Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department

Hanna Phan, Marc Leder, Matthew Fishley, Matthew Moeller, Milap Nahata

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Objectives: The study objectives were to (1) determine the types and frequency of off-label (OL) or unlicensed (UL) medications used in a pediatric emergency department (PED) and before admission, (2) describe OL/UL-associated adverse drug events (ADEs) resulting in admission to the PED and those occurring during patient care in PED, and (3) determine the outcomes of these ADEs. Methods: Medical records of patients 18 years or younger admitted to the PED over a 5-month period were reviewed. Off-label/UL use of medications was determined based on Food and Drug Administration-approved labeling. The Adverse Drug Reaction Probability Scale was used to determine ADE causality. Data were analyzed using descriptive statistics. Results: A total of 2191 patients with 6675 medication orders were evaluated. About 26.2% (n = 1712) of medication orders were considered as OL/ UL use; 70.5% (n = 1208) of these medications were ordered as part of treatment in the PED, and the remaining 29.5% (n = 504) were home medications before their PED evaluation. Inhaled bronchodilators (30.4%), antimicrobials (14.8%), and antihistamines/antiemetics (9.1%) were the most common OL/UL medication classes. The frequency of ADEs among licensed medication use was greater compared with OL/UL use by 2-fold. Reported overall rate of ADEs was 0.6% (n = 40). Of these 40 ADEs, 5 resulted from the use of an OL/UL medication, 3 from home medication use, and 2 from PED-prescribed medications. Conclusions: The frequency of reported ADEs associated with OL/UL medications was less than the frequency of ADEs from licensed medication use, with overall ADE frequency of less than 1%.

Original languageEnglish (US)
Pages (from-to)424-430
Number of pages7
JournalPediatric Emergency Care
Volume26
Issue number6
DOIs
StatePublished - Jun 2010

Fingerprint

Drug-Related Side Effects and Adverse Reactions
Hospital Emergency Service
Pediatrics
Off-Label Use
Antiemetics
Histamine Antagonists
Bronchodilator Agents
United States Food and Drug Administration
Causality
Medical Records
Patient Care

Keywords

  • Adverse drug event
  • Off-label
  • Unlicensed

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Emergency Medicine
  • Medicine(all)

Cite this

Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department. / Phan, Hanna; Leder, Marc; Fishley, Matthew; Moeller, Matthew; Nahata, Milap.

In: Pediatric Emergency Care, Vol. 26, No. 6, 06.2010, p. 424-430.

Research output: Contribution to journalArticle

Phan, Hanna ; Leder, Marc ; Fishley, Matthew ; Moeller, Matthew ; Nahata, Milap. / Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department. In: Pediatric Emergency Care. 2010 ; Vol. 26, No. 6. pp. 424-430.
@article{a3e357e8bb774270947b1c5530e236b2,
title = "Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department",
abstract = "Objectives: The study objectives were to (1) determine the types and frequency of off-label (OL) or unlicensed (UL) medications used in a pediatric emergency department (PED) and before admission, (2) describe OL/UL-associated adverse drug events (ADEs) resulting in admission to the PED and those occurring during patient care in PED, and (3) determine the outcomes of these ADEs. Methods: Medical records of patients 18 years or younger admitted to the PED over a 5-month period were reviewed. Off-label/UL use of medications was determined based on Food and Drug Administration-approved labeling. The Adverse Drug Reaction Probability Scale was used to determine ADE causality. Data were analyzed using descriptive statistics. Results: A total of 2191 patients with 6675 medication orders were evaluated. About 26.2{\%} (n = 1712) of medication orders were considered as OL/ UL use; 70.5{\%} (n = 1208) of these medications were ordered as part of treatment in the PED, and the remaining 29.5{\%} (n = 504) were home medications before their PED evaluation. Inhaled bronchodilators (30.4{\%}), antimicrobials (14.8{\%}), and antihistamines/antiemetics (9.1{\%}) were the most common OL/UL medication classes. The frequency of ADEs among licensed medication use was greater compared with OL/UL use by 2-fold. Reported overall rate of ADEs was 0.6{\%} (n = 40). Of these 40 ADEs, 5 resulted from the use of an OL/UL medication, 3 from home medication use, and 2 from PED-prescribed medications. Conclusions: The frequency of reported ADEs associated with OL/UL medications was less than the frequency of ADEs from licensed medication use, with overall ADE frequency of less than 1{\%}.",
keywords = "Adverse drug event, Off-label, Unlicensed",
author = "Hanna Phan and Marc Leder and Matthew Fishley and Matthew Moeller and Milap Nahata",
year = "2010",
month = "6",
doi = "10.1097/PEC.0b013e3181e057e1",
language = "English (US)",
volume = "26",
pages = "424--430",
journal = "Pediatric Emergency Care",
issn = "0749-5161",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department

