A multicentre observational study to investigate feasibility of a direct oral penicillin challenge in de-labelling ‘low risk’ patients with penicillin allergy by non-allergy healthcare professionals (SPACE study): Implications for healthcare systems

The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of ‘point-of-care’ tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct...

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Published inThe Journal of infection Vol. 88; no. 3; pp. 106116 - None
Main Authors Krishna, Mamidipudi Thirumala, Bhogal, Rashmeet, Ng, Bee Yean, Kildonaviciute, Kornelija, Jani, Yogini H., Williams, Iestyn, Sandoe, Jonathan A.T., Pollard, Rachel, Jones, Nicola, Dunsmure, Louise, Powell, Neil, Hullur, Chidanand, Balaji, Ariyur, Moriarty, Catherine, Jackson, Beverley, Warner, Amena, Daniels, Ron, West, Robert, Thomas, Caroline, Misbah, Siraj A., Savic, Louise
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 01.03.2024
W.B. Saunders
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Abstract The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of ‘point-of-care’ tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling. This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC. N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors. DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings. [Display omitted] Non-allergy healthcare professionals can safely perform direct oral penicillin challenges.A high proportion of patients did not progress in the study pathway.Outpatient settings offer greater opportunities for penicillin allergy de-labelling.Multi-pronged strategies are needed in the patient pathway to enhance uptake.
AbstractList ga1 Non-allergy healthcare professionals can safely perform direct oral penicillin challenges. A high proportion of patients did not progress in the study pathway. Outpatient settings offer greater opportunities for penicillin allergy de-labelling. Multi-pronged strategies are needed in the patient pathway to enhance uptake.
The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of 'point-of-care' tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling. This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC. N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors. DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.
The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of 'point-of-care' tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling.OBJECTIVEThe huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of 'point-of-care' tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling.This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC.METHODSThis prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC.N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors.RESULTSN = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors.DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.INTERPRETATIONDPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings.
The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy specialists and lack of ‘point-of-care’ tests. We investigated the feasibility of non-allergy healthcare professionals (HCPs) delivering direct oral penicillin challenges (DPCs) for penicillin allergy de-labelling. This prospective observational study was conducted in three hospitals in England across three settings (acute medical, pre-surgical and haematology-oncology). Patients with a PAL were screened and stratified as low risk/high risk. Low risk patients (non-immune mediated symptoms, benign rash, tolerated amoxicillin since and family history) underwent a DPC. N = 2257 PALs were screened, 1054 were eligible; 643 were approached, 373 declined, 270 consented and 259 risk stratified (low risk = 155; high risk = 104). One hundred and twenty-six low risk patients underwent DPC, 122 (96.8%) were de-labelled with no serious allergic reactions. Conversion rate from screening-to-consent was 12% [3.3% and 17.9% in acute and elective settings respectively; odds ratios for consent were 3.42 (p < 0.001) and 5.53 (p < 0.001) in haematology-oncology and pre-surgical setting respectively. Common reasons for failure to progress in the study included difficulty in reaching patients, clinical instability/medical reasons, lacking capacity to consent and psychological factors. DPCs can be delivered by non-allergy HCPs. A high proportion of patients with PALs did not progress in the study pathway. Strategies to deliver DPC at optimal points of the care pathway are needed to enhance uptake. Elective settings offer greater opportunities than acute settings for DPC. The safety and simplicity of DPCs lends itself to adoption by healthcare systems beyond the UK, including in resource-limited settings. [Display omitted] Non-allergy healthcare professionals can safely perform direct oral penicillin challenges.A high proportion of patients did not progress in the study pathway.Outpatient settings offer greater opportunities for penicillin allergy de-labelling.Multi-pronged strategies are needed in the patient pathway to enhance uptake.
ArticleNumber 106116
Author Balaji, Ariyur
Hullur, Chidanand
Daniels, Ron
Moriarty, Catherine
Jackson, Beverley
Misbah, Siraj A.
Dunsmure, Louise
Kildonaviciute, Kornelija
Thomas, Caroline
Jones, Nicola
West, Robert
Sandoe, Jonathan A.T.
Warner, Amena
Williams, Iestyn
Powell, Neil
Savic, Louise
Bhogal, Rashmeet
Pollard, Rachel
Jani, Yogini H.
