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Hospitalised neonates in Estonia commonly receive potentially harmful excipients

BACKGROUND: Information on the neonatal exposure to excipients is limited. Our aim was to describe the extent of excipient intake by Estonian neonates; to classify the excipients according to potential neonatal toxicity and thereby to measure the extent of exposure of neonates to potentially harmful...

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Autores principales: Lass, Jana, Naelapää, Kaisa, Shah, Utpal, Käär, Ruth, Varendi, Heili, Turner, Mark A, Lutsar, Irja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3483231/
https://www.ncbi.nlm.nih.gov/pubmed/22931304
http://dx.doi.org/10.1186/1471-2431-12-136
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author Lass, Jana
Naelapää, Kaisa
Shah, Utpal
Käär, Ruth
Varendi, Heili
Turner, Mark A
Lutsar, Irja
author_facet Lass, Jana
Naelapää, Kaisa
Shah, Utpal
Käär, Ruth
Varendi, Heili
Turner, Mark A
Lutsar, Irja
author_sort Lass, Jana
collection PubMed
description BACKGROUND: Information on the neonatal exposure to excipients is limited. Our aim was to describe the extent of excipient intake by Estonian neonates; to classify the excipients according to potential neonatal toxicity and thereby to measure the extent of exposure of neonates to potentially harmful excipients. METHODS: A prospective cohort study that recorded all medicines prescribed to patients aged below 28 days admitted to Tartu University Hospital from 01.02-01.08 2008 and to Tallinn Children’s Hospital from 01.02- 01.08 2009 was conducted. Excipients were identified from Summaries of Product Characteristics and classified according to toxicity following a literature review. RESULTS: 1961 prescriptions comprising 107 medicines were written for 348/490 neonates admitted. A total of 123 excipients were found in 1620 (83%) prescriptions and 93 (87%) medicines. 47 (38%) of these excipients were classified as potentially or known to be harmful to neonates. Most neonates (97%) received at least one medicine (median number 2) with potentially or known to be harmful excipient. Parabens were the most commonly used known to be harmful excipients and sodium metabisulphite the most commonly used potentially harmful excipient, received by 343 (99%) and 297 (85%) of treated neonates, respectively. CONCLUSIONS: Hospitalised neonates in Estonia are commonly receiving a wide range of excipients with their medication. Quantitative information about excipients should be made available to pharmacists and neonatologists helping them to take into account excipient issues when selecting medicines and to monitor for adverse effects if administration of medicines containing excipients is unavoidable.
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spelling pubmed-34832312012-10-30 Hospitalised neonates in Estonia commonly receive potentially harmful excipients Lass, Jana Naelapää, Kaisa Shah, Utpal Käär, Ruth Varendi, Heili Turner, Mark A Lutsar, Irja BMC Pediatr Research Article BACKGROUND: Information on the neonatal exposure to excipients is limited. Our aim was to describe the extent of excipient intake by Estonian neonates; to classify the excipients according to potential neonatal toxicity and thereby to measure the extent of exposure of neonates to potentially harmful excipients. METHODS: A prospective cohort study that recorded all medicines prescribed to patients aged below 28 days admitted to Tartu University Hospital from 01.02-01.08 2008 and to Tallinn Children’s Hospital from 01.02- 01.08 2009 was conducted. Excipients were identified from Summaries of Product Characteristics and classified according to toxicity following a literature review. RESULTS: 1961 prescriptions comprising 107 medicines were written for 348/490 neonates admitted. A total of 123 excipients were found in 1620 (83%) prescriptions and 93 (87%) medicines. 47 (38%) of these excipients were classified as potentially or known to be harmful to neonates. Most neonates (97%) received at least one medicine (median number 2) with potentially or known to be harmful excipient. Parabens were the most commonly used known to be harmful excipients and sodium metabisulphite the most commonly used potentially harmful excipient, received by 343 (99%) and 297 (85%) of treated neonates, respectively. CONCLUSIONS: Hospitalised neonates in Estonia are commonly receiving a wide range of excipients with their medication. Quantitative information about excipients should be made available to pharmacists and neonatologists helping them to take into account excipient issues when selecting medicines and to monitor for adverse effects if administration of medicines containing excipients is unavoidable. BioMed Central 2012-08-29 /pmc/articles/PMC3483231/ /pubmed/22931304 http://dx.doi.org/10.1186/1471-2431-12-136 Text en Copyright ©2012 Lass et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Lass, Jana
Naelapää, Kaisa
Shah, Utpal
Käär, Ruth
Varendi, Heili
Turner, Mark A
Lutsar, Irja
Hospitalised neonates in Estonia commonly receive potentially harmful excipients
title Hospitalised neonates in Estonia commonly receive potentially harmful excipients
title_full Hospitalised neonates in Estonia commonly receive potentially harmful excipients
title_fullStr Hospitalised neonates in Estonia commonly receive potentially harmful excipients
title_full_unstemmed Hospitalised neonates in Estonia commonly receive potentially harmful excipients
title_short Hospitalised neonates in Estonia commonly receive potentially harmful excipients
title_sort hospitalised neonates in estonia commonly receive potentially harmful excipients
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3483231/
https://www.ncbi.nlm.nih.gov/pubmed/22931304
http://dx.doi.org/10.1186/1471-2431-12-136
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