Hannah Jacobs

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Hannah Eniola Angela Ayomipo Jacobs who died on 8 February 2023

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 20 August 2024 concerning the death of Hannah Eniola Angela Ayomipo Jacobs on 8 February 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Hannah’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Hannah’s care have been listened to and reflected upon.

I respond to each of the concerns raised in your Report below.
1. The evidence at the inquest referred to allergy action plans discussed in the healthcare settings and given to parents and patients. Hannah displayed what appeared to be excessive salivation at the dentist which her paediatric consultant (who gave evidence) said, with the benefit of hindsight was a manifestation of her inability to swallow. This is a sign of anaphylaxis. This was not recognised by dental staff as an inability to swallow and thus of anaphylaxis. Saliva secretion is dependent on autonomic nerve signals, which are stimulated by the smell, taste, and chewing of food. In this tragic case it could be reasonable to assume that Hannah had hypersalivation in response to her chocolate drink and that her distress would also alter her salivary rate. The Resuscitation Council, the UK’s national expert in resuscitation and the organisation whose guidelines form the basis of anaphylaxis management in the UK, do not list excess salivation as a sign or symptom of anaphylaxis. It is therefore not unreasonable that the dentist or dental team did not assume early anaphylaxis from hypersalivation.
2. The other symptom Hannah demonstrated was swelling of her lips which is listed on allergy plans as a mild to moderate symptom and thus provided a false sense of reassurance to her mother that cetirizine was what she needed. National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

14 October 2024

The allergy plans from the British Society of Allergy and Clinical Immunology (BSACI), a national academic society whose core aim is to improve allergy care by providing allergy resources for healthcare professionals, including clinical guidelines and educational meetings, states that reactions may progress from mild and moderate symptoms to anaphylaxis. This is also explicitly stated in the Resuscitation Council UK Guideline for healthcare practitioners. It is expected that clinicians make this clear when discussing the plans with families of children with severe allergies. Action plans also advise not to stand up a child in the case of a severe reaction and make clear to use adrenaline, whenever in doubt as to the severity of a reaction. Standard teaching practice accompanying these plans is that where there is uncertainty, the default should be to use the adrenaline auto-injectors (AAI). This is also supported by guidance from the Medicines and Healthcare Products Regulatory Authority (MHRA).
3. The risk of future deaths in the context of anaphylaxis remains in the absence of further consideration of what constitutes an anaphylactic reaction as opposed to a mild reaction, and the education of parents and patients of the safety of using AAls (adrenaline auto injectors) if in doubt. Significant stakeholder consultation, including with patients of all ages (including children), their families, schoolteachers and other lay individuals informed the Resuscitation Council UK Guideline and the BSACI plans guidance on what may be considered as possible indications of anaphylaxis, and the ‘if in doubt’ message to use AAI wherever there might be uncertainty. Any additions to the plan must be carefully balanced with the existing messaging to ensure there is no risk of detracting from the key headline symptoms and the ‘if in doubt’ message.
4. There was shortage of AAI at the time but a vial of adrenaline was available at the chemist. However, it takes time to draw up. I am not sure if (assuming no national shortage) all chemists have AAI in stock for emergencies. The shortage of AAI has been resolved. At the time Hannah went into anaphylaxis, there was a shortage of Jext and a recall of Emerade, both of which are AAIs. My Patient Safety colleagues in North East London have confirmed that community pharmacies were notified of the shortage of Jext, however they have not been able to confirm if the same message was sent to all GPs. They are therefore currently reviewing their communications approach to alerting GP practices. The Pharmacy and Medicines Optimisation Team do include updates from the MHRA in their newsletters along with a link to Medicines Supply Tool – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice and this provides information on national shortages and how to manage them. The Pharmacy and Medicines Optimisation Team have been reviewing the use of AAIs and their supply. The detail of this work is still being finalised but my regional colleagues in London have been asked to ensure the national team are provided with updates on this work.

I would also like to provide further assurances on 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 off Hannah, 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.

Dear Dr Radcliffe,

Regulation 28 Report concerning Ms Hannah Eniola Angela Ayomipo Jacobs

Thank you for letter dated 21st August 2024 in which you asked The British Society for Allergy & Clinical Immunology (BSACI) to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the tragic death of Hannah Eniola Angela Ayomipo Jacobs.

The British Society for Allergy and Clinical Immunology (BSACI) is the national, professional and academic society which represents the specialty of allergy at all levels. Its aim is to improve the management of allergies and related diseases of the immune system in the United Kingdom, through education, training and research. We wish to respond to all matters which fall under our remit.

