Massive presence of off‐label medicines in Danish neonatal departments: A nationwide survey using national hospital purchase data
C Gade, S Trolle, ML Mørk, A Lewis… - Pharmacology …, 2023 - Wiley Online Library
There is currently insufficient knowledge of gestational age dependent medicine disposition
in neonates. Accordingly, the use of off‐label medication, ie, use of medicines outside its …
in neonates. Accordingly, the use of off‐label medication, ie, use of medicines outside its …
Off‐label and unlicensed use of medicinal products in the neonatal setting in the Slovak Republic
J Schweigertova, A Durisova, D Dolnikova… - Pediatrics …, 2016 - Wiley Online Library
Background Frequent prescription of medication in an unapproved manner (off‐label or
unlicensed) in the neonatal setting is a result of the limited availability of adequately studied …
unlicensed) in the neonatal setting is a result of the limited availability of adequately studied …
[HTML][HTML] Drug utilisation and off-label use on a German neonatal intensive care unit: a retrospective cohort study and 10-year comparison
C Geißler, C Schulze, S Botzenhardt, W Rascher… - Pharmacy, 2020 - mdpi.com
Pharmacotherapy of neonates is complex and marked to a large extent of off-label use. The
implementation of the Paediatric Regulation (2007) gave hope for a change in the safety …
implementation of the Paediatric Regulation (2007) gave hope for a change in the safety …
Exploratory findings of prescribing unlicensed and off-label medicines among children and neonates
Objective A cross-sectional study was carried out to evaluate the practice of unlicensed and
off-label drug prescribing/dispensing in children and neonates by physicians and clinical …
off-label drug prescribing/dispensing in children and neonates by physicians and clinical …
Drug utilisation pattern and off-label use of medicines in Estonian neonatal units
J Lass, R Käär, K Jõgi, H Varendi, T Metsvaht… - European journal of …, 2011 - Springer
Objectives To characterise neonatal hospital drug use and to compare the availability of
drug information between Estonian Summaries of Product Characteristics (SPCs) and other …
drug information between Estonian Summaries of Product Characteristics (SPCs) and other …
Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society …
L Schrier, A Hadjipanayis, T Stiris… - European journal of …, 2020 - Springer
Health-care professionals who prescribe medicines have the professional duty to choose
medicines that are in the best interest of their individual patient, irrespective if that patient is …
medicines that are in the best interest of their individual patient, irrespective if that patient is …
Off-label drug in the newborn
L Cuzzolin - Journal of Pediatric and Neonatal Individualized …, 2014 - jpnim.com
The lack of specific drugs and labelling recommendations for the neonatal population is a
long-standing problem throughout the world. With the introduction of the Paediatric …
long-standing problem throughout the world. With the introduction of the Paediatric …
Unlicensed and off-label use of medicines at a neonatology clinic in Italy
M Dell'Aera, AR Gasbarro, M Padovano… - Pharmacy world & …, 2007 - Springer
Objective Many drugs used for children are not licensed or are used off-label. An increased
risk of medication errors and unexpected adverse drug reactions (ADR) associated with off …
risk of medication errors and unexpected adverse drug reactions (ADR) associated with off …
Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety
L Cuzzolin, A Atzei, V Fanos - Expert opinion on drug safety, 2006 - Taylor & Francis
This review aims to give an updated overview of the worldwide situation of off-label and
unlicensed drug use in the paediatric field, also taking into account the safety of this kind of …
unlicensed drug use in the paediatric field, also taking into account the safety of this kind of …
Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions: comparative regulation framework of off label prescriptions in …
B Guidi, A Parziale, L Nocco, A Maiese… - International journal of …, 2022 - Springer
Background Off-label uses of medicines are common in pediatrics. The literature reports that
at least one-third of children in hospital and up to 90% of newborns in neonatal intensive …
at least one-third of children in hospital and up to 90% of newborns in neonatal intensive …