AU - Phan, Hanna

AU - Leder, Marc

AU - Fishley, Matthew

AU - Moeller, Matthew

AU - Nahata, Milap

PY - 2010/6

Y1 - 2010/6

N2 - Objectives: The study objectives were to (1) determine the types and frequency of off-label (OL) or unlicensed (UL) medications used in a pediatric emergency department (PED) and before admission, (2) describe OL/UL-associated adverse drug events (ADEs) resulting in admission to the PED and those occurring during patient care in PED, and (3) determine the outcomes of these ADEs. Methods: Medical records of patients 18 years or younger admitted to the PED over a 5-month period were reviewed. Off-label/UL use of medications was determined based on Food and Drug Administration-approved labeling. The Adverse Drug Reaction Probability Scale was used to determine ADE causality. Data were analyzed using descriptive statistics. Results: A total of 2191 patients with 6675 medication orders were evaluated. About 26.2% (n = 1712) of medication orders were considered as OL/ UL use; 70.5% (n = 1208) of these medications were ordered as part of treatment in the PED, and the remaining 29.5% (n = 504) were home medications before their PED evaluation. Inhaled bronchodilators (30.4%), antimicrobials (14.8%), and antihistamines/antiemetics (9.1%) were the most common OL/UL medication classes. The frequency of ADEs among licensed medication use was greater compared with OL/UL use by 2-fold. Reported overall rate of ADEs was 0.6% (n = 40). Of these 40 ADEs, 5 resulted from the use of an OL/UL medication, 3 from home medication use, and 2 from PED-prescribed medications. Conclusions: The frequency of reported ADEs associated with OL/UL medications was less than the frequency of ADEs from licensed medication use, with overall ADE frequency of less than 1%.

AB - Objectives: The study objectives were to (1) determine the types and frequency of off-label (OL) or unlicensed (UL) medications used in a pediatric emergency department (PED) and before admission, (2) describe OL/UL-associated adverse drug events (ADEs) resulting in admission to the PED and those occurring during patient care in PED, and (3) determine the outcomes of these ADEs. Methods: Medical records of patients 18 years or younger admitted to the PED over a 5-month period were reviewed. Off-label/UL use of medications was determined based on Food and Drug Administration-approved labeling. The Adverse Drug Reaction Probability Scale was used to determine ADE causality. Data were analyzed using descriptive statistics. Results: A total of 2191 patients with 6675 medication orders were evaluated. About 26.2% (n = 1712) of medication orders were considered as OL/ UL use; 70.5% (n = 1208) of these medications were ordered as part of treatment in the PED, and the remaining 29.5% (n = 504) were home medications before their PED evaluation. Inhaled bronchodilators (30.4%), antimicrobials (14.8%), and antihistamines/antiemetics (9.1%) were the most common OL/UL medication classes. The frequency of ADEs among licensed medication use was greater compared with OL/UL use by 2-fold. Reported overall rate of ADEs was 0.6% (n = 40). Of these 40 ADEs, 5 resulted from the use of an OL/UL medication, 3 from home medication use, and 2 from PED-prescribed medications. Conclusions: The frequency of reported ADEs associated with OL/UL medications was less than the frequency of ADEs from licensed medication use, with overall ADE frequency of less than 1%.

KW - Adverse drug event

KW - Off-label

KW - Unlicensed

UR - http://www.scopus.com/inward/record.url?scp=77953361267&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77953361267&partnerID=8YFLogxK

U2 - 10.1097/PEC.0b013e3181e057e1

DO - 10.1097/PEC.0b013e3181e057e1

M3 - Article

VL - 26

SP - 424

EP - 430

JO - Pediatric Emergency Care

JF - Pediatric Emergency Care

SN - 0749-5161

IS - 6

ER -