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Rigshospitalet - a part of Copenhagen University Hospital
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Potentially harmful excipients in neonatal medicines: a pan-European observational study

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  • Georgi Nellis
  • Tuuli Metsvaht
  • Heili Varendi
  • Karolin Toompere
  • Jana Lass
  • Inge Mesek
  • Anthony J Nunn
  • Mark A Turner
  • Irja Lutsar
  • ESNEE consortium (Elsebeth Iyore, member)
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OBJECTIVES: We aimed to describe administration of eight potentially harmful excipients of interest (EOI)-parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride-to hospitalised neonates in Europe and to identify risk factors for exposure.

METHODS: All medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis.

RESULTS: Overall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient.

CONCLUSIONS: European neonates receive a number of potentially harmful pharmaceutical excipients. Regional differences in EOI administration suggest that EOI-free products are available and provide the potential for substitution to avoid side effects of some excipients.

Original languageEnglish
JournalArchives of Disease in Childhood
Volume100
Issue number7
Pages (from-to)694-9
Number of pages6
ISSN0003-9888
DOIs
Publication statusPublished - Jul 2015

    Research areas

  • Drug Administration Schedule, Drug Prescriptions, Drug Substitution, Drug Utilization, Europe, Excipients, Gestational Age, Hospitalization, Humans, Infant, Newborn, Infant, Premature, Intensive Care Units, Neonatal, Risk Factors

ID: 46229299