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Celia Marsh died on 27 December 2017 at Royal United Hospital, Bath. She had a known allergy to milk. On that day whilst in Bath City Centre she ate a super veg rainbow flatbread which she believed was safe to eat; she suffered an anaphylaxis reaction caused by milk protein which was in an ingredient within the wrap; this caused her to collapse and despite the efforts of the medical teams The medical cause of death was 1a) Anaphylaxis triggered by the consumption of milk protein. Coroner's Matters of Concerns: Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA). There needs to be better education both to doctors and to patients in risk groups to prevent future death. In relation to Pathology: The current guidance is 10 years old, the suggestion is for this to be revisited and specifically: If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing. That an early blood sample is taken after death and stored for late analysis. That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity. That an early blood sample is taken after death. The post mortem examination should be prioritised. At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken. A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation. In relation to doctors/patients: To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group. To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure. In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care: To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content. Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk. In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality: The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim. With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume. In relation to the FSA: A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need. Nationally recognised best practice and technical advice to assist those investigating such cases.

This blog by Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson, looks at safety and regulatory issues associated with Essure, a permanent contraceptive implant. Essure anchors inside the fallopian tubes and reacts with the tissues, causing them to become inflamed and scarred. The resulting scar tissue then blocks the tubes off, intending to prevent fertilisation. The devices are about 4cm long and contain a stainless steel, nickel and titanium inner coil and an expanding outer coil containing iron, chromium and tin. Essure has been shown to cause allergic reactions, lifelong inflammatory reactions and internal injuries. The authors examine how Essure came to be approved for use in the USA, the UK and the rest of Europe, highlighting regulatory failings and conflicts of interest with the medical tech industry. They also highlight how pressure from women harmed by Essure resulted in its use being banned in several countries. The blog then describes ongoing efforts to access UK data on reports of adverse events due to Essure that are held by the Medicines and Healthcare Regulations Agency (MHRA). Freedom of Information requests for this data have been denied.

Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely. Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled. Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.

On 22 May 2021, 17-year-old Alexandra Briess underwent a tonsillectomy and subsequently experienced post-operative bleeding, requiring second operation carried out at Royal Berkshire Hospital on the 30 May. During anaesthesia, she experienced a sudden deterioration and cardiac arrest. Despite extensive resuscitation efforts, Alexandra died on the 31 May. Subsequent investigations have revealed that the most likely cause of her sudden deterioration was an anaphylactic reaction to Rocuronium. In this report, the Coroner highlights connections between this case and three other Prevention of Future Deaths Report’s and suggests there needs to be greater funding and a role within the NHS to coordinate a national approach to prevent/reduce future deaths. The report highlights three other cases where similar concerns have been raised: Shante Turay-Thomas Ruben Bousquet Celia Marsh The Coroner states that it seems clear in all these cases, that the only way to improve understanding and prevent or reduce future deaths is to gather information nationally and fund appropriate research. Coroner’s Matters of Concern There is significant goodwill and desire to improve amongst numerous organisations involved in anaphylaxis work. What is lacking is national leadership and funding. In my view, consideration should be given to creating a leadership role and responsibility within NHS England to coordinate a national approach. As considered by other coroners before me, it should be mandatory to refer fatal anaphylaxis cases. UK Fatal Anaphylaxis Registry (UKFAR) has indicated that they would be prepared to take on the role of receiving these reports (to avoid duplication for reporting clinicians), with the responsibility to forward the relevant information to other organisations such as the Medicines and Healthcare products Regulatory Agency (MHRA), where appropriate. Whilst my focus is on fatal anaphylaxis, inclusion of non-fatal cases would be a matter for the lead role to consider. Gathering data and using this to research and reduce the risk of future deaths requires funding, and this should be reviewed. Information sharing amongst the organisations referred to in this report should be straightforward. Confidentiality constraints are important, but not the same in the case of a deceased person as they are for a living person. I believe that a confidential advisory group has already started to consider this matter. Consideration of including contact details for the UKFAR in algorithms used by doctors attempting to resuscitate patients – so that there is a clear requirement for referral to UKFAR in the event of an unsuccessful resuscitation. This is currently being considered by the Resuscitation Council UK.

