title: Hospitalised neonates in Estonia commonly receive potentially harmful excipients.
abstract: BACKGROUND
  Information on the neonatal exposure to excipients is limited. Our aim was to describe the extent of excipient intake by Estonian neonates; to classify the excipients according to potential neonatal toxicity and thereby to measure the extent of exposure of neonates to potentially harmful excipients.
  
  
  METHODS
  A prospective cohort study that recorded all medicines prescribed to patients aged below 28 days admitted to Tartu University Hospital from 01.02-01.08 2008 and to Tallinn Children's Hospital from 01.02- 01.08 2009 was conducted. Excipients were identified from Summaries of Product Characteristics and classified according to toxicity following a literature review.
  
  
  RESULTS
  1961 prescriptions comprising 107 medicines were written for 348/490 neonates admitted. A total of 123 excipients were found in 1620 (83%) prescriptions and 93 (87%) medicines. 47 (38%) of these excipients were classified as potentially or known to be harmful to neonates. Most neonates (97%) received at least one medicine (median number 2) with potentially or known to be harmful excipient. Parabens were the most commonly used known to be harmful excipients and sodium metabisulphite the most commonly used potentially harmful excipient, received by 343 (99%) and 297 (85%) of treated neonates, respectively.
  
  
  CONCLUSIONS
  Hospitalised neonates in Estonia are commonly receiving a wide range of excipients with their medication. Quantitative information about excipients should be made available to pharmacists and neonatologists helping them to take into account excipient issues when selecting medicines and to monitor for adverse effects if administration of medicines containing excipients is unavoidable.
authors.affiliation: Institute of Microbiology, Tartu University, Tartu, Estonia. jana.lass@kliinikum.ee
authors.forename: Jana
authors.initials: J
authors.lastname: Lass
authors.forename: Kaisa
authors.initials: K
authors.lastname: Naelapää
authors.forename: Utpal
authors.initials: U
authors.lastname: Shah
authors.forename: Ruth
authors.initials: R
authors.lastname: Käär
authors.forename: Heili
authors.initials: H
authors.lastname: Varendi
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turner
authors.forename: Irja
authors.initials: I
authors.lastname: Lutsar
mesh_terms: D015331:Cohort Studies; D005079:Excipients / Q000633:toxicity*; D006760:Hospitalization; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000139:chemically induced; D011446:Prospective Studies
chemical_list: D005079:Excipients