title: Unlicensed and off-label drug use in an Irish neonatal intensive care unit: a prospective cohort study.
abstract: OBJECTIVE
  Many drugs are not licensed for use in children and drugs that are licensed may be given to them in an unapproved manner. We wanted to determine the extent of unlicensed and off-label prescribing in our neonatal intensive care unit (NICU).
  
  
  METHODS
  All infants admitted to our tertiary-level NICU over 2 months were prospectively studied. We recorded demographic data, and all the drugs prescribed and compared the use of each drug to the licensed indications in the Summary of Product Characteristics.
  
  
  RESULTS
  All the 110 infants admitted received a prescribed drug, with 69 different drugs prescribed, a median (IQR) of four (range: 3-11) drugs each. Just less than a fifth (19%) were unlicensed and 39% were off-label, with 45 infants (44%) receiving both an unlicensed and off-label drug, three (3%) receiving an unlicensed drug and 35 (32%) receiving just an off-label drug. Most infants <32 weeks received unlicensed (91%) and off-label (94%) drugs, and all infants <28 weeks received an unlicensed and an off-label drug.
  
  
  CONCLUSIONS
  Most drugs prescribed to newborns are unlicensed or used for off-label reasons. Many infants, and the majority of preterm infants, admitted to our NICU received unlicensed and off-label drugs.
authors.affiliation: Department of Neonatology, The National Maternity Hospital, Dublin, Ireland; National Children's Research Centre, Dublin, Ireland; School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.
authors.forename: Emily A
authors.initials: EA
authors.lastname: Kieran
authors.forename: Noreen
authors.initials: N
authors.lastname: O'Callaghan
authors.forename: Colm P F
authors.initials: CP
authors.lastname: O'Donnell
mesh_terms: D015331:Cohort Studies; D017277:Drug Approval; D004363:Drug Utilization / Q000706:statistics & numerical data*; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007494:Ireland; D056687:Off-Label Use / Q000706:statistics & numerical data*; D011446:Prospective Studies
keywords: Drug; Infant; Neonatal Intensive Care Unit; Newborn; Off-label; Unlicensed