Safety and Outcomes of Test Doses for the Evaluation of Adverse Drug Reactions

A 5-Year Retrospective Review

Melissa M. Iammatteo, Kimberly G. Blumenthal, Rebecca Saff, Aidan A. Long, Aleena Banerji

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Background: Graded challenges are the criterion standard for evaluating adverse drug reactions (ADR). Evidence-based guidelines regarding the optimal number of steps for challenges are lacking. Objective: To determine the safety and outcomes of 1- or 2-step test doses among patients with ADRs seen by the allergy/immunology consult service and to compare the outcomes of 1- or 2-step test doses with multistep challenges performed during the same time period. Methods: We conducted a retrospective chart review of all 1- or 2-step test doses and multistep challenges at a single academic center between 2008 and 2013. Patient demographics, symptoms of initial ADRs, and outcomes of test doses and multistep challenges were reviewed. ADRs were classified by type and were graded by severity. Outcomes of 1- or 2-step test doses were compared with multistep challenges. Results: We identified 456 patients who underwent 497 one- or 2-step test doses (mean age, 51 years; 67.5% female patients). The most common drugs that prompted test doses were β-lactams (62%). The majority of patients (n= 444 [89%]) did not experience any ADRs during test doses. ADRs that occurred during test doses (n= 53 [11%]) were most commonly non-immune-mediated (45%) or IgE-mediated (32%), with grade 1 or 2 severity (100%). Forty-nine percent of ADRs during test doses did not receive any treatment. The ADR rate during multistep challenges (10/82 [12%]) was similar to test doses. Conclusion: One- or 2-step test doses were safe for evaluation of ADRs. Multistep challenges did not confer added safety. Furthermore, 1- or 2-step test doses did not raise concern for induction of tolerance.

Original languageEnglish (US)
Pages (from-to)768-774
Number of pages7
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume2
Issue number6
DOIs
StatePublished - 2014
Externally publishedYes

Fingerprint

Drug-Related Side Effects and Adverse Reactions
Exercise Test
Safety
Lactams
Allergy and Immunology
Immunoglobulin E
Demography
Guidelines
Pharmaceutical Preparations

Keywords

  • Adverse drug reaction
  • Drug allergy
  • Drug provocation test
  • Graded challenge
  • Hypersensitivity reaction
  • Test dose

ASJC Scopus subject areas

  • Immunology and Allergy
  • Medicine(all)

Cite this

Safety and Outcomes of Test Doses for the Evaluation of Adverse Drug Reactions : A 5-Year Retrospective Review. / Iammatteo, Melissa M.; Blumenthal, Kimberly G.; Saff, Rebecca; Long, Aidan A.; Banerji, Aleena.

In: Journal of Allergy and Clinical Immunology: In Practice, Vol. 2, No. 6, 2014, p. 768-774.

Research output: Contribution to journalArticle

@article{a1ee48da2d83441dba240fc9857a43bc,
title = "Safety and Outcomes of Test Doses for the Evaluation of Adverse Drug Reactions: A 5-Year Retrospective Review",
abstract = "Background: Graded challenges are the criterion standard for evaluating adverse drug reactions (ADR). Evidence-based guidelines regarding the optimal number of steps for challenges are lacking. Objective: To determine the safety and outcomes of 1- or 2-step test doses among patients with ADRs seen by the allergy/immunology consult service and to compare the outcomes of 1- or 2-step test doses with multistep challenges performed during the same time period. Methods: We conducted a retrospective chart review of all 1- or 2-step test doses and multistep challenges at a single academic center between 2008 and 2013. Patient demographics, symptoms of initial ADRs, and outcomes of test doses and multistep challenges were reviewed. ADRs were classified by type and were graded by severity. Outcomes of 1- or 2-step test doses were compared with multistep challenges. Results: We identified 456 patients who underwent 497 one- or 2-step test doses (mean age, 51 years; 67.5{\%} female patients). The most common drugs that prompted test doses were β-lactams (62{\%}). The majority of patients (n= 444 [89{\%}]) did not experience any ADRs during test doses. ADRs that occurred during test doses (n= 53 [11{\%}]) were most commonly non-immune-mediated (45{\%}) or IgE-mediated (32{\%}), with grade 1 or 2 severity (100{\%}). Forty-nine percent of ADRs during test doses did not receive any treatment. The ADR rate during multistep challenges (10/82 [12{\%}]) was similar to test doses. Conclusion: One- or 2-step test doses were safe for evaluation of ADRs. Multistep challenges did not confer added safety. Furthermore, 1- or 2-step test doses did not raise concern for induction of tolerance.",
keywords = "Adverse drug reaction, Drug allergy, Drug provocation test, Graded challenge, Hypersensitivity reaction, Test dose",
author = "Iammatteo, {Melissa M.} and Blumenthal, {Kimberly G.} and Rebecca Saff and Long, {Aidan A.} and Aleena Banerji",
year = "2014",
doi = "10.1016/j.jaip.2014.08.001",
language = "English (US)",
volume = "2",
pages = "768--774",
journal = "Journal of Allergy and Clinical Immunology: In Practice",
issn = "2213-2198",
publisher = "Elsevier",
number = "6",

