Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data

Background: Unlicensed and off-label (UL/OL) prescriptions have been associated with an increased risk of drug-related problems. Data of their prevalence at hospital discharge remain insufficient. We aimed to describe the prevalence of UL/OL drugs in outpatient prescriptions at discharge in children...

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Main Authors: Elham Jaberi, Inesse Boussaha, Xavier Dode, Guillaume Grenet, Behrouz Kassai, Kim An Nguyen
Format: Article
Language:English
Published: MDPI AG 2024-01-01
Series:Healthcare
Subjects:
Online Access:https://www.mdpi.com/2227-9032/12/2/208
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author Elham Jaberi
Inesse Boussaha
Xavier Dode
Guillaume Grenet
Behrouz Kassai
Kim An Nguyen
author_facet Elham Jaberi
Inesse Boussaha
Xavier Dode
Guillaume Grenet
Behrouz Kassai
Kim An Nguyen
author_sort Elham Jaberi
collection DOAJ
description Background: Unlicensed and off-label (UL/OL) prescriptions have been associated with an increased risk of drug-related problems. Data of their prevalence at hospital discharge remain insufficient. We aimed to describe the prevalence of UL/OL drugs in outpatient prescriptions at discharge in children. Methods: We conducted a retrospective study using the routinely collected health data of children at discharge from 2014 to 2016. The primary reference source for determining licensed labelling was the summaries of product characteristics (SPCs) in a French industry-independent formulary named Thériaque. We described the characteristics of UL/OL prescriptions at discharge and looked for predictors of UL/OL prescriptions. Results: We included 2536 prescriptions of 479 children. Licensed, OL, and UL prescriptions accounted for 58.6% (95% CI: 56.7–60.5), 39.2% (95% CI: 37.3–41.1), and 2.3% (95% CI: 1.7–2.9), respectively. A total of 323 (74%) children received at least one UL/OL drug. Among the licensed drugs, bronchodilators (8.8%) and analgesics (8.6%), and among the OL drugs, antibiotics (2.8%), were the most prescribed. The younger age of the children and higher number of drugs they received increased the probability of UL/OL prescriptions (unadjusted <i>p</i>-value of ≤0.05). Conclusion: The prevalence of UL/OL prescriptions is about 40% at discharge from a pediatric university hospital in France.
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spelling doaj.art-0417af7b50124bdcb84e5ea47c3dfd912024-01-26T16:46:08ZengMDPI AGHealthcare2227-90322024-01-0112220810.3390/healthcare12020208Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health DataElham Jaberi0Inesse Boussaha1Xavier Dode2Guillaume Grenet3Behrouz Kassai4Kim An Nguyen5UMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, CEDEX 08, F-69376 Lyon, FranceDepartment of Clinical Epidemiology, Hospices Civils de Lyon, CIC 1407 de Lyon, Inserm, CHU-Lyon, F-69677 Bron, FrancePharmacy Department, Hospices Civils de Lyon University Hospital, F-69002 Lyon, FranceUMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, CEDEX 08, F-69376 Lyon, FranceUMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, CEDEX 08, F-69376 Lyon, FranceUMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, CEDEX 08, F-69376 Lyon, FranceBackground: Unlicensed and off-label (UL/OL) prescriptions have been associated with an increased risk of drug-related problems. Data of their prevalence at hospital discharge remain insufficient. We aimed to describe the prevalence of UL/OL drugs in outpatient prescriptions at discharge in children. Methods: We conducted a retrospective study using the routinely collected health data of children at discharge from 2014 to 2016. The primary reference source for determining licensed labelling was the summaries of product characteristics (SPCs) in a French industry-independent formulary named Thériaque. We described the characteristics of UL/OL prescriptions at discharge and looked for predictors of UL/OL prescriptions. Results: We included 2536 prescriptions of 479 children. Licensed, OL, and UL prescriptions accounted for 58.6% (95% CI: 56.7–60.5), 39.2% (95% CI: 37.3–41.1), and 2.3% (95% CI: 1.7–2.9), respectively. A total of 323 (74%) children received at least one UL/OL drug. Among the licensed drugs, bronchodilators (8.8%) and analgesics (8.6%), and among the OL drugs, antibiotics (2.8%), were the most prescribed. The younger age of the children and higher number of drugs they received increased the probability of UL/OL prescriptions (unadjusted <i>p</i>-value of ≤0.05). Conclusion: The prevalence of UL/OL prescriptions is about 40% at discharge from a pediatric university hospital in France.https://www.mdpi.com/2227-9032/12/2/208childrendrug prescriptiondischargeunlicensedoff-label
spellingShingle Elham Jaberi
Inesse Boussaha
Xavier Dode
Guillaume Grenet
Behrouz Kassai
Kim An Nguyen
Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data
Healthcare
children
drug prescription
discharge
unlicensed
off-label
title Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data
title_full Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data
title_fullStr Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data
title_full_unstemmed Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data
title_short Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data
title_sort unlicensed off label drug prescriptions at hospital discharge in children an observational study using routinely collected health data
topic children
drug prescription
discharge
unlicensed
off-label
url https://www.mdpi.com/2227-9032/12/2/208
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