This study in the International Journal of Environmental Research and Public Health examines the demographic, clinical and socioeconomic factors associated with diagnosis of Long Covid in children aged 5 to 18 years. The authors conducted a population-based cross-sectional study using data from 20,601 children living in Israel who tested positive for Covid between 1 February 2020 and 30 June 2021. They found several variables associated with the development of Long Covid, including: the severity of acute infection being hospitalised recurrent acute infection ADHD diagnosis chronic allergic rhinitis chronic urticaria. The authors call for heightened clinical awareness that Long Covid can be present in children, and highlight that this should affect public health policy because of Covid-19's long-term health impacts.

There has been an increasing trend in commercially available diagnostic tests for food allergy and intolerance, but many of these tests lack an evidence base. In this article, Philippe Bégin from the University of Montreal describes the risks involved with using unproven diagnostic tests for food allergies and intolerances. He highlights that alongside their high cost, they may lead to false diagnoses, with associated anxiety and unnecessary strict avoidance diets. They may also lead truly allergic people to believe they are not allergic to certain foods, which could cause them to eat a food that gives them a life-threatening reaction. He also provides a list of tests that are offered to consumers, but that are unproven and should be avoided.

Anaphylaxis is a severe and often sudden allergic reaction that occurs when someone with allergies is exposed to something they are allergic to (known as an allergen). Anaphylaxis is potentially life-threatening, and always requires an immediate emergency response. Between 10 May 2017 and 10 May 2019, 55 hospital trusts reported 77 incidents relating to allergens in hospital, three of which involved the patient going into anaphylaxis, a severe and potentially life-threatening condition. This e-learning course is for nurses, healthcare assistants, ward managers, staff educators, directors of nursing, dieticians and anyone else involved in patient care on the ward. It has been designed to equip participants with knowledge and understanding about food allergies so that they can ensure the necessary processes are in place to keep inpatients with food allergies safe. The course takes around two hours to complete and can be completed at any pace. It covers the following topics: Understanding anaphylaxis The treatment of anaphylaxis Food allergens and understanding labels Roles and responsibilities in hospitals Practical management of food allergies in hospital

A new Information Standard has been published by NHS Digital to support improved medication and allergy/intolerance information sharing across healthcare services in England. The new Information Standard will standardise medication message content, enabling transfer of prescription information across health and care settings in England to help reduce medicines related errors and improve patient safety. The Standard will enable medicines information to be more efficiently shared between NHS and social care organisations, including primary and secondary care – from hospitals and GP practices to residential care homes, mental health trusts, and pharmacies. It will be particularly beneficial in reducing medication errors when patients transfer between care locations. As well as providing clinicians with a more detailed and consistent source of medicines related information across all care settings, the Standard will also enable healthcare professionals to obtain medicines information in a quicker, more efficient manner, saving valuable time and improving patient care.

This is the transcript of an Adjournment Debate from the House of Commons on the 29 October 2021 on NHS Allergy Services, tabled by Jon Cruddas MP. What is an Adjournment Debate? There is a 30-minute Adjournment Debate at the end of each day's sitting of the House of Commons. They provide an opportunity for an individual backbench MP to raise an issue and receive a response from the relevant Minister. Unlike many other debates, these take place without a question which the House of Commons must then make a decision on.[1] NHS Allergy Services In this debate Jon Cruddas MP raised a series of points about improving allergy services in the UK and in support of numerous recommendations made in a recent report by the All-Party Parliamentary Group on Allergy and the National Allergy Strategy Group in their report, Meeting the challenges of the National Allergy Crisis. The Minister for Care and Mental Health, Gillian Keegan MP, subsequently provided the Government’s response. You can find the full transcript here. Reference UK Parliament, Adjournment Debates, Last Accessed 25 September 2020.

The All Party Parliamentary Group for Allergy, in conjunction with the National Allergy Strategy Group (NASG), has launched a new report which calls for the appointment of an influential lead for allergy who can implement a new national strategy to help the millions of people across the UK affected by allergic disease. This report brings to Ministers’ attention the growing allergy epidemic and the lack of NHS services for people with allergic disease. 20 million people in the UK, a third of the population, are living with allergic disease with five million of these severe enough to require specialist care yet our allergy services remain inadequate, often hard to access and are failing those who need them the most. Change is required and is now long overdue. For the growing number of people living with allergic disease in the UK, their condition can have a significant and negative impact on their lives. It is frightening and restrictive to live with a condition which could cause a severe or life threatening reaction at any time. Key recommendations: Create more training posts in allergy. Train many more doctors to be allergy specialists. Increase the number of consultant allergists. Increase allergy knowledge in primary care through training and education. Bring allergy care into the 21st century, raise standards and the consistency of care across the UK. Further reading: Why allergies are the Cinderella service of the NHS – a blog by Tim McLachlan

