Drs Joanne Walsh and Elizabeth Angier explore NICE quality standards on food allergy and anaphylaxis and the importance of education and communication for both patients and practitioners
Read this article to learn more about:
- why NICE quality standards were needed for care of people with food allergy and/or anaphylaxis
- how to recognise IgE-mediated and non-IgE-mediated allergy
- possible strategies to help to improve care and patient outcomes.
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In the UK, 1 in 3 people has an allergic disease.1 Allergies are the most common chronic disorder in children; 6–8% of children up to the age of 3 years in Europe and North America are thought to have a food allergy.2,3 Estimates from the UK suggest that 1 in 1333 of the population in England has experienced anaphylaxis at some point in their lives.4 In the UK, around £900m per year is spent on allergies in primary care and £68m on allergy-related hospital admissions. Much of this expense is considered to be avoidable.2
In 2011, NICE published Clinical Guideline (CG) 116, Food allergy in under 19s: assessment and diagnosis.5 Later that year, NICE published a second allergy guideline, Anaphylaxis: assessment and referral after emergency treatment (CG134) (see Box 1, below).4
The guidelines were commissioned by the Department of Health following a 2006 review of allergy services in the UK, which revealed inequalities in the health care of those with allergy and suspected allergic conditions.6 Despite the publication of these guidelines, inequalities remain and the guidance is rarely implemented. NICE CG116 is one of the few NICE guidelines aimed specifically at primary care, yet many healthcare professionals working in primary care, including GPs, appear to be unaware of it. The anaphylaxis guideline, CG134, includes important messages for those in primary, secondary, and tertiary care who manage patients at risk of anaphylaxis.4
In March 2016 NICE published Quality Standard (QS) 118 on Food Allergy (QS118),7 and NICE QS119 on Anaphylaxis.8 It is hoped that these will further help healthcare professionals to implement the recommendations from the associated NICE guidelines. Doing so will improve the care and quality of life for those with allergies, reduce the burden on accident and emergency departments from those presenting with avoidable reactions, and ensure referrals to secondary and tertiary care are appropriate.
This article will discuss each of the quality standards in turn. They were both developed by the same working group as there is some degree of overlap (e.g. food allergy can be a reason for a presentation of anaphylaxis); however, the quality statements in QS118 are generally based on the management of children and young people, as this is what the NICE guideline on food allergy covered. The NICE guideline on anaphylaxis makes recommendations for all age groups. We will also consider some of the service delivery options, and current enablers and barriers to care.
Quality Standard 118 on food allergy
Successful implementation of NICE QS118 will require an educational component. The majority of GPs have received little training on diagnosing and managing food allergy.9
Food allergy is an area of medicine where there have been many developments in recent years, but even the pattern recognition of the symptoms of IgE-mediated disease compared with non-IgE-mediated disease is poorly understood by many healthcare professionals. In future, decision support tools linked to local guidelines and management tools embedded in the GP desktop software may have a role.10 The six quality statements for QS118 are listed in Table 1, see below. Note that statements 1–4 refer only to food allergy in those under the age of 19 years, as this group was the focus of CG116.5
|1||Children and young people with suspected food allergy have an allergy-focused clinical history taken.|
|2||Children and young people whose allergy-focused clinical history suggests an IgE-mediated food allergy are offered skin prick or blood tests for IgE antibodies to the suspected food allergens and likely co-allergens.|
|3||Children and young people whose allergy-focused clinical history suggests a non-IgE-mediated food allergy, and who have not had a severe delayed reaction, are offered a trial elimination of the suspected allergen and subsequent reintroduction.|
|4||Children and young people are referred to secondary or specialist allergy care when indicated by their allergy-focused clinical history or diagnostic testing.|
|5||(placeholder) Diagnosing food allergy in adults.|
|6||(placeholder) Nutritional support for food allergy.|
|NICE (2016) QS118. Food allergy.
