The Cost of Penicillin Allergy Evaluation

doi:10.1016/j.jaip.2017.08.006

The Journal of Allergy and Clinical Immunology: In Practice

Volume 6, Issue 3, May–June 2018, Pages 1019-1027.e2

https://doi.org/10.1016/j.jaip.2017.08.006 Get rights and content

Background

Unverified penicillin allergy leads to adverse downstream clinical and economic sequelae. Penicillin allergy evaluation can be used to identify true, IgE-mediated allergy.

Objective

To estimate the cost of penicillin allergy evaluation using time-driven activity-based costing (TDABC).

Methods

We implemented TDABC throughout the care pathway for 30 outpatients presenting for penicillin allergy evaluation. The base-case evaluation included penicillin skin testing and a 1-step amoxicillin drug challenge, performed by an allergist. We varied assumptions about the provider type, clinical setting, procedure type, and personnel timing.

Results

The base-case penicillin allergy evaluation costs $220 in 2016 US dollars: $98 for personnel, $119 for consumables, and $3 for space. In sensitivity analyses, lower cost estimates were achieved when only a drug challenge was performed (ie, no skin test, $84) and a nurse practitioner provider was used ($170). Adjusting for the probability of anaphylaxis did not result in a changed estimate ($220); although other analyses led to modest changes in the TDABC estimate ($214-$246), higher estimates were identified with changing to a low-demand practice setting ($268), a 50% increase in personnel times ($269), and including clinician documentation time ($288). In a least/most costly scenario analyses, the lowest TDABC estimate was $40 and the highest was $537.

Conclusions

Using TDABC, penicillin allergy evaluation costs $220; even with varied assumptions adjusting for operational challenges, clinical setting, and expanded testing, penicillin allergy evaluation still costs only about $540. This modest investment may be offset for patients treated with costly alternative antibiotics that also may result in adverse consequences.

Section snippets

Base case

We considered the base case of an outpatient penicillin allergy visit with an American Board of Allergy and Immunology–certified Allergist/Immunologist who, after taking the allergy history, ordered skin testing with major determinant and dilutions of penicillin G, as well as a 1-step amoxicillin 500 mg oral challenge for all patients whose skin test result was negative. To estimate the cost of the base case, we defined each step along the outpatient penicillin allergy evaluation pathway in a

The TDABC method

Measured mean personnel times for each process (Figure 1) resulted in an estimated personnel cost of $98 (Table I), consumables cost of $119 (Table II), and space cost of $3 (Table III). The base-case penicillin allergy evaluation cost $220 in 2016 USD.

Assessing variations in 1-way sensitivity analyses led to different TDABC estimates (Figure 2). If skin testing were not performed, the cost was $84; $82 for personnel, less than $1 for consumables, and $2 for space. Using a nurse practitioner

Discussion

Using a TDABC approach, we found that the base-case penicillin allergy evaluation, penicillin skin testing, and a 1-step amoxicillin drug challenge performed by an allergy-boarded physician cost $220 in 2016 USD, with more than half of the cost attributed to consumables and about 45% attributed to personnel. Under alternative assumptions, we identified a cost range from $40 to $537 per penicillin allergy evaluation. Finally, we identified that the TDABC estimates were lower than estimates using

Acknowledgements

We thank Stephen Resch, MPH, PhD, and members of MGH Allergy Unit, including Sean Gilligan, Karen Ferreira, Lacey B. Robinson, MD, Amy S. Levin, MD, Benjamin Slawski, NP, Stephanie R. Orifice, RN, Cherri A. Figueroa, and Shelly Lucchesi, RN.

