Harmful excipients in medicines for neonates in Spain
Beatriz Garcia-Palop1, Emma Movilla Polanco2, Carmen Cañete Ramirez2
1Pharmacy Service, Vall d'Hebron University Hospital, Pº Vall d'Hebron 119-129, 08035, Barcelona, Spain. b.garcia.palop@gmail.com.
Insights
Many neonatal drugs contain harmful excipients, potentially exceeding safe adult intake levels. Healthcare providers must carefully consider excipient content when prescribing for neonates to ensure patient safety.
Area of Science:
- Neonatal pharmacology
- Drug safety evaluation
- Pediatric pharmacotherapy
Background:
- Neonates exhibit unique physiological responses to drug components compared to adults.
- Excipients deemed safe for adults may pose risks to neonates.
- Understanding drug composition is crucial for safe pediatric prescribing.
Purpose of the Study:
- To quantify harmful excipient content in medications used in neonatal intensive care units.
- To compare estimated neonatal excipient exposure with established adult Acceptable Daily Intakes (ADIs).
Main Methods:
- Comprehensive review of drugs listed in the neonatal treatment guide.
- Analysis of package inserts and summaries of product characteristics for harmful excipients (e.g., metabisulfite, sorbitol).
- Calculation of estimated neonatal excipient exposure based on minimum and maximum daily doses and comparison with adult ADIs.
Main Results:
- A significant proportion of neonatal formulations contain harmful excipients: 32% of intravenous and 62% of oral drugs.
- Quantitative analysis revealed that 25% of intravenous and 19% of oral drugs exceeded adult ADIs for harmful excipients.
Conclusions:
- Commonly prescribed neonatal medications may contain harmful excipients at levels exceeding adult safety thresholds.
- Clinicians require heightened awareness of excipient content to optimize neonatal treatment strategies.
- Further research into safer excipient alternatives for pediatric formulations is warranted.
Background:
Neonates may respond differently from adults to drug components. Hence, ingredients that seem safe in adults may not be safe in this age group.
Objective:
To 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.
Methods:
All 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.
Results:
In 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.
Conclusion:
Several 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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