Background Excipients are essential for many medicines. Some have been associated with significant consequences in neonates. We aimed to identify substitution possibilities among medicines used in European neonates in order to minimise the administration of potentially harmful excipients of interest (EOI).
Methods A 3-day survey recording all medicines prescribed to neonates was performed in European NICUs. Based on existing toxicity data in neonates the EOI included parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride. Opportunities for product substitution were defined as EOI-containing formulations for which an EOI-free product was reported in the survey with identical active pharmaceutical ingredient (API), galenic form and strength.
Results Of 31 invited European countries 20 with 115 NICUs responded. A total of 564 trade names (TN) with 53 APIs were used in more than 10% of units. EOI containing formulations (n = 151) were used for 31 APIs, found overall in 363 TNs. Compared to parenteral forms (50/199; 25%), enteral (83/130; 64%) and topical TNs (18/34; 53%) contained EOI more frequently (OR; 95% CI 5.3; 3.3–8.5 and 3.4; 1.6–7.1, respectively). An EOI free substitution was available for 31/50 parenteral (63%), 17/83 enteral (21%) and 3/18 topical (17%) TNs. Overall, 51/151 (34%) TNs with EOI could be replaced; substitution was possible in 92/151 (61%) of cases if the requirement for identical API strength was ignored.
Conclusions EOI-free formulations available on the European market could be used to reduce the number of TNs with EOI by at least a third.