Off-label use of prescription analgesics among hospitalized children in the United States.
analgesic medications
off-label drug use
pediatric therapeutics
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
28
08
2019
revised:
04
02
2020
accepted:
06
02
2020
pubmed:
27
2
2020
medline:
25
3
2021
entrez:
27
2
2020
Statut:
ppublish
Résumé
Analgesics are the most frequently administered medications among hospitalized children. However, current analgesic prescribing patterns have not been well defined among hospitalized children. In addition, it is unknown what proportion of prescription analgesics is approved for use in children and what proportion is used "off-label." Nationally representative data from 52 tertiary care children's hospitals in the Pediatric Health Information System were queried to determine prescribing rates of analgesic medications. We analyzed hospitalizations for children <18 years occurring between 1 April 2010 and 30 June 2018. Food and Drug Administration (FDA) drug labels were reviewed for pediatric information, and prescriptions were classified as on- or off-label based on age, route, and formulation. Among 4.9 million hospitalizations, 1.8 million (37.6%, 95% confidence interval [CI] = 37.6-37.7) were associated with use of a prescription analgesic. Overall, 36.7% (95% CI = 36.7-36.7) of hospitalizations included off-label analgesic therapy, with 26.4% (95% CI = 26.4-26.5) associated with two or more off-label analgesics. Off-label analgesic use was higher among hospitalizations in the intensive care unit (61.5%) or with an operating room procedure (92.8%). Rates of off-label prescribing increased with age, peaking at 50.5% for adolescents. Prescription analgesics administered most frequently were morphine, fentanyl, and ketorolac, with off-label use occurring in 24.5%, 23.1%, and 11.3% of hospitalizations, respectively. Over a third of pediatric hospitalizations were associated with the administration of prescription analgesics that have not been labeled for use in children. Our findings highlight the critical need to ensure that safe and effective analgesics are developed for children and that pediatric labeling is expanded for existing analgesics to inform treatment decisions.
Substances chimiques
Analgesics
0
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
474-481Informations de copyright
© 2020 John Wiley & Sons Ltd.
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