1. Modelling and Simulation Group, School of Pharmacy Pharmacokinetic/Pharmacodynamic Understanding For Fentanyl IntraNasal in the Paediatric Population Aaron Basing Supervisors Prof. Carl Kirkpatrick Dr David Herd A/Prof. Bruce Charles Dr Ross Norris PUFFIN

2. Modelling and Simulation Group, School of Pharmacy Overview Recap on justification for research What we want to achieve with PUFFIN Results so far

3. Modelling and Simulation Group, School of Pharmacy What is INF ? Fentanyl that is administered via the nasal route for analgesia

4. Modelling and Simulation Group, School of Pharmacy Clinical Context Paediatric Emergency Room –Painful injuries are common  –Painful procedures are common Most frequent diagnoses of paediatric ED patients at PREDICT sites (n = 314 025 presentations at nine sites)

5. Modelling and Simulation Group, School of Pharmacy Summary so far Painful injuries and procedures are common in paediatric emergency departments. INF has several features that are well suited to use within a paediatric emergency department

6. Modelling and Simulation Group, School of Pharmacy What we DON’T know about INF The underlying pharmacokinetics for INF in the paediatric population

7. Modelling and Simulation Group, School of Pharmacy What we don’t know about Dosing strategies have been developed empirically from adult pharmacokinetic studies  Potential for therapeutic catastrophe

8. Modelling and Simulation Group, School of Pharmacy Why is this important Fentanyl has serious side effects a b a.Adapted from yassen 2006 b. Adapted from foster 2008

9. Modelling and Simulation Group, School of Pharmacy We’re Doing What to PUFFINS??? PUFFIN = Paediatric Understanding for Fentanyl Intranasal UNDERSTANDING = A discrete body of knowledge that allows the safety and efficacy of a medication to be maximised

10. Modelling and Simulation Group, School of Pharmacy What’s Inside a PUFFIN Evidence Base Actual Usage Pharmacogovernance Nurse Initiation Adsorption and and Dead-space testing Optimal Design Puffin Pilot

11. Modelling and Simulation Group, School of Pharmacy Evidence Base Question –Where is INF place in paediatric practice Answer –Do systematic review of transmucosal Opiates for acute pain in paediatric patients

12. Modelling and Simulation Group, School of Pharmacy Evidence Base Two new questions arose –Why INF –Why not other opiates

13. Modelling and Simulation Group, School of Pharmacy Actual Use Is the scale of problem sufficient to make all this effort worthwhile? –Yes, very rapid growth in INF usage at Mater

14. Modelling and Simulation Group, School of Pharmacy Pharmacogovernance Off licence use of INF –How is INF being used –How is the absence of paediatric clinical pharmacology of INF being managed

15. Modelling and Simulation Group, School of Pharmacy Nurse Initiation Can Nurse Initiated INF improve analgesia for paediatric patients?

16. Modelling and Simulation Group, School of Pharmacy Adsorption and Dead-space Testing How much Drug actually gets delivered?

17. Modelling and Simulation Group, School of Pharmacy Optimal Design Optimise sampling Times Explore the effects of parameter misspecification

18. Modelling and Simulation Group, School of Pharmacy Puffin Pilot http://www.puffinpalooza.com/puffin- pilot-free-online-puffin-game/

19. Modelling and Simulation Group, School of Pharmacy Proposed Timeline