ArticleBMC pediatrics2012
Hospitalised neonates in Estonia commonly receive potentially harmful excipients.
Article in BMC pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study.Therapeutic innovation & regulatory science · 2024Observational
- Development of a Hydroxypropyl-β-Cyclodextrin-Based Liquid Formulation for the Oral Administration of Propranolol in Pediatric Therapy.Pharmaceutics · 2023Article
- Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review.Pharmaceutics · 2023Review
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan.Journal of pharmaceutical health care and sciences · 2021Article
- High concentrations of urinary ethanol metabolites in neonatal intensive care unit infants.Pediatric research · 2020Article
- Pediatric Safety of Polysorbates in Drug Formulations.Children (Basel, Switzerland) · 2019Article
- A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia.European journal of hospital pharmacy : science and practice · 2018Article
- Excipient exposure in very low birth weight preterm neonates.Journal of perinatology : official journal of the California Perinatal Association · 2018Article
- Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.Pharmaceutical medicine · 2018Article
- Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates.Paediatric drugs · 2016Article
- Harmful excipients in medicines for neonates in Spain.International journal of clinical pharmacy · 2016Article
- Challenges Associated with Route of Administration in Neonatal Drug Delivery.Clinical pharmacokinetics · 2016Review
- Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study.BMC pediatrics · 2016Article
- Pharmacokinetics in neonatal prescribing: evidence base, paradigms and the future.British journal of clinical pharmacology · 2015Review
- Toxic excipients in medications for neonates in Brazil.European journal of pediatrics · 2014Article
- The use of ethanol in paediatric formulations in New Zealand.European journal of pediatrics · 2013Article
- Neonates need tailored drug formulations.World journal of clinical pediatrics · 2013Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundInformation 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.
methodsA 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.
results1961 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.
conclusionsHospitalised 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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