Reproduced with permission
Allergy-focused history—statement 1
An allergy-focused clinical history should be taken whenever food allergy is suspected.7 This is the cornerstone of diagnosis and relies on the healthcare professional having a suspicion of food allergy from the presenting symptoms. If food allergy is suspected, the severity of the reaction and the likely mechanism determine the next steps in management.
The symptoms of IgE-mediated disease usually occur within minutes to 2 hours after consumption of a food. Most GPs will be confident in recognising symptoms such as urticaria, angioedema, and anaphylaxis as possible IgE-mediated allergy; however, many healthcare professionals have not previously considered non-IgE-mediated symptoms, such as gastro-oesophageal reflux disease, abdominal pain, and eczema, to be possible symptoms of food allergy. Symptoms are often present in multiple organ systems, including gastrointestinal, skin, and respiratory. A diagnosis of food allergy is more likely if there are symptoms in more than one organ system, or when troublesome symptoms fail to respond to the usual management strategies.5 See Table 2, below for signs and symptoms of possible food allergy.
|Acute urticaria—localised or generalised||Atopic eczema|
|Acute angioedema—most commonly of the lips, face and around the eyes|
|The gastrointestinal system|
|Angioedema of the lips, tongue and palate||Gastro-oesophageal reflux disease|
|Oral pruritus||Loose or frequent stools|
|Nausea||Blood and/or mucus in stools|
|Colicky abdominal pain||Abdominal pain|
|Diarrhoea||Food refusal or aversion|
|Pallor and tiredness|
|Faltering growth in conjunction with at least one or more gastrointestinal symptoms above (with or without significant atopic eczema)|
|The respiratory system (usually in combination with one or more of the above symptoms and signs)|
|Upper respiratory tract symptoms (nasal itching, sneezing, rhinorrhoea or congestion [with or without conjunctivitis])|
|Lower respiratory tract symptoms (cough, chest tightness, wheezing or shortness of breath)|
|Signs or symptoms of anaphylaxis or other systemic allergic reactions|
|Note: this list is not exhaustive. The absence of these symptoms does not exclude food allergy|
|NICE (2011) CG116. Food allergy in under 19s: assessment and diagnosis.
Reproduced with permission
Testing for IgE-mediated food allergy—statement 2
If IgE-mediated food allergy is suspected, NICE QS118 recommends that specific IgE antibodies should be tested for, either by skin prick tests or blood tests.7 It is unusual for skin prick testing to take place in primary care; however, NICE considers that any setting with resuscitation facilities for anaphylaxis is safe for testing to take place. This includes primary care settings where immunisations are given (as immunisations carry a risk of anaphylaxis).3
Implementing this statement may involve considering the availability of skin prick testing in the community. Tests should only be done by those competent to perform and interpret them.5 This will require training and a service development plan. Specific IgE blood tests can be offered instead of skin prick tests, but again staff will need the competencies to be able to choose the correct test from the context of the patient's history and interpret the results in light of this, as well as the ability to liaise with specialists about test results. If training and staffing is not available to address this need, many of these patients will need a referral to a secondary care service.
Provision of a suitable, local service for appropriate testing and interpretation of results is ideal, preferably as part of a hub and spoke model, for example, the North West multidisciplinary team (MDT) Allergy Network—a Department of Health pilot project with a specialist centre acting as a hub and local centres acting as spokes.2 This local service would ideally comprise: a tertiary care centre for specialist allergy care such as venom immunotherapy, several secondary care centres with adult and paediatric services, and community bases where less severe allergies can be adequately managed.
