Abstract

A focused reflection on rational medicines use in neonates is valuable and relevant, because indicators to assess rational medicines use are difficult to apply to neonates. Polypharmacy and exposure to antibiotics are common, while dosing regimens or clinical guidelines are only rarely supported by robust evidence in neonates. This is at least in part due to the extensive variability in pharmacokinetics and subsequent effects of medicines in neonates. Medicines utilization research informs us on trends, on between unit variability and on the impact of guideline implementation. We illustrate these aspects using data on drugs for gastroesophageal reflux, analgesics or anti-epileptic drugs. Areas for additional research are drug-related exposure during breastfeeding (exposure prediction) and how to assess safety (tools to assess seriousness, causality, and severity tailored to neonates) since both efficacy and safety determine rational drug use. To further improve rational medicines use, we need more data and tools to assess efficacy and safety in neonates. Moreover, we should facilitate access to such data, and explore strategies for effective implementation. This is because prescription practices are not only rational decisions, but also have psychosocial aspects that may guide clinicians to irrational practices, in part influenced by the psychosocial characteristics of this population.

Highlights

  • We should facilitate access to such data, and explore strategies for effective implementation. This is because prescription practices are rational decisions, and have psychosocial aspects that may guide clinicians to irrational practices, in part influenced by the psychosocial characteristics of this population

  • In the current narrative review, we focus on drug utilization of specific ATC groups, such as drugs for peptic ulcer and gastroesophageal reflux (Section 2.1), analgesics (Section 2.2) or anti-epileptics (Section 2.3), in neonates; drug utilization studies to illustrate how such studies can inform us on trends over time; between unit variability; and the impact of implementation of guidelines on drug utilization patterns

  • “We like to believe that decisions on medicines use in neonates are driven by rational processes, but we should explore the psychosocial aspects that guide our decisions.”

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Summary

Introduction

“Why a focused reflection on rational use of medicines in neonates is valuable and relevant.”. Quality (compare practices to guidelines and local drug formularies), patterns (extent or profiles of drug use and trends), outcomes (health outcomes and both benefits and adverse effects) or determinants (prescriber characteristics and impact of interventions) can still be explored as potential indicators of irrational practices [7,8] In this narrative review on rational medicines use in neonates, we highlight trends on anti-reflux drugs (Section 2.1), analgesics (Section 2.2) and anti-epileptics (Section 2.3) as Anatomical Therapeutic. Different approaches have been considered to proceed to better evidence and rational drug utilization These strategies included more advanced technology with bedside neuro-physiological monitoring (reduce the number of inaccurate diagnoses) instead of clinical observations based on motor or autonomic events, and strategies to reduce the mean phenobarbital burden and reduction in the incidence of AED exposure at discharge (reduce the duration of exposure in treated newborns) [29]. Better insights into the variety of mechanisms (asphyxia, infarction, channelopathies, and metabolic syndromes) involved in the “seizure phenotype” should enable us to shift from a “one drug fits all” approach to individualized pharmacotherapy (better mechanism driven medicine selection) [30]

Areas in Need of Research on Perinatal Drug Exposure
Findings
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