Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates
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.
Nellis, G., Metsvaht, T., Varendi, H. et al. Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates. Pediatr Drugs 18, 221–230 (2016). https://doi.org/10.1007/s40272-016-0173-5