Concern 1 “The evidence at the inquest referred to allergy action plans discussed in the healthcare settings and given to parents and patients. Hannah displayed what appeared to be excessive salivation at the dentist which her paediatric consultant (who gave evidence) said, with the benefit of hindsight was actually a manifestation of her inability to swallow. This is a sign of anaphylaxis. This was not recognised by dental staff as an inability to swallow and thus of anaphylaxis.”

The BSACI Allergy Action Plans do state that difficulty swallowing is a manifestation of anaphylaxis. These plans were developed with allergy healthcare professionals and patient representatives. The BSACI is developing an online allergy education platform for all healthcare professionals and non-healthcare professionals which will include anaphylaxis. This will include the signs and symptoms and management approach for mild, moderate and severe allergic reactions. This will be rolled out extensively to a wide range of stakeholders. We would welcome the involvement of healthcare professionals across tertiary, secondary and primary care (e.g. Royal College of General Practitioners, Royal College of Nursing) in this activity, and healthcare leadership (e.g. NHS England, devolved nations heath boards, Integrated Care Boards).

Concern 2 “The other symptom Hannah demonstrated was swelling of her lips which is listed on allergy plans as a mild to moderate symptom and thus provided a false sense of reassurance to her mother that cetirizine was what she needed.”

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BSACI Allergy Action Plans do state that reactions may progress from mild to moderate to anaphylaxis.

Healthcare professionals managing patients with food allergies advise patients and their carers to always carry two adrenaline autoinjectors with them at all times. This is also the advice of the MHRA. This would include on the way to and from school. The BSACI education programme being developed aims to target all those who may have responsibility for people living with the risk of anaphylaxis, including school staff.

Concern 3 “The risk of future deaths in the context of anaphylaxis remains in the absence of further consideration of what constitutes an anaphylactic reaction as opposed a mild reaction, and the education of parents and patients of the safety of using AAls (adrenaline auto injectors) lF lN DOUBT.”

The BSACI Allergy Action Plans have two boxes that clearly list the symptoms and signs of firstly a mild or moderate reaction and secondly anaphylaxis. These were developed with a wide range of healthcare professionals and patient groups. Additionally, plans state “if in doubt, give adrenaline”.

As mentioned BSACI are developing an online allergy education platform for all healthcare professionals and non-healthcare professionals, which will include anaphylaxis, specifically its recognition and management. This will be rolled out extensively to a wide range of stakeholders.

BSACI has collaborated with patient organisations to develop guidelines and information leaflets. This includes an Anaphylaxis patient information leaflet which can be viewed here. This clearly states the signs and symptoms of anaphylaxis and is accessible to all patients.

Concern 4 “I was made aware there had been a shortage of AAI at the time, but a vial of adrenaline was available at the chemist. However, it takes time to draw up. I am not sure if (assuming no national shortage) all chemists have AAI in stock for emergencies.”

BSACI is unable to comment on this point.

We trust that this letter addresses the concerns that have been raised in your report, however, please do contact us should you require any further information.

Your sincerely,

President – British Society for Allergy & Clinical Immunology

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Dear Dr Radcliffe

Report to prevent future deaths Hannah Eniola Angela Ayomipo Jacobs 09.10.2024

The Royal College of Physicians (RCP) notes with concern the content of the Regulation 28 report for the prevention of future deaths related to the death of Hannah Eniola Angela Ayomipo Jacobs.

We send our sincere condolences to the family of Hannah Eniola Angela Ayomipo Jacobs.

The Regulation 28 report is addressed to the President of the Royal College of Physicians but we note that Hannah was 13 years old, and therefore her care would be part of paediatric services, rather than adult services. However, RCP holds a Joint Committee on Immunology and Allergy that brings together professional leads in allergy for adult services. In addition the RCP hosts the IQAS accreditation programme for adult allergy services that develops standards for allergy services, and accredits services for achieving these standards. Sadly the key elements outlined in this tragic case have also been outlined in previous Regulation 28 notices when people have died from the preventable effects of acute allergic reactions. The dominant issues in Hannah’s case were the recognition of allergic/anaphylactic reaction by the patient, parent and health professionals, and the carrying and use of self administered adrenaline when anaphylaxis may be occurring. These elements need to be addressed through
• Adequate provision of allergy services across the UK for both adults and children. This will be important as part of NHS England and other nations workforce plans. A14