In some areas there is also limited access to secondary care allergy services. Not only will allergy services need to be developed, they will also need to be able to cope with the potentially high demand, for example through projects such as the 'itchy sneezy wheezy project', an integrated respiratory and allergy pathway to improve the management of allergy in children.11 GPwSI clinics for integrated care or specialised health visitor clinics may need to be developed. Charities such as Allergy UK and Anaphylaxis Campaign can also play an important role in patient and healthcare education alongside feedback from their helplines. The services developed will need to be based on local needs. Upskilling and investing in primary care may reduce some of the demand on secondary care and lessen the associated costs of referral; NICE Clinical Knowledge Summary on Cow's milk protein allergy in children acknowledges that many children with suspected IgE-mediated disease will need to be referred due to lack of competencies and/or resources in primary care.12
Testing for non-IgE-mediated food allergy—statement 3
In non-IgE-mediated food allergy, diagnosis should be confirmed by eliminating the suspected food from the diet and, unless the symptoms are severe, reintroducing it to confirm the diagnosis.5,7 In infants with suspected cow's milk protein allergy, for example, for a totally breast-fed infant, this would involve elimination of milk from the mother’s diet; for a formula-fed infant, substitution with an extensively hydrolysed formula (or in severe cases, amino acid formula). If weaning on to solid foods has commenced, dairy foods such as cheese and yoghurt would need to be removed from the diet. The food reintroduction to prove the diagnosis is usually performed between 2 and 6 weeks after starting the elimination diet.5,12,13 NICE provides a list of information that healthcare professionals should offer children and young people (and their parents/carers if appropriate), see Box 2, below.
Box 2: Trial elimination of food allergen: information7
Healthcare professionals offer children and young people (and their parents or carers if appropriate) information on:
- what foods and drinks to avoid
- how to interpret food labels
- alternative sources of nutrition to ensure adequate nutritional intake
- the safety and limitations of an elimination diet
- the proposed duration of the elimination diet
- when, where and how an oral food challenge or food reintroduction may be undertaken
- the safety and limitations of oral food challenge or food reintroduction.
NICE (2016) QS118. Food allergy.
Reproduced with permission
Appropriate referral—statement 4
Some people with food allergy can be managed in primary care; however, further input from secondary or specialist care is often needed. If allergy is indicated by the allergy-focused clinical history or by diagnostic testing, some patients should be referred without any further testing. This is needed when the allergy-focused clinical history indicates:5
- acute systemic reactions or severe delayed reactions
- faltering growth and gastrointestinal symptoms
- significant atopic eczema with suspicion of multiple food allergies
- possible multiple food allergies.
Again, referral of these patients requires access to an appropriate service, ideally a designated allergy clinic or a clinic run by a paediatrician with an interest in allergy.
As previously mentioned, many patients without access to community testing, may be referred to secondary care purely for specific IgE testing to confirm a diagnosis. If the testing does take place in primary care, some patients will then require a referral. Those with a likely IgE-mediated reaction (i.e. a clinical history that correlates with a positive blood/skin prick test for a specific food) and with asthma should be referred.5 Asthma is a risk factor for a severe reaction.14 If allergy test results are negative, but the history gives a strong clinical suspicion of IgE-mediated allergy, these patients should also be referred5—the allergen may not have been immediately obvious and therefore not tested for.
In non-IgE-mediated disease, those with symptoms that do not respond to a single allergen elimination diet, for example, in infants where removal of milk protein alone has not improved the symptoms, should be referred if food allergy is still suspected.5
Persisting parental suspicion of food allergy but an unconvincing history is another indication for referral.5
Food allergy in adults and dietetic support—statements 5 and 6
Statements 5 and 6 are referred to as placeholder statements, which NICE defines as: 'an area of care that has been prioritised by the Quality Standards Advisory Committee but for which no source guidance is currently available. A placeholder statement indicates the need for evidence-based guidance to be developed in this area.'
NICE was unable to develop a quality statement on diagnosing food allergy in adults, although it recognised that this is an increasingly considered diagnosis and must be addressed.7 It is accepted that research is needed in this field. Food associated reactions in adults can often involve cofactors such as exercise and alcohol intake, which make the diagnosis and management more complex.
