From Nadine Donies MP Department Parliamentary Under Secrelary of State for Mental Health; Suicide Prevention and Patient Safety of Health & Social Care 39 Victoria Street London SW1H OEU Your Ref: AAHIRE152021 020 7210 4850 Our Ref: PFD-1197497 Mrs Margaret J Jones HM Assistant Coroner, Staffordshire (South) 1 Staffordshlre Place Stafford ST16 2LP 2 | Jt January 2020 Mc &o; 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: Firstly, would like to say how saddened was to read of the tragic circumstances of Mrs Mllton'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 bums with paraffin-containing and paraffin-free emollients in December 2018 through a press release and an article in 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 service, healthcare professionals and their representative btps www_gov ukldng-safcty-updatelemollicnts-new-infomation-aboutisk-of-sevcre-und-fatel-bums-with: panin-conlaining-and panffn_free cmollicnts Drug fire

bodies, organisations that provide guidance to health and social care workers, patient ropresentatives and organisations that speak for relevant patient populations such as the National Eczema Society: The stakeholder group is designing and optimising sustainable and educational resources for healthcare professionals and the public and their tehog ondistibutoancaoteges toensure 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 plans 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 Na_ NADINE DORRIES ~nJ

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 petrol-based emollients being flammable 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 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 Formular (BNE) provides prescribers and other healthcare professionals 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 wwniceorg uk (nice@niceorg:uk We being

MHRACommission 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 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 & risk of fire [ABPL_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_

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 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. Yowrefaderely FOHteam they