A review of excipient levels in paediatric intensive care unit (PICU) patients

Introduction: Most drugs cannot be delivered in isolation and therefore require excipients to ensure suitability of the dosage form. Excipients can cause unwanted effects; however the quantity of excipients in products is not commonly accounted for during prescribing. Paediatric patients are particularly vulnerable to the potential toxic effects of excipients, especially those in intensive care settings. The aim of this study was to identify and quantify the excipients included in the medications administered to a selection of patients from the Paediatric Intensive Care Unit (PICU) at Birmingham Children’s Hospital.
Materials & Methods Design: Data were collected from five randomly selected patients. Manufacturers were contacted to ascertain excipient quantities present. Setting: Paediatric Intensive Care Unit (PICU), Birmingham Children’s Hospital, UK.
Main outcome measures: Identity and quantity of excipients administered.
Results: In total, twenty-seven manufacturers were contacted, and two-thirds (67%, n = 18/27) responded to the information request. Overall (excluding intravenous fluids), the patients were taking 49 medicines; however, it was only possible to find out the details for all of the excipients present for 22% (n = 11/49) of products, with details for selected excipients provided for 31% (n = 15/49) of products. Although in-depth analysis of the excipients could not be carried out due to the limited response from the manufacturers, it was still evident that some patients were receiving potentially toxic excipient doses. For example, one multi-syndrome infant was receiving five times the WHO recommended maximum daily amount of propylene glycol a day, from one medicinal product.
Discussions, Conclusion: The lack of readily available information from manufacturers on excipients and their quantities is worrying. This small study has indicated that some paediatric patients receive potentially toxic levels of selected excipients. For example, excessive propylene glycol can cause ototoxicity, nephrotoxicity, lactic acidosis and seizure in children. Therefore, it is vital that excipients are monitored in PICU patients and information on excipient quantities should be readily available for practitioners to refer to when required.
Disclosure of Interest: None Declared.