Penicillin Allergy Evaluation Research Articles

Prospective, Multicenter, Head-to-Head Comparison Between Allergists Versus Nonallergists in Low-Risk Penicillin Allergy Delabeling: Effectiveness, Safety, and Quality of Life (HK-DADI2)

BackgroundPenicillin “allergy” labels are prevalent but frequently misdiagnosed. Mislabelled allergies are associated with adverse outcomes and increased antimicrobial resistance. With an urgent need to delabel the overwhelming number of mislabelled allergies, non-allergist evaluations have been advocated for low-risk individuals. Despite growing interest in non-allergist-led initiatives; evidence on their effectiveness, safety, and impact by direct comparisons are lacking. ObjectiveWe assessed the comparative outcomes of penicillin allergy evaluations conducted by allergists vs. non-allergists. MethodsA prospective, multi-centre, pragmatic study was conducted at four tertiary hospitals (one allergist- vs. three non-allergist-led) for low-risk penicillin allergy patients in Hong Kong – the Hong Kong Drug Allergy Delabelling Initiative 2 (HK-DADI2). ResultsAmong 228 low-risk patients who underwent testing (32.9% by allergists, 67.1% by non-allergists), only 14 (6.1%) had positive penicillin allergy testing. Delabelling rates (94.1% vs. 93.3%, p=0.777), positive skin tests (2.6% vs. 2.7%, p=1.000) and drug provocation tests (3.3% vs. 2.7%, p=1.000) were similar between allergists and non-allergists. There were no systemic reactions in either cohort. All patients had significant improvements in health-related quality-of-life (DrHy-Q scores −5.00 vs. −8.33, p=0.072). Non-allergist evaluations had shorter waiting times (0.57 vs. 15.7 months, p<0.001), while allergists required fewer consultations with higher rate of completing evaluations within a single-visit (OR=0.04, p<0.001). ConclusionWith training and support, non-allergists can independently evaluate low-risk penicillin allergies. Compared to allergists, evaluation of low-risk penicillin allergy by non-allergists can be comparably effective, safe, and impactful on quality-of-life. More multi-disciplinary partnerships to empower non-allergists to conduct allergy evaluations, should be encouraged.

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

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. 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. The startup cost of program development and educational initiatives was $19,920, or $86 per patient. The median allergy evaluation cost was $397 (interquartile range: $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 nonreferred patients. Overall, the total cost per person did not differ significantly between study groups (median: $18,931 vs. $18,314, p = 0.69). 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. · The cost of developing and implementing an antepartum penicillin allergy referral program is modest.. · Program cost did not significantly alter short-term cost with a potential for long-term cost benefit.. · Penicillin allergy verification is an important part of antibiotic stewardship and should be expanded..

Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients.

Approximately 15% of patients in sexually transmitted infection (STI) clinics report penicillin allergies, complicating treatment for syphilis and gonorrhea. Nonetheless, >90% do not have a penicillin allergy when evaluated. We developed and validated an algorithm to define which patients reporting penicillin allergy can be safely treated at STI clinics with these drugs. Randomized controlled trial to assess feasibility and safety of penicillin allergy evaluations in STI clinics. Participants with reported penicillin allergy answered an expert-developed questionnaire to stratify risk. Low-risk participants underwent penicillin skin testing (PST) followed by amoxicillin 250 mg challenge or a graded oral challenge (GOC)-amoxicillin 25 mg followed by 250 mg. Reactions were recorded, and participant/provider surveys were conducted. Of 284 participants, 72 (25.3%) were deemed high risk and were excluded. Of 206 low-risk participants, 102 (49.5%) underwent PST without reactions and 3 (3%) had mild reactions during the oral challenge. Of 104 (50.5%) participants in the GOC, 95 (91.3%) completed challenges without reaction, 4 (4.2%) had mild symptoms after 25 mg, and 4 (4.2%) after 250-mg doses. Overall, 195 participants (94.7%) successfully completed the study and 11 (5.3%) experienced mild symptoms. Of 14 providers, 12 (85.7%) completed surveys and 11 (93%) agreed on the safety/effectiveness of penicillin allergy assessment in STI clinics. An easy-to-administer risk-assessment questionnaire can safely identify patients for penicillin allergy evaluation in STI clinics by PST or GOC, with GOC showing operational feasibility. Using this approach, 67% of participants with reported penicillin allergy could safely receive first-line treatments for gonorrhea or syphilis. Clinical Trials Registration. Clinicaltrials.gov (NCT04620746).

