Better medicines for neonates: Improving medicine development, testing, and prescribing

Area of Science:

• Neonatal pharmacology
• Clinical pharmacy
• Drug development

Background:

• Pharmacotherapy significantly impacts neonatal outcomes but its full health effects are underexplored.
• Current neonatal drug use often relies on off-label prescriptions, indicating a trial-and-error approach.
• A structured framework is needed to guide neonatal pharmacotherapy and improve patient care.

Purpose of the Study:

• To advocate for a structured approach in neonatal pharmacotherapy.
• To highlight the need for improved dose selection and outcome assessment tools.
• To emphasize the importance of considering neonatal-specific needs in future drug development.

Main Methods:

• Review of the current regulatory framework for drug development.
• Analysis of existing pharmacokinetic models for dose selection.
• Examination of ongoing drug repurposing projects for neonates.

Main Results:

• The current regulatory framework can guide structured reflection on neonatal pharmacotherapy.
• Pharmacokinetic models and long-term safety assessments are crucial for dose selection.
• Drug repurposing initiatives show potential for improving neonatal treatment options.

Conclusions:

• A structured, research-driven approach is essential to advance neonatal pharmacotherapy.
• Clinical researchers play a vital role in bridging knowledge gaps in neonatal drug use.
• Translating accumulated knowledge into improved prescribing practices is the ultimate goal.