A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia

Abstract

BackgroundMedicines used in neonates contain different excipients, which may not be safe in this age group.ObjectiveTo analyse the frequency at which hospitalised neonates are exposed to harmful excipients (HEs) and to identify substitution possibilities for medicines containing HEs.Materials and methodsRetrospective, observational study at a university paediatric hospital from 1 September 2015 till 29 February 2016. All hospitalised neonates who received a prescription for medicines containing an HE were included. Neonates were divided into four groups according to gestational age (<28 weeks; 28 to <32 weeks; 32 to <37 weeks and ≥37 weeks). The following excipients were analysed: parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride. Excipients were identified from the Summaries of Product Characteristics.Results296 (102(34.5%) preterm) neonates included in the study received 1472 prescriptions for 106 medicines. The most often used formulations were intravenous (48/106; 45.3%) and oral solid formulations (20; 18.9%). The total number of different excipients was 169. In total, 29/106 (27.4%) medicines contained at least one HE. In total 82/102 (80.4%) preterm and 118/194 (60.8%) term neonates received medications with at least one HE. Substitution was possible for 9/29 (31.0%) HE-containing medicines.ConclusionsUse of HEs can be reduced by using HE-free products available on the European market. However, medicine substitution was possible in only a small number of cases. Therefore the main focus should be on information and education of the hospital specialists about HEs used in medicines and their adverse reactions.

The potentially harmful excipients in prescribed medications in a Neonatal Intensive Care Unit in Kosovo and available safer alternatives

“…Our study shows that while EOI were present in one-third of prescribed medications, approximately two-thirds of hospitalized neonates were exposed to at least one of these EOI. Generally, our data are in line with previous studies [15][16][17] , which also reported a small number of medications containing EOI, provided that in our study the frequency of exposure was higher, suggesting that a few, commonly prescribed medications cause a high frequency of EOI exposure and that substitution of this small portion of products containing EOI with EOI-free counterparts could spare a large number of neonates from exposure to these harmful excipients. 15,16,18 Our findings on the opportunities for products' substitution make this suggestion even more reasonable; we identified a relatively high possibility of products' substitution and demonstrated that substitution of products that had alternatives with the same API as well as dosage forms would significantly reduce the exposure to EOIcontaining prescriptions.…”

“…In our study, there were only two prescriptions for gentamicin injection, while this medicine accounted for the largest number of EOI-containing prescriptions in the Latvian study. 17 An important factor associated with EOI exposure was the route of administration. The main route of administration in hospitalized neonates is parenteral.…”

“…The excipient content of each prescribed medicine was identified from the SPC and/or manufacturers' websites. Our research, based on previous studies [15][16][17] , was focused on the EOI recognized as potentially harmful to neonates, namely benzalkonium chloride, benzyl alcohol, benzoic acid, sodium benzoate, ethyl-, methyl-, and propylparaben, ethanol, propylene glycol, polysorbate 80 saccharin sodium and sorbitol. 15…”

“…11 Unfortunately, the use of these potentially harmful excipients in medicine administered to neonates is not a rare case in practice, as demonstrated in some previous studies. [12][13][14][15][16][17] However, this issue remains largely unknown. On the other hand, according to a previous study 18 , exposure of neonates to these EOI could be reduced by using EOI-free formulations.…”

“…We are not aware of any study relating to EOI exposure among neonates in a European country that is not included in two previous European studies 15,18 on these topics. Given the need to reduce the prescription of EOI containing medications in the neonatal population and the lack of such studies in Kosovo, we aimed to investigate, based on a previous study 17 , the exposure to EOI among neonates admitted to a neonatal intensive care unit (NICU) in Kosovo and to identify substitution possibilities for medication containing these EOI.…”