Rational Use of Medicines in Neonates: Current Observations, Areas for Research and Perspectives.

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.