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

11 September 2018 in London, United Kingdom

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

The EuPFI is inviting expressions of interest in a workshop to be held 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 is 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, are invited to the workshop as well as representatives from national competent authorities and EU institutions.

The workshop will include presentations from keynote speakers and break-out sessions for discussion on specific topics.

Click here to complete and submit form for expression of interest to attend the workshop. The form should be submitted by 27thJuly 2018.

Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations, and so please do not book travel arrangements until your attendance has been confirmed.

A report of the workshop, the action plan and presentations from the workshop will be published on this 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
08:30 Arrival and Registration
09:30 Welcome address
09:40 Introduction and workshop objectives
09:50 – 12:00

 

 

(Coffee break – 11:10- 11:30)

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?
Healthcare professionals’ perspectives
Caregiver/patients’ perspectives
Pharmaceutical industry perspectives
Administration device suppliers’ perspectives
12:00 – 12:30 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.Regulatory expectations and requirements for paediatric administration devices.
Regulatory perspectives
12:30 Lunch
13:30 – 15:00 Breakout session
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 (dosing devices, dosing accuracy etc) should be addressed?
• What are constructive solutions that could mitigate these challenges and facilitate  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?
15:00 Coffee Break
15:30 -17:00 Group feedback and discussion
17:00 – 17:30 Conclusion and next steps
17:30 End of workshop
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