Pharmacoequity and Biologics in the Allergy Clinic: Providing the Right Care, at the Right Time, Every Time, to Everyone.

Pharmacoequity refers to equity in access to pharmacotherapy for all patients and is an especially large barrier to biologic agents in patients with allergic diseases. Value-based care models can prompt clinicians to address social determinants of health, promoting pharmacoequity. Pharmacoequity is influenced by numerous factors including socioeconomic status, which may be mediated through insurance status, educational attainment, and access to specialist care. In addition to lower socioeconomic status, race and ethnicity, age, locations isolated from care systems, and off-label indications for biologic agents all constitute barriers to pharmacoequity. Whereas pharmaco-inequity is more apparent for expensive biologics, it also affects many other allergy treatments including epinephrine autoinjectors and SMART for asthma. Current programs aimed at alleviating cost barriers are imperfect. Patient assistance programs, manufacturer-sponsored free drug programs, and rebates often increase the complexity of care, with resultant inequity, particularly for patients with lower health literacy. Ultimately, single silver-bullet solutions are elusive. Long-term improvement instead requires a combination of research, advocacy, and creative problem-solving to design more intelligent and efficient systems that provide timely access to necessary care for every patient, every time.

Anaphylaxis: A 2023 practice parameter update.

This practice parameter update focuses on 7 areas in which there are new evidence and new recommendations. Diagnostic criteria for anaphylaxis have been revised, and patterns of anaphylaxis are defined. Measurement of serum tryptase is important for diagnosis of anaphylaxis and to identify underlying mast cell disorders. In infants and toddlers, age-specific symptoms may differ from older children and adults, patient age is not correlated with reaction severity, and anaphylaxis is unlikely to be the initial reaction to an allergen on first exposure. Different community settings for anaphylaxis require specific measures for prevention and treatment of anaphylaxis. Optimal prescribing and use of epinephrine autoinjector devices require specific counseling and training of patients and caregivers, including when and how to administer the epinephrine autoinjector and whether and when to call 911. If epinephrine is used promptly, immediate activation of emergency medical services may not be required if the patient experiences a prompt, complete, and durable response. For most medical indications, the risk of stopping or changing beta-blocker or angiotensin-converting enzyme inhibitor medication may exceed the risk of more severe anaphylaxis if the medication is continued, especially in patients with insect sting anaphylaxis. Evaluation for mastocytosis, including a bone marrow biopsy, should be considered for adult patients with severe insect sting anaphylaxis or recurrent idiopathic anaphylaxis. After perioperative anaphylaxis, repeat anesthesia may proceed in the context of shared decision-making and based on the history and results of diagnostic evaluation with skin tests or in vitro tests when available, and supervised challenge when necessary.

A Synopsis of Guidance for Allergic Rhinitis Diagnosis and Management From ICAR 2023.

An updated edition of the International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR) has recently been published. This consensus document, which included the participation of 87 primary authors and 40 additional consultant authors, who critically appraised evidence on 144 individual topics concerning allergic rhinitis, provides guidance for health care providers using the evidence-based review with recommendations (EBRR) methodology. This synopsis highlights topical areas including pathophysiology, epidemiology, disease burden, risk and protective factors, evaluation and diagnosis, aeroallergen avoidance and environmental controls, single and combination pharmacotherapy options, allergen immunotherapy (subcutaneous, sublingual, rush, cluster), pediatric considerations, alternative and emerging therapies, and unmet needs. Based on the EBRR methodology, ICAR:AR includes strong recommendations for the treatment of allergic rhinitis: (1) for the use of newer generation antihistamines compared with first-generation alternatives, intranasal corticosteroid, intranasal saline, combination therapy with intranasal corticosteroid plus intranasal antihistamine for patients not responding to monotherapy, and subcutaneous immunotherapy and sublingual tablet immunotherapy in properly selected patients; (2) against the use of oral decongestant monotherapy and routine use of oral corticosteroids.

Relationship of Reaction History to Positive Penicillin Skin Tests.

