title: The prevalence and pattern of pharmaceutical and excipient exposure in a neonatal unit in Slovenia.
abstract: OBJECTIVE
  Because of the restraints on conducting studies on pharmaceutical use in sick newborns, many drugs are used off-label in this population. Moreover, industrially manufactured pharmaceuticals may contain different excipients, which may be either untested or not licensed for use in neonates. The aim of our study was to determine the prevalence and pattern of pharmaceutical and excipient exposure in newborns hospitalized at the Department of Neonatology, Ljubljana, Slovenia.
  
  
  METHODS
  A longitudinal prospective cross-sectional study was performed during a one-month period and included all hospitalized neonates. Route of administration, site of action, type of manufacture, licensing status, type and concentrations of excipients for all pharmaceuticals given to the neonates were determined.
  
  
  RESULTS
  Twenty seven different pharmaceutical preparations were prescribed to a total of 48 hospitalized newborns. In most cases, newborns were prescribed various pharmaceuticals that were not approved for use in this population. Newborns were exposed to 60 different excipients in industrially manufactured pharmaceutical preparations. More than half of the received pharmaceuticals contained potentially harmful and harmful excipients.
  
  
  CONCLUSIONS
  Two-thirds of pharmaceutical preparations for neonates were used off-label. Newborns receive more auxiliary substances, which may be unsuitable for this age group and may even be toxic to them, via industrially manufactured pharmaceuticals.
authors.affiliation: a Department of Neonatology, Division of Pediatrics , University Medical Centre Ljubljana , Ljubljana , Slovenia .
authors.forename: Petja
authors.initials: P
authors.lastname: Fister
authors.affiliation: b Department of Pharmacy , University Medical Centre Ljubljana , Ljubljana , Slovenia , and.
authors.forename: Spela
authors.initials: S
authors.lastname: Urh
authors.affiliation: a Department of Neonatology, Division of Pediatrics , University Medical Centre Ljubljana , Ljubljana , Slovenia .
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Karner
authors.affiliation: c Faculty of Medicine , Institute of Pharmacology and Experimental Toxicology, University of Ljubljana , Ljubljana , Slovenia.
authors.forename: Mojca
authors.initials: M
authors.lastname: Krzan
authors.affiliation: a Department of Neonatology, Division of Pediatrics , University Medical Centre Ljubljana , Ljubljana , Slovenia .
authors.forename: Darja
authors.initials: D
authors.lastname: Paro-Panjan
mesh_terms: D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D005079:Excipients / Q000008:administration & dosage* / Q000633:toxicity; D005260:Female; D006760:Hospitalization; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D008137:Longitudinal Studies; D008297:Male; D009359:Neonatology; D056687:Off-Label Use; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010865:Pilot Projects; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D017524:Slovenia
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations
keywords: Additives; newborn; off-label use of medicinal preparations