Trends in adverse events and related health-care facility utilization from cough and cold medication exposures in children

Introduction: Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children.

Methods: Data were collected from 2009 to 2016. Case eligibility included: age <12 years; exposure to an over-the-counter product containing ≥1 CCM pharmaceutical ingredient; ≥1 significant AE that occurred in the United States.

Results: About 4756 (72.6%) cases were determined at least potentially related to an index ingredient. Accidental unsupervised ingestions (AUIs; 3134; 65.9%) were the most common case type. Nearly half of AE cases involved children 2 to <4 years old (2,159; 45.4%). The AE case rate did not change significantly over time (p = 0.22). The proportion of AE cases resulting in HCF admission increased from 32.4% (207) in 2009 to 43.4% (238) in 2016 (p < 0.01). Exposures to diphenhydramine (1,305; 67.3%) and/or dextromethorphan (591; 30.5%) were involved in the majority of HCF admissions.

Conclusions: The proportion of AE cases resulting in HCF admission increased from 2009 to 2016. Efforts to prevent AUIs such as packaging innovation and engineering controls, particularly for diphenhydramine and dextromethorphan-containing products, should be pursued.

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Work Title Trends in adverse events and related health-care facility utilization from cough and cold medication exposures in children
Access
Open Access
Creators
  1. George Sam Wang
  2. Jody L. Green
  3. Kate M. Reynolds
  4. William Banner
  5. G. Randall Bond
  6. Ralph E. Kauffman
  7. Robert B. Palmer
  8. Ian M. Paul
  9. Malin Rapp-Olsson
  10. Richard C. Dart
Keyword
  1. Pediatric safety surveillance
  2. Cough/cold medication safety
  3. Trends
  4. Sales adjusted rates
  5. Medication safety
License In Copyright (Rights Reserved)
Work Type Article
Publisher
  1. Clinical Toxicology
Publication Date September 11, 2020
Publisher Identifier (DOI)
  1. https://doi.org/10.1080/15563650.2020.1815761
Deposited July 20, 2022

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Version 1
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  • Created

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added 2021_Cough_Cold_Adverse_Event_Trends_Clin_Tox.pdf

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator George Sam Wang

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Jody L. Green

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Kate M. Reynolds

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator William Banner

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator G. Randall Bond

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Ralph E. Kauffman

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Robert B. Palmer

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Ian M. Paul

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Malin Rapp-Olsson

    July 20, 2022 18:23 by Researcher Metadata Database

  • Added Creator Richard C. Dart

    July 20, 2022 18:23 by Researcher Metadata Database

  • Published

    July 20, 2022 18:23 by Researcher Metadata Database

  • Updated Keyword, Description, Publication Date Show Changes

    December 04, 2023 15:21 by avs5190

    Keyword
    • Pediatric safety surveillance, Cough/cold medication safety, Trends, Sales adjusted rates, Medication safety
    Description
    • <p>Introduction: Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children. Methods: Data were collected from 2009 to 2016. Case eligibility included: age &lt;12 years; exposure to an over-the-counter product containing ≥1 CCM pharmaceutical ingredient; ≥1 significant AE that occurred in the United States. Results: About 4756 (72.6%) cases were determined at least potentially related to an index ingredient. Accidental unsupervised ingestions (AUIs; 3134; 65.9%) were the most common case type. Nearly half of AE cases involved children 2 to &lt;4 years old (2,159; 45.4%). The AE case rate did not change significantly over time (p = 0.22). The proportion of AE cases resulting in HCF admission increased from 32.4% (207) in 2009 to 43.4% (238) in 2016 (p &lt; 0.01). Exposures to diphenhydramine (1,305; 67.3%) and/or dextromethorphan (591; 30.5%) were involved in the majority of HCF admissions. Conclusions: The proportion of AE cases resulting in HCF admission increased from 2009 to 2016. Efforts to prevent AUIs such as packaging innovation and engineering controls, particularly for diphenhydramine and dextromethorphan-containing products, should be pursued.</p>
    • Introduction: Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children.
    • Methods: Data were collected from 2009 to 2016. Case eligibility included: age &lt;12 years; exposure to an over-the-counter product containing ≥1 CCM pharmaceutical ingredient; ≥1 significant AE that occurred in the United States.
    • Results: About 4756 (72.6%) cases were determined at least potentially related to an index ingredient. Accidental unsupervised ingestions (AUIs; 3134; 65.9%) were the most common case type. Nearly half of AE cases involved children 2 to &lt;4 years old (2,159; 45.4%). The AE case rate did not change significantly over time (p = 0.22). The proportion of AE cases resulting in HCF admission increased from 32.4% (207) in 2009 to 43.4% (238) in 2016 (p &lt; 0.01). Exposures to diphenhydramine (1,305; 67.3%) and/or dextromethorphan (591; 30.5%) were involved in the majority of HCF admissions.
    • Conclusions: The proportion of AE cases resulting in HCF admission increased from 2009 to 2016. Efforts to prevent AUIs such as packaging innovation and engineering controls, particularly for diphenhydramine and dextromethorphan-containing products, should be pursued.
    Publication Date
    • 2021-01-01
    • 2020-09-11
  • Updated

    April 04, 2024 10:21 by [unknown user]