ArticleInternational journal of clinical pharmacy2016
Harmful excipients in medicines for neonates in Spain.
Article in International journal of clinical pharmacy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 19 citations in OpenAlex.
- 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
- 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
- Therapeutic Drug Monitoring Is a Feasible Tool to Personalize Drug Administration in Neonates Using New Techniques: An Overview on the Pharmacokinetics and Pharmacodynamics in Neonatal Age.International journal of molecular sciences · 2020Review
- Benefits and Prerequisites Associated with the Adoption of Oral 3D-Printed Medicines for Pediatric Patients: A Focus Group Study among Healthcare Professionals.Pharmaceutics · 2020Article
- A Focus Group Study about Oral Drug Administration Practices at Hospital Wards-Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children.Pharmaceutics · 2020Article
- A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia.European journal of hospital pharmacy : science and practice · 2018Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNeonates may respond differently from adults to drug components. Hence, ingredients that seem safe in adults may not be safe in this age group.
objectiveTo describe the content of harmful excipients in drugs used in our neonatal wards and compare the daily dose a neonate may receive with the accepted daily intake (ADI) in adults.
methodsAll drugs included in the hospital's neonatal treatment guide were reviewed, using information from the package inserts or the summary of product characteristics. Those containing at least one harmful excipient (e.g., metabisulfite, sorbitol) were analyzed. Minimum and maximum usual daily drug doses were determined, and excipient exposure was estimated by extrapolation of the minimum and maximum of excipient referred to the active ingredient. These amounts were compared with ADIs for each excipient in adults.
resultsIn total, 32 % of intravenous and 62 % of oral formulations used in neonates contained at least one harmful excipient. On quantitative analysis, 25 % of intravenous and 19 % of oral drugs contained harmful excipients exceeding the ADI in adults.
conclusionSeveral drugs commonly used to treat neonates contain harmful excipients in amounts that may exceed the ADI in adults. Clinicians should be aware of this to prescribe appropriate treatment in this population.
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Registered trials
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