The impact of a best practice alert on outpatient penicillin allergy evaluation referrals

The impact of a best practice alert on outpatient penicillin allergy evaluation referrals

Demographic factors associated with penicillin allergy evaluation in pregnancy

Demographic factors associated with penicillin allergy evaluation in pregnancy

Impact of a dedicated referral pathway for the evaluation of penicillin allergy during pregnancy

Impact of a dedicated referral pathway for the evaluation of penicillin allergy during pregnancy

APAAACI clinical pathway on direct provocation testing for penicillin allergy delabeling

Background: Allergy to penicillin is commonly reported in many countries and is an overwhelming global public health concern. Penicillin allergy labels can lead to the use of less effective antibiotics and can be associated with antimicrobial resistance. Appropriate assessment of suspected penicillin allergy (often including skin testing, followed by drug provocation testing [DPT] performed by allergists) can prevent the unnecessary restriction of penicillin or delabelling. Many countries in the Asia Pacific (AP) have very limited access to allergy services, and there are significant disparities in the methods of evaluating penicillin allergy. Therefore, a clinical pathway for the management of penicillin allergy is essential. Objectives: To develop a risk-stratified clinical pathway for delabeling penicillin allergy, taking into account the distinct epidemiology, patient/sensitization profiles, and disparities of allergy services or facilities within the AP. Methods: A risk-stratified penicillin allergy delabeling clinical pathway was formulated by the Drug Allergy Committee of the Asia Pacific Association of Allergy, Asthma and Clinical Immunology. and members of the Penicillin Allergy Disparities survey in AP each representing one country/region of the AP. The clinical pathway was tested based on a database of anonymized patients who were sequentially referred for and completed penicillin allergy evaluation in Hong Kong. Results: The clinical pathway was piloted employing a “hub-and-spoke” approach to foster multidisciplinary collaboration between allergists and nonallergists. A simulation run of the algorithm on a retrospective Hong Kong cohort of 439 patients was performed. Overall, 367 (84%) of patients were suitable for direct DPT and reduced the need for skin testing or specialist’s care for 357 (97%) skin test-negative individuals. Out of the skin test-negative patients, 345 (94%) patients had a negative DPT. Conclusions: This risk-stratification strategy for direct oral DPT can reduce the need for unnecessary skin testing in patients with low-risk penicillin allergy histories. The hub and spoke model of care may be considered for further piloting and validation in other AP populations that lack adequately trained allergists.

Penicillin Allergy Evaluation Should Be Performed Proactively in Patients With a Penicillin Allergy Label

Penicillin allergy is the most common drug allergy in the US population. A penicillin allergy label is associated with poor patient outcomes including increased hospital length of stay, increased perioperative infections, and overall increased mortality. A penicillin allergy evaluation accurately identifies approximately 9 of 10 patients who, despite reporting a history of penicillin allergy, can receive penicillins safely. Penicillin allergy evaluations should be offered proactively to healthy patients during routine visits, including children and pregnant women, in advance of antibiotic need.