Krishna, Mamidipudi Thirumala
Ng, Bee Yean
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  email: m.t.krishna@bham.ac.uk
  organization: Institute of Immunology and Immunotherapy, University of Birmingham and Department of Allergy and Immunology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
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  givenname: Rashmeet
  orcidid: 0000-0002-1849-6521
  surname: Bhogal
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  organization: Department of Pharmacy, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
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  givenname: Bee Yean
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  surname: Ng
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  organization: Department of Pharmacy, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
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  organization: Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust and UCL School of Pharmacy, London, UK
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  surname: Williams
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  organization: Health Services Management Centre, University of Birmingham, Birmingham, UK
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  givenname: Jonathan A.T.
  surname: Sandoe
  fullname: Sandoe, Jonathan A.T.
  organization: Healthcare Associated Infection Group, Leeds Institute of Medical Research, University of Leeds and Leeds Teaching Hospitals NHS Trust, Leeds, UK
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  givenname: Rachel
  orcidid: 0009-0008-8102-3795
  surname: Pollard
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  givenname: Nicola
  orcidid: 0000-0003-0468-9282
  surname: Jones
  fullname: Jones, Nicola
  organization: Department of Infectious Diseases, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
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  surname: Dunsmure
  fullname: Dunsmure, Louise
  organization: Department of Pharmacy, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
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  givenname: Neil
  surname: Powell
  fullname: Powell, Neil
  organization: Department of Pharmacy, Royal Cornwall Hospitals NHS Trust, Truro, UK
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  givenname: Chidanand
  orcidid: 0009-0007-8176-1811
  surname: Hullur
  fullname: Hullur, Chidanand
  organization: Department of Anaesthesia, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
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  surname: Balaji
  fullname: Balaji, Ariyur
  organization: Acute Medicine Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
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  givenname: Catherine
  surname: Moriarty
  fullname: Moriarty, Catherine
  organization: Theatres and Anaesthetics Research Team, St James' University Hospital, Leeds Teaching Hospitals, Leeds, UK
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  givenname: Beverley
  orcidid: 0000-0002-6893-2344
  surname: Jackson
  fullname: Jackson, Beverley
  organization: Theatres and Anaesthetics Research Team, St James' University Hospital, Leeds Teaching Hospitals, Leeds, UK
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  givenname: Amena
  surname: Warner
  fullname: Warner, Amena
  organization: Allergy UK, Crayford, UK
– sequence: 17
  givenname: Ron
  surname: Daniels
  fullname: Daniels, Ron
  organization: The UK Sepsis Trust, Walsall, UK
– sequence: 18
  givenname: Robert
  surname: West
  fullname: West, Robert
  organization: Healthcare Associated Infection Group, Leeds Institute of Medical Research, University of Leeds and Leeds Teaching Hospitals NHS Trust, Leeds, UK
– sequence: 19
  givenname: Caroline
  surname: Thomas
  fullname: Thomas, Caroline
  organization: Department of Anaesthesia, St James' University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
– sequence: 20
  givenname: Siraj A.
  surname: Misbah
  fullname: Misbah, Siraj A.
  organization: Department of Clinical Immunology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
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  givenname: Louise
  surname: Savic
  fullname: Savic, Louise
  organization: Department of Anaesthesia, St James' University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
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Issue 3
Keywords High risk
Direct oral penicillin challenge
Antimicrobial resistance
Low risk
Penicillin allergy
Risk stratification
Language English
License This is an open access article under the CC BY-NC-ND license.
Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.
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S.A.M. and L.S. are joint senior authors.
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Snippet The huge burden of inaccurate penicillin allergy labels (PALs) is an important driver of antimicrobial resistance. This is magnified by insufficient allergy...
ga1 Non-allergy healthcare professionals can safely perform direct oral penicillin challenges. A high proportion of patients did not progress in the study...
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SubjectTerms Anti-Bacterial Agents - adverse effects
Antimicrobial resistance
Delivery of Health Care
Direct oral penicillin challenge
Drug Hypersensitivity - diagnosis
Feasibility Studies
High risk
Humans
Hypersensitivity
Low risk
Penicillin allergy
Penicillins - adverse effects
Risk stratification
Skin Tests
Title A multicentre observational study to investigate feasibility of a direct oral penicillin challenge in de-labelling ‘low risk’ patients with penicillin allergy by non-allergy healthcare professionals (SPACE study): Implications for healthcare systems
URI https://dx.doi.org/10.1016/j.jinf.2024.01.015
https://www.ncbi.nlm.nih.gov/pubmed/38331329
https://www.proquest.com/docview/2924997678
https://pubmed.ncbi.nlm.nih.gov/PMC10961940
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