Allergy Labels as a Patient Safety Problem: Misattribution, De-labelling and Safer Care Pathways

Allergy labels, whether for vaccines, drugs (notably antibiotics), foods, or perioperative agents, are among the most common and consequential pieces of clinical risk information carried in a patient's record. When frontline services cannot reliably distinguish anxiety-mediated or non-immune reactions from true IgE-mediated or otherwise clinically significant allergy, two systematic safety failures follow: genuine reactions are under-recognized and sub-optimally managed, while benign or incidental events are misattributed as allergy. This misattribution drives unnecessary, often lifetime allergy labelling, inappropriate treatment avoidance or medical exemption, inaccurate electronic health record (EHR) documentation, and cascading risk across future healthcare encounters, from missed first-line antibiotics and antimicrobial stewardship failures, to avoidable vaccine hesitancy and perioperative complications. Immunization services are a leading and especially high-volume exemplar of this problem, given the scale of population vaccination programs and the acute, time-pressured setting in which allergy-risk decisions must be made, but the same diagnostic-error and de-labelling challenge recurs across drug allergy, perioperative allergy documentation, and antimicrobial stewardship. Designing, implementing, and evaluating safety safeguards and diagnostic-risk pathways that prevent these errors, across the allergy label's full lifecycle from initial attribution through to de-labelling, is a core patient safety, human factors, and clinical governance challenge. Aligned directly with the Patient Safety specialty section, this Research Topic focuses on the measurement, monitoring, and improvement of safety and quality around the allergy label as a clinical risk artifact across vaccination, drug and antibiotic allergy, perioperative and EHR allergy documentation, and antimicrobial stewardship. We welcome contributions addressing the implementation and clinical efficacy of safety interventions at the frontline, organizational, and policy levels; the integration of patient-reported safety and co-design in allergy risk assessment and de-labelling; and human factors, system design, or safety science analyses of diagnostic misattribution and clinical de-labelling pathways. Immunization services serve as the lead exemplar throughout, illustrating the scale and urgency of the problem, but contributions are equally welcome from drug/antibiotic allergy, perioperative care, and antimicrobial stewardship settings where the same misattribution and de-labelling dynamics apply. Themes and Primary Research Questions Theme 1: Safety Interventions Across the Allergy Label Lifecycle (PRIMARY)- How can immunization, drug-allergy, and perioperative services design, implement, and validate clinical safeguards that prevent both the under-recognition of true allergic/anaphylactic reactions and the misattribution of non-allergic events (e.g., immunization stress-related responses, non-immune drug reactions?)- What is the clinical efficacy and system-wide safety of integrating pre-vaccination or pre-treatment risk-stratification protocols directly into routine point-of-care workflows, including antimicrobial stewardship decision points? Theme 2: Measurement, Monitoring, and Patient-Reported Safety (PRIMARY)- What is the role of patient-reported outcome measures (PROMs) and safety tools in detecting, differentiating, and reporting adverse versus stress-mediated or non-immune events across allergy label types? - How can patient and family involvement in co-designing safety protocols prevent clinical error, support accurate allergy documentation in the EHR, and mitigate treatment-associated anxiety in atopic or highly labelled cohorts? Theme 3: Human Factors, Misattribution, and De-labelling Safety (SECONDARY)- Applying human factors engineering and safety science frameworks, what are the systemic drivers of diagnostic error and premature allergy labelling across vaccination, drug/antibiotic allergy, and perioperative care? - How do systemic care pathways and communication protocols safely coordinate de-labelling across primary care, specialist allergy services, pharmacy, and antimicrobial stewardship teams? Theme 4: Safety in Low-Resource and Inequitable Settings (SECONDARY)- How can safe, allergy-aware care pathways spanning vaccination, drug allergy, and perioperative safeguards be standardized and resourced in low- and middle-income countries (LMICs) and for socioeconomically vulnerable or highly atopic subpopulations (supporting SDG 3 and SDG 10).Populations of Interest: Clinical risk and safety managers, healthcare quality improvement researchers, immunization and primary care service providers, pharmacists and antimicrobial stewardship teams, perioperative and anesthesia teams, frontline clinical staff, human factors engineers, allergic patient cohorts, and patients/families acting as active safety co-design partners. Significance and Novelty: By framing this collection around the allergy label as a patient safety artifact and clinical systems engineering challenge rather than around a single care pathway (vaccination) or individual clinical allergy diagnosis and cognitive psychology alone, this Research Topic introduces a major system-level contribution. Using immunization services as the lead exemplar while explicitly admitting drug/antibiotic allergy, perioperative and EHR allergy documentation, and antimicrobial stewardship work broadens the evidence base and comparative power of the collection, while still anchoring it firmly in the Patient Safety section's core remit. It addresses allergy-label misattribution and de-labelling as a systems safety, process design, and clinical governance problem establishing actionable, scalable, and measured safeguards to optimize safe care delivery across settings. Article Types: Original Research, Systematic Review, Policy and Practice Reviews, Brief Research Report, Study Protocol, Methods, Perspective, OpinionTopic editor Tom Dawson is on the advisory board of ALK and Viatris. As part of the Advisory Board role, he received financial support from ALK and Viatris for talks given between 2023 and 2026. The other Topic Editors report no competing interests related to this Research Topic.Topic Editor Evridiki (Evie) Fioratou holds shares in Moderna and Eli Lilly & Co. as part of a stock market portfolio. The other Topic Editors report no competing interests related to this Research Topic. Topic editors: Dr Beré Kezia Mahoney, Richard Clarke, Evridiki (Evie) Fioratou, Stephen O'Hickey, Tom C Dawson Source: https://www.frontiersin.org/research-topics/81770/allergy-labels-as-a-patient-safety-problem-misattribution-de-labelling-and-safer-care-pathways