Dietetic support is an important and integral component in the management of food allergy. NICE CG116 recognised that dietitians should be involved whenever cow's milk is removed from an infant's diet.5 Access to and demand for dietetic services is an issue for primary care when it comes to implementing the NICE guidance. Although there is no evidence on the need for those with food allergy to receive ongoing nutritional advice from a dietitian, NICE has accepted that this is an area for consideration and so have developed a placeholder statement.7
Quality Standard 119 on anaphylaxis
NICE defines anaphylaxis as:4'a severe, life-threatening, generalised or systemic hypersensitivity reaction. It is characterised by rapidly developing, life-threatening problems involving: the airway (pharyngeal or laryngeal oedema) and/or breathing (bronchospasm with tachypnoea) and/or circulation (hypotension and/or tachycardia).'
As with NICE QS118, education packages will need to be developed around the quality standard on anaphylaxis. Implementation will again depend on adequate provision of services and ideally the development of pathways, user-friendly tools, patient information packages, and communication between primary and secondary care. The four quality statements for QS119 are listed in Table 3, see below.
|1||People who have emergency treatment for suspected anaphylaxis are referred to a specialist allergy service.|
|2||People who are prescribed an adrenaline auto-injector after emergency treatment for suspected anaphylaxis are given training in how and when to use it before being discharged.|
|3||People who have a systemic reaction to wasp or bee stings are referred to a specialist allergy service to assess whether venom immunotherapy would be suitable.|
|4||(placeholder) Ongoing training in adrenaline auto-injector use.|
|NICE (2016) QS119. Anaphylaxis.
Reproduced with permission
Referral to a specialist allergy service—statement 1
The first quality statement is that people treated for suspected anaphylaxis are referred to a specialist allergy service.8 NICE defines suspected anaphylaxis as:4'the diagnosis, prior to assessment by a specialist allergist, for people who present with symptoms of anaphylaxis.' Ideally the referral should be made by secondary care (either the emergency department or medical admissions) prior to discharge, but this will depend on local pathways, time pressures, and staff training within those units. Alternatively, patients may be advised, in their discharge letter, to see their GP for a referral. It is therefore vital that there is good communication between professionals managing the emergency presentation, primary care, and the appropriate allergy service. A list of allergy clinics can be found on the British Society of Allergy and Clinical Immunology (BSACI) website.
Training on use of adrenaline device—statement 2
Following treatment for suspected anaphylaxis (except after some drug reactions), an adrenaline auto-injector should be prescribed and dispensed to the patient before they leave hospital. Statement 2 also covers the provision of training to patients (ideally before discharge) in how to use these devices.8 This, alongside advice on avoidance of triggers, is an important safety net, since there may be a significant delay before patients are seen in an allergy unit. Pharmacists could play an important role in providing the initial training with a training device demonstration and ensuring that patients continue to be confident in using their device. Clear communication is required between primary and secondary care to ensure an appropriate repeat prescription and ongoing patient training is provided. Local areas may have preferred devices on their formulary and this will need to be communicated. It is important to ensure that the device the patient receives is the one they are trained to use as there are now several devices available in the UK. Current Medicines and Healthcare products Regulatory Agency guidance advises that patients should carry two devices, as they may not respond sufficiently to the first injection, or sometimes symptoms may recur up to 24 hours after the initial reaction (known as a biphasic reaction).15
Referral for consideration of immunotherapy in those with venom allergy—statement 3
The third statement referring to bee or wasp stings will be dependent on determining the severity of the reaction. Due to the success of venom immunotherapy, people with systemic reactions to bee or wasp stings should be referred to a specialist allergy service for consideration of desensitisation.8 There will need to be an accessible allergy centre with the capacity to accept these referrals and also staff with the experience to provide immunotherapy. Development of a local pathway would ideally ensure that this referral is made directly from the emergency department. Communication between primary, secondary, and possibly tertiary care will again be required to implement this quality statement. There may be many patients who have never been referred for consideration of immunotherapy who might warrant referral, which again may put a strain on the currently sparse allergy clinics.