Barriers to penicillin allergy de-labeling in the inpatient and outpatient settings: a qualitative study

BackgroundPenicillin allergy is the most commonly reported drug allergy in the US. Despite evidence demonstrating that up to 90% of labels are incorrect, scalable interventions are not well established. As part of a larger mixed methods investigation, we conducted a qualitative study to describe the barriers to implementing a risk-based penicillin de-labeling protocol within a single site Veteran’s hospital.MethodsWe conducted individual and group interviews with multidisciplinary inpatient and outpatient healthcare teams. The interview guides were developed using the Theoretical Domains Framework (TDF) to explore workflows and contextual factors influencing identification and evaluation of patients with penicillin allergy. Three researchers iteratively developed the codebook based on TDF domains and coded the data using thematic analysis.ResultsWe interviewed 20 clinicians. Participants included three hospitalists, five inpatient pharmacists, one infectious disease physician, two anti-microbial stewardship pharmacists, four primary care providers, two outpatient pharmacists, two resident physicians, and a nurse case manager for the allergy service. The factors that contributed to barriers to penicillin allergy evaluation and de-labeling were classified under six TDF domains; knowledge, skills, beliefs about capabilities, beliefs about consequences, professional role and identity, and environmental context and resources. Participants from all groups acknowledged the importance of penicillin de-labeling. However, they lacked confidence in their skills to perform the necessary evaluations, such as test dose challenges. The fear of inducing an allergic reaction and adding further complexity to patient care exacerbated their reluctance to de-label patients. The lack of ownership of de-labeling initiative was another significant obstacle in establishing consistent clinical workflows. Additionally, heavy workloads, competing priorities, and ease of access to alternative antibiotics prevented the prioritization of tasks related to de-labeling. Space limitations and nursing staff shortages added to challenges in outpatient settings.ConclusionOur findings demonstrated that barriers to penicillin allergy de-labeling fall under multiple behavioral domains. Better role clarification, opportunities to develop necessary skills, and dedicated resources are needed to overcome these barriers. Future interventions will need to employ a systemic approach that addresses each of the behavioral domains influencing penicillin allergy de-labeling with stakeholder engagement of the inpatient and outpatient health care teams.

Safety of Direct Drug Provocation for the Evaluation of Penicillin Allergy in Low-Risk Adults

About 10% of patients have a penicillin allergy label, but less than 5% of them are actually allergic. Unnecessary penicillin avoidance is associated with serious medical consequences. Given the growing number of these labels, it is imperative that our diagnostic strategy for penicillin allergy be as efficient as possible. The validity of traditionally used skin tests (STs) has been questioned, whereas drug provocation testing (DPT), the criterion standard, without previous ST appears very safe in most cases. To evaluate the safety of direct DPT without consideration for ST results and the validity of ST in the diagnosis of penicillin allergy. In this prospective cohort study without a control group, we recruited patients consulting an allergist for penicillin allergy. Patients underwent ST followed by DPT regardless of ST results. Patients with anaphylaxis to penicillin within the past 5 years or a severe delayed reaction were excluded, as were those with significant cardiorespiratory comorbidity. None of the 1002 recruited patients had a serious reaction to DPT. Ten (1.0%) had a mild immediate reaction, of whom only 1 (0.1%) was considered likely IgE-mediated. The positive and negative predictive values of ST for an immediate reaction were 3.6% and 99.1%, respectively. In a low-risk adult population reporting penicillin allergy, ST has very poor positive predictive value. Direct DPT without ST is safe and appears to be an ideal diagnostic strategy to remove penicillin allergy labels that could be implemented in first-line practice.

Evaluating the PEN-FAST Clinical Decision-making Tool to Enhance Penicillin Allergy Delabeling

This cohort study evaluated the diagnostic accuracy of PEN-FAST as a clinical decision-making tool to enhance penicillin allergy evaluation.

The evaluation of penicillin allergy in dialysis patients.

