Noted
NICE acknowledges the concerns but states that overseeing medicine safety, product warnings, and running safety awareness campaigns do not fall within its remit; they refer to existing BNF guidance for prescribers. (AI summary)
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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_