European Paediatric Formulation Initiative workshop report: Improving the administration of oral liquid medicines in paediatrics using dosing syringes and enteral accessories.

Accurate dosing of the right medicine to the right patient is a key element of safe and efficacious pharmacotherapy, yet prone to technical challenges and human error when dosing involves the administration of small volumes of liquid medicines. For this reason, the topic has gained increased attention over the last decade from multiple stakeholder parties e.g. academia, hospital pharmacy, the medical device and pharmaceutical industry, and regulatory agencies. It is now well acknowledged that spoons and cups are not suitable for the measurement of small volumes of oral liquid medicines and that syringes are a better alternative, but syringes for parenteral use should not be used for oral dosing in order to avoid accidental parenteral delivery of oral products. However, dosing accuracy of very small volumes of liquid medicines to young children, and especially pre-term neonates, is still not sufficiently ensured. A workshop was organised in 2018 by the European Paediatric Formulation Initiative to reflect on current status and challenges (first part) and possible strategies to improve the present situation (second part). A voting system (n = 24) was used to consider the most favourable solutions. The harmonisation and/or standardisation of the technical design of oral syringes (including e.g. female/male connection) was considered a key priority.

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Declaration of Competing Interest Rutger de Vries & Diana van Riet-Nales are members of the European Medicines Agency (EMA) Paediatric Committee (PDCO) Formulation Working Group (FWG). Diana van Riet-Nales is also member of the EMA Quality Working Party and the Dutch Medicines Evaluation Board (MEB) Committee on Clinical Practice. Diana van Riet-Nales was rapporteur for the EMA Guideline on pharmaceutical development of medicines for paediatric use, the reflection paper on the pharmaceutical development of medicines for use in the older population and the EMA Q&A on small volumes. She was a drafting group member of the Q&A on enteral feeding and the EMA guideline on drug device combination products. Rutger de Vries supported the work on the paediatric guideline. He was a member of the drafting group on the EMA Q&A for small volumes and enteral feeding. Jennifer Walsh, Esmerald Hermans, Gareth Hilton, Paul Blowers and Smita Salunke are members of the European Paediatric Formulation Initiative. This Workshop did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. None of the authors or speakers received any compensation or funding for the Workshop or manuscript publication.