title: Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis.
abstract: OBJECTIVE
  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.
authors.affiliation: Centre for Paediatric Pharmacy Research, The School of Pharmacy and Institute of Child Health, University of London, London, UK. antje.neubert@pharmacy.ac.uk
authors.forename: Antje
authors.initials: A
authors.lastname: Neubert
authors.forename: Kristin
authors.initials: K
authors.lastname: Lukas
authors.forename: Thomas
authors.initials: T
authors.lastname: Leis
authors.forename: Harald
authors.initials: H
authors.lastname: Dormann
authors.forename: Kay
authors.initials: K
authors.lastname: Brune
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rascher
mesh_terms: D017277:Drug Approval; D004348:Drug Labeling; D004363:Drug Utilization; D005260:Female; D005858:Germany; D006760:Hospitalization; D006776:Hospitals, Pediatric; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay; D008297:Male; D056687:Off-Label Use; D011446:Prospective Studies