Navigating the complexities of medicating paediatric patients: Insights from an enteral feeding tube workshop.

Enteral feeding tubes (EFT) are used to administer nutrition into the gastrointestinal tract of patients who are unable to take nutrition via mouth. A wide range of children may require enteral feeding through EFT which are also used to administer medication. However, many medicines are not licensed for administration via this route. Numerous factors can impact EFT medicine administration, including for example, dosage form properties and composition, EFT size, design and material, and operational aspects such as tube flushing. As a result, the risk of sub-optimal dosing and medication error is much higher in patients with EFT compared to those without. EuPFI organised a preconference workshop to review the current state of knowledge around aspects to be considered in the verification of EFT administration of medications to children, and considerations for EFT use, and to highlight the areas that remain challenging. Healthcare professional, pharmaceutical industry and regulatory agency perspectives were shared, and case studies discussed. It was agreed that simple and clear standardised global procedures are required for the evaluation and administration of medicines via EFT, and collaboration between all key stakeholders is recommended.

Putting children first: Understanding caregivers' and children's perspectives on the usability of oral and respiratory administration devices for paediatric medication.

A multi-national online survey was developed to obtain feedback on users' experiences of administration devices for oral and inhaled paediatric medicines. The questionnaire was divided into two identical parts: 1) for caregivers looking after children aged 0-18 years, and 2) for children aged 10 years and above, with parental consent. Each part of the questionnaire consisted of a section regarding oral devices and the other about respiratory devices. All data were anonymous and handled and stored in compliance with GDPR. Ethics approval (REC4612-016) was obtained. The study involved eight countries: Albania, Italy, Israel, the Netherlands, Romania, Spain, UK, and USA. A total of 206 adults and 43 children agreed to take part in the survey. Oral dosage forms were more used than inhaled medicines. For oral liquid medicines, oral syringe was the device mostly used by European and Israeli participants. Measuring spoon was the second most common device used, and was also often used in the USA. For respiratory devices, manually actuated and breath actuated metered dose inhalers were the most common everywhere. All devices were deemed easy to use by most of respondents and instructions clear. However, a recurrent suggestion was to simplify device instructions by adding explanatory images and to summarise or highlight key points. Moreover, respondents proposed other improvements related to device appearance and design that would make the device more acceptable for them to use. Understanding paediatric patients and caregivers' experiences about oral and respiratory devices is key to provide industry with information that can help improve the use and acceptability of administration devices. Aspects that device suppliers and healthcare professionals would need to prioritise are the provision of simpler instructions in the form of images and key summaries, and to provide adequate training on device use. These improvements are essential to ensure that children and caregivers are able to use the device appropriately.

Age-appropriate solid oral formulations for pediatric applications with a focus on multiparticulates and minitablets: Summary of September 2019 EuPFI workshop.

This paper presents the output of a workshop held at the 11th Annual Conference of EuPFI (European Paediatric Formulation Initiative), in September 2019 in Malmo, Sweden, on the development of multiparticulates and minitablets as pediatric formulations. The workshop focused on three specific facets of pediatric drug development, namely selection of the formulation platform, selection of the package or dosing device, and administration of minitablets/multiparticulates with soft food. The workshop discussion indicated significant interest in the use of these dosage forms, filled into stick-packs or capsules, as age-appropriate formulations for younger children, along with a growing consensus that larger sized tablets and capsules designed for adults are often also suitable for adolescents. Among the areas that were identified as technical challenges were: understanding the acceptability of multiparticulates and minitablets relative to alternate formulations; the need for a streamlined approach to compatibility testing with soft foods; the desire to avoid the need to co-administer these products with soft food; and the need for more suitable dosing devices.

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.