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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

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Antibiotic use in children - off-label use

Walter Zingg1, Klara M Posfay-Barbe

  • 1Infection Control Program, University of Geneva Hospitals, 4 Rue Gabrielle Perret-Gentil, 1211 Geneva 14, Switzerland. walter.zingg@hcuge.ch

Current Drug Targets
|April 20, 2012
PubMed

Insights

Off-label antibiotic use in children is common due to development challenges and a lack of incentives for new drug formulations. Addressing these issues is crucial for combating rising multidrug-resistant pathogens in pediatric populations.

Area of Science:

  • Pediatric pharmacology
  • Infectious disease management
  • Drug development economics

Background:

  • Systemic antibiotics are frequently prescribed for pediatric patients.
  • Off-label antibiotic prescribing remains prevalent in both community and hospital settings for children.
  • Factors contributing to off-label use include patient age, incorrect dosage, and administration frequency.

Purpose of the Study:

  • To highlight the significant incentive gap hindering pediatric drug development, particularly for antibiotics.
  • To identify key challenges in developing and approving new antibiotic agents for pediatric use.
  • To underscore the implications of limited approved antibiotic options for children in the face of antimicrobial resistance.

Main Methods:

  • Review of existing literature on pediatric antibiotic use and drug development.
  • Analysis of economic and regulatory factors impacting pharmaceutical research for pediatric populations.
  • Examination of the complexities in pediatric drug formulation and clinical trial conduct.

Main Results:

  • A substantial incentive gap exists for pediatric antibiotic development, driven by small market size and a high prevalence of off-patent drug use.
  • Developing new antibiotics for children is complicated by physiological variations, the need for specific formulations (e.g., oral for neonates), and ethical considerations.
  • While older antibiotics are often labeled for pediatric use, newer agents like fluoroquinolones and azithromycin lack such approvals.

Conclusions:

  • The lack of approved indications for newer antibiotics in children poses a significant risk, especially with the rise of multidrug-resistant pathogens.
  • Addressing the economic and scientific barriers is essential to ensure appropriate and effective antibiotic treatment options for pediatric infections.
  • Further research and policy interventions are needed to incentivize the development and approval of novel antibiotics for the pediatric population.

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