Neonates and medicines: a roadmap to further improve neonatal pharmaceutical care

摘要: The treatment of newborns with safe and effective medicines is critical importance for their outcome subsequent quality life. Despite this, it still a common practice to prescribe neonates outside the label, extrapolating from dosing regimens indications validated in older populations based on non-neonatal pathophysiology. In recent meta-analysis (2015) evaluating 829 (1994–2012) studies prescribing practices pediatric hospital care, off-label unlicensed prescriptions ranged 12 71 % 0.2 48 %. These authors hereby reconfirmed that (pre)term were most commonly exposed [12]. federal US legislation similar European initiatives have resulted relevant increase pharmacological children, significant label changes. Unfortunately, too few included drug changes specific neonates. To further illustrate there 406 (Food Drug Administration, 1997–2010), but only 23 drugs 11 labeled (e.g., linezolid, rocuronium, remifentanil, sevoflurane, stavudine, nevirapine) absence change was because unproven efficacy, despite fact these compounds paracetamol, caspofungin, valganciclovir) are likely [14]. This may largely reflect difficulties proof efficacy due heterogeneity patients, variability variables, uncertainty biomarkers, addition demonstrating safety (risk adverse events) improvements knowledge pharmacotherapy remain therapeutic orphans [2, 14]. this issue journal, Campino et al. report rate errors (calculation or accuracy) intravenous medicine preparations when performed either bedside 10 Spanish neonatal intensive care units (NICUs) pharmacy (HP) services. study group evaluated impact structured intervention (protocol standardization, education) number documented both calculation (1.35 0 %) accuracy (54.7 38.3 14.6 NICU HP, respectively) [6]. paper follows previous which described pre-intervention phase [5] illustrates potential preventive strategies extent errors. Development roadmap improve pharmaceutical should aim clinical pharmacology, pharmacy, approaches use pharmacovigilance [1]. Another keystone component such focus development, i.e., development driven by pathophysiology (Fig. 1). Communicated Patrick Van Reempts