Rate of unconfirmed penicillin allergy labels among children raises concerns
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An examination of the health records of more than 330,000 children in two large pediatric primary care networks has raised concerns about the validity of penicillin allergy labels, according to a study published in JAMA Network Open.
The results showed that many penicillin allergy labels (PALs) in children were placed before 2 years and age and after little or no exposure to penicillin.
Margaret G. Taylor, MD, a clinical postdoctoral fellow at Baylor College of Medicine, and colleagues noted that unconfirmed PALs could lead to unnecessary use of broad-spectrum, second-line antibiotics.
Children with unconfirmed PALs also have longer hospital stays, higher rates of adverse events and more infections caused by Clostridium difficile and vancomycin-resistant Enterococcus than children who do not have PALs, the researchers wrote.
The retrospective, longitudinal birth cohort study involved 334,465 children (mean age at censor date, 3.8 years; interquartile range [IQR], 1.7-6.6; 49.1% girls; 44.4% non-Hispanic white) attending 90 primary care pediatric practices related to Texas Children’s Pediatrics (TCP) and Children’s Hospital of Philadelphia (CHOP).
During the study period, 946,592 penicillin derivatives were prescribed, most of which (80.2%) were prescribed in the primary care setting.
Overall, 5.4% of these children had a PAL, placed at a median age of 1.3 years (IQR, 0.9-2.3), with 90.8% placed within 24 hours of a primary care encounter or health care communication. Only 12.5% of these PALs were eventually removed during the study period.
Children identified as non-Hispanic white had significantly greater odds of receiving a PAL than non-Hispanic Black children (adjusted OR = 1.7; 95% CI, 1.6-1.8).
Children who received at least one penicillin prescription via primary care before age 2 years were more likely to receive a PAL than those who did not (aOR = 1.7; 95% CI, 1.6-1.8).
Whereas 37.7% of the children received a PAL after their first penicillin prescription from TCP or CHOP health care settings, 7.9% were labeled without receiving any penicillin prescription. Overall, the researchers said, almost half of the children in the study received a PAL after one or zero penicillin prescriptions.
Based on previous studies showing that less than 5% of children with a PAL are found to have a type 1 hypersensitivity allergy after skin testing or oral challenges, the researchers wrote that more than 16,000 children in their cohort would likely have inaccurate PALs.
The researchers called for quality improvement efforts directed toward primary care providers, who are most likely to engage with children outside of acute illness, to address unconfirmed PALs and identify ways to redocument these children.
Because most hypersensitivity responses follow at least two distinct exposures to penicillin derivatives, the researchers wrote, the 37.7% of children who were labeled after their first penicillin prescription probably had a prior anticipated adverse drug reaction or an unspecified viral illness. Graded oral challenges may be needed to remove their PALs.
The PALs given to children who did not receive any penicillin may be due to in utero exposure to penicillin derivatives, exposure to cephalosporin antibiotics or a family history of penicillin allergy, the researchers wrote, adding that future research should explore the reasons behind these PALs.
Perspective
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This is a very interesting study that addresses some epidemiologic gaps in the literature.
I think the finding that almost 8% of patients labeled as penicillin-allergic had zero penicillin prescriptions seems like an area of huge opportunity for educating families and health care providers that penicillin allergy does not “run in families.”
I also think the divide between non-Hispanic white patients and Black patients is an interesting finding. This could be due to genetic influences or also reflective of access to care (or both). But this deserves further study, because many drug allergy studies include a disproportionate number of non-Hispanic white patients.
I additionally think a very important take-home point is that a lot of penicillin allergy labeling occurs early in life based on these data. It can be really difficult to distinguish a viral rash from a drug rash. Health care providers need to recognize that drug allergies, especially penicillin allergy, should be revisited in childhood and not kept as a lifelong black box.
Perspective
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These findings are consistent with prior studies that continue to highlight the importance of primary care practitioners in determining the relevance of possible adverse drug reactions. But one component of the study that I did find surprising was that chronic conditions were not associated with penicillin allergy labeling. This may reflect the different types of chronic conditions that affect the pediatric population compared with the adult population, which we know is associated with higher rates of PAL.
The vast majority of penicillin allergy labels are inaccurate, and research has shown that more than 90% of those patients with a label would tolerate a penicillin-based antibiotic without issue. We also note a large variation between primary care practices as far as what is considered an allergy rather than drug intolerance or a viral exanthem on patients' electronic medical records.
Further education is needed for all patient-facing health care providers, as they are often the first contact for patients who develop symptoms while on penicillin-based antimicrobials. Understanding the wide array of nonallergic adverse reactions and viral exanthems is of utmost importance in providing reassurance to patients and families.
As the authors mentioned, an important next step would be to determine what contributes to the wide range of penicillin allergy prevalence among practices. It would be helpful to determine if these differences relate to clinician or patient factors.
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Taylor MG, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.2117.
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