29 May 2018 Brian Leonard Bicat · Prevention of Future Deaths report West Yorkshire (Western)
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Concerns raised 6 Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases View source Lack of accurate national data on fire incidents involving paraffin-based skin products View source Inconsistent fire-risk alerts and warnings across NHS prescribing systems View source Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams View source Failure to display fire-risk warnings on all product packaging View source Fire hazard from paraffin-based ointments and low-paraffin emollient creams View source See 3 more concerns
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AI-generated summary
Brian Leonard Bicat · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Brian Leonard Bicat sustained severe burns at home on 22 September 2017 when his dressing gown caught fire while he was smoking a cigarette. He died later that day from his extensive cutaneous burns, with evidence indicating that paraffin-based emollient creams and ointments increased the speed and intensity of the fire. The principal concerns were that low-paraffin emollients may pose a fire hazard, that warnings were not displayed consistently on packaging or communicated by healthcare professionals, and that related prescribing alerts and incident data were inconsistent or incomplete.
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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. The report was sent to Alliance Pharmaceuticals Limited; that does not assign responsibility.
PFD Monitor interpretation Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases
Wider context from the report “Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Alliance Pharmaceuticals Limited; that does not assign responsibility.
PFD Monitor interpretation Lack of accurate national data on fire incidents involving paraffin-based skin products
Wider context from the report “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
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Alliance Pharmaceuticals Limited; that does not assign responsibility.
PFD Monitor interpretation Inconsistent fire-risk alerts and warnings across NHS prescribing systems
Wider context from the report “The NHS prescribing systems (system One and Optimise) appear to be updated by individual CCG’s resulting inconsistent alerts and warnings .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Alliance Pharmaceuticals Limited; that does not assign responsibility.
PFD Monitor interpretation Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams
Wider context from the report “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
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Alliance Pharmaceuticals Limited; that does not assign responsibility.
PFD Monitor interpretation Failure to display fire-risk warnings on all product packaging
Wider context from the report “Warnings of such risks are not displayed on all product packaging
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Alliance Pharmaceuticals Limited; that does not assign responsibility.
PFD Monitor interpretation Fire hazard from paraffin-based ointments and low-paraffin emollient creams
Wider context from the report “Paraffin based ointments and emollient creams which contain a low level of paraffin pose a potential fire hazard risk
” Open source report
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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 Complete a Hydromol product-labelling review to improve warning prominence, clarity, content and consistency across paraffin concentrations.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 1 · response Published 30 October 2018
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Undertake a cross-functional expert assessment of Hydromol labelling using information from the incident to identify further improvement opportunities.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 2 · response Published 30 October 2018
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review proposed Hydromol labelling changes with user groups to confirm that the intended safety message is understandable.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 2 · response Published 30 October 2018
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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 Publish revised Hydromol labelling, website content and promotional materials incorporating improved fire-risk information.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 1 · response Published 30 October 2018
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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 Engage West Yorkshire Fire Service to ensure Hydromol labelling clearly explains the mechanisms of fire risk.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 2 · response Published 30 October 2018
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Work with the MHRA and PAGB to develop a consolidated fire-risk warning for all relevant product packaging across the industry.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 2 · response Published 30 October 2018
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Update personnel communicating with healthcare professionals and the public on the assessment outcome and subsequent labelling changes.
Verbatim wording from the response “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.”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 2 · response Published 30 October 2018
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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 Add a fire-risk warning to Hydromol product labelling, explaining ignition risks involving contaminated dressings, clothing and bedding.
Verbatim wording from the response “The labelling now states:”
Source location 2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer Page 1 · response Published 30 October 2018
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