• Education of healthcare professionals in all sectors on recognition diagnosis and management of allergy and anaphylaxis, including the carrying and use of self administered adrenaline.
• National leadership for allergy within the NHS and across sectors that can contribute to reducing the risk for patients and populations. The RCP will work with Royal College of Paediatrics and Child Health, Royal College of Pathologists, British Society for Immunology – Clinical Immunology Professional Network, British Society for Allergy and Clinical Immunology, dental and pharmacy professional groups, to agree and support standards of care and education related to allergy. This will include updating standards for allergy accreditation, including the adoption of the BSACI adult allergy action plan where many of the aspects related to this case are addressed including carrying adrenaline autoinjectors, and difficulty in swallowing is an indication for the use of adrenaline. The RCP will continue to highlight the importance of education (around self-management and allergen avoidance) and access to service user support groups for services registered and accredited with IQAS, and more widely. We will also continue to promote multidisciplinary care for people with allergy including dietetic support. As a member of the expert advisory group on allergy (EAGA) the RCP is working on the development of the UK National Allergy Strategy. The UK National Allergy Strategy aims to provide a collaborative approach to improving health outcomes and other unmet needs of the allergic community across the UK.

Dear Dr Radcliffe,

RE: Regulation 28 Report to Prevent Future Deaths Report

I write in response to your Regulation 28 Report to Prevent Future Deaths (the Report) dated 20 August 2024 in respect of the inquest into the death of Miss Hannah Eniola Angela Ayomipo Jacobs.

This is a tragic case, and it is the great sadness that I learnt of Hannah’s death. I extend my sincere condolences to Hannah’s family and loved ones.

I note that you have expressed concern in relation to the circumstances that arose when Hannah attended at a dental surgery on 8 February 2023. Hannah began to show symptoms of excessive salivation in the dentist’s room, which, in hindsight, was not recognised by dental staff as the early symptoms of an anaphylactic reaction brought on by an inability to swallow. Hannah refused treatment and was rushed to the pharmacist by her mother.

I have carefully considered the standards that we set and guidance that the General Dental Council (GDC) provides for the dental team as relevant to these events, and whether further or different standards or guidance are required or whether there is any further action which the GDC should consider.

The Role of the GDC

The GDC is the UK-wide statutory regulator of dentists and dental care professionals. Our overarching objective is the protection of the public. To achieve this, we register qualified dental professionals, quality assure the standards of dental education, set standards and issue guidance for the dental team and investigate complaints about dental professionals' fitness to practise.

Although we have some regulatory responsibility for how businesses that practise dentistry is constituted, dental premises are regulated by the Care Quality Commission.

The GDC sets standards and issues guidance that are relevant to how dentists are prepared for and respond to medical emergencies when they arise. The GDC also endorse the standards and guidance set by other organisations that are applicable to dental professionals. The framework of standards and guidance that is applicable to the events that took place on 8 February 2023 is set out below.

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GDC standards and requirements

The GDC sets requirements, Preparing for Practice, for the learning outcomes which UK training courses must achieve where the resulting qualification is the basis for allowing people to register as dental professionals. It sets a general requirement that “Students must be trained in accordance with appropriate requirements in relation to dealing with medical emergencies.” There is also a specific requirement for each of the dental professional groups, with dentists require to be able to “identify, assess and manage medical emergencies.”

The GDC also set standards for registered dental professionals, Standards for the Dental Team. These are standards that set out the conduct, performance and ethics that are expected of the dental team.

The following standards are relevant to how dentists are prepared for and respond to medical emergencies.

Standard 1.5 sets out “You must treat patients in a hygienic and safe environment” and requires the dental team to follow the guidance on medical emergencies and training updates issued by the Resuscitation Council (UK) (Standard 1.5.3).

Standard 7.1 obliges dental professionals to provide good quality care based on current evidence and authoritative guidance, including an obligation to find out about current evidence and best practice that affects their work, premises, equipment and business and follow them (Standard
7.1.1). This standard also obliges dental professionals who have not followed established practice and guidance to explain why (Standard 7.1.2).

The effect of the Standards

The effect of Standard 1.5 is that members of the dental team are obliged to follow the Resuscitation Council UK guidance on medical emergencies and training updates (the RCG). If they do not, and a concern was raised with the GDC, this might result in regulatory proceedings to examine their fitness to practise dentistry.

Any concerns raised with the GDC are considered carefully in accordance with our Fitness to Practise Rules and regulatory framework.

The RCG sets out the quality standards that apply to healthcare organisations. This includes an obligation to provide a high-quality resuscitation service and ensure that staff are trained and updated regularly to a level of proficiency appropriate to everyone’s expected role. The RCG includes a list of primary care equipment that must be available. The list includes adrenaline.

