Allergic Reactions Captured by Voluntary Reporting

Abstract

Background: The epidemiology of hospital adverse reactions (ARs), particularly allergic reactions, or hypersensitivity reactions (HSRs), is poorly defined. To determine priorities for allergy safety in healthcare, we identified and described safety reports of allergic reactions.

Methods: We searched the safety report database of a large academic medical center from April 2006 to March 2016 using 101 complete, truncated, and/or misspelled key words related to allergic symptoms, treatments, and culprits (e.g., medications, foods). Patient and event data were summarized for ARs and two types of ARs, HSRs and side effects/toxicities.

Results: Among 9111 key word search-identified events, 876 (10%) were ARs, of which 436 (5%) were HSRs and the remaining 440 (5%) were side effect reactions or toxicities. Whereas the most common HSRs were simple cutaneous reactions (83%), the following severe immediate HSRs were also identified: shortness of breath (16%), anaphylaxis (14%), and angioedema (12%). Most HSRs were caused by drugs (81%), with antibiotics (26%), particularly β-lactams (11%), and vancomycin (8%), commonly implicated. Other causes of drug HSRs included contrast agents (24%), chemotherapeutics (7%), and opioids (6%). Nondrug HSRs were from blood products (8%), latex (3%), and devices (3%). Food reactions were rarely identified (1%).

Conclusions: We identified ARs, HSRs, and side effects/toxicities, contained in a decade of safety reports at an academic medical center. Allergy safety in the healthcare setting should target approaches to common and severe reactions, with a focus on the safe administration of β-lactams, vancomycin, contrast agents, chemotherapeutics, and opioids. Priority nondrug HSR culprits include blood products, latex, and devices.

Figure 1. Events and reactions identified through voluntary safety reporting

Of 9,111 reviewed event reports, 876 (10%) represented adverse reactions. Adverse reactions were either hypersensitivity reactions (n=436, 50%) or side effect/toxicity reactions (n=440, 50%).

Figure 2. Safety reports indicating adverse reactions and hypersensitivity reactions identified per year

Adverse reactions and hypersensitivity reactions identified from allergy safety report searching remained consistent over the study period (2006 through 2015); for adverse reactions from 62–103 events per year, and for hypersensitivity reactions from 30–57 events per year.

Figure 3. Common agents for hypersensitivity reactions captures by voluntary reporting

This figure displays the most common causative agents for hypersensitivity reactions identified by safety reports, and the indicated reactions. Cardiac symptoms included tachycardia, tachypnea, palpitations, bradycardia, cardiac arrest, reduced cardiac function, chest pain, chest tightness or pressure, and abnormal electrocardiogram. Mental status changes include agitation, anxiety, hallucination, behavioral and movement change, fatigue, psychosis, sedation, somnolence, unconsciousness, confusion, delirium, depression. Gastrointestinal symptoms included nausea, vomiting, diarrhea, stomach distress, and small bowel obstruction. Respiratory symptoms included airway compromise, shortness of breath, wheezing, bronchospasm, decreased oxygen saturation, dyspnea, acute respiratory failure, stridor, lung crackles, pulmonary edema, cyanosis, sneezing, coughing, and congestion.