This free online e-learning course is designed for parents and carers of severely allergic children. This course aims to improve and update knowledge about the everyday management of severe allergies. Topics include: What happens in an anaphylactic reaction Early recognition of the signs and symptoms of anaphylaxis How and when to use adrenaline injectors, and how to care for these devices Crisis management The long-term management, such as avoidance of allergens What you need to know to lessen the risk of a severe allergic reaction Food labelling regulations in the UK and Europe The role of parents and carers in enabling schools to support children who have severe allergies. Individuals can work through this course at their own pace, it will take around 1 hour to complete. Upon successful completion of this AllergyWise course (75% pass rate) you can buy a certificate for £5 plus VAT for proof. To register please follow the link below.

A deep learning algorithm accurately identified allergic reactions in hospital patient safety reports, which could help providers avoid medical errors and improve event surveillance, according to a study from Yang et al. published in JAMA Network Open. Allergic reactions – to medications, foods, and healthcare products – are becoming increasingly common in the US. Researchers noted that up to 36% of patients report drug allergies, and 4-10% report food allergies. Patients in healthcare settings are at particularly high risk of developing an allergic reaction, and it’s critical that providers are able to quickly detect and monitor these events. Results of this study suggest that deep learning can improve the accuracy and efficiency of the allergic reaction identification process, which may facilitate future real-time patient safety surveillance and guidance for medical errors and system improvement.

The Patient Safety Authority has put together information and tips for patients on a range of topics. C-Diff Dentures in the healthcare setting Discharge instructions Drug allergies End of life care Falls at home Getting the right diagnosis Handwashing Hospital ratings Influenza (the flu) Latex allergies Medical records Medication safety at home Medication safety: Hospital and doctor's office Metric-based patient weights MRI safety MRSA Neonatal abstinence syndrome (NAS) Norovirus (stomach flu) Obstructive sleep apneoa Pneumonia Pressure injuries (bed sores) Sepsis What is an MRI? Wrong-site surgery

The National Institute for Health and Care Excellence (NICE) has released updated guidance which says that healthcare professionals should now prescribe those people with severe allergies two Adrenaline auto-injectors (AAIs) when discharging patients from hospital, and patients should always carry two devices with them. This article from the Natasha Allergy Research Foundation (NARF) notes that the updated guidance came in response to the inquest into Shante Turay-Thomas, who died in north London just 18 years old, from anaphylaxis after eating hazelnut. The Coroner found that she had not been properly advised that the reason for carrying two AAIs was that in the event of a severe food allergy. A second dose of adrenaline can be a life preserving measure whilst waiting for emergency medical treatment. The coroner warned that action is needed to ensure that people with severe food allergies are aware that two AAIs must be carried at all times and they must be properly trained in how to use them. This would help to prevent further, avoidable deaths from severe food allergies. Follow the link below to read the full article from NARF. The full updated NICE guidance is also attached below.

The latest figures from NHS Digital show the number of hospital episodes in England with a primary diagnosis of anaphylaxis increased from 5,497 in 2018-19 to 5,517 in 2019-20. Previous figures have shown the number of cases of children hospitalised with severe allergic reactions in England has increased by 72 per cent over the last six years. Overall, including adults, there has been a 34 per cent rise in admissions over the same period. Figures from 2019 reveal wide regional differences among children admitted to hospital with anaphylaxis. The health region with the highest increase is London where the number of cases has risen by 167% from 180 in 2013-14 to 480 in 2018-19. Among those ten and under, the increase is a staggering 200 per cent.  Natasha Allergy Research Foundation (NARF) has renewed its call for the Government to appoint an ‘Allergy Tsar’ to co-ordinate and take steps to make sure people with allergies get the treatment and care they need.  NARF first called for the appointment of an ‘Allergy Tsar’ earlier this year following the inquest of Shante Turay-Thomas, 18, who died in 2018 from anaphylaxis after eating hazelnut.