Literature DB >> 20140705

Drug treatments in a neonatal setting: focus on the off-label use in the first month of life.

Angelica Dessì1, Claudia Salemi, Vassilios Fanos, Laura Cuzzolin.   

Abstract

OBJECTIVE: The purpose of this work was to analyse drugs prescribed in the first month of life among a group of newborns admitted to the Neonatal Intensive Care Unit and Neonatal Pathology of Cagliari University Hospital.
METHOD: This pilot study was prospectively conducted during a 1-month period and involved all newborns admitted to our hospital that received a pharmacotherapy. After obtaining written parental consent, data collected from each newborn included date of birth, sex, gestational age and weight. Also, diagnosis and information about each drug administered during the first month of life: dose, frequency, route of administration, and indication for use was collected.
RESULTS: Among the 79 newborn infants admitted to our hospital during the study period, 38 received a pharmacotherapy and were enrolled in our study. A total of 88 treatments were given: 41 (47%) followed the terms of the product license, 47 (53%) were used in an unlicensed or off-label manner.
CONCLUSION: Our results confirm this trend of drug use in the neonatological field and suggest the need to update information contained in the data sheets of medicines.

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Year:  2010        PMID: 20140705     DOI: 10.1007/s11096-009-9356-2

Source DB:  PubMed          Journal:  Pharm World Sci        ISSN: 0928-1231


  10 in total

Review 1.  Unlicensed and off-label drug use in children: implications for safety.

Authors:  Imti Choonara; Sharon Conroy
Journal:  Drug Saf       Date:  2002       Impact factor: 5.606

2.  Unlicensed and off label drug use in neonates.

Authors:  S Conroy; J McIntyre; I Choonara
Journal:  Arch Dis Child Fetal Neonatal Ed       Date:  1999-03       Impact factor: 5.747

3.  Unlicensed and off-label drug use in a Swiss paediatric university hospital.

Authors:  Ermindo R Di Paolo; Hans Stoetter; Jacques Cotting; Peter Frey; Mario Gehri; Maja Beck-Popovic; Jean-François Tolsa; Sergio Fanconi; André Pannatier
Journal:  Swiss Med Wkly       Date:  2006-04-01       Impact factor: 2.193

4.  Effects of inhaled formoterol compared with salbutamol in ventilated preterm infants.

Authors:  E Rieger-Fackeldey; D Reinhardt; A Schulze
Journal:  Pulm Pharmacol Ther       Date:  2004       Impact factor: 3.410

Review 5.  The use of unlicensed and off-label medicines in the neonate.

Authors:  Sharon Conroy; John McIntyre
Journal:  Semin Fetal Neonatal Med       Date:  2005-01-25       Impact factor: 3.926

Review 6.  Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety.

Authors:  Laura Cuzzolin; Alessandra Atzei; Vassilios Fanos
Journal:  Expert Opin Drug Saf       Date:  2006-09       Impact factor: 4.250

7.  Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years.

Authors:  A Ceci; M Felisi; P Baiardi; F Bonifazi; M Catapano; C Giaquinto; A Nicolosi; M Sturkenboom; A Neubert; I Wong
Journal:  Eur J Clin Pharmacol       Date:  2006-10-05       Impact factor: 2.953

8.  Unlicensed and off-label use of medicines at a neonatology clinic in Italy.

Authors:  Maria Dell'Aera; Anna Rita Gasbarro; Margherita Padovano; Nicola Laforgia; Donatella Capodiferro; Biagio Solarino; Roberto Quaranta; Alessandro S Dell'Erba
Journal:  Pharm World Sci       Date:  2007-03-10

Review 9.  Research in children.

Authors:  Jeffrey P Burns
Journal:  Crit Care Med       Date:  2003-03       Impact factor: 7.598

Review 10.  Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies.

Authors:  P Impicciatore; I Choonara; A Clarkson; D Provasi; C Pandolfini; M Bonati
Journal:  Br J Clin Pharmacol       Date:  2001-07       Impact factor: 4.335

  10 in total
  13 in total

1.  Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study.

Authors:  Laura Cuzzolin; Rocco Agostino
Journal:  Eur J Clin Pharmacol       Date:  2016-01       Impact factor: 2.953

2.  Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia.

Authors:  Jian Lynn Lee; Adyani Md Redzuan; Noraida Mohamed Shah
Journal:  Int J Clin Pharm       Date:  2013-12

Review 3.  Two decades of off-label prescribing in children: a literature review.

Authors:  Shamala Balan; Mohamed Azmi Ahmad Hassali; Vivienne S L Mak
Journal:  World J Pediatr       Date:  2018-09-14       Impact factor: 2.764

4.  Clinical pharmacological studies in children: From exploratory towards confirmation driven methodology.

Authors:  Karel Allegaert
Journal:  World J Clin Pediatr       Date:  2012-08-08

5.  Neonates need tailored drug formulations.

Authors:  Karel Allegaert
Journal:  World J Clin Pediatr       Date:  2013-02-08

Review 6.  Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.

Authors:  Joana Magalhães; António Teixeira Rodrigues; Fátima Roque; Adolfo Figueiras; Amílcar Falcão; Maria Teresa Herdeiro
Journal:  Eur J Clin Pharmacol       Date:  2014-10-16       Impact factor: 2.953

7.  Drug utilisation pattern and off-label use of medicines in Estonian neonatal units.

Authors:  Jana Lass; Ruth Käär; Kaarin Jõgi; Heili Varendi; Tuuli Metsvaht; Irja Lutsar
Journal:  Eur J Clin Pharmacol       Date:  2011-06-11       Impact factor: 2.953

8.  Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.

Authors:  Lise Aagaard; Ebba Holme Hansen
Journal:  Br J Clin Pharmacol       Date:  2011-05       Impact factor: 4.335

Review 9.  Drug-induced renal damage in preterm neonates: state of the art and methods for early detection.

Authors:  Anna Girardi; Emanuel Raschi; Silvia Galletti; Elisabetta Poluzzi; Giacomo Faldella; Karel Allegaert; Fabrizio De Ponti
Journal:  Drug Saf       Date:  2015-06       Impact factor: 5.606

10.  Prescription of off-label and unlicensed drugs for preterm infants in a neonatal intensive care unit.

Authors:  Verônica Cheles Vieira; Renart Santos Costa; Raquel Cristina Gomes Lima; Daiane Borges Queiroz; Danielle Souto de Medeiros
Journal:  Rev Bras Ter Intensiva       Date:  2021 Apr-Jun
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