Modelling and Simulation Group, School of Pharmacy Pharmacokinetic/Pharmacodynamic Understanding For Fentanyl IntraNasal in the Paediatric Population Aaron.

Slides:



Advertisements
Similar presentations
Critical Airway Management: In a Teaching Institution Manu Malhotra & Jennifer Ritz.
Advertisements

Safety and Extrapolation Steven Hirschfeld, MD PhD Office of Cellular, Tissue and Gene Therapy Center for Biologics Evaluation and Research FDA.
Introduction to Pharmacology. Overview Pharmaceutics Pharmacokinetics Pharmacodynamics.
Healthy People 2010 Focus Area 17: Medical Product Safety Progress Review October 19, 2007.
© 2014 by McGraw-Hill Education. This is proprietary material solely for authorized instructor use. Not authorized for sale or distribution in any manner.
Clinical Practice Guidelines ….cookbook medicine? Mike Starr Chair, Statewide CPG Steering Group.
+ Drug Development and Review Process. + Objectives Learn the processes involved in drug discovery and development Define the phases involved in FDA drug.
Concerns in Medication Safety in Regards to the Older Adult Population Stephanie A. Ball, Taylor W. Brickley, Macey F. Davenport, Kelly L. Erexson, Emily.
E-Drug: Malawi – essential training in safe prescribing Louisa Alfazema 1, David Dewhurst 2 and Ross Ward 2 1 Department of Pharmacy, College of Medicine,
Victoria E. Aldridge, Pharm.D. JUSTIFICATION OF CLINICAL STAFFING Victoria E. Aldridge, Pharm.D.
Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.
CINAHL Nursing Guide –Nearly 3,600 Evidence-based lessons on procedures, diseases and conditions, legal cases and drugs 2,200+ care sheets & lessons 700+
1 EMCON 3, 29 th December 2010 to 1 st January 2011, Dhaka, Bangladesh “ I will remember that I do not treat a fever chart, a cancerous growth, but a sick.
Spiro Consulting Overview of Technology Approaches of Medication Management in Long-Term Care Rachelle “Shelly” Spiro, RPh, FASCP President, Spiro Consulting.
Social Pharmacy Lecture no. 8 Rational prescribing guidelines.
MEDICATION ERROR PURPOSE / POLICY Purpose: To provide a process for identifying, reporting, and reviewing medication errors Policy: Any med error will.
PENTHROX™ - Methoxyflurane
Modelling and Simulation Group, School of Pharmacy Pharmacokinetic/Pharmacodynamic Understanding For Fentanyl IntraNasal in the Paediatric Population Aaron.
WAR QUM …..What is it good for?. A R EVIEW OF Q UALITY U SE OF M EDICINES (QUM) P ROJECTS AT THE M ATER C HILDREN ’ S E MERGENCY D EPARTMENT.
CHEE DRUG PRODUCT DEVELOPMENT u Drug ä agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man or animals.
Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.
Imagine IT February, Our goals for today  Review why we need an electronic Health Record  Present a high level overview of the plan  Steps we.
Improving Analgesia in Emergency Departments: Optimising Use of Pethidine A Multi-centre DUE Project Coordinated by NSW Therapeutic Assessment Group Funded.
Orientation to Pharmacology
SPSP Medicines Paediatric Networking Event Prepared by: David Maxwell.
Mater Emergency Research in Children and Youth Pharmaco-governance of INF use in children in QLD Emergency Departments Amie Lloyd-Jones 4 th Year BPharm.
Modelling and Simulation Group, School of Pharmacy Intranasal Fentanyl in a Nutshell Aaron Basing.
Amie Lloyd-Jones QUM Project – Mater Children’s Emergency Department (Under supervision of Dr David Herd and Aaron Basing) University of Queensland.
Proposal for End-of-Phase 2A (EOP2A) Meetings Advisory Committee for Pharmaceutical Sciences Clinical Pharmacology Subcommittee November 17-18, 2003 Lawrence.
Mater Emergency Research in Children and Youth Pharmaco-governance of INF use in children in QLD Emergency Departments Amie Lloyd-Jones 4 th Year BPharm.
IAEA International Atomic Energy Agency Regulations Part III: Radiation Protection Performance Requirements Day 8 – Lecture 5(3)
Therapeutic Drug Monitoring (TDM) Sticker Project A New Method for Documenting Times of Medication Doses and Drug Levels.
At the Bedside Evidence Based Medicine Stephen R. Hayden, MD Department of Emergency Medicine UCSD Medical Center, San Diego Teaching.
Modelling and Simulation Lab, School of Pharmacy, University of Otago, New Zealand D-optimal Adaptive Bridging Studies in Pharmacokinetics Lee-Kien Foo.
Pharmacokinetics of Vancomycin in Adult Oncology Patients Hadeel Al-Kofide MS.c; Iman Zaghloul PhD; and Lamya Al-Naim PharmD Department of Clinical Pharmacy,
Pharmacodynamics Ed Bilsky, Ph.D. Department of Pharmacology University of New England.
Biotechnology Industry Organization (BIO) Risk Management Public Workshop Day 1 - April 9, 2003 Risk Assessment in Drug and Biological Development Joanna.
Applying New Science to Drug Safety Janet Woodcock, M.D. Acting Deputy Commissioner for Operations April 15, 2005.
Effect of Captopril first doses on Blood Pressure and Renal Function in Children with Congestive Cardiac Failure Dr Hussain Mulla, Co-Director, Centre.
Clinical Trials - PHASE II. Introduction  Important part of drug discovery process  Why important??  Therapeutic exploratory trial  First time in.
Launch of Supplementary Drug Charts
Methods The initial audit was carried out retrospectively, looking at the acute paediatric presentations from January 2014 to May 2014 inclusive. Patient.
Topic #1: EOP2A Meetings Please comment on the goals of the proposed EOP2A meeting and the impact that such meetings could have on optimizing dose selection.
The transdermal route of delivery has increased in popularity over the past decade with a wide range of medicines now being available [1]. However with.
Managing Type 2 Diabetes
Pediatric Pharmacology Overview
Emergency Department Asthma Care Pathway (EDACP)
The Nursing Process and Drug Therapy
Prof. Dr. Basavaraj K. Nanjwade
The machine and its calibration
Concepts of Paediatric Investigation Plans (PIP)
A Recommendation from Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from ACOP and APS By Rhys Dela Cruz, Angela Hickey,
Biopharmaceutics Dr Mohammad Issa Saleh.
Clinical audit 2017/18 National Results
Introduction to Clinical Pharmacology Chapter 16 Opioid Antagonists
Clinical Pharmacokinetics
Managing Type 2 Diabetes
Clinical audit 2017/18 National Results
Principles of Drug Administration Ch. 3
Clinical Pharmacokinetics
Madeleine robinson, dr alan mcshane, dr neil mcdonald
Development Plans: Study Design and Dose Selection
Clinical Challenges and Updates in Managing Seizure Clusters
Introduction to Pharmacogenetics
An introduction to EMA’s support for medicines development
Principles and Methods of Drug Administration
Pharmaceutical care plans Ola Ali Nassr
Introduction to Clinical Pharmacology Chapter 16 Opioid Antagonists
Clinical Governance Support Unit
Presentation transcript:

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

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

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

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 = presentations at nine sites)

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

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

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

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

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

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

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

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

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

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

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

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

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

Modelling and Simulation Group, School of Pharmacy Puffin Pilot pilot-free-online-puffin-game/

Modelling and Simulation Group, School of Pharmacy Proposed Timeline