Literature DB >> 19756556

Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis.

Antje Neubert1, Kristin Lukas, Thomas Leis, Harald Dormann, Kay Brune, Wolfgang Rascher.   

Abstract

PURPOSE: This study aims to describe the drug use on a Neonatal Intensive Care Unit (NICU) at a University Children's Hospital in Germany, to investigate the licensing status of the drugs used and to conclude critical areas in neonatal intensive care to support prioritisation of future research.
METHODS: An 11-month, prospective cohort study was conducted on the NICU at the University Children's Hospital Erlangen, Germany. All products prescribed during the study period were analysed whether or not the SPC contains information on term and preterm neonates.
RESULTS: A total of 183 patients (102 male) with a mean gestational age of 33.6 weeks (minimum = 24, maximum = 42) were included. The mean length of hospitalisation was 19.4 days (minimum = 2, maximum = 167). On average, patients received 11.1 drugs (minimum = 0, maximum = 46). The majority of prescriptions were accounted for by antibiotics (n = 515), which were received by 90% of all patients, followed by CNS drugs (n = 448) and respiratory drugs (n = 306). Of all the different drugs prescribed (n = 102) only 38% had information regarding their use in patients aged less than 1 month in their SPC. Analgesics and cardiovascular drugs were prescribed frequently, but without having information for use in neonates. Seventy percent of all patients and 100% of very preterm infants received at least one of these drugs.
CONCLUSIONS: Treatment strategies on a preterm intensive care unit are complex and little information is available for the drugs used. Analgesics and cardiovascular drugs are of major concern. Efforts will have to be made to conduct well-designed and powered studies in this vulnerable population.

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Year:  2009        PMID: 19756556     DOI: 10.1007/s00228-009-0722-8

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  22 in total

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5.  Unlicensed and off-label drug use in an Australian neonatal intensive care unit.

Authors:  Colm P F O'Donnell; Robyn J Stone; Colin J Morley
Journal:  Pediatrics       Date:  2002-11       Impact factor: 7.124

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Review 10.  Antibiotic regimens for suspected late onset sepsis in newborn infants.

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  30 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.  Drug utilisation profile in the neonatal unit of a university hospital: a prospective observational study in Brazil.

Authors:  Adriana Cristina de Souza Gonçalves; Adriano Max Moreira Reis; Ana Carolina Marçal Gusmão; Maria Cândida Ferrarez Bouzada
Journal:  Int J Clin Pharm       Date:  2015-04-02

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.  Ranitidine-induced Thrombocytopenia in a Neonate - A Case Report and Review of Literature.

Authors:  Levi Hoste; Isabel George
Journal:  J Pediatr Pharmacol Ther       Date:  2019 Jan-Feb

5.  Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine.

Authors:  Maher R Khdour; Hussein Othman Hallak; Kawther Shab'an Atallah Alayasa; Qusai Nabeel AlShahed; Ahmed F Hawwa; James C McElnay
Journal:  Int J Clin Pharm       Date:  2011-05-13

6.  Toxic excipients in medications for neonates in Brazil.

Authors:  Alcidésio Souza; Djanilson Santos; Said Fonseca; Marina Medeiros; Lívia Batista; Mark Turner; Helena Coelho
Journal:  Eur J Pediatr       Date:  2014-02-06       Impact factor: 3.183

Review 7.  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

8.  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

9.  Off-label use of antimicrobials in neonates in a tertiary children's hospital.

Authors:  Niina Laine; Ann Marie Kaukonen; Kalle Hoppu; Marja Airaksinen; Harri Saxen
Journal:  Eur J Clin Pharmacol       Date:  2017-01-18       Impact factor: 2.953

10.  Adverse Drug Reactions in Children: Pediatric Pharmacy and Drug Safety.

Authors:  Michael Rieder
Journal:  J Pediatr Pharmacol Ther       Date:  2019 Jan-Feb
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