Allegaert Karel
Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Doctor Molenwaterplein 40, 3015 GD Rotterdam, The Netherlands.
Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000 Leuven, Belgium.
Healthcare (Basel). 2018 Sep 14;6(3):115. doi: 10.3390/healthcare6030115.
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.
对新生儿合理用药进行有针对性的思考是有价值且相关的，因为评估合理用药的指标很难应用于新生儿。联合用药和使用抗生素的情况很常见，而给药方案或临床指南在新生儿中很少有强有力的证据支持。这至少部分是由于新生儿药代动力学以及药物后续效应存在广泛变异性。药物利用研究为我们提供了有关趋势、单位间变异性以及指南实施影响方面的信息。我们使用有关胃食管反流药物、镇痛药或抗癫痫药物的数据来说明这些方面。母乳喂养期间与药物相关的暴露（暴露预测）以及如何评估安全性（针对新生儿量身定制的评估严重性、因果关系和严重程度的工具）是需要进一步研究的领域，因为疗效和安全性都决定了合理用药。为了进一步改善合理用药，我们需要更多数据和工具来评估新生儿的疗效和安全性。此外，我们应该促进获取此类数据，并探索有效实施的策略。这是因为处方行为不仅是理性决策，还具有社会心理方面的因素，这些因素可能会引导临床医生采取不合理的做法，部分原因是受该人群社会心理特征的影响。
