Background Hospitalized neonates receive the highest number of drugs compared to all other age groups, but consumption rates vary between studies depending on patient characteristics and local practices. There are no large-scale international studies on drug use in neonatal units. Objective We aimed to describe drug use in European neonatal units and characterize its associations with geographic region and gestational age. Setting A one-day point prevalence study was performed as part of the European Study of Neonatal Exposure to Excipients from January to June 2012. Method All neonatal prescriptions and demographic data were registered in a web-based database. The impact of gestational age and region on prescription rate were analysed with logistic regression. Main outcome measure The number and variety of drugs prescribed to hospitalized neonates in different gestational age groups and geographic regions. Results In total, 21 European countries with 89 neonatal units participated. Altogether 2173 prescriptions given to 726 neonates were registered. The 10 drugs with the highest prescription rate were multivitamins, vitamin D, caffeine, gentamicin, amino acids for parenteral nutrition, phytomenadione, ampicillin, benzylpenicillin, fat emulsion for parenteral nutrition and probiotics. The six most commonly prescribed ATC groups (alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous, respiratory and cardiovascular system) covered 98% of prescriptions. Gestational age significantly affected the use of all commonly used drug groups. Geographic region influenced the use of alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous and respiratory system drugs. Conclusion While gestational age-dependent differences in neonatal drug use were expected, regional variations (except for systemic anti-infectives) indicate a need for cooperation in developing harmonized evidence-based guidelines and suggest priorities for collaborative work.
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ESNEE consortium: Susan Graham (UK), Utpal Shah (UK), Hussain Mulla (UK), Hitesh Pandya (UK), James McElnay (UK), Jeff Millership (UK), Shirish Yakkundi (UK), Andre Rieutord (France), Thomas Storme (France), Pascal Vaconsin (France). All members of ESNEE designed the study and monitored data collection. We thank all national contact persons who provided lists of neonatal units and helped run the study in their own country: Bernhard Resch (Austria), Pieter De Cock (Belgium), Nelly Jekova (Bulgaria), Elisabeth Iyore (Denmark), Pascal Vaconsin (France), Kosmas Sarafidis (Greece), Aranka Vegso (Hungary), Noreen O’Callaghan (Ireland), Rocco Agostino (Italy), Daiga Kviluna (Latvia), Rasa Tameliene (Lithuania), Rene F. Kornelisse (Netherlands), Dag Bratlid (Norway), Almerinda Pereira (Portugal), Maria Livia Ognean (Romania), Milica Bajcetic (Serbia), Darja Paro (Slovenia), Elizabeth Valls (Spain), Per Nydert (Sweden), Hans Ulrich Bucher (Switzerland), Maria Cordina (Malta). We also thank local pharmacists for providing data on excipient content: Caroline Fonzo-Christe (Switzerland), Domenico Tarantino (Italy), Velina Grigorova (Bulgaria), Milica Baj-cetic (Serbia), Elizabeth Valss (Spain), Claudine Milstein (France), Jennifer Duncan (England), Sabina Zalar (Slovenia), Per Gustaf Hartvig Honoré (Denmark). We would like to express our gratitude to Hiie Soeorg for valuable statistical advice.
ESNEE was funded through ERA-NET PRIOMEDCHILD by the following national agencies: Medical Research Council from the UK, Estonian Research Council (IUT 34-24) from Estonia, Agence Nationale de la Recherche from France. The funders of the study had no role in study design, data collection, data analysis, data interpretation, writing of the report, or in the decision to submit the paper for publication.
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Ethics committees that approved the European Study of Neonatal Exposure to Excipients point prevalence study
Universitair Ziekenhuis Gent, Comissie voor Mediche Ethiek, Belgium.
Scientific Committee of each participating hospital in Greece.
Research Ethics Committee of the University of Tartu, Estonia.
Ethics Committee of the Semmelweis University Clinic, Hungary.
Ethics Committee of the National Maternity Hospital, Dublin Ireland.
Comitato di Bioetica della Provincia Romana del FBF, Italy.
Kauno Regioninis Biomedicininiu Tyrimu Etikos Komitetas, Lithuania.
University of Malta Research Ethics Committee—UREC, Malta.
Institutional Review Board of the Erasmus MC, the Netherlands.
Komisija Republike Slovenije Medicinsko Etiko, Slovenia.
Comite Etico de Investigacion Clinica de EUSCADI (CEIC-E), Spain.
Kantonale Ethikkomission Zürich, Switzerland.
NRES Committee East of England—Cambridge Central, National Ethics Service, UK; NHS/HSC.
Ethics Committee approval was not required in Austria, France, Portugal, Latvia, Serbia and Bulgaria.
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Mesek, I., Nellis, G., Lass, J. et al. Medicines prescription patterns in European neonatal units. Int J Clin Pharm 41, 1578–1591 (2019). https://doi.org/10.1007/s11096-019-00923-2