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Educational paper: Do we need neonatal clinical pharmacologists?

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Abstract

Effective and safe drug administration in young infants should be based on integrated knowledge concerning the evolving physiological characteristics of the infant who will receive the drug and the pharmacokinetic and pharmacodynamic characteristics of a given drug. Consequently, clinical pharmacology in neonates is as dynamic and diverse as the neonates we are entitled to take care of. Even more than median estimates, covariates of variability within the population are of clinical relevance. We aim to illustrate the complexity and the need for neonatal clinical pharmacology based on the gap between current and likely best clinical practice for two commonly administered compounds (aminoglycosides for infection and ibuprofen for patent ductus arteriosus) and one new compound (bevacizumab, to treat threshold retinopathy of prematurity). Progression has been made to render pharmacokinetic studies child size, e.g., low volume samples, optimal study design, and population pharmacokinetics. Challenges to further improve clinical pharmacology in neonates include, when appropriate, the validation of off-patent drug dosing regimens and of infant-tailored formulations. Knowledge integration, i.e., the use of available data to improve current drug use and to predict pharmacokinetics/pharmacodynamics for similar compounds is needed. Development of clinical research networks is helpful to achieve these goals.

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Acknowledgments

Karel Allegaert is supported by the Fund for Scientific Research, Flanders (Belgium) (F.W.O. Vlaanderen) by a Fundamental Clinical Investigatorship (1800209N) and a research grant (1506409N). Jean-Paul Langhendries is supported partly by the FP5 grants QLRT-2001-00389 and QKL1-CT-2002-30582, the FP6 grant EARNEST Food-CT-2005-007036, and FP7 grants TINN (223614) and TINN2 (260908). Johannes van den Anker is supported in part by NIH grants (R01HD060543, K24DA027992, R01HD048689, U54HD071601) and FP7 grants TINN (223614), TINN2 (260908), and NEUROSIS (223060).

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Authors and Affiliations

  1. Neonatal Intensive Care Unit, Division of Woman and Child, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

    Karel Allegaert

  2. CHC-Site St Vincent, NICU, Rue François Lefèbvre 207, Liege-Rocourt, Belgium

    Jean Paul Langhendries

  3. Division of Pediatric Clinical Pharmacology, Children’s National Medical Center, Washington, D.C., USA

    John N. van den Anker

  4. Departments of Pediatrics, Pharmacology, Physiology and Integrative Systems Biology, George Washington University School of Medicine and Health Sciences, Washington, D.C., USA

    John N. van den Anker

  5. Intensive Care, Erasmus MC-Sophia Children’s Hospital, Rotterdam, the Netherlands

    John N. van den Anker

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  1. Karel Allegaert
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Correspondence to Karel Allegaert.

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Allegaert, K., Langhendries, J.P. & van den Anker, J.N. Educational paper: Do we need neonatal clinical pharmacologists?. Eur J Pediatr 172, 429–435 (2013). https://doi.org/10.1007/s00431-012-1734-4

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  • DOI: https://doi.org/10.1007/s00431-012-1734-4

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