BACKGROUND: Previous data suggest that up to one-third of patients classified as allergic based on positive penicillin skin tests have a vague reaction history. Direct oral challenge (DOC) has been recommended for patients with a low-risk reaction history. A variety of published models stratify reaction risk to guide the use of DOC. OBJECTIVE: To reassess the proportion of penicillin skin test-positive patients with vague or low-risk reaction histories and evaluate the relationship between the reaction risk history and the likelihood of positive skin test results. METHODS: We identified patients who underwent penicillin allergy evaluation over a 5-year period. We recorded drug reaction history, demographic variables, skin testing, and challenge results. Matched controls whose skin tests were negative were identified for skin test-positive patients. Drug reaction histories were assigned a risk category based on 2 previously published risk stratification models. We used logistic regression to investigate whether reaction history risk was associated with positive skin test results. RESULTS: Penicillin skin testing was performed in 3382 patients; 207 (6.1%) were positive. Positive skin tests were more frequent in outpatients (P < .001), younger patients (P < .001), and female patients (P < .001). Percentages of each risk category in each model were similar in cases versus matched controls. The likelihood for positive skin tests increased with a high-risk reaction history in one stratification model. CONCLUSION: Our data confirm that a substantial proportion of patients who self-report penicillin allergy and have positive skin test results have a low-risk history and imply that penicillin skin testing is associated with a poor positive predictive value.

Anaphylaxis in Pregnancy.

Anaphylaxis in pregnancy is a rare event, but has important implications for the pregnant patient and fetus. The epidemiology, pathophysiology, diagnosis, and treatment all carry important considerations unique to the pregnant patient. Common culprits of anaphylaxis are primarily medications, particularly antibiotics and anesthetic agents. Diagnosis can be difficult given the relative lack of cutaneous symptoms, and normal physiologic changes in pregnancy such as low blood pressure and tachycardia. Apart from patient positioning, treatment is similar to that of the general population, with a focus on prompt epinephrine administration.

Review of evidence supporting the use of nasal corticosteroid irrigation for chronic rhinosinusitis.

OBJECTIVE: To analyze published reports on the efficacy and safety of CSI in CRS and evaluate the clinical implications of current gaps in evidence. Corticosteroid irrigation (CSI) is commonly used for management of chronic rhinosinusitis (CRS) with nasal polyps; however, such use is not approved by the US Food and Drug Administration (FDA). DATA SOURCES: Publications were obtained through PubMed searches through January 2022. STUDY SELECTION: Searches were conducted using 2 terms: "chronic rhinosinusitis" or "nasal polyps" as the first term and "corticosteroid irrigation," "steroid nasal lavage," or "sinus rinse" as the second term. We reviewed relevant, peer-reviewed literature (19 original research [9 controlled, 10 uncontrolled trials], 7 reviews, and 1 meta-analysis) reporting safety and efficacy of CSI in patients with CRS. RESULTS: Studies were difficult to compare because they used a variety of solution volumes (60 mL to 125 mL per nostril), corticosteroid agents (budesonide, betamethasone, mometasone, or fluticasone), corticosteroid doses, preparation protocols (by compounding pharmacy or by patient), and administration (frequency, time of day, body positioning). It is difficult to determine which parameters might substantially influence clinical effects because studies were generally small, showed marginal benefits, and rarely assessed safety. To date, no studies evaluating CSI have shown statistically significant differences in a type-I error-controlled primary end point over any comparator, possibly owing to small sample sizes. CONCLUSION: Designing more robust clinical trials may help determine whether CSI is a valid treatment option. Until more evidence supporting CSI use exists, health care professionals should strongly consider choosing FDA-approved therapies for the treatment of CRS.

Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making.

The Food and Drug Administration is tasked with evaluating the efficacy and safety of a drug. Despite having a regimented appraisal process in place, safety evidence can emerge during clinical trials as well as from observations and studies conducted after the drug has been on the market, which might require a boxed warning. The boxed warning is the most severe warning that the Food and Drug Administration can give to an approved drug. It is commonly referred to as a Black Box Warning because it is outlined in the package insert by a thick black box to garner the attention of prescribers and patients. There are currently more than 400 medications that have boxed warnings, and the information addressing major risks associated with a particular drug may, appropriately or inappropriately, influence patient and clinician decision making. Health care professionals must use the best evidence and clinical judgment in determining whether to prescribe medications with these warnings. Use of an approved drug at dosages or for indications other than what it was originally licensed for is referred to as "off-label" and is legal, commonplace, and may be evidence-based. All drugs may expose patients to possible harm, so prescribers have an obligation to discuss the best available evidence regarding benefits and harms so that patients can participate in shared decision making.

Optimization of care for patients with hereditary angioedema living in rural areas.

