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Paediatr Drugs. 2016 Jun;18(3):221-30. doi: 10.1007/s40272-016-0173-5.

Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates.

Author information

1
Institute of Microbiology, University of Tartu, Tartu, Estonia. georgi.nellis@kliinikum.ee.
2
Neonatal Unit, Children's Clinic, Tartu University Hospital, N. Lunini 6, Tartu, 51014, Estonia. georgi.nellis@kliinikum.ee.
3
Institute of Microbiology, University of Tartu, Tartu, Estonia.
4
Clinic of Anaesthesiology and Intensive Care, Paediatric Intensive Care Unit, Tartu University Hospital, Tartu, Estonia.
5
Neonatal Unit, Children's Clinic, Tartu University Hospital, N. Lunini 6, Tartu, 51014, Estonia.
6
Pharmacy Department, Tartu University Hospital, Tartu, Estonia.
7
Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
8
Neonatal Unit, Liverpool Women's Hospital, Liverpool, UK.
9
Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

Abstract

OBJECTIVES:

Our objectives were to explore the possibility of avoiding neonatal exposure to potentially harmful excipients of interest (EOI)-parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol and ethanol-through product substitution in Europe.

METHODS:

We performed a 3-day service evaluation survey and a 1-day point prevalence study in 20 and 21 European countries, respectively. Analysis included active pharmaceutical ingredients (APIs) used in ≥10 % of units. We calculated the potential reduction in number of products with EOI through substitution in three stages: (1) similar API and route of administration, (2) plus similar dosage form and (3) plus similar strength. The reduction of individual exposure was analysed according to the second-stage criteria.

RESULTS:

We identified 137 products for 25 APIs that contained EOI. Substitution with EOI-free product(s) was available for 88 % (n = 120), 66 % (n = 91) and 31 % (n = 42) of products according to the first-, second- and third-stage criteria, respectively. Overall, 456 (63 % of 726) neonates received products containing EOI. Substitution of the products that had alternatives with similar API and dosage form would reduce the number of exposed neonates from 456 to 257 (44 % reduction).

CONCLUSIONS:

EOI-free formulations are available for a substantial number of products currently used in European neonates. Replacement of only the most frequently used products may spare almost half of neonates from unnecessary exposure to EOI.

PMID:
27099961
DOI:
10.1007/s40272-016-0173-5
[Indexed for MEDLINE]

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