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Penicillin allergy is reported by 10% to 20 % of patients, but when evaluated only 1% to 2% may have a true allergy. Patients undergoing hematopoietic stem cell transplantation (HSCT) have a high likelihood of requiring beta-lactam antibiotics due to increased infection risk, which can be limited by a penicillin allergy label. When a penicillin allergy is recorded, alternatives are needed, including more expensive broader-spectrum antibiotics, with increases in drug-resistant bacteria, longer hospital stays, higher expenditures, and increases in nosocomial infections, such as Clostridium difficile colitis. This group of patients already undergoes extensive pretreatment testing and would especially benefit from allergy delabeling. This study aimed to develop a self-sustaining, low-cost pipeline between an HSCT clinic and an allergy clinic to identify and successfully delabel low-risk patients who endorse an allergy to penicillin, amoxicillin, amoxicillin-clavulanate, piperacillin-tazobactam, or ampicillin before admission to the hospital. We developed a survey to triage allergy risk, identified key stakeholders in building the pipeline, and underwent 4 plan, do, study, act (PDSA) cycles. Changes were made in each of the PDSA cycles to minimize cost and uncompensated provider time, as well as to increase patient retention throughout the pipeline by increasing appointment availability and decreasing reliance on patients to independently progress through the pathway. Of the 410 patients with planned HSCT who were screened over 11 months, 89 (21.7%) were listed as having a penicillin and/or beta lactam allergy. All but 1 (66 of 67; 98.5%) of the participants completed the survey accurately when confirmed by an allergist, and the survey was 100% accurate in predicting delabeling success in low-risk patients. Of eligible patients, 43.8% (n = 39) were successfully delabeled before their transplant date, and 97.4% of these (n = 38) have undergone HSCT to date. This pipeline is maintained by approximately 5 hours of work per week (1 hour of allergy physician time, 4 hours of nurse and/or clinical coordinator time), with no other direct costs. There is an estimated direct savings of at least $1914.93 per patient delabeled. We successfully designed and implemented a pipeline between the HSCT clinic and the allergy clinic as a quality improvement initiative to identify and address high rates of reported beta-lactam allergies. We identified and addressed patient-based factors, logistical, temporal, and financial barriers that impacted patient retention and sustainability. This model is expected to yield significant and sustained cost savings for the healthcare system as well as to improve patient outcomes, and this hypothesis is currently undergoing formal analysis. We anticipate that this model can be used to create a similar pipeline in other healthcare systems for HSCT recipients, as well as patients in other clinical settings, such as oncology and chimeric antigen receptor T cell therapy.
Performance Characteristics of Basophil Activation Tests for Diagnosing Penicillin Allergy: A Meta-Analysis
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Approximately 10% of the global population identify themselves as penicillin allergic, yet 90% are not truly allergic and could safely tolerate penicillin. There is no simple way to identify these people. Current in vitro diagnostics include specific immunoglobulin E (with a sensitivity of 19% and specificity of 97%) and a basophil activation test (BAT) with undefined sensitivity and specificity.
To define the sensitivity and specificity of BAT in the diagnosis of penicillin allergy
We searched PubMed and EMBASE from inception to April 2, 2023, for original studies evaluating the performance characteristics of BAT for penicillin allergy in adults. Study selection, data extraction, risk of bias, assessment with QUADAS-2 tool, certainty assessment with Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology were performed independently, in duplicate. Meta-analysis was performed using Reitsma methodology.
Twenty-two studies fulfilled the inclusion criteria. Twelve used the same positive threshold giving a summary point sensitivity 51% (95% confidence interval [95% CI]46%–56%) and specificity 89% (95% CI 85%–93%). Significant risk of bias was identified owing to patient selection. GRADE certainty of evidence rated sensitivity very low due to imprecision and specificity as low. There was great heterogeneity in methods used. Use of 1,000 basophils per test did not improve performance above 500 basophils.
BAT sensitivity is highly variable across studies and remains too low to be considered as a routine element of clinical practice. BAT specificity is not as good as specific immunoglobulin E in penicillin allergy diagnosis. Significant further work is required in this field before clinical application of BAT in routine practice.
Extended- or Single-Day Drug Challenge, That Is the Question
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Safety of Direct Drug Provocation for the Evaluation of Penicillin Allergy in Low-Risk Adults
2024, Journal of Allergy and Clinical Immunology: In Practice
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.
Penicillin Allergy Evaluation Should Be Performed Proactively in Patients With a Penicillin Allergy Label
2023, Journal of Allergy and Clinical Immunology: In Practice
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.
Does the Penicillin Allergy Label Affect Outcomes of Complicated Odontogenic Infections?
2023, Journal of Oral and Maxillofacial Surgery
Penicillins are a potent antibiotic in managing odontogenic infections, but 10% of the population is labelled as allergic to these drugs. This has limited their use and resulted in increased utilization of health care resources as well as complications associated with alternative antibiotics. The purpose of the study was to measure the association between patients labeled as penicillin allergic and treatment outcomes in a sample of patients treated for complicated odontogenic infections. Additionally, we sought to investigate antibiotic resistance patterns in these patients.
A retrospective cohort study was performed at the Michigan Medicine health care system to include patients who were treated for complicated odontogenic infections by oral and maxillofacial surgery between 2016 and 2020. Complicated odontogenic infection was defined as any odontogenic infection requiring admission and surgical management in the operating room. The primary predictor variable was the penicillin allergy label, which was determined by chart review and not confirmed with formal testing. Outcomes were measures of disease severity. The primary outcome variable was hospital length of stay. Secondary outcome variables were ICU admission (yes/no), repeat computed tomography scan(s), repeat surgery (yes/no), and re-admission (yes/no). Co-variates included were age, sex (male/female), tobacco use status, diabetes, immunocompromised state, number of spaces involved, white blood cell count upon admission and insurance status. For our secondary aim, the primary predictor variable was again penicillin allergy and outcome variable was antibiotic resistance as determined by wound culture results following surgical intervention. Negative binomial regression and logistic regression analyses were performed. P < .05 was considered significant.
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: This work was supported by the National Institutes of Health (NIH) (grant no. K01AI125631) and the American Academy of Allergy Asthma and Immunology Foundation. R.P.W. was supported by the Steven and Deborah Gorlin Massachusetts General Hospital Research Scholars Award. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

