact with their dressings, clothing or bedding was issued in our publication Drug Safety Update in April 2016. This article was linked to support materials published by NHS Improvement along with details of how to report incidents of harm. The article is attached at annex A.”

Source location

Response from Chief Fire Officers Association and MHRA
Page 2 · response
Published 27 April 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Publish a reminder advising healthcare professionals to warn patients against smoking or using naked flames near emollient-treated dressings, clothing or bedding.

Verbatim wording from the response

“The MHRA issued advice to healthcare professionals in 2008 to inform them whilst paraffin based emollients in themselves are not flammable they can act as accelerants when used in large quantities and patients' clothes or bedding become saturated with these products. A reminder article, reiterating that healthcare professionals should advise patients not to smoke or use naked flames whilst emollients are in contact with their dressings, clothing or bedding was issued in our publication Drug Safety Update in April 2016. This article was linked to support materials published by NHS Improvement along with details of how to report incidents of harm. The article is attached at annex A.”

Source location

Response from Chief Fire Officers Association and MHRA
Page 2 · response
Published 27 April 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Add fire-risk label warnings to emollient products containing predominantly paraffin-based ingredients.

Verbatim wording from the response

“In 2009 on the basis of the evidence available at the time, the MHRA added label warnings to those emollient products which included predominantly paraffin based ingredients to warn patients and carers of the risks if used in large quantities of acting as an accelerant. The warning statement which appears on the outer packaging is:”

Source location

Response from Chief Fire Officers Association and MHRA
Page 3 · response
Published 27 April 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Communicate the fire risk to the Medication Safety Officer network for dissemination and organisational action.

Verbatim wording from the response

“NHS England and the MHRA have a network of Medication Safety Officers (MSOs) working within NHS trusts and other providers of NHS-funded healthcare. The role of MSOs is to ensure that systems are in place to improve medication safety. This risk will be communicated by NHS Improvement to this MSO network so the risk can be appropriately communicated and addressed within their organisations.”

Source location

2016-0163-Response-by-NHS-Improvement
Page 3 · response
Published 27 April 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Ask care-sector organisations and professional bodies to communicate the fire risk through suitable newsletters and bulletins.

Verbatim wording from the response

“Whilst the MHRA Bulletin, the MSO network and the changes to BNF are helpful for healthcare professionals, including GPs, as you are aware, E45 cream® is widely available to the general public without prescription. The changes of labelling will be important to ensure awareness of the risk reaches people who buy E45 cream® without prescription. We appreciate that similar risks may apply even to substances sold as moisturisers when these are used by less mobile adults and children. As this vulnerable group may not always have routine contact with NHS staff we have asked the Care Quality Commission, the Royal College of Nursing, and networks within the care home sector to communicate the risk via suitable newsletter and bulletin articles.”

Source location

2016-0163-Response-by-NHS-Improvement
Page 3 · response
Published 27 April 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Inform BNF editors that fire-risk warnings should cover less concentrated aqueous paraffin-containing products.

Verbatim wording from the response

“The British National Formulary (BNF) is a widely used resource that contains essential information on the safe and effective use of medicines that are prescribed, monitored, supplied and administered to patients by healthcare professionals. The BNF already provides important safety information on fire hazard for paraffin based emollients such as emulsifying ointment, white soft paraffin 50% and liquid paraffin 50% ointment in their online and paper based publications. NHS Improvement have informed the editors of the BNF that the risk also applies to less concentrated aqueous based paraffin containing products, and the BNF will in future include a revised warning that will inform healthcare professionals of the risk applying to all paraffin containing products.”

Source location

2016-0163-Response-by-NHS-Improvement
Page 3 · response
Published 27 April 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Release the specified E45 medicinal and cosmetic products with revised labels containing flammability warnings and safe-use guidance.

Verbatim wording from the response

“The below warning will be added to the product labelling:”

Source location

2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
Page 2 · response
Published 27 April 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Conduct an additional safety assessment and reassess flammability labelling across the E45 product portfolio.

Verbatim wording from the response

“Despite regularly assessing our products we have taken this tragedy as a reason to conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As a result of our safety review, we will be submitting an application to the MHRA to update the labelling to include guidance on potential flammability, of the following medicinal product:”

Source location

2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
Page 1 · response
Published 27 April 2016

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Submit an MHRA variation application to add flammability warnings and safe-use guidance to specified E45 medicinal and cosmetic products.

Verbatim wording from the response

“Despite regularly assessing our products we have taken this tragedy as a reason to conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As a result of our safety review, we will be submitting an application to the MHRA to update the labelling to include guidance on potential flammability, of the following medicinal product:”

Source location

2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
Page 1 · response
Published 27 April 2016

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. 1

    Circulate the report and its identified concern to fire and rescue service leaders and practitioners through CFOA communities.

    Stated by National Fire Chiefs CouncilStated completedThe respondent said that this action was complete when they made their response on 27 April 2016.
  2. 2

    Collaborate with the MHRA to reduce fire risks from paraffin-containing products.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 27 April 2016.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Circulate the report and its identified concern to fire and rescue service leaders and practitioners through CFOA communities.

Verbatim wording from the response

“Accordingly, I can advise you that your letter and attached Regulation 28: Report to Prevent Future Deaths has been circulated to Chief Fire Officers/Chief Executives and other practitioners in the fire and rescue services via a number of the CFOA Communities. Particular attention has been drawn to Section 5 of your report i.e. the Matter of Concern.”

Source location

Response from Chief Fire Officers Association and MHRA
Page 1 · response
Published 27 April 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Collaborate with the MHRA to reduce fire risks from paraffin-containing products.

Verbatim wording from the response

“Since hearing of Mr Holyoake’s tragic death we have worked closely with the MHRA in seeking to take steps to reduce the risk of future deaths.”

Source location

2016-0163-Response-by-NHS-Improvement
Page 2 · response
Published 27 April 2016

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026