Provided by UCL School of Pharmacy
University College London (UCL) supported European Paediatric Formulation Initiative’s (EuPFI) mission to promote and facilitate safe medicines for children by hosting the workshop at UCL School of Pharmacy, with the aim of finding an optimal path towards the correct oral dosing of all paediatric patients with dosing syringes and enteral accessories (adaptors), that meets the requirements of patients, regulators, healthcare professionals and Industry. The event was full of lively discussion and debate on the challenges in relation to the administration of oral liquid medicines to the paediatric population in both a hospital and home setting (dosing devices, dosing accuracy etc), with moving facts from real life events.
The workshop organised by members of the EuPFI Devices Workstream provided an opportunity for direct dialogue between regulators, industry, clinicians, pharmacists and device manufacturers/suppliers on harmonised approaches that can provide acceptable dosing volumes to minimise errors across the entire spectrum of paediatric practice. A good mix of delegates from both the UK and overseas attended the workshop on invitation.
It was opened by Professor Catherine Tuleu (UCL School of Pharmacy, EuPFI chair). Dr Smita Salunke (EuPFI CSO, UCL School of Pharmacy) reminded the delegates of the very reason why they were all there and emphasised that only by working together we can make a difference! The feedback from delegates was very positive. Different stakeholders provided their perspectives on their current practices and challenges associated with oral dosing syringes and enteral accessories.
“Hope is not just a dream” said Dr Sara Arenas Lopez from Evelina London Children’s Hospital, UK. “We really need to sort this out since we feel that the syringes are not compatible with hospital practice requirements and harmonisation/standardisation of these devices is required.”
The first session chaired by Dr Jenny Walsh (Jenny Walsh Consulting, UK) highlighted several key themes – the challenges HCPs have in dosing small volumes and having to use enteral accessories that require a different technique to dosing with an oral syringe alone, both of which can lead to dosing errors. The regulatory framework for oral administration devices is globally inconsistent and unclear which is a challenge for industry and device suppliers who spend significant resources on designing and testing devices to ensure they are suitably accurate and user-friendly.
The second session focused on regulatory perspective and was chaired by Gareth Hilton (AstraZeneca, UK). The talks in this session gave an overview of current EU regulatory requirements and guidance, together with examples from daily practice of dosing small volumes and the associated challenges and problems/failure modes. The potential danger of inadvertently injecting IV oral or enteral liquids prepared in parenteral syringes was emphasised and safe practice recommendations shared.
The day concluded with an interactive breakout session (lead by Gareth Hilton (AstraZeneca, UK), Paul Blowers (AbbVie, USA) and moderated by Esmerald Hermans (Janssen, Belgium) and Jenny Walsh (Jenny Walsh Consulting, UK), where delegates discussed some of the real time key challenges currently faced. For example, the enteral accessories (adaptors) that must be used in hospitals may not be compatible for use with the dosing devices and products developed and supplied by Industry. They are therefore often discarded by hospitals, and alternative generic devices used instead, which may have sub-optimal low dose volume accuracy for the product.
Participants voted on potential solutions that were considered to have the highest impact on the safe and effective administration of oral liquid medicines to children. The harmonisation/standardisation of oral syringe designs globally was deemed to be a key priority as well as the improvement of the accuracy of dosing small volumes.