: Conflicts of interest: A. A. Long receives royalties from UpToDate. The rest of the authors declare that they have no relevant conflicts of interest.

View full text

Original ArticleThe Cost of Penicillin Allergy Evaluation

Background

Objective

Methods

Results

Conclusions

Section snippets

Base case

The TDABC method

Discussion

Acknowledgements

J Allergy Clin Immunol Pract

J Allergy Clin Immunol

Healthc (Amst)

J Vasc Interv Radiol

Knee

Ann Emerg Med

Ann Allergy Asthma Immunol

J Allergy Clin Immunol Pract

Ann Allergy Asthma Immunol

Jt Comm J Qual Patient Saf

Allergol Immunopathol (Madr)

J Allergy Clin Immunol

The incidence of antimicrobial allergies in hospitalized patients: implication regarding prescribing patters and emerging bacterial resistance

Arch Intern Med

Utility of penicillin skin testing in patients with a history of penicillin allergy

Asia Pac Allergy

Collaboration between allergists and pharmacists increases beta-lactam antibiotic prescriptions in patients with a history of penicillin allergy

Int Arch Allergy Immunol

The impact of reporting a prior penicillin allergy on the treatment of methicillin-sensitive Staphylococcus aureus bacteremia

PLoS One

Impact of reported beta-lactam allergy on inpatient outcomes: a multicenter prospective cohort study

Clin Infect Dis

Improving clinical outcomes in patients with methicillin-sensitive Staphylococcus aureus bacteremia and reported penicillin allergy

Clin Infect Dis

Allergy to penicillin with good tolerance to other penicillins: study of the incidence in subjects allergic to beta-lactams

Clin Exp Allergy

Allergic reactions to ampicillin: studies on the specificity and selectivity in subjects with immediate reactions

Clin Exp Allergy

Drug allergy: an updated practice parameter

Ann Allergy Asthma Immunol

The big idea: how to solve the cost crisis in health care

Harvard Business Rev

Using time-driven activity-based costing to identify value improvement opportunities in healthcare

J Healthc Manag

Utilizing time-driven activity-based costing to understand the short- and long-term costs of treating localized, low-risk prostate cancer

Cancer

A new costing model in hospital management: time-driven activity-based costing system

Health Care Manag (Frederick)

How Cleveland Clinic used TDABC to improve value

Healthc Financ Manage

Applying cost accounting to operating room staffing in otolaryngology: time-driven activity-based costing and outpatient adenotonsillectomy

Otolaryngol Head Neck Surg

Original Article
The Cost of Penicillin Allergy Evaluation