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Arch Dis Child. 2015 Jul;100(7):694-9. doi: 10.1136/archdischild-2014-307793. Epub 2015 Apr 8.

Potentially harmful excipients in neonatal medicines: a pan-European observational study.

Author information

1
Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia Neonatal Unit, Tartu University Hospital, Childreńs Clinic, Tartu, Tartumaa, Estonia.
2
Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia Paediatric Intensive Care Unit, Tartu University Hospital, Clinic of Anaesthesiology and Intensive Care, Tartu, Tartumaa, Estonia.
3
Neonatal Unit, Tartu University Hospital, Childreńs Clinic, Tartu, Tartumaa, Estonia.
4
Department of Public Health, Tartu University, Tartu, Tartumaa, Estonia.
5
Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia Pharmacy Department, Tartu University Hospital, Tartu, Tartumaa, Estonia.
6
Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia.
7
Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
8
Neonatal Unit, Liverpool Women's Hospital, Liverpool, UK Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

Abstract

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.

KEYWORDS:

Neonatology; Pharmacology

[Indexed for MEDLINE]

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