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Potentially Harmful Excipients in Neonatal Medications: An Observational and Cross-Regional Comparison of Japan and Europe

Jumpei Saito, Miki Akabane, Yoichi Ishikawa, Hidefumi Nakamura and Akimasa Yamatani

Objectives: We aimed to examine the administration of eight potentially harmful excipients of interest (EOI), including paraben, polysorbate 80, propylene glycol, benzoate, saccharin sodium, sorbitol, ethanol, and benzalkonium chloride, to hospitalized neonates in Japan and to compare the frequency of exposure to these excipients with previously reported European data.
Methods: Data on all medicines administered to neonates during hospitalization between May 2014 and March 2018 along with patients’ demographic data were extracted from the patients’ medical records. Excipients were identified from the Summaries of Product Characteristics.
Results: For parenteral medications, the records showed 178,858 prescriptions for 292 products administered to 1895 neonates. The EOI were found in 31,978 (17.9%) prescriptions for a relatively small number of products (n=29; 9.9%) and were administered to 1,454 (76.7%) neonates. In the parenteral prescriptions, benzyl alcohol, found in 20 (69.0%) products administered to 884 (46.6%) neonates, was the most common EOI. In enteral prescriptions, saccharin, found in nine (36.0%) products administered to 137 (13.7%) neonates, was the most common EOI. EOI administration was most frequent for the extremely preterm group of neonates. There was no difference in the number of EOI-containing prescription medications between Japan and Europe. However, a pan-European study reported a larger number of EOI-containing prescriptions and EOI-exposed neonates (OR: 2.5, 95%CI: 2.3 to 2.8, OR: 2.1, 95% CI: 1.8 to 2.5, respectively).
Conclusions: Neonates admitted to our center received several potentially harmful pharmaceutical excipients as in the previously studied European centers, but the frequency of exposure was lower at our center. Administration of pharmaceutical products in powder form may have contributed to lowering EOI exposure at our center.