Food Allergy.

Food allergy is a growing health problem affecting both pediatric and adult patients. Food allergies are often immunoglobulin E (IgE) mediated but other food-induced non-IgE-mediated diseases exist. Diagnosis of food allergy relies on the combination of clinical and reaction history, skin and IgE testing as well as oral food challenges. Although oral immunotherapy has been able to achieve sustained unresponsiveness in some patients, no cure for food allergies has been found to date. Avoidance of the inciting food as well as availability of epinephrine autoinjectors remains the mainstay of treatment.

Food Allergy.

Food allergy is a growing health problem affecting both pediatric and adult patients. Food allergies are often immunoglobulin E (IgE) mediated but other food-induced non-IgE-mediated diseases exist. Diagnosis of food allergy relies on the combination of clinical and reaction history, skin and IgE testing as well as oral food challenges. Although oral immunotherapy has been able to achieve sustained unresponsiveness in some patients, no cure for food allergies has been found to date. Avoidance of the inciting food as well as availability of epinephrine autoinjectors remains the mainstay of treatment.

Anaphylaxis and epinephrine autoinjector use in pediatric patients with cutaneous mastocytosis.

BACKGROUND/OBJECTIVES: Mastocytosis is a complex disorder presenting with a broad clinical spectrum. In this study, we aimed to evaluate the frequency of systemic symptoms, necessity of the usage of epinephrine autoinjectors (EAI), and factors affecting the use of EAI among pediatric patients with cutaneous mastocytosis (CM). METHODS: The study population was composed of 53 patients with CM. The clinical data were collected from the medical files. A questionnaire about the patient's anaphylaxis experiences and treatment attitudes toward EAI was performed. RESULTS: Thirty-three of 53 patients were male (62.3%), and the median age of the study participants was 80 months. Anaphylaxis was reported in two patients (3.7%). One of the patients had drug-induced anaphylaxis, and the other had venom-induced anaphylaxis. Three patients (5.6%) reported a personal history of EAI use due to systemic symptoms. Patients with higher serum tryptase level and cases of familial mastocytosis had more systemic symptoms (P = .012 and P = .010, respectively). The patient rate of compliance with EAI for prescription filling and carrying the EAI was 88.7% and 79.2% respectively. 41.5% of parents were hesitant to use EAI when necessary, although they were trained for the use of it by medical staff. CONCLUSIONS: The rate of anaphylaxis in patients with CM in the current study wassignificant and justifies prescribing EAI. Detailed education and counseling on EAI usage are needed to reduce parental hesitancy.

Healthcare workers` knowledge level regarding anaphylaxis and usage of epinephrine auto-injectors.

BACKGROUND: Inadequate practices in diagnosis and management of anaphylaxis in parallel with an increase in its prevalence may cause serious public health problems today. This is the first study aiming to assess the theoretical knowledge of professional and non-professional healthcare workers from different lines of the healthcare service chain about anaphylaxis management, and their practice approaches for epinephrine autoinjectors (EAIs) together. METHODS: The study included 697 participants comprising physicians, dentists, pharmacists, and school staff. In face-to-face interviews, each participant was asked to fill out the questionnaire forms prepared for assessing their demographic characteristics, experience with a case of anaphylaxis and EAI and theoretical knowledge about the diagnosis and treatment of anaphylaxis, and to demonstrate how to use EAI in practice with trainer device. RESULTS: The rates of 391 physicians, 98 dentists, 102 pharmacists and 105 school staff of knowing the diagnosis criteria of anaphylaxis were 47.6%, 31.6%, 31.1%, 19%, and knowing the first and life-saving treatment of anaphylaxis were 87.2%, 79.6%, 47.6%, 15.2%, respectively. Predictors that affected physicians in knowing the first and life-saving treatment of anaphylaxis were having experience with EAIs [OR:5.5, (%95CI:1.330-23.351, p=0.015)] and a case of anaphylaxis [OR:2.4, (%95CI:1.442-4.020, p=0.001)], and knowing the administration route of epinephrine correctly [OR:1.9, (%95CI:1.191-3.314, p=0.008)]. 31.1% of the participants demonstrated the EAI usage correctly. The EAI usage steps with the most errors were `Place the appropriate injection tip into outer thigh/Press the trigger so it `clicks`` and `Turn the trigger to arrow direction` (60.3% and 34.9%, respectively). CONCLUSIONS: Healthcare workers` knowledge level regarding anaphylaxis management and ability to use EAIs correctly are not adequate. That most errors were made in the same steps of EAI usage indicates that the industry should continue to strive for developing the ideal life-saving device.

A Cost-Effectiveness Analysis of Epinephrine Autoinjector Risk Stratification for Patients with Food Allergy-One Epinephrine Autoinjector or Two?

BACKGROUND: Food-allergic patients are routinely prescribed 2 epinephrine autoinjectors (EAIs). The cost-effectiveness of this strategy is unknown. OBJECTIVE: To evaluate the cost-effectiveness of routinely prescribing all patients 2 EAI devices versus a risk-stratified approach (2 EAIs prescribed only for patients with a risk factor). METHODS: Markov models compared universal versus risk-stratified approaches on the basis of either a previous medical history of anaphylaxis (PMH-ana) or anaphylaxis requiring multiple epinephrine doses (multi-epi). Cohorts of children with peanut allergy were evaluated over an 80-year time horizon from both US and UK societal and health care perspectives. Models assumed prescribing a second EAI provided a baseline 10-fold risk reduction versus anaphylaxis-related fatality and hospitalization. Cost-effectiveness threshold was $100,000/quality-adjusted life-year (QALY). RESULTS: From a US perspective, universal prescription of 2 EAIs to all patients with peanut allergy was not cost-effective in the base case versus risk stratification by PMH-ana. Universal prescription of 2 EAIs was associated with an incremental cost of $10,696,036/QALY versus the PMH-ana strategy, and $17,514,558/QALY versus the multi-epi strategy. However, the universal strategy became cost-effective versus a multi-epi strategy when single EAI costs were less than $80, second epinephrine dose requirements more than 25.5%, anaphylaxis hospitalization costs more than $18,453, annual anaphylaxis risk more than 76.5%, or anaphylaxis hospitalization rate more than 74.9%. From a UK perspective, universally prescribing 2 EAIs was also not cost-effective (incremental cost of $4,132,440/QALY vs PMH-ana and $6,208,227/QALY vs multi-epi) at single device costs more than $18. CONCLUSIONS: At current EAI prices and low rates of needing 2 devices, limiting the second EAIs to patients with PMH-ana is more cost-effective than routinely prescribing 2 EAIs to all patients (particularly in resource-constrained settings).

World allergy organization anaphylaxis guidance 2020.

Anaphylaxis is the most severe clinical presentation of acute systemic allergic reactions. The occurrence of anaphylaxis has increased in recent years, and subsequently, there is a need to continue disseminating knowledge on the diagnosis and management, so every healthcare professional is prepared to deal with such emergencies. The rationale of this updated position document is the need to keep guidance aligned with the current state of the art of knowledge in anaphylaxis management. The World Allergy Organization (WAO) anaphylaxis guidelines were published in 2011, and the current guidance adopts their major indications, incorporating some novel changes. Intramuscular epinephrine (adrenaline) continues to be the first-line treatment for anaphylaxis. Nevertheless, its use remains suboptimal. After an anaphylaxis occurrence, patients should be referred to a specialist to assess the potential cause and to be educated on prevention of recurrences and self-management. The limited availability of epinephrine auto-injectors remains a major problem in many countries, as well as their affordability for some patients.

Anaphylaxis in children.

Anaphylaxis in children is a potential acute life-threatening systemic hypersensitivity reaction. Anaphylaxis fatality rate is estimated to be 0.65% to 2%. Food is the main anaphylaxis trigger in children, notably cow's milk, peanuts, and tree nuts. Mucocutaneous manifestations are observed in more than 90% of cases, but it is not essential for diagnosis. Deaths are rather secondary to the laryngeal edema, observed in 40%-50% of cases. Personal history of asthma, allergy to particular foods such as peanuts and tree nuts, and adolescence are known risk factors for anaphylaxis and more severe reactions. Epinephrine (adrenaline) is the medication of choice for the first-aid treatment of anaphylaxis. However, adrenaline auto-injectors (AAIs) are commercially available in only 32% of world countries. There are still considerable unmet needs in the field of anaphylaxis in children. Therefore, the Montpellier WHO Collaborating Centre aims to start the global action plan applied to anaphylaxis.

Health and Economic Outcomes of Home Maintenance Allergen Immunotherapy in Select Patients with High Health Literacy during the COVID-19 Pandemic: A Cost-Effectiveness Analysis During Exceptional Times.

BACKGROUND: Allergen immunotherapy (AIT) is safe and effective but is typically administered under strict clinic observation to mitigate the risk of a systemic reaction to immunotherapy (SRIT). However, in the setting of the global coronavirus disease 2019 pandemic, alternative care models should be explored. OBJECTIVE: To evaluate the cost-effectiveness of home immunotherapy self-administration (HITSA) in a highly idealized circumstance for provision of maintenance AIT in a shelter-in-place or other scenarios of unforeseen reduction in nonessential medical services. METHODS: Markov modeling was used to compare in-office clinic AIT in selected patients using cohort analysis and microsimulation from the societal and health care perspectives. RESULTS: Assuming similar SRIT rates, HITSA was found to be a cost-effective option with an incremental cost-effectiveness ratio of $44,554/quality-adjusted life-year when considering both incremental epinephrine autoinjector costs and coronavirus disease 2019 risks. Excluding epinephrine autoinjector costs, HISTA dominated other options. However, outside of pandemic considerations, HITSA was not cost-effective (incremental cost-effectiveness ratio, $198,877,286) at annual epinephrine autoinjector costs above $287. As the incremental HITSA SRIT rate increased above 15%, clinic AIT was the most cost-effective strategy. Excluding both pandemic risks and risk of motor vehicle accident fatality from round-trip clinic transit, clinic AIT dominated other strategies. Clinic AIT was the more cost-effective option at very high fatality relative risk for HITSA or at very low annual risk of contracting coronavirus disease 2019. CONCLUSIONS: Under idealized assumptions HITSA can be a safe and cost-effective option during a global pandemic in appropriately selected patients provided home rates of SRIT remain stable.

Action Plan to Ensure Global Availability of Adrenaline Autoinjectors.

Adrenaline (epinephrine) is the first-line treatment for anaphylaxis and, therefore, is listed as an essential medication for the treatment of anaphylaxis by the World Health Organization (WHO). However, the availability of adrenaline autoinjectors (AAI) for use as first-aid treatment is limited to only 32% of all the world's 195 countries, most of which are high-income countries. The key issues leading to the lack of availability of AAIs include cost, national regulations, lack of regional evidence on the value of epinephrine, and limited accurate data about the epidemiology of anaphylaxis. For these reasons, regional and international allergy academies support initiatives to narrow these gaps. Our WHO Collaborating Centre is deeply involved in this process. This document aims to serve as a baseline to ensure the following: (1) adequate access to affordable autoinjectors for all patients/societies; and (2) the development of disease-/patient-specific approaches. Therefore, we propose a 5-step action plan that aims to gather accurate epidemiological data on anaphylaxis and autoinjector consumption, confirm partnerships, strengthen awareness, and include AAIs in the WHO Model List of Essential Medicines. These aspects should be considered in combination. A prioritized research agenda should encapsulate all these steps within the framework a global initiative against anaphylaxis. More than calling for universal availability of autoinjectors for optimal management of anaphylaxis, we propose an action plan as the baseline for a global initiative against anaphylaxis. We strongly believe that combined efforts will ensure a strong public health and societal approach that will lead to optimal care of allergic patients and best practices in allergology.

Hooked epinephrine auto-injector devices in children: four case reports with three different proposed mechanisms.