Journal Article Accepted manuscript The evaluation of penicillin allergy in dialysis patients Get access Simo Sirkeoja, Simo Sirkeoja Department of Internal Medicine, Tampere University Hospital and Faculty of Medicine and Life Sciences, University of Tampere, Finland Correspondence to: Simo Sirkeoja; E-mail: simo.sirkeoja@pirha.fi Search for other works by this author on: Oxford Academic PubMed Google Scholar Meeri Honkanen, Meeri Honkanen Department of Internal Medicine, Tampere University Hospital and Faculty of Medicine and Life Sciences, University of Tampere, Finland Search for other works by this author on: Oxford Academic PubMed Google Scholar Reetta Huttunen, Reetta Huttunen Department of Internal Medicine, Tampere University Hospital and Faculty of Medicine and Life Sciences, University of Tampere, Finland Search for other works by this author on: Oxford Academic PubMed Google Scholar Satu Mäkelä, Satu Mäkelä Department of Internal Medicine, Tampere University Hospital and Faculty of Medicine and Life Sciences, University of Tampere, Finland Search for other works by this author on: Oxford Academic PubMed Google Scholar Jaana Syrjänen Jaana Syrjänen Department of Internal Medicine, Tampere University Hospital and Faculty of Medicine and Life Sciences, University of Tampere, Finland Search for other works by this author on: Oxford Academic PubMed Google Scholar Nephrology Dialysis Transplantation, gfad072, https://doi.org/10.1093/ndt/gfad072 Published: 17 April 2023

Relationship of Reaction History to Positive Penicillin Skin Tests

Previous data suggest that up to one-third of patients classified as allergic based on positive penicillin skin tests have a vague reaction history. Direct oral challenge (DOC) has been recommended for patients with a low-risk reaction history. A variety of published models stratify reaction risk to guide the use of DOC. To reassess the proportion of penicillin skin test-positive patients with vague or low-risk reaction histories and evaluate the relationship between the reaction risk history and the likelihood of positive skin test results. We identified patients who underwent penicillin allergy evaluation over a 5-year period. We recorded drug reaction history, demographic variables, skin testing, and challenge results. Matched controls whose skin tests were negative were identified for skin test-positive patients. Drug reaction histories were assigned a risk category based on 2 previously published risk stratification models. We used logistic regression to investigate whether reaction history risk was associated with positive skin test results. Penicillin skin testing was performed in 3382 patients; 207 (6.1%) were positive. Positive skin tests were more frequent in outpatients (P < .001), younger patients (P < .001), and female patients (P < .001). Percentages of each risk category in each model were similar in cases versus matched controls. The likelihood for positive skin tests increased with a high-risk reaction history in one stratification model. Our data confirm that a substantial proportion of patients who self-report penicillin allergy and have positive skin test results have a low-risk history and imply that penicillin skin testing is associated with a poor positive predictive value.

A Nurse-Led, Protocol-Driven Penicillin Allergy Evaluation from the Hong Kong Drug Allergy Delabelling Initiative: Effectiveness, Safety and Real-World Outcomes

There is a high prevalence of misdiagnosed penicillin ‘allergy’, associated with a multitude of adverse clinical outcomes. With the overwhelming burden of incorrect labels and lack of allergy specialist services, new delabelling strategies are urgently needed. We compared the effectiveness, safety and real-world outcomes of a nurse-led, protocol-driven evaluation of penicillin allergy – Hong Kong Drug Allergy Delabelling Initiative (HK-DADI).

A Quality Improvement Initiative to Increase Access to Penicillin Allergy Evaluations in Pediatric Surgical Patients

Surgical patients with a penicillin allergy label have worse clinical outcomes and increased healthcare costs compared to patients without a penicillin allergy label. Our aim is to decrease the number of pediatric patients presenting to surgery with a penicillin allergy label by increasing access to pre-operative penicillin allergy evaluation.

Low frequency of allergy referral for penicillin allergy evaluation in an urban Boston primary care setting.

