Journal ArticleDOI
Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety
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TLDR
The extent of paediatric unlicensed/off label use is higher in neonatal and paediatric intensive care units and oncology wards, compared with primary care, and future research should be directed towards the identification of individual drugs that cause serious adverse drug reactions and lack product information.Abstract:
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 treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in the systematic review. From the authors' analysis of the literature, the extent of paediatric unlicensed/off label use is higher in neonatal and paediatric intensive care units and oncology wards, compared with primary care. Moreover, among the nine studies reporting the contribution of an off-label/unlicensed drug use to the occurrence of adverse events, the percentage of unlicensed and/or off-label prescriptions involved in an adverse drug reaction ranged between 23 and 60%. To ensure that children are not exposed to unnecessary risks, controlled clinical trials are required. In addition, future research should be directed towards the identification of individual drugs that cause serious adverse drug reactions and lack product information.read more
Citations
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Journal ArticleDOI
The ontogeny of drug metabolism enzymes and implications for adverse drug events
TL;DR: An overview of DME developmental expression patterns is provided and some implications of the data with regards to drug therapy are discussed and common themes emerging from the current knowledge also will be discussed.
Journal ArticleDOI
Medication Use in the Neonatal Intensive Care Unit
Emily M. Hsieh,Emily M. Hsieh,Christoph P. Hornik,Reese H. Clark,Matthew M. Laughon,Daniel K. Benjamin,P. Brian Smith +6 more
TL;DR: Medication use in the NICU has changed substantially over time, and only 35% of the most commonly prescribed medications are Food and Drug Administration -approved in infants.
Journal ArticleDOI
Pediatric drug formulations: a review of challenges and progress
TL;DR: Five key issues need to be addressed to stimulate the further development of better medicines for children: the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries.
Journal ArticleDOI
Ontogeny of human hepatic cytochromes P450.
TL;DR: Substantial increases in expression are observed within the first 1–2 years after birth; however, considerable interindividual variability is observed in the immediate postnatal onset or increase in expression of these enzymes, often resulting in a window of hypervariability.
Journal ArticleDOI
Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations.
Fang Liu,Sejal R. Ranmal,Hannah Batchelor,Mine Orlu-Gul,Terry B. Ernest,Iwan W. Thomas,Talia Flanagan,Catherine Tuleu +7 more
TL;DR: A better understanding of the acceptability of existing formulations highlights opportunities for the development of new and more acceptable medicines and facilitates safe and effective prescribing for the young and older populations.
References
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Journal ArticleDOI
Survey of unlicensed and off label drug use in paediatric wards in European countries
Sharon Conroy,Imti Choonara,Piero Impicciatore,Angelika Mohn,Henrik Arnell,Anders Rane,Carmen Knoeppel,Hannsjoerg Seyberth,Chiara Pandolfini,Maria Pia Raffaelli,Francesca Rocchi,Maurizio Bonati,Geert W. ‘t Jong,Matthijs de Hoog,John N. van den Anker +14 more
TL;DR: The problem of off label and unlicensed drug prescribing in children is a European problem that requires European action and is likely to affect children throughout Europe.
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Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies.
Piero Impicciatore,Piero Impicciatore,Imti Choonara,Amanda Clarkson,Davide Provasi,Chiara Pandolfini,Maurizio Bonati +6 more
TL;DR: The results show that ADRs in children are a significant public health issue and methodologically sound drug surveillance studies are necessary for an effective promotion of a safer use of drugs in children.
Journal ArticleDOI
Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study
TL;DR: Use of drugs in an off‐label or unlicensed manner to treat children is widespread and ADRs are a significant problem following unlicensed or off-label drug prescriptions.
Journal ArticleDOI
Unlicensed and off label drug use in paediatric wards: prospective study
TL;DR: Children in hospital are often treated with drugs not specifically licensed for use in children (unlicensed), and drugs are also used outside the terms of the product licence that apply to indication, age, dose, or route of administration (off label prescribing).
Journal ArticleDOI
Unlicensed and off label drug use in neonates
TL;DR: In this paper, the extent of use of drugs that are either not licensed (unlicensed), or are outside the terms of their product licence (off label) in a neonatal intensive care unit was determined.