BACKGROUND: The prevalence of epinephrine auto-injectors (EAI) use is on the rise. Our objective was to describes children with hooked EAI needles that were embedded in soft tissues. CASE PRESENTATION: Results: Two children self-injected in their shins. The embedded EAIs required removal in the Emergency Department. Both needles were hooked and splayed at the tip. A boy in anaphylaxis kicked his leg during EAI injection and the hooked needle embedded under his skin and was difficult to dislodge. The exposed needle was curved. A girl had an EAI administered for anaphylaxis, which was also difficult to dislodge. On removal, the distal needle tip was hooked approximately 160 degrees. Images of the device revealed that the needle fired off-center from the device and the device components were cracked. We propose three different explanations for these hooked EAI needles. The first is that the needle could hit bone during injection and curve rather than penetrates further. Secondly, the needle could bend when the patient moves during injection. Thirdly, if a needle fires sufficiently off-center to hit the cartridge carrier, this could hook the needle prior to injection. CONCLUSIONS: Awareness of the reasons for needle hooking, damage observed, and challenges and successful approaches to their removal, can better prepare the provider for these uncommon events. Teaching parents, children and educators about safe EAI storage and appropriate restraint during use may prevent some of these accidental injuries. Reporting device failures may lead to improvements in device performance and design.

Epinephrine Auto-Injectors for Anaphylaxis Treatment in the School Setting: A Discussion Paper.

Introduction:Anaphylaxis is a serious, life-threatening systemic allergic reaction that may occur in individuals not previously diagnosed with an allergy. Emergency first-line treatment of choice for acute anaphylaxis is intramuscular administration of epinephrine via an auto-injector. In the school setting, students with known allergies typically keep or carry an epinephrine auto-injector (EAI). For students who do not have a known allergy or for those whose personal EAIs are unavailable, an anaphylactic event could have serious adverse outcomes if an EAI is not available via an undesignated stock supply in the school.Methods:We searched the published literature from 2000 through 2018 in CINAHL, MEDLINE, and PubMed using the following search terms: anaphylaxis, school setting, epinephrine auto-injector, and food allergies. Throughout this article, undesignated stock EAIs, stock EAIs, EAI stock, and open-order EAIs are used interchangeably.Conclusion:Anaphylaxis is increasing worldwide as the incidence of food allergies increases. Although stock EAIs for students in schools can have important benefits, the availability of EAIs in the school setting is limited. Barriers to undesignated stock EAIs include the lengthy administrative process for developing school policies and protocols; gaps in nurses' self-perceived knowledge versus objective knowledge on the topic of anaphylaxis; limited resources in many school districts; and complex role demands, lack of confidence in trained staff, or insufficient school nurse staffing. It is important that epinephrine be readily available in schools. Barriers to facilitating stock EAIs include those that can be addressed directly by nurses and those that may require policy changes. Nurses, particularly those working in school settings or pediatrics, could take the lead in discussions about the benefits of stock EAIs in schools, advocating for policy changes as warranted. Fully informed nurses can be better prepared to serve as advocates in ensuring that EAIs are available in school settings.

The High Cost of Epinephrine Autoinjectors and Possible Alternatives.

Epinephrine autoinjectors provide potentially life-saving therapy for pediatric and adult subjects with systemic allergic reactions, including anaphylaxis. However, the cost of these devices, specifically the EpiPen (Mylan, Canonsburg, Pa), is increasing exponentially. Epinephrine autoinjectors are commonly prescribed in the United States but are not readily available worldwide. Alternatives for the self-administration of epinephrine exist and should be considered for patients who cannot afford or do not have access to these devices. The epinephrine prefilled syringe, stored in an eyeglass or pencil case, is a safe and viable option for the self-administration of epinephrine. Epinephrine prefilled syringes may not be as ideal as using autoinjectors but are superior to patients living without access to this medication.

Anaphylaxis to food.

This article provides a clinically focused review of food-induced anaphylaxis that includes epidemiology, risk factors, allergens, diagnosis, and management. Currently, there is no treatment for food allergy. Dietary avoidance and emergency preparedness are the cornerstones of management. Effective and safe therapies to reduce the risk of serious food-induced reactions are urgently needed, as are reliable biomarkers to predict severity.