A key strategy to combat the public health crisis of antimicrobial resistance is to use appropriate antibiotics, which is difficult in patients with a penicillin allergy label. Our aim was to investigate racial and ethnic differences related to penicillin allergy labeling and referral to allergy/immunology in primary care. This was a retrospective study of Tufts Medical Center's Boston-based primary care patients in 2019. Univariable and multivariable logistic regression models were used to examine demographic associations with (1) penicillin allergy label and (2) allergist referral. Of 21,918 primary care patients, 2,391 (11%) had a penicillin allergy label; of these, 249 (10%) had an allergist referral. In multivariable logistic regression models, older age (adjusted odds ratio [aOR]= 1.06 [95% CI= 1.04-1.09]) and female sex (aOR= 1.58 [95% CI = 1.44-1.74]) were associated with higher odds of penicillin allergy label carriage. Black race (aOR= 0.77 [95% CI= 0.69-0.87]) and Asian race (aOR= 0.47 [95%CI = 0.41-0.53]) were associated with lower odds of penicillin allergy label carriage. In multivariable regression, allergist referral was associated with female sex (aOR= 1.52 [95% CI= 1.10-2.10]) and Black race (aOR= 1.74 [95% CI= 1.25-2.45]). Of 93 patients (37%) who completed their allergy visit, 26 (28%) had received penicillin allergy evaluation or were scheduled to receive a penicillin allergy evaluation at a future visit. There were racial differences in penicillin allergy labeling and referral. Allergy referral for penicillin allergy assessment was rare. Larger studies are needed to assess penicillin allergy labeling and delabeling with an equity focus on optimizing patient health outcomes.

Improving Access To Penicillin Allergy Testing Among Pregnant Patients In An Obstetrics Clinic

Beta-lactam antibiotics are first-line for most infections during pregnancy and delivery. We assessed outcomes of proactive screening and referral from an obstetrics (OB) clinic for penicillin allergy evaluation.

Prospective Assessment of Penicillin Allergy (PAPA): Evaluating the performance of penicillin allergy testing and post-delabelling outcomes among Hong Kong Chinese.

Incorrect penicillin 'allergy' labels predispose patients to adverse outcomes but are under-recognised in many Asian countries. Studies on performance and post-delabelling outcomes of penicillin allergy evaluation among Chinese remain scarce. To evaluate the diagnostic performance of allergy testing and post-delabelling outcomes among Chinese patients in a prospective penicillin allergy cohort - Prospective Assessment of Penicillin Allergy (PAPA). All adult patients (age ≥ 18 years) who underwent penicillin allergy evaluation between January 2020 to December 2021 were recruited and prospectively reviewed by both medical records and individual interviews at least 6 months after delabelling or allergy confirmation. Out of 372 patients who completed penicillin allergy evaluation, 335 (90%) patients were delabelled. The overall negative predictive value of penicillin skin testing was 95%, but lower for patients with non-immediate type reactions (88%). History of non-immediate symptom onset (OR = 4.501 [95%CI = 2.085-9.716], p < 0.001) and duration since index reaction (OR = 0.942 [95%CI = 0.899-0.987], p = 0.012) were associated with positive skin testing. After at least 6 months, 60 (18%) of de-labelled patients had received penicillins again without any adverse reactions. Fluoroquinolone-use was significantly lower among delabelled patients compared to those with penicillin allergy (38[11%] vs 11[30%], p = 0.004). After at least 6 months, one in six delabelled patients already received penicillins again safely, with significantly lower fluoroquinolone usage. None experienced adverse reactions. History of non-immediate onset and shorter duration since index reaction were associated with genuine allergy. In patients with severe non-immediate reactions, skin tests should be supplemented with thorough clinical history and adjunct diagnostic evaluations.

Penicillin allergy evaluation in hospitalized patients with hematologic malignancy

A penicillin allergy testing service (PATS) assessed penicillin allergy in patients with hematologic malignancies; 17 patients who met criteria had negative skin testing. Patients who underwent penicillin challenge passed and were delabeled. Of delabeled patients, 87% received and tolerated β-lactams during follow-up. Providers found the PATS valuable.

Perceived usefulness of a mnemonic to improve nurses' evaluation of reported penicillin allergies.

We surveyed clinicians to evaluate the perceived usefulness of a mnemonic, STORY, to improve penicillin allergy evaluation. Survey responses indicated that the perceived usefulness of STORY was high, and support for nurses' involvement in penicillin allergy assessment was high. Future research may evaluate the feasibility of STORY implementation in clinical care.