Georgi Nellis1,2, Tuuli Metsvaht3,4, Heili Varendi5, Jana Lass6, Jennifer Duncan7, Anthony J Nunn7, Mark A Turner8,9, Irja Lutsar3. 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.
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.
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