Actualización en las recomendaciones del tratamiento del choque anafiláctico: novedades sobre el uso de adrenalina / Update on anaphylactic shock treatment recommendations: What's new in the use of epinephrine?

En 1998, la Sociedad Argentina de Pediatría publicó la recomendación del tratamiento del choque anafiláctico. Mientras en dicha recomendación se sugería el uso de adrenalina por vía subcutánea, actualmente se considera la vía intramuscular como la más adecuada. Aspectos farmacodinámicos determinan esta preferencia. Para el tratamiento extrahospitalario, el uso de autoinyectores de manera correcta puede colaborar en el control rápido y eficaz de la afección. El uso del resto de las medicaciones propuestas en la recomendación de 1998 se mantiene sin cambios.

In 1998, the Sociedad Argentina de Pediatría issued the recommendation of the treatment of anaphylactic shock. While this recommendation suggested the use of subcutaneous epinephrine, currently the intramuscular via is considered the most appropriate one. Pharmacological aspects determine this preference. For outpatient treatment, the correct use of autoinjectors can control anaphylaxis quickly and effectively. The use of other medications in the proposed 1998 recommendation remains unchanged.

Anaphylaxis: Unique aspects of clinical diagnosis and management in infants (birth to age 2 years).

In this rostrum we aim to increase awareness of anaphylaxis in infancy in order to improve clinical diagnosis, management, and prevention of recurrences. Anaphylaxis is increasingly reported in this age group. Foods are the most common triggers. Presentation typically involves the skin (generalized urticaria), the respiratory tract (cough, wheeze, stridor, and dyspnea), and/or the gastrointestinal tract (persistent vomiting). Tryptase levels are seldom increased because of infant anaphylaxis, although baseline tryptase levels can be increased in the first few months of life, reflecting mast cell burden in the developing immune system. The differential diagnosis of infant anaphylaxis includes consideration of age-unique entities, such as food protein-induced enterocolitis syndrome with acute presentation. Epinephrine (adrenaline) treatment is underused in health care and community settings. No epinephrine autoinjectors contain an optimal dose for infants weighing 10 kg or less. After treatment of an anaphylactic episode, follow-up with a physician, preferably an allergy/immunology specialist, is important for confirmation of anaphylaxis triggers and prevention of recurrences through avoidance of confirmed specific triggers. Natural desensitization to milk and egg can occur. Future research should include validation of the clinical criteria for anaphylaxis diagnosis in infants, prospective longitudinal monitoring of baseline serum tryptase levels in healthy and atopic infants during the first year of life, studies of infant comorbidities and cofactors that increase the risk of severe anaphylaxis, development of autoinjectors containing a 0.1-mg epinephrine dose suitable for infants, and inclusion of infants in prospective studies of immune modulation to prevent anaphylaxis recurrences.

The development and implementation of the Chicago public schools emergency EpiPen® policy.

BACKGROUND: Food allergy affects 1 in 13 children, or 2 children per classroom. Food allergies are the leading cause of anaphylaxis, a severe allergic reaction that can result in death. In fact, 25% of first-time anaphylactic reactions among children occur in school. To address this, the Chicago Public Schools (CPS) Office of Student Health and Wellness amended the Administration of Medication Policy in 2012. METHODS: The CPS Administration of Medication Policy was reviewed and analyzed. RESULTS: The policy allows all CPS district schools to be stocked with EpiPens and authorizes school nurses to administer them to students that the nurse in good faith professionally believes is having a first-time anaphylactic reaction. Although the policy has proven effective, CPS faces challenges during implementation. CPS school nurse coverage is low, and therefore, there are times when no nurse is onsite to administer EpiPen treatment to a student experiencing a first-time reaction. CONCLUSIONS: This landmark policy provides quick and easy access to lifesaving treatment and protects nurses from liability in the event of an anaphylactic emergency. A challenge to this policy's utilization includes the lack of funding for daily nurse coverage in each school.

Recognition and first-line treatment of anaphylaxis.

