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The effectiveness of interventions that support penicillin allergy assessment and delabeling of adult and pediatric patients by nonallergy specialists: a systematic review and meta-analysis
Pharmacy Department, Royal Cornwall Hospital, Truro, United Kingdom TR1 3LJ / School of Biomedical Sciences, University of Plymouth, Plymouth, United Kingdom
Penicillin allergy delabeling by nonallergists is safe.
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Less intensive methods delabeled a smaller proportion of patients.
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Once patients were assessed as suitable for testing, rates of delabeling were high.
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A diverse workforce engaged in delabeling incorrect penicillin allergy records.
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Penicillin allergy delabeling interventions are described.
Abstract
Objectives
Penicillin allergy records are often incorrect and may result in harm. We aimed to systematically review the effectiveness and safety of nonallergist health care worker delivery of penicillin allergy delabeling.
Methods
We searched EMBASE/MEDLINE/CINAHL (Ovid), PsycInfo, Web of Science, and Cochrane CENTRAL from inception to January 21, 2022 and unpublished studies and gray literature. The proportion of patients allergic to penicillin delabeled and harmed was calculated using random-effects models.
Results
Overall, 5019 patients were delabeled. Using allergy history alone, 14% (95% confidence interval [CI], 9-21%) of 4350 assessed patients were delabeled without reported harm. Direct drug provocation testing resulted in delabeling in 27% (95% CI, 18-37%) of 4207 assessed patients. Of the 1373 patients tested, 98% were delabeled (95% CI, 97-99%), and nonserious harm was reported in 1% (95% CI, 0-2%). Using skin testing, followed by drug provocation testing, 41% (95% CI, 24-59%) of 2890 assessed patients were delabeled. Of the 1294 tested patients, 95.0% (95% CI, 90-99%) were delabeled, and the reported harm was low (0%; (95% CI 0-1%).
Conclusion
Penicillin allergy delabeling by nonallergists is efficacious and safe. The proportion of assessed patients who can be delabeled increases with the complexity of testing method, but substantial numbers can be delabeled without skin testing.
Warning: allergic to penicillin': association between penicillin allergy status in 2.3 million NHS general practice electronic health records, antibiotic prescribing and health outcomes.
). Penicillin-based antibiotics are first-line treatment for many infections, but patients with penA labels are usually treated with second-line antibiotics (
), which are often more costly, can be less effective in certain clinical circumstances, more toxic, and often have broader spectrum, potentially increasing a patient's risk of future infections with resistant bacteria (
). Traditional penA testing requires skin testing (ST) before drug provocation testing, which remains the main testing method in Europe, making penA testing resource intense (
). Direct drug provocation testing (DPT), an oral challenge test, in patients with a low-risk allergy history is less resource intense. Two systematic reviews have confirmed the safety and efficacy of DPT (without previous ST) as a method of delabeling adults, delivered both by allergists and nonallergists (
) with the Infectious Diseases Society of America wrote to the Centers for Medicare and Medicaid Services to urge US hospitals to include verification of penA as part of its mandatory antibiotic stewardship programs. The World Health Organization (
) has since recommended antibiotic delabeling as an effective antimicrobial stewardship strategy. The enablement of the wider health care workforce to delabel eligible patients is required to deliver penA assessment and delabeling at a large scale. Understanding the wider frameworks that enable nonallergists to safely delabel is required, enabling the development of effective interventions that facilitate penA delabeling by nonallergy specialists.
We systematically reviewed the literature to determine the proportion of patients with a reported penA who were safely delabeled by nonallergy health care workers (HCWs), categorizing the components of interventions using the Effective Practice and Organisation of Care (EPOC) taxonomy of health interventions (
Effective practice and organisation of care (EPOC 2016). The EPOC taxonomy of health systems interventions. EPOC Resources for review authors. epoc.cochrane.org/epoc-taxonomy, 2016 (accessed 16 May 2022).
) and report any measured antimicrobial stewardship and health system impact.
Methods
This systematic review and meta-analysis were conducted in accordance with the Joanna Briggs Institute methodology for systematic reviews of effectiveness (
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration.
The inclusion criteria are as follows: (i) any patient (adult/child) with a penA record in any health care context, (ii) having undergone penA delabeling (PADL) using any method; and (iii) by nonallergy specialists, defined as a medical professional whose primary specialization is not in allergy or who has not trained in allergy as part of their specialty (
). The penA assessment and delabeling interventions delivered by immunologists or allergy specialists were excluded. All study designs were included, except case reports.
Search strategy
The following databases were searched from inception to January 21, 2022 (NP) EMBASE (Ovid), MEDLINE (Ovid), CINAHL (Ovid), PsycInfo, Web of Science, and Cochrane CENTRAL, as was the gray literature. Known experts in the topic were contacted to ensure we have not overlooked relevant literature. The search strategy was reviewed by an experienced information specialist (KO). Only studies published in English were included due to a lack of funding for translation services (Appendix 1).
