Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories

11 September 2018 in London, United Kingdom

devices workshop pic

European Paediatric Formulation Initiative (EuPFI) Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories – Sponsored by Janssen

The EuPFI  devices workstrean organised a workshop on 11thSeptember 2018 at University College London (UCL) School of Pharmacy premises, to identify and discuss challenges and potential improvements in the development, control and utilization of oral dosing syringes and enteral accessories for paediatric liquid medicines.

Although oral liquids are acceptable for the whole paediatric age range (birth to 18 years), a key challenge with their administration is to ensure the correct dose is measured. The oral syringe is considered to be the measuring device of choice, with high dosing accuracy and uniformity, especially when small volumes are required. However, dose variability may occur where oral syringes are not suitable for the specific drug product and dose being administered, leading to under dosing with diminished treatment efficacy or overdosing with potential for toxic effects.

Where a dosing syringe is supplied with a specific medicine, the pharmaceutical product licence holder ensures the acceptability of its dosing accuracy in line with Regulatory requirements, however deviations in dosing accuracy may occur when “off-the-shelf” dosing syringes are used for the measurement of small volumes. In addition, it may be necessary to use several adaptors to accurately measure and administer medication in clinical practice which can be challenging and potentially lead to dosing errors. Furthermore, the provision of multiple oral syringes for different products which may have different units of measure and/or graduations to patients for domiciliary use can cause confusion.

The aim of the workshop was to facilitate the establishment of an optimal path towards the correct oral dosing of all paediatric patients with dosing syringes and enteral accessories, that meets the requirements of all stakeholders involved (Patients, Regulators, Practitioners and Industry).

A broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia, attended the workshop as well as representatives from national competent authorities and EU institutions.

The workshop 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 general consensus from the workshop participants was that harmonisation/standardisation of these devices is required (amongst other suggestions).

The presentations from workshop are available for invited participants/delegates only.

A report of the workshop, the action plan will be published on the website.

Background and Objectives

Background

Although oral liquids are acceptable for the whole paediatric age range (birth to 18 years), a key challenge with their administration is to ensure the correct dose is measured. Dose variability may occur where oral syringes are not suitable for the specific drug product and dose being administered, leading to under dosing with diminished treatment efficacy or overdosing with potential for toxic effects.

EuPFi is organising a one-day workshop that will bring together a broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia to share current practices and issues regarding the development and handling of oral dosing syringes and enteral accessories, to facilitate awareness and identify areas for improvement.

 Objectives

  • To give an overview of the main challenges associated with the administration of oral liquid medicines to the paediatric population in both a hospital and domiciliary setting, including practical considerations.
  • To review factors (e.g. users, environment, design and technical factors) that have an impact on accurate administration of doses routinely prescribed to paediatrics, and practical considerations for dosing small volumes.
  • To share current practices and challenges associated with the development, control and supply of oral dosing syringes and enteral accessories.
  • To describe the requirements and regulations industry must comply with and how industry develops, selects or assesses the dosing syringe.
  • To exchange ideas on what can be improved to achieve a safer administration of medicines to paediatrics.

Workshop Agenda

Time Topic Presenter
08:30 Arrival and Registration
09:30 Welcome address Catherine Tuleu, UCL School of Pharmacy, UK
09:40 Introduction and Workshop Objectives Smita Salunke, UCL School of Pharmacy, UK
Topic 1: Stakeholders’ perspective on challenges associated with the administration of oral liquid medicines to the paediatric population
1. What are the current practices regarding the.
development/supply/use of paediatric oral dosing syringes
and enteral accessories?
2. What are the key challenges faced with these
administration devices?
3. What measures could be taken to address these challenges
and hence facilitate the correct dosing of all paediatric
patients with dosing syringes and enteral accessories?
Chair: Jenny Walsh, Jenny Walsh Consulting Ltd, UK
9:50 – 11.10 Healthcare professionals’ perspectives *Consultant Paediatric Pharmacist: Sara Arenas Lopez, Evelina London Children’s Hospital, UK.

*Paediatric Research Pharmacist: Mandy Wan, Evelina London Children’s Hospital, UK.

*Paediatricians: Johan Vande Walle, Ghent Univsersity Hospital and Pauline de Bruyne,  Erasmus University Medical Center, Belgium.

*Medicines Management Nurse: Joanna Correa West, Birmingham Women’s and Children’s NHS Foundation Trust, UK.

11:10 – 11:30 Break
11:30 – 11:50 Pharmaceutical industry perspectives *Esmerald Hermans, Janssen Pharmaceutica NV (J&J), Belgium.
11:50-12:15 Administration device suppliers’ perspectives *Cristiane Rocha Cunha, BD, USA.                                                                                                      *Sascha Moehs, ELM-Plastic GmbH, Germany.
Topic 2: Overview of regulatory expectations and requirements of paediatric administration devices.
Example case studies where data have been provided/ questions have been raised regarding the administration of an oral liquid using an administration device.
Chair: Gareth Hilton, AstraZeneca, UK.
12:15 – 13:00 Regulatory perspectives *Rutger de Vries, Quality Assessor, Medicines Evaluation Board, Netherlands.

*Enitan Taiwo, Devices Safety and Surveillance, Medicines and Healthcare products Regulatory Agency, UK.

13:00 – 14:00 Lunch
14.00-16:00 Breakout Session, Group Feedback and Discussion
Stakeholders’ perspective on overcoming challenges to achieve a safer administration of medicines to paediatrics.
• Which procedural and operational challenges in relation to administration of oral liquid medicines to the paediatric population in both a hospital and domiciliary setting (dosing devices, dosing accuracy etc) should be addressed?
• What are constructive solutions that could facilitate the establishment of an optimal path towards the correct oral dosing of all paediatric patients with dosing syringes and enteral accessories, that meets the requirements of all stakeholders involved 
Leads: Gareth Hilton, AstraZeneca, UK and Paul Blowers, AbbVie Inc, USA.

Moderators: Jenny Walsh, Jenny Walsh Consulting Ltd UK; Esmerald Hermans, Janssen Pharmaceutica NV (J&J) Belgium. 

16:00 – 16:45 Break & Affinity Mapping Moderators: Gareth Hilton, AstraZeneca, UK; Paul Blowers, AbbVie Inc, USA; Jenny Walsh, Jenny Walsh Consulting Ltd UK; Esmerald Hermans, Janssen Pharmaceutica NV (J&J) Belgium.
16:45-17:15 Conclusion and next steps Jenny Walsh, Jenny Walsh Consulting Ltd, UK
17:30 End of workshop Jenny Walsh, Jenny Walsh Consulting Ltd, UK
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