Safety of direct oral challenge to amoxicillin in pregnant patients at a Canadian tertiary hospital

Mak, Raymond; Zhang, Bei Yuan; Paquette, Vanessa; Erdle, Stephanie; Schalkwyk, Julie E Van; Wong, Tiffany; Watt, Melissa H.; Elwood, Chelsea

doi:10.1016/j.jaip.2022.03.025

Cited by 27 publications

(6 citation statements)

References 9 publications

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“…The PEN-FAST tool was previously externally validated in a mixed prospective derivation and a retrospective validation cohort of patients tested for penicillin allergy from Australia and the US and in 2 additional adult populations. 13,14,18 This randomized clinical trial now provides evidence that direct oral challenge is an effective and safe method of assessing lowrisk penicillin allergies (PEN-FAST score <3) in a predominately White, adult, outpatient population. This supports the work of a previously published explorative single-center randomized clinical trial in North American of 2-step direct oral challenge.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy

et al. 2023

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ImportanceFewer than 5% of patients labeled with a penicillin allergy are truly allergic. The standard of care to remove the penicillin allergy label in adults is specialized testing involving prick and intradermal skin testing followed by an oral challenge with penicillin. Skin testing is resource intensive, limits practice to specialist-trained physicians, and restricts the global population who could undergo penicillin allergy delabeling.ObjectiveTo determine whether a direct oral penicillin challenge is noninferior to the standard of care of penicillin skin testing followed by an oral challenge in patients with a low-risk penicillin allergy.Design, Setting, and ParticipantsThis parallel, 2-arm, noninferiority, open-label, multicenter, international randomized clinical trial occurred in 6 specialized centers, 3 in North America (US and Canada) and 3 in Australia, from June 18, 2021, to December 2, 2022. Eligible adults had a PEN-FAST score lower than 3. PEN-FAST is a prospectively derived and internationally validated clinical decision rule that enables point-of-care risk assessment for adults reporting penicillin allergies.InterventionsPatients were randomly assigned to either direct oral challenge with penicillin (intervention arm) or a standard-of-care arm of penicillin skin testing followed by oral challenge with penicillin (control arm).Main Outcome and MeasureThe primary outcome was a physician-verified positive immune-mediated oral penicillin challenge within 1 hour postintervention in the intention-to-treat population. Noninferiority was achieved if a 1-sided 95% CI of the risk difference (RD) did not exceed 5 percentage points (pp).ResultsA total of 382 adults were randomized, with 377 patients (median [IQR] age, 51 [35-65] years; 247 [65.5%] female) included in the analysis: 187 in the intervention group and 190 in the control group. Most patients had a PEN-FAST score of 0 or 1. The primary outcome occurred in 1 patient (0.5%) in the intervention group and 1 patient (0.5%) in the control group, with an RD of 0.0084 pp (90% CI, −1.22 to 1.24 pp). The 1-sided 95% CI was below the noninferiority margin of 5 pp. In the 5 days following the oral penicillin challenge, 9 immune-mediated adverse events were recorded in the intervention group and 10 in the control group (RD, −0.45 pp; 95% CI, −4.87 to 3.96 pp). No serious adverse events occurred.Conclusions and RelevanceIn this randomized clinical trial, direct oral penicillin challenge in patients with a low-risk penicillin allergy was noninferior compared with standard-of-care skin testing followed by oral challenge. In patients with a low-risk history, direct oral penicillin challenge is a safe procedure to facilitate the removal of a penicillin allergy label.Trial RegistrationClinicalTrials.gov Identifier: NCT04454229

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Section: Discussionmentioning

confidence: 99%

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy

et al. 2023

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“…The practice of direct oral challenge without skin testing was rarely used in our cohort; however, its safety is increasingly supported by the literature, including some studies in pregnancy, which could continue to drive down the cost. [37][38][39][40][41] The cost could likely be decreased even further through utilization of advanced practice providers to perform testing or through use of telehealth for the initial visit when a two-visit approach is preferred.…”

Section: Discussionmentioning

confidence: 99%

The Cost of Developing and Implementing an Antepartum Referral Program for Penicillin Allergy Evaluation at a Single Academic Tertiary Care Hospital

Burn,

Xu,

Kwah

et al. 2024

Am J Perinatol

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Objectives: Approximately 10% of pregnant individuals report a penicillin allergy, yet most are not truly allergic. Allergy verification during pregnancy is safe and recommended, however, many hospitals lack the infrastructure to execute testing. Our aim was to evaluate the cost of developing and implementing a penicillin allergy referral program for pregnant individuals at an academic institution and to compare costs of care between patients who were referred and not referred through the program. Study Design: We conducted an economic analysis of our institution’s antepartum penicillin allergy referral program. We prospectively collected detailed resource utilization data and conducted the analysis from the program’s perspective, accounting for costs related to program development, allergy verification, antibiotic cost, and delivery hospitalization. Costs were compared between patients who were referred for evaluation versus patients who were not referred using bivariate tests, as well as quantile regression adjusting for baseline differences. A sensitivity analysis was performed for allergy testing cost. All cost estimates were inflation adjusted to 2021 U.S. dollars. Results: The startup cost of program development and educational initiatives was $19,920, or $86 per patient. The median allergy evaluation cost was $397 (IQR $303-$663). There was no significant difference in maternal (median: $13,579 vs. $13,999, p=0.94) or neonatal (median: $3,565 vs. $3,577, p=0.55) delivery hospitalization cost or antibiotic cost (median: $1.57 vs. $3.87, p=0.10) between referred and non-referred patients. Overall, the total cost per person did not differ significantly between study groups (median: $18,931 vs. $18,314, p=0.69). Conclusion: The cost of developing a penicillin allergy referral program in pregnancy was modest and did not significantly alter short term cost of care with potential for long-term cost benefit. Verification of a reported penicillin allergy is an integral part of antibiotic stewardship, and the pregnancy period should be utilized as an important opportunity to perform this evaluation.

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“…Safety data for testing during pregnancy are available from several studies. 2 , 3 , 6 A 2022 study conducted at a tertiary care hospital in Canada reported that the direct oral challenge was safe for patients at low risk, with a delayed cutaneous reaction rate of 1.9% and no severe adverse events. 6 Delayed cutaneous reactions can be uncomfortable, but can be treated with antihistamines and low-dose steroid ointment to affected areas.…”

Section: Delabelling During Pregnancy Has Been Shown To Be Safe and E...mentioning

confidence: 99%

Penicillin allergy delabelling in pregnancy

Atkinson

Poliquin

Elwood

2023

CMAJ

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Safety of direct oral challenge to amoxicillin in pregnant patients at a Canadian tertiary hospital

Cited by 27 publications

References 9 publications

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy

The Cost of Developing and Implementing an Antepartum Referral Program for Penicillin Allergy Evaluation at a Single Academic Tertiary Care Hospital

Penicillin allergy delabelling in pregnancy

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