Abstract
Pharmacotherapy of neonates is complex and marked to a large extent of off-label use. The implementation of the Paediatric Regulation (2007) gave hope for a change in the safety and efficacy for drugs used in neonatal intensive care units (NICU). This study investigates drug utilisation patterns and off-label use in a German neonatal intensive care unit (NICU) in 2014. A 12-months retrospective, observational cohort study was performed at the NICU of the University Children’s Hospital Erlangen, Germany. Licensing status was determined using the Summary of Product Characteristics (SmPC). Results are compared with a similar study conducted 10 years earlier. The study included 204 patients (57.8% male) (2004: 183) and 2274 drug prescriptions were recorded (2004: 1978). The drugs that were mostly prescribed were drugs for the nervous system (2004: 22.6%; 2014: 26.9%) and anti-infectives for systemic use (2004: 26.0%; 2014: 24.9%);34.3% (2004) and 39.2% (2014) of all prescriptions were off-label;62.7% of all patients received at least one off-label or unlicensed drug (2004: 70%). For 13 drugs, the licensing status changed either from off-label to label (n = 9) or vice versa (n = 4). Overall, there was no significant change neither in terms of the drugs used nor regarding their licensing status. Further studies are needed to validate these findings in a European context.
Highlights
Pharmacological treatment of neonates is a complex process and requires considerable expertise in neonatology and pharmacology [1]
Previously published studies show lower numbers varying between 6.4 and 8.8 [3,16,17,18,19,20,21,22,23,24,25]. The reason for this might be that our neonatal intensive care unit (NICU) is part of a university hospital, which means that more patients with rare diseases and with conceivable difficult outcomes are treated and those patients need a more intensive pharmacotherapy and receive more drugs
This study provides a comprehensive overview of paediatric drug utilisation
Summary
Pharmacological treatment of neonates is a complex process and requires considerable expertise in neonatology and pharmacology [1]. Many organ functions such as the hepatic and renal metabolic and elimination capacity are not fully developed yet. In the neonatal intensive care unit (NICU) setting, this situation is even more complex due to severe diseases, a large amount of drugs prescribed and early gestational age with low birth weight [3,4]. Preterm neonates often require life support and suffer from organ immaturity. Term neonates on the ICU commonly suffer from congenital diseases and peri-/postnatal complications
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