}

TY - JOUR

T1 - Safety and Outcomes of Test Doses for the Evaluation of Adverse Drug Reactions

T2 - A 5-Year Retrospective Review

AU - Iammatteo, Melissa M.

AU - Blumenthal, Kimberly G.

AU - Saff, Rebecca

AU - Long, Aidan A.

AU - Banerji, Aleena

PY - 2014

Y1 - 2014

N2 - Background: Graded challenges are the criterion standard for evaluating adverse drug reactions (ADR). Evidence-based guidelines regarding the optimal number of steps for challenges are lacking. Objective: To determine the safety and outcomes of 1- or 2-step test doses among patients with ADRs seen by the allergy/immunology consult service and to compare the outcomes of 1- or 2-step test doses with multistep challenges performed during the same time period. Methods: We conducted a retrospective chart review of all 1- or 2-step test doses and multistep challenges at a single academic center between 2008 and 2013. Patient demographics, symptoms of initial ADRs, and outcomes of test doses and multistep challenges were reviewed. ADRs were classified by type and were graded by severity. Outcomes of 1- or 2-step test doses were compared with multistep challenges. Results: We identified 456 patients who underwent 497 one- or 2-step test doses (mean age, 51 years; 67.5% female patients). The most common drugs that prompted test doses were β-lactams (62%). The majority of patients (n= 444 [89%]) did not experience any ADRs during test doses. ADRs that occurred during test doses (n= 53 [11%]) were most commonly non-immune-mediated (45%) or IgE-mediated (32%), with grade 1 or 2 severity (100%). Forty-nine percent of ADRs during test doses did not receive any treatment. The ADR rate during multistep challenges (10/82 [12%]) was similar to test doses. Conclusion: One- or 2-step test doses were safe for evaluation of ADRs. Multistep challenges did not confer added safety. Furthermore, 1- or 2-step test doses did not raise concern for induction of tolerance.

AB - Background: Graded challenges are the criterion standard for evaluating adverse drug reactions (ADR). Evidence-based guidelines regarding the optimal number of steps for challenges are lacking. Objective: To determine the safety and outcomes of 1- or 2-step test doses among patients with ADRs seen by the allergy/immunology consult service and to compare the outcomes of 1- or 2-step test doses with multistep challenges performed during the same time period. Methods: We conducted a retrospective chart review of all 1- or 2-step test doses and multistep challenges at a single academic center between 2008 and 2013. Patient demographics, symptoms of initial ADRs, and outcomes of test doses and multistep challenges were reviewed. ADRs were classified by type and were graded by severity. Outcomes of 1- or 2-step test doses were compared with multistep challenges. Results: We identified 456 patients who underwent 497 one- or 2-step test doses (mean age, 51 years; 67.5% female patients). The most common drugs that prompted test doses were β-lactams (62%). The majority of patients (n= 444 [89%]) did not experience any ADRs during test doses. ADRs that occurred during test doses (n= 53 [11%]) were most commonly non-immune-mediated (45%) or IgE-mediated (32%), with grade 1 or 2 severity (100%). Forty-nine percent of ADRs during test doses did not receive any treatment. The ADR rate during multistep challenges (10/82 [12%]) was similar to test doses. Conclusion: One- or 2-step test doses were safe for evaluation of ADRs. Multistep challenges did not confer added safety. Furthermore, 1- or 2-step test doses did not raise concern for induction of tolerance.

KW - Adverse drug reaction

KW - Drug allergy

KW - Drug provocation test

KW - Graded challenge

KW - Hypersensitivity reaction

KW - Test dose

UR - http://www.scopus.com/inward/record.url?scp=84922377976&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84922377976&partnerID=8YFLogxK

U2 - 10.1016/j.jaip.2014.08.001

DO - 10.1016/j.jaip.2014.08.001

M3 - Article

VL - 2

SP - 768

EP - 774

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

SN - 2213-2198

IS - 6

ER -