The GDC also provides further guidance to registrants on our website which is linked here. This page provides a link to the RCG and additionally sets out an obligation on all registrants that they must be trained in dealing with medical emergencies and possess up to date evidence of capability within the scope of their role.

As part of the guidance, we signpost further guidance provided by the National Institute for Health and Care Excellence (NICE) for dental professionals. This includes a list of medication that must be included in an emergency drugs kit in a dental practice set out in the British National Formulary. This list contains adrenaline/epinephrine. NICE also provides guidance to dental professionals on the management of common medical emergencies.

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There is specific guidance from NICE regarding how dental professionals should deal with anaphylactic reactions. It provides information about how anaphylactic reactions may arise, outlines that they may be associated with additives and excipients in food and lists the common symptoms and signs of anaphylaxis. The list of symptoms does not, however, include excessive salivation. This was the symptom displayed by Hannah on the premises. The guidance goes on to inform dental professionals that the first line treatment for anaphylaxis is the administration of intramuscular adrenaline/epinephrine.

The effect of Standard 7.1 is that dental professionals are obliged by the GDC to provide good quality care based on current evidence and authoritative guidance and follow best practice or explain why they have not done so, if required. Current guidance includes the NICE guidelines which are specifically referenced within the GDC guidance on our website, as set out above.

In addition, the GDC recommends that dental professionals complete at least 10 hours of continuing professional development in relation to medical emergencies, in each five-year CPD cycle and at least two hours of this type of activity every year.

Other Standards

The Care Quality Commission (CQC) regulates dental premises, and the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 are applicable. The CQC requires that a provider must have arrangements in place to take appropriate action if there is a medical emergency (Regulation 12(2)(b)) and that providers must have sufficient medication available in case of emergencies (Regulation 12(2)(f)).

Further action

I have carefully considered the applicable guidance and standards and whether different or additional guidance or standards are required.

The current framework of standards and guidance sets out clear obligations for dental professionals to have appropriate training and keep medication on their premises to use in the event of a medical emergency. I think that it is appropriate to continue to require adherence to the RCG as set out at Standard 1.5 and other appropriate guidance, including the NICE guidance as set out in Standard 7.1.

Whilst I note your concern that dental professionals did not recognise the early symptoms of anaphylaxis, I also note that the symptom of excessive salivation is not listed as a potential symptom in the NICE guidance. We will write to NICE to highlight this, and to ask them to consider reviewing the listed symptoms of anaphylaxis and their guidance to dental professionals more broadly.

We are currently in the process of reviewing our CPD requirements, and we will consider whether we should propose changes to the recommendations regarding medical emergencies as part of the review. The review is expected to conclude in 2025, but some potential changes would require legislative changes, the timing of which is not under our control.

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Should you require any further information in respect of the role of the GDC, our Standards, requirements for Continuing Professional Development or our Fitness to Practise processes, please do not hesitate to contact me.

Dear Dr Radcliffe,

Re: RCPCH Response to the Inquest Touching the Death of Hannah Jacobs A Regulation 28 Report – Action to Prevent Future Deaths

Thank you for sharing your report with us regarding the tragic and untimely passing of Hannah Jacobs. I was very sorry to hear of Hannah’s death. I have shared your report with other senior paediatric colleagues within RCPCH, namely our Officers for Clinical Standards and Quality Improvement. We have read your report carefully and note the following RCPCH activity in relation to the matters of concern.

As the Royal College of Paediatrics and Child Health, we are primarily responsible for the education and training of paediatricians across the UK. We are not involved in the training of dentists and dental staff and have no role in the supply of epi-pens to pharmacies. As part of our training, we run CPD courses on child health topics that are of interest and relevance to the wider child health workforce. This includes Paediatric Allergy Training study days that focus on the practical clinical management of allergy in children and young people. These courses are suitable for all professionals seeing children with allergic disease. You can read more about these courses on our RCPCH Learning platform. We will ensure these continue to be widely promoted across the child health workforce.

Our training curriculum has the following competency which is relevant to this case: “Recognises and manages the acute presentations and after-care of anaphylaxis, prescribing and training the family to use adrenaline autoinjectors, including documenting events and producing an emergency action plan with appropriate onward referrals.”

The College also has a role in providing paediatric clinical guidelines and standards. Relevant to this matter would be our allergy care pathways which are signposted clearly on our website.

The College will be sharing information and suggestions for local improvement from your report with our paediatric members via its patient safety portal. The anonymised information within your report will also be shared for discussion with the RCPCH Clinical Quality in Practice Committee, where further actions may be identified.

Thank you for seeking our views and reminding us of the importance of this work. Our sincere condolences are with Hannah’s family.