Open Access Research article

Hospitalised neonates in Estonia commonly receive potentially harmful excipients

Jana Lass12*, Kaisa Naelapää3, Utpal Shah4, Ruth Käär5, Heili Varendi6, Mark A Turner78 and Irja Lutsar1

Author Affiliations

1 Institute of Microbiology, Tartu University, Tartu, Estonia

2 Pharmacy Department, Tartu University Hospital, Tartu, Estonia

3 Department of Pharmaceutics and Analytical Chemistry, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

4 Cheshire, Merseyside & North Wales LRN, Medicines for Children Research Network, Alder Hey Children's NHS Foundation Trust, Liverpool, UK

5 Tallinn Children’s Hospital, Tallinn, Estonia

6 Children’s Clinic, Estonia Neonatal Unit, Tartu University Hospital, Tartu, Estonia

7 University of Liverpool, Liverpool, UK

8 Neonatal Unit, Liverpool Women’s Hospital, Liverpool, UK

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BMC Pediatrics 2012, 12:136  doi:10.1186/1471-2431-12-136

Published: 29 August 2012

Abstract

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.

Keywords:
Harmful excipient; Neonate