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Interactive session 2 – Compounding for Paediatrics – A Survival Guide through GMP

Room:

Array

Facilitator:

Alcobia, Armando

Speakers:

Abstract:

Linked to EAHP Statements

Section 3 – Production and Compounding: Statements – 3.1, 3.2, 3.3, 3.4, 3.5
Section 4 – Clinical Pharmacy Services: Statements – 4.4, 4.2, 4.3, 4.6, 4.7, 4.8
Section 5 – Patient Safety and Quality Assurance: Statements – 5.1, 5.3, 5.9
Section 6 – Education and Research: Statement – 6.4

ACPE UAN: 0475-0000-22-017-L07-PA knowledge-based activity.

Abstract

Paediatric patients are not mini-adults. This statement, although so often heard, is normally not fully explored. Why are children so different? Weight, height, gastric emptying time, gastric pH, distribution volume, hepatic metabolism, renal clearance, and other features contribute to different needs comparing to adults. And those needs require paediatric formulations, with different doses, different pharmaceutical forms, suitable palatability and so on.

All paediatric pharmacists face the problem of not having the medicine in need, at the required dose, or on the proper pharmaceutical form. So, compounding is frequently mandatory.

In addition, there are substantial differences between paediatric formulations available in each country, which make this task even harder. Therefore, in this seminar, we will deliver a “survival guide” to recognize how to adapt the medicines we need to administrate to our patients without compromising its safety and effectiveness.

In fact, we intend to answer the following questions:

1- Do I have to compound this medicine? Is there another option on the market?
2- Do I have what it takes? – go through the GMP
3- Is there any other hospital or health centre doing the same thing? – create your network. Ask a partner.
4- Use suitable literature – we will review some of the platforms that can be used as well as books, articles, authors and so on.
5- Which is the best pharmaceutical form for my patient considering its age? – we will discuss the best options for paediatric patients.
6- What about the excipients – which to avoid?
7- Expiration date – how do I know?
8- Batch release – quality control: packaging and labelling will be discussed
9- After administration, how to evaluate the clinical efficacy? – ask the child, ask the parents, ask the physician, ask the nurse. Make sure your patient is happy.

Finally, some clinical examples of the daily practice will be discussed.

Learning objectives
A
fter the interractive session, participants should be able to:

  • Understand the need to adapt drugs to paediatric population
  • Understand the need to preserve the medicine´s efficacy with safety compounding
  • Recognize GMP compliance with the need to address concrete issues in clinical practice

Educational need addressed
All hospital pharmacists contact with the necessity to use compounded drugs in their daily practice. Therefore, this synergy will address the need to use a safety compound technique, suitable to respond to our paediatric patients’ needs.

Keywords: Paediatrics, compounded drugs, GMP, safety, therapeutic effectiveness.

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