Dear Dr, Swann; Firstly; we want t0 express our deep sorrow towards lhe family of Mr Holyoake, who we understand perished tragically: We have confirmed in our records that no previous adverse events have been reported to RB relating t0 the flammability of E45 The labelling and usage instructions of our cosmetic products is in full compliance with the Cosmetic Product Regulation; or in case Of our medicinal products approved by the Medicines and Healthcare products Regulatory Agency (MHRA): Despite regularly assessing our products we have taken this tragedy as a reason t0 conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As & 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: E45 Cream 50g, 125g,350g, 500g (PL 00063/0404) and the following cosmetic products: E45 Body Lotion Hydrate & Protect 250ml, 40Oml E45 Body Lotion Intense Recovery 260ml, 40Oml E45 Body Lotion Nourish & Restore 250ml, 40Oml E45 Moisturising Lotion 200ml, 500ml E45 Intense Recovery Fast Action 24H Spray Moisturiser 200ml E45 Junior Moisturising Lotion 200ml The above products have been Identified due t0 their use, being leave on products (i.e not being removed after application) with potentially high single dose or high frequency of low dosing containing >5% wlv levels of combined paraffins . RB Reckitt Benckiser Group plc 103-105 Bath Road, Slough; Berkshire SLI 3UH; United Kingdom Tel +44 /0) 1753 217 800 Fax: +44 (0)175] 217 899 WwW Fb com RECEEo

The below warning be added to the product labelling: HEALTH HYGIENE HOME "If using large quantities, regularly change clothing, bedding or dressings impregnated with the product and keep away from fire a8 may pose & fire hazard We aim t0 make these changes according to the following timeline: Submission of our varialion package (0 (he MHRA in 2016 Subject t0 & favourable approval by Ihe MHRA release products with revised labels In summer 2017 Cosmetic range of products will follow a similar timing of release Thank you for raising this issue with us. We will implement this additional safety information t0 ensure the safe use of E45 for all consumers

Dear Dr Swann RE: Christopher Michael HOL YOAKE Thank you for your letter dated 27 April 2016 in respect of the above. I am responding as the current President ofthe Chief Fire Officers Association (CFOA). recently retired from the service. 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. Chief Fire Officers/Chief Executives will ensure that the information and details contained within your report are shared with the appropriate staff. Please do not hesitate to contact me if I can be of any further assistance. Yours sincerely President r,lllf.J F rt Otl!::e1,:, As3oclrt1ion I 9-11 PPhhlA Cloc;1-t I Aminl]IOI\ I Tflmworth Slc1'frncbh•ra I B77 4R0 rvw-Jt.1,,,.ec111 Eng'.artj ,.o,) Um1l-xt C-.xr,pvrr1. tio 0::6"711:ii ...j:.',;.r,hnr.i-, ...u ffll1R?71f)?:¥}(l J FM)( ,.,14 ffll1R?7 -~n.7::iAQI w.....wrfn;1 nrn Ilk' 1,J_,,,.,.,,...,.,ni;..n1.vv1 ..... rh,.,,~. Mt\1n.,.,.rn1 lllt.TA..,,,n.~1<11'...V..~J,., cwv., ,,·•.:;,.: IIR

Medicines & Healthcare products
* Regulatory Agency 151 Buckingham Palace Road London SW1W9SZ United Kingdom

H.M Coroner Leicester City and South Leicestershire The Town Hall Town Hall Square Leicester LE1 98G 30 June 2016

Regulation 28 Report concerning Christopher Michael HOLYOAKE CEM/GA/02481-2015 Thank you for your letter of 24th May 2016 in which you asked the MHRA to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Mr Christopher Michael Holyoake. The MHRA as a regulatory agency has a responsibility to ensure that medicines are efficacious and acceptably safe and that guidance on the use of a medicine is appropriately described in the authorised product information (summary of product characteristics, labelling and patient information leaflet). Your report identified two matters of concern which falls within the remit of the MHRA.
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 product itself. The MHRA issued advice to healthcare professionals in 2008 to inform them that whilst paraffin based emollients in themselves are not flammable they can act as accelerants when use 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. 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.

2. 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 ofignition. 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 WARNING: If this product comes into contact with dressing and clothing, the fabric can be easily ignited with a naked flame. You should keep away from the fire and do not smoke when using this product. 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. I will write to you again when our action is completed.

Dear Dr Swann, Regulation 28 Report concerning Christopher Michael HOLYOAKE Your reference: Thank you for your letter dated 24t" May 2016 informing us of the tragic death of Christopher Michael Holyoake and the inquest findings. You have requested that NHS Improvement provide a response to your matters of concern outlined in the original Regulation 28 report-that you had addressed to NHS England, and we understand you have also written to the Medicines and Healthcare products Regulatory Agency (MHRA). NHS Improvement is responsible for overseeing foundation trusts, NHS trusts and independent providers. We offer the support these providers need to give patients consistently safe, high quality, compassionate care within local health systems that are financially sustainable, By holding providers to account and, where necessary, intervening, we help the NHS to meet its short-term challenges and secure its future. 1

NHS Improvement is the operational name for the organisation that brings together Monitor, NHS Trust Development Authority, Patient Safety, the National Reporting and Learning System, the Advancing Change team and the Intensive Support Teams. Your letter described how Mr Holyoake had been prescribedE45 cream0 to be applied daily, and that because E45 cream0 is a paraffin containing product that had become soaked into his clothing and bedding, it was implicated in a fire resulting in his death. Firstly it may be helpful to understand previous advice issued in relation to the risk. An alert was issued by the National Patient Safety Agency in November 2007, following a similar fatality which occurred in a hospital. This alert highlighted the fire hazard risks associated with paraffin based products, particularly when they become soaked into dressings and clothing, The alert can be viewed at http~//www.nrls,npsa.nhs.uk/resources/?entr~d45=59876 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. You may already be aware that the MHRA issued a Drug Safety Update bulletin in April 2016, which reminds all healthcare professionals of the fire hazard risks associated with paraffin based products. Please see link to this MHRA update hops•//www qov uk/drug safety-update/paraffin-based-skin-emollients-an-dressings- or-clothing-fire-risk and also please see enclosed paper version. As you are aware, E45 cream0 does not at present have warnings on its packaging concerning potential fire hazards, however since receiving your letter we have been informed by the MHRA and the manufacturers of E450, Reckitt Benckiser Group, that the company plan to introduce a warning onto the packaging of all E450 products as soon as possible. We understand that the MHRA also plan to require manufacturers of similar aqueous based paraffin containing products to introduce this warning onto their packaging.

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. 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. Whilst the MHRA Bulletin, the MOSO network and the changes to BNF are helpful for healthcare professionals,. including GPs, as you are aware, E45 cream0 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 cream0 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, appreciate you making me aware of this risk and giving me and my team the opportunity to take action to prevent future deaths. Please do pass my sincere condolences on to Mr Holyoake's friends and family.

Please accept my best wishes, NHS National Director of Patient Safety NHS Improvement