Background Excipients in drug formulations have been historically considered harmless to the patient. However, this may not be true when they are used in specific populations, for example paediatric or neonatal patients. Because of the immaturity of newborns’ metabolism, the continuous exposure can produce an accumulation of some excipients. In these cases, exceeding the acceptable daily intake (ADI) could induce some harmful effects.
Purpose Analyse the content of harmful excipients (HE) of the medications included in the hospital’s neonatal intensive care unit (NICU) treatment guide.
Elaborate educational material about different toxicities of HE in neonates, addressed to physicians and nurses of NICU.
Material and methods We conducted a bibliographic revision concerningt HE, their potential toxicity and if ADI was established in neonatology. With this information, we reviewed the summary of product characteristics (SmPC) of the pharmaceutical products (PP) and compounded preparations (CP) used in our NICU, to determine the qualitative and quantitative composition in HE.
Total daily excipient exposures, for each drug, were established by calculating the average amount of HE administered secondary to the recommended maximum daily drug doses for newborns that appears in Neofax (R).
Results Nine HE and their toxicities were considered and reviewed: benzoates, benzyl alcohol, aspartame, benzalkonium chloride, ethanol, polysorbate 80, propylene glycol, parahydroxybenzoates and sorbitol. Two-hundred and twenty-seven medicines (182 PP and 45 CP) were analysed. Of the PP, 52 contained at least one HE (28.6%) and in 13 of them (7%) the amount was greater than their ADI defined. The quantitative analysis was not possible with the SmPC in 28 of them. Of the CP, 17 (40%) had one or more HE but none exceeded the ADI recommended. Based on this information, we arranged a training session for prescribers and nurses, and leaflets with the reviewed medications, their toxicities and the qualitative and quantitative content in HE.
Conclusion Harmful excipients are frequently present in medications available in the NICU. Raising the awareness of healthcare professionals is important in order to choose, if it is possible, safer alternatives.
The quantitative composition in HE was lacking in some SmPC despite it being a requirement from the EMA. The development of paediatric medicines with appropriate excipients is necessary.
References and/or acknowledgements No conflict of interest.
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