Ongoing training in adrenaline auto-injector use—statement 4
A placeholder statement was made to acknowledge the importance of ensuring that people prescribed adrenaline auto-injectors receive ongoing training in how to use them.8 This could be incorporated into annual reviews, often performed by practice nurses, of those with adrenaline devices, in particular those with asthma and allergy (perhaps through incorporation into the asthma template). Professionals would need to be familiar with the devices themselves and need a longer consultation time to carry out the training. They should check that the device is in date, is always carried, and ensure that the patient has a relevant allergy action plan. Action plans for children can be downloaded from BSACI website.
It is important that asthma is well controlled as the recurring themes of deaths from anaphylaxis are poor asthma control and either not carrying the adrenaline auto-injector or delaying its use, with teenagers being a particularly high-risk group.16–18
Successful implementation of these two quality standards will require support for patients in self-management alongside development of health information for patients, families, and schools. Education packages for healthcare professionals to enhance early diagnosis and ongoing management will also be needed.
There is currently a lack of knowledge and accessible education across the system, including in A&E; poor investment in GPwSI allergy; time constraints; a lack of clinical ownership; and poor communication. Staff turnover and lack of education can add to poor management. Better information needs to be given to patients on discharge and appropriate referrals arranged. A standard discharge checklist in A&E departments, alongside an interim management plan and patient information leaflets, adrenaline device training, and provision for appropriate referrals would be beneficial. Better communication is needed between primary and secondary care, and will depend on accessible secondary and tertiary care allergy services.
Issues of funding for MDT training and specialist services, including the key role of emergency clinicians, will need to be addressed. As well as improving quality of life for individuals and their families, investment in allergy services should reduce the costs of emergency and hospital care for reactions which, with better management, could have been avoided. Allergy clinics should be able to deal with all symptoms likely to be allergy related, offsetting the need for appointments in respiratory, ENT, gastroenterology, and dermatology clinics.
A national policy for improving allergy care, such as the Finnish Asthma and Allergy Programme, 19 could help standardise approach. Allergy is increasingly a multisystem disease, so earlier recognition and treatment might prevent multiple attendances to different units. The delivery model could be by an interprofessional team working on integrated pathways supervised by specialists.
The emerging BSACI allergy clinical networks will support better communication, management, and user-friendly tools being developed for primary care and the wider system. Appropriately trained health visitors, pharmacists, and practice nurses could play an important role. The current financial models based on payment by results with incentives for outpatient care and activity might be better replaced by a broader, capitation-based payments system encouraging wider community care in line with some of the new care models.
- An allergy-focused clinical history is the key to clarifying the likelihood of an allergic reaction, its severity, and its mechanism
- Food allergy can be IgE-mediated or non-IgE-mediated
- Specific IgE testing, either blood or skin prick tests, is only relevant in the diagnosis of those with immediate reactions to foods. Test results can only be interpreted within the context of the clinical history
- Non-IgE-mediated food allergy is diagnosed by an elimination diet. Unless considered severe, a reintroduction should be taken after 4–6 weeks to ‘prove’ the diagnosis. Blood testing is not required
- Those who have had suspected anaphylaxis or who have severe reactions to food must be referred to an allergy clinic for identification of triggers, confirmation of the diagnosis, management of comorbidities, and a management plan
- Venom immunotherapy is effective. Patients with systemic reactions to bee and wasp stings should be prescribed adrenaline and referred for consideration
- Adrenaline devices and instructions on their use (including carrying it with them at all times) should be given to a patient who has been treated for anaphylaxis before they leave hospital
- NICE recognises that there is no guidance and little research on food allergy in adults and invites research in this area
- Dietitians are an integral aspect of the multidisciplinary team in managing patients with food allergy and referral should be made for all infants on a cow’s milk free diet
- Education of primary care healthcare professionals and development of patient pathways are an essential initial component to improving the holistic management of those with allergic symptoms.