The International Classification of Diseases (ICD)-9 included a code only for anaphylactic shock. The improved ICD-10 coding defines the different symptoms and types of anaphylaxis and includes coding for anaphylaxis without shock. This new coding is consistent with the efforts of the National Institute of Allergy and Infectious Diseases (NIAID) and the Food Allergy and Anaphylaxis Network (FAAN), who convened a panel to formulate a definition of and the diagnostic criteria for anaphylaxis. Anaphylaxis is a serious reaction that has a rapid onset and may cause death. It is a systemic immunoglobulin E-mediated reaction resulting from the sudden release of multiple mediators from mast cells and basophils. Foods are the most common triggers for anaphylactic reactions, followed by drugs, insect stings, and idiopathic anaphylaxis (anaphylaxis of unknown cause). If the NIAID/FAAN criteria are met and anaphylaxis is diagnosed, epinephrine administration is mandatory. Delays in epinephrine administration have been associated with fatalities. Patients should have ready access to >1 epinephrine autoinjector in the outpatient setting. An individualized emergency action plan should be developed for each patient at risk for anaphylaxis.

A majority of parents of children with peanut allergy fear using the epinephrine auto-injector.

Prompt epinephrine administration is crucial in managing anaphylaxis, but epinephrine auto-injectors (EAIs) are underutilized by patients and their families. Children with peanut allergy were recruited from the Allergy Clinics at the Montreal Children's Hospital, food allergy advocacy organizations and organizations providing products to allergic individuals. Parents of children who had been prescribed an EAI were queried on whether they were fearful of using it and on factors that may contribute to fear. A majority of parents (672/1209 = 56%) expressed fear regarding the use of the EAI. Parents attributed the fear to hurting the child, using the EAI incorrectly or a bad outcome. Parents whose child had longer disease duration or a severe reaction and parents who were satisfied with the EAI training or found it easy to use were less likely to be afraid. Families may benefit from simulation training and more education on the recognition and management of anaphylaxis.

Canadian allergists' and nonallergists' perception of epinephrine use and vaccination of persons with egg allergy.

BACKGROUND: Studies suggest knowledge gaps about epinephrine use and vaccination of persons with egg allergy. OBJECTIVE: We compared the perception of Canadian allergists and nonallergists on issues related to epinephrine use and vaccination of persons with egg allergy. METHODS: Canadian allergists, pediatricians, general practitioners/family physicians and emergency room physicians were recruited through medical associations and surveyed on these issues. Multivariate logistic regression models were used to identify determinants of specific responses. RESULTS: One-hundred fourteen allergists and 613 nonallergists participated. For most issues with accepted best practices, allergists were more likely to adhere to recommendations. Allergists versus nonallergists were more likely to recommend intramuscular epinephrine for anaphylaxis (odds ratio [OR] = 3.8; 95% CI, 1.43-10.11). Older physicians (OR = 0.98; 95% CI, 0.97-0.99), Canadian-Paediatric-Surveillance-Program participants (OR = 0.48; 95% CI, 0.24-0.96), family physicians (OR = 0.39; 95% CI, 0.16-0.96), and general practitioners (OR = 0.14; 95% CI, 0.04-0.52) were less likely to recommend intramuscular use. However, in severe anaphylaxis, >25% of both groups would not give epinephrine for patients presenting with breathing difficulties or hypotension. Use of epinephrine for severe anaphylaxis was less likely in older physicians (OR = 0.97; 95% CI, 0.95-0.99), female physicians (OR = 0.60; 95% CI, 0.39-0.89), and those practicing in Ontario (OR = 0.56; 95% CI, 0.36-0.86), Manitoba (OR = 0.42; 95% CI, 0.19-0.90), or Nova-Scotia (OR = 0.31; 95% CI, 0.12-0.78). Allergists (OR = 6.22; 95% CI, 3.60-10.72) and physicians treating mainly children (OR = 3.41; 95% CI, 1.87-6.25), or practicing in Quebec (OR = 1.68; 95% CI, 1.12-2.55) were more likely to recommend measles-mumps-rubella vaccination in a community facility. CONCLUSION: Knowledge gaps about mode and indications for epinephrine administration and vaccination policies need to be addressed in future education programs to ensure prompt epinephrine use and to avoid unnecessary restriction of vaccines.