Titles and abstracts were screened by two independent reviewers (NP, SA, DK, RO, JS) against the inclusion criteria (RAYYAN software;
) and included the study design, country, setting, population age, gender, inclusion criteria, exclusion criteria, allergy testing method(s), HCW(s) delivering PADL, components of the PADL interventions, details about education and training, number of assessed patients, number tested, number that experienced unintended harm, and any reported antibiotic stewardship or health care system impact. The extraction of data from seven (10%) studies was validated by a second reviewer. Intervention components were categorized using the EPOC taxonomy of health interventions, enabling the grouping of health system interventions by conceptual or practical similarities (
Effective practice and organisation of care (EPOC 2016). The EPOC taxonomy of health systems interventions. EPOC Resources for review authors. epoc.cochrane.org/epoc-taxonomy, 2016 (accessed 16 May 2022).
). Studies that used a risk stratification protocol for allergy testing were categorized in the “packages of care” subcategory. Complex interventions were categorized into the “care pathways” subcategory (
). Governance arrangements were categorized as “authority and accountability for quality of practice”.
Definitions
See Appendix 4 for definitions for delabeling, ST/DPT, direct DPT (DDPT) and direct delabeling on history alone (DDL), successful delabel, and definitions of harm.
Data analysis
The population-weighted proportional meta-analysis was conducted on studies with a low/moderate risk of bias to determine the proportion of participants successfully delabeled and the proportion with a positive penA test by the delabel method (DDL, DDPT, and ST/DPT) using the R package meta v 5.2.0 (
). Statistical heterogeneity was assessed using the chi-square test (threshold P <0.1) and the I2 statistic (I2 values <25%, 25-75%, and >75% were considered to represent low, moderate, and high heterogeneity, respectively). Overall estimates were obtained using random-effects models (
) were excluded from the analysis to assess their influence on the overall estimates. The remaining data are presented in narrative form.
Results
Study inclusion
In total, 11,545 studies were identified, of which 3411 were excluded due to duplication. The review of titles and abstracts by two authors (DK, NP, SA, RO, JS) led to the retrieval of 191 full papers for screening by two authors (NP, RO, JS, MU, STC); 69 were included in the systematic review (Figure 1). A total of 56 studies were case series (
Regulatory approval, implementation, and brief assessment of a pharmacist- and pharmacy trainee-administered penicillin allergy assessment and skin testing program.
An algorithm-based approach to routinely delabel penicillin allergy in pre-hematopoietic stem cell transplant patients with low risk of reaction. In: Proceedings of the Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2019.
Implementation of pharmacist-driven penicillin allergy skin testing in a community hospital resulting in a change in scope of practice for pharmacists.
P31: Pharmacist-led penicillin allergic risk categorisation in intensive care patients for the purpose of rapid penicillin allergy delabeling (rapid phire) pilot study.
Of the 56 case series studies, six, 19, and 31 had a high, moderate, and low risk of bias, respectively. The risk of bias assessments are shown in Appendix 5.
Characteristics of included studies
The 69 included studies reported on the successful PADL of 5019 patients (adults n = 4314 [
Regulatory approval, implementation, and brief assessment of a pharmacist- and pharmacy trainee-administered penicillin allergy assessment and skin testing program.
An algorithm-based approach to routinely delabel penicillin allergy in pre-hematopoietic stem cell transplant patients with low risk of reaction. In: Proceedings of the Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2019.
Implementation of pharmacist-driven penicillin allergy skin testing in a community hospital resulting in a change in scope of practice for pharmacists.
P31: Pharmacist-led penicillin allergic risk categorisation in intensive care patients for the purpose of rapid penicillin allergy delabeling (rapid phire) pilot study.
Regulatory approval, implementation, and brief assessment of a pharmacist- and pharmacy trainee-administered penicillin allergy assessment and skin testing program.
Implementation of pharmacist-driven penicillin allergy skin testing in a community hospital resulting in a change in scope of practice for pharmacists.
P31: Pharmacist-led penicillin allergic risk categorisation in intensive care patients for the purpose of rapid penicillin allergy delabeling (rapid phire) pilot study.
An algorithm-based approach to routinely delabel penicillin allergy in pre-hematopoietic stem cell transplant patients with low risk of reaction. In: Proceedings of the Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2019.
Regulatory approval, implementation, and brief assessment of a pharmacist- and pharmacy trainee-administered penicillin allergy assessment and skin testing program.
Implementation of pharmacist-driven penicillin allergy skin testing in a community hospital resulting in a change in scope of practice for pharmacists.
P31: Pharmacist-led penicillin allergic risk categorisation in intensive care patients for the purpose of rapid penicillin allergy delabeling (rapid phire) pilot study.
An algorithm-based approach to routinely delabel penicillin allergy in pre-hematopoietic stem cell transplant patients with low risk of reaction. In: Proceedings of the Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2019.
Implementation of pharmacist-driven penicillin allergy skin testing in a community hospital resulting in a change in scope of practice for pharmacists.
P31: Pharmacist-led penicillin allergic risk categorisation in intensive care patients for the purpose of rapid penicillin allergy delabeling (rapid phire) pilot study.
An algorithm-based approach to routinely delabel penicillin allergy in pre-hematopoietic stem cell transplant patients with low risk of reaction. In: Proceedings of the Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2019.
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