Ashana Charles

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Ashana Charles who died on 20th November 2018.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 11th December 2025 concerning the death of Ashana Charles on 20th November 2018. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Ashana’s family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Ashana’s care have been listened to and reflected upon.

Your Report raises concerns with the inconsistent guidance on the use of filters in parenteral (PN) feeding. You highlighted that the regulatory systems for the production and administration of PN feeding need to be better integrated, with sharing of risk assessment data and consistent guidance.

The British Pharmaceutical Nutrition Group (BPNG) issued a position statement in August 2025 recommending that all PN admixtures should be administered via a filter with a pore size of 1.2 μm. This position statement includes:

“The National Institute for Health and Care Excellence (NICE) guidelines for PN for adults and neonates provide no guidance on the use of filters for PN administration. The Royal College of Nursing (RCN) in their Standards for infusion therapy, which are currently under review, state that for lipid infusions or total nutrient preparations that require filtration, a 1.2 μm filter should be used. The UK Injectable Medicines Guide (Medusa) in their PN monographs advise the use of 1.2 μm filters, and in their paediatric guide, 1.2μm filters for lipid-containing bags and syringes and 0.2μm filters for aqueous (lipid-free) admixtures. To our knowledge there is currently no other UK- based national guidance on filtering PN admixtures….

… The guidance in the 2001 BPNG position statement remains valid and our guidance is unchanged. Detailed advice on filtering PN needs to be included in national UK PN guidance such as that proposed by NICE, BAPEN or similar. For clarity, we also suggest manufacturers of PN and PN amino acid/lipid emulsions revise their SPCs to National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

26th January 2026

include appropriate advice on filtering, including details on recommended filter pore size for the administration of their products.”

This information suggests that there are potential gaps in:

1. current national resources regarding the recommendation to use a filter when administering parenteral nutrition;
2. the Marketing Authorisation Holders Summaries of Product Characteristics (SmPC) information regarding the requirement to use appropriate filters.

We note that your Report is also addressed to the Medicines and Healthcare Products Regulatory Agency (MHRA) and are of the opinion that, given the recommendations within the BPNG position statement and your concerns, the MHRA, as the regulator of medical devices and medication, is the appropriate responsible authority to respond to the question of regulation. It is within their remit to ensure that relevant information is included in the designated SmPCs. The MHRA is also expertly placed to liaise with NICE, the British Association for Parenteral and Enteral Nutrition (BAPEN) and the RCN for incorporation of the recommendations they consider necessary into relevant guidance around administration of parenteral nutrition.

We have taken the opportunity to consider whether to anticipate any availability issues, should there be an increased demand for 1.2 μm filters across healthcare upon greater awareness of recommended practice. However, given these devices have other uses within intravenous administration, we do not consider this to be a risk.

Local Action The NHS England London Region Team have liaised with the South East London Integrated Care System (ICS) on the action taken by Lewisham & Greenwich NHS Trust in relation to this case. They have informed us that the Trust has evaluated the use of 1.2 micron filters in PN feeding and is in the process of setting up the ordering process for the 1.2-micron inline filters. This will ensure the correct products are ordered and that there is central stock control by the pharmacy service. Once this has been completed, training will commence for relevant staff. This action is being monitored through the relevant committees within the Trust.

I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Ashana, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.