5PSQ-124 Exceeding safe excipient limits in neonatology unit medications: a call for safer pharmaceutical alternatives

<h3>Background and Importance</h3> Excipients in drug formulations have been historically considered harmless. However, due to the immaturity of newborns’ metabolism, continuous exposure to certain excipients can lead to accumulation. In these cases, exceeding the accepted daily intake (ADI) could result in harmful effects. Periodic reviews of pharmaceutical specialties (PS) are necessary to detect such risk. <h3>Aim and Objectives</h3> Analyse the presence of harmful excipients (HE) in PS used in neonatology unit (NICU) and propose safer alternatives for those that exceed ADI. <h3>Material and Methods</h3> Descriptive observational study of the PS consumed in the NICU over last 6 months excluding pharmaceutical compounding (PC). Eight HE were considered based on literature: benzoates, benzyl alcohol, benzalkonium chloride, ethanol, polysorbate 80, propylenglycol, parabens and sorbitol. Summary of product characteristics (SmPC) was reviewed to determine the qualitative and quantitative composition. To assess whether the quantitative composition exceeded ADI, we extrapolated excipient exposure based on the maximum usual daily drug doses. Safer alternative PSs were sought for those that exceeded ADI. <h3>Results</h3> Seventy-six PSs were analysed. The routes of administration included: 44 parenteral, 18 oral, 7 topical, 5 ocular, 1 inhalation and 1 endotracheal. SmPC were available for 75 PSs. Nineteen PSs (25%) contained at least one HE: 14PSs contained 1HE, 3PS contained 2HEs and 2PS contained 3HEs. Among the detected HEs: 6PSs contained ethanol, 5 propylenglycol, 5 parabens, 3 benzyl alcohol, 3 benzoates, 2 benzalkonium chloride, 2 sorbitol and none contained polysorbate 80. Of the 19 PSs, 13 contained HEs quantities that exceeded ADI, and 1 PS did not provide quantitative excipient composition. For these 13 PSs, safer alternatives were sought: 5PSs were replaced with commercial alternatives, 2 PSs were replaced by PC and 6 PSs no alternative was available. <h3>Conclusion and Relevance</h3> Neonates are frequently exposed to HEs. Some prescribed drugs exceeding ADI, and in some cases, these drugs could be administered simultaneously. Detecting the presence of HEs in medications used in NICU is critical for selecting the safer options. However, composition in HE was missing in some SmPC, despite being required by the EMA, and in some instances, no safer alternatives were available. The development of paediatric medicines with appropriate excipients is necessary. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest