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Potentially harmful excipients in neonatal medicines: a pan-European observational study
  1. Georgi Nellis1,2,
  2. Tuuli Metsvaht1,3,
  3. Heili Varendi2,
  4. Karolin Toompere4,
  5. Jana Lass1,5,
  6. Inge Mesek1,
  7. Anthony J Nunn6,
  8. Mark A Turner7,8,
  9. Irja Lutsar1
  10. on behalf of the ESNEE consortium
    1. 1Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia
    2. 2Neonatal Unit, Tartu University Hospital, Childreńs Clinic, Tartu, Tartumaa, Estonia
    3. 3Paediatric Intensive Care Unit, Tartu University Hospital, Clinic of Anaesthesiology and Intensive Care, Tartu, Tartumaa, Estonia
    4. 4Department of Public Health, Tartu University, Tartu, Tartumaa, Estonia
    5. 5Pharmacy Department, Tartu University Hospital, Tartu, Tartumaa, Estonia
    6. 6Alder Hey Children's NHS Foundation Trust, Liverpool, UK
    7. 7Neonatal Unit, Liverpool Women's Hospital, Liverpool, UK
    8. 8Institute of Translational Medicine, University of Liverpool, Liverpool, UK
    1. Correspondence to Dr Georgi Nellis, Neonatal Unit, Children's Clinic, Tartu University Hospital, N.Lunini 6, Tartu, Tartumaa 51014, Estonia; georgi.nellis{at}


    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.

    • Neonatology
    • Pharmacology

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