GP commissioning messages
written by Dr David Jenner, GP, Cullompton, Devon
- Food allergy, although relatively common in children, is often overlooked or misunderstood by GPs despite the publication of NICE QS118 and QS119 in March 2016
- Care pathways listing simple tests that can be performed in primary care and indications for specialist referral should be developed and shared with primary care services
- Commissioners should:
- consider specific training programmes for primary care staff on the recognition and investigation of food allergy and anaphylaxis
- ensure they have commissioned specialist allergy services and also consider commissioning GPs with Special Interests to provide simple allergy testing (e.g. skin prick testing in primary care)
- PbR tariff costs for a paediatric outpatient: first attendance, £222; follow-up attendance, £135.a
QS=quality standard; PbR=payment by results
- MINTEL. Not to be sneezed at—almost half of all brits are allergy sufferers. www.mintel.com/press-centre/beauty-and-personal-care/not-to-be-sneezed-at-almost-half-of-all-brits-are-allergy-sufferers (accessed 28 June 2016)
- Parliamentary Office of Science and Technology. Childhood allergies. Houses of Parliament, 2014. Available at: www.parliament.uk/briefing-papers/post-pn-467.pdf
- National Clinical Guideline Centre. Food allergy in children and young people. London: National Clinical Guideline Centre, 2011. Available at: www.nice.org.uk/guidance/cg116/evidence/full-guideline-136470061
- NICE.Anaphylaxis: assessment and referral after emergency treatment. NICE Clinical Guideline 134. NICE, 2011. Available at: nice.org.uk/CG134
- NICE. Food allergy in under 19s: assessment and diagnosis. NICE Clinical Guideline 116. NICE, 2011. Available at: nice.org.uk/CG116
- Department of Health. A review of the services for allergy: the epidemiology, demand for and provision of treatment and effectiveness of clinical interventions. DH, 2006. Available at: webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4137365
- NICE. Food allergy. NICE Quality Standard 118. NICE, 2016. Available at: nice.org.uk/qs118
- NICE. Anaphylaxis. NICE Quality Standard 119. NICE, 2016. Available at: nice.org.uk/qs119
- Ellis J, Rafi I, Smith H et al. Identifying current training provision and future training needs in allergy available for UK general practice trainees: national crosssectional survey of General Practitioner Specialist Training programme directors. Prim Care Respir J 2013; 22 (1): 19–22.
- Jones R, Ashurst E, Jones D et al. Development and implementation of a decision pathway for general practitioners for the management or referral of suspected allergy. J Public Health Res 2014; 3 (2): 248.
- North West London Integrated Respiratory and Allergy Care Pathway Project (Itchy Sneezy Wheezy Project). www.itchysneezywheezy.co.uk (accessed 11 July 2016).
- NICE. Cow's milk protein allergy in children. NICE Clinical Knowledge Summaries. NICE, 2014. Available at: cks.nice.org.uk/cows-milk-protein-allergy-in-children
- Venter C, Brown T, Shah N et al. Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy—a UK primary care practical guide. Clin Transl Allergy 2013; 3 (1): 23.
- Muraro A, Roberts G, Worm M et al. Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology. Allergy 2014; 69 (8): 1026–1045.
- Medicines and Healthcare products Regulatory Agency. Adrenaline auto-injectors: a review of clinical and quality considerations. MHRA, 2014. Available at: www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con423091.pdf
- Pumphrey R. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy 2000; 30 (8): 1144–1150.
- The National Review of Asthma Deaths. Why asthma still kills. RCP, 2014. Available at: www.rcplondon.ac.uk/projects/outputs/why-asthma-still-kills
- Turner P. Increase in anaphylaxis-related hospitalizations but no increase in fatalities: an analysis of United Kingdom national anaphylaxis data, 1992–2012. J Allergy Clin Immunol 2015; 135 (4): 956–963.
- Haahtela1 T, Hertzen1 L, Mäkelä1 M. Finnish Allergy Programme 2008–2018—time to act and change the course. Allergy 2008; 63 (6): 634–645. G