BACKGROUND: People living in rural areas of the United States experience greater health inequality than individuals residing in urban or suburban locations and encounter several barriers to obtaining optimal health care. Health disparities are compounded for patients with rare diseases such as hereditary angioedema (HAE), an autosomal dominant genetic disorder characterized by recurrent, severe abdominal pain and life-threatening oropharyngeal or laryngeal swelling. OBJECTIVE: To explore the challenges of managing patients with HAE in rural areas and suggest possible improvements for optimizing care. DATA SOURCES: PubMed was searched for articles on patient care management, treatment challenges, rural health, and HAE. STUDY SELECTIONS: Relevant articles were selected and reviewed. RESULTS: Challenges in managing HAE in the rural setting were identified, including obtaining a diagnosis of HAE, easy access to a physician with expertise in HAE, continuity of care, availability of telemedicine services, access to approved HAE therapies, patient education, and economic barriers to treatment. Ways to improve HAE patient care in rural areas include health care provider recognition of the patient with undiagnosed HAE, development of individualized management plans, expansion of telemedicine, effective care at the local level, appropriate access to HAE medication, and increased awareness of patient support and advocacy groups. CONCLUSION: For patients with HAE living in rural areas, optimal care is complicated by health disparities. Given the scarcity with which these topics have been covered in the literature to date, it is intended that this article will serve as the impetus for a range of further initiatives focused on improving access to care.

The impact of telemedicine as a disruptive innovation on allergy and immunology practice.

Telemedicine is a disruptive innovation in the health care marketplace that holds the potential for transforming medicine by improving access to medical care and providing a more affordable way of delivering care. On the basis of consumer demand, ongoing technologic advances, desire for greater practice efficiency, and behavioral and demographic trends, it is likely that more frequent use of telemedicine will be maintained post-pandemic and into the future. Looming areas for growth include the following: chronic disease management, care for patients in remote (eg, rural) areas, and expansion beyond direct-to-consumer models. On the basis of the multiple influences that will drive ongoing use of telemedicine, the future of allergy and immunology practice will likely entail traditional medicine in addition to telemedicine.

Anaphylaxis to Drugs, Biological Agents, and Vaccines.

Anaphylaxis is a multi-system syndrome resulting from the release of mediators from mast cells and basophils. Drugs are common causes. Anaphylaxis to certain drugs, vaccines, and biological agents present clinical challenges, and merit referral to a board-certified allergist/immunologist for further evaluation and management.

Anaphylaxis to vaccinations: A review of the literature and evaluation of the COVID-19 mRNA vaccinations.

Recent reports of allergic reactions to the Pfizer-BioNTech and the Moderna COVID-19 vaccines have resulted in questions about how and to whom they can be safely administered. Although anaphylaxis was not observed in clinical trials for either vaccine, there have been 21 reported possible cases of anaphylaxis associated with the Pfizer vaccine (11.1 cases per million doses administered) and 10 possible cases associated with the Moderna vaccine (2.5 anaphylaxis cases per million doses administered). The etiology of anaphylaxis in these cases is not fully understood and is an area of active research. The overall incidence of anaphylaxis to COVID-19 mRNA vaccines is very low. By following recommendations from the US Centers for Disease Control and Prevention, an overwhelming majority of the US population can be safely immunized.

Digital Health Technology in Asthma: A Comprehensive Scoping Review.

BACKGROUND: A variety of digital intervention approaches have been investigated for asthma therapy during the past decade, with different levels of interactivity and personalization and a range of impacts on different outcome measurements. OBJECTIVE: To assess the effectiveness of digital interventions in asthma with regard to acceptability and outcomes and evaluate the potential of digital initiatives for monitoring or treating patients with asthma. METHODS: We evaluated digital interventions using a scoping review methodology through a literature search and review. Of 871 articles identified, 121 were evaluated to explore intervention characteristics, the perception and acceptability of digital interventions to patients and physicians, and effects on asthma outcomes. Interventions were categorized by their level of interactivity with the patient. RESULTS: Interventions featuring non-individualized content sent to patients appeared capable of promoting improved adherence to inhaled corticosteroids, but with no identified improvement in asthma burden; and data-gathering interventions appeared to have little effect on adherence or asthma burden. Evidence of improvement in both adherence and patients' impairment due to asthma were seen only with interactive interventions involving two-way responsive patient communication. Digital interventions were generally positively perceived by patients and physicians. Implementation was considered feasible, with certain preferences for design and features important to drive use. CONCLUSIONS: Digital health interventions show substantial promise for asthma disease monitoring and personalization of treatment. To be successful, future interventions will need to include both inhaler device and software elements, combining accurate measurement of clinical parameters with careful consideration of ease of use, personalization, and patient engagement aspects.