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.

RAAAF's office landscape The End of Sitting: Energy expenditure and temporary comfort when working in non-sitting postures.

An earlier study suggested that the activity-inviting office landscape called "The End of Sitting", designed by Rietveld Architecture Art Affordances (RAAAF), should be considered as an alternative working environment to prevent sedentary behavior. The End of Sitting lacks chairs and tables but consists instead of a myriad of sloped surfaces at different heights that afford workers to stand, lean or recline at different locations. In this study, we assessed the impact of four of its workspaces on physical intensity, temporary comfort and productivity of office work and compared the outcomes with sitting and standing behind a desk. Twenty-four participants worked for 10 minutes in each of the six test conditions. Energy expenditure, measured by indirect calorimetry, and heart rate were recorded. Questionnaires were used to assess the perceived comfort. The number of words found in the word search test was counted as a measure of productivity. The majority of The End of Sitting workspaces led to a significant increase in energy expenditure compared with sitting behind a desk (ps < .05). Average MET values ranged from 1.40 to 1.58 which is a modest rise in energy expenditure compared to sitting (1.32 METs) and not significantly different from standing (1.47 METs). The scores on the general comfort scale indicated that some workspaces were less comfortable than sitting (ps < .05), but the vast majority of participants reported that at least one of The End of Sitting workspaces was equally or more comfortable than sitting. No differences in productivity between the test conditions were found. Further long-term studies are required to assess the behavioral adaptations, productivity and the level of comfort when using The End of Sitting as a permanent office.

Paediatric Drug Development and Formulation Design-a European Perspective.

The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize "better" medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the "Guideline on the Pharmaceutical Development of Medicines for Paediatric Use." Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.