david sless cri medicine labelling @ arcs 2015
TRANSCRIPT
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© CRI 2015
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• established 1985
• not-for-profit
• 200 + organisations helped
• international reputation
• research
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• communication.org.au for more information.
CRI
Communication Research Institute
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In a world full of information, CMI and medicine packaging are just one more thing to read.
If they are not designed specifically for people, the only contribution they make is to landfill.
Labelling lessons from communication research
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Labelling lessons from communication research
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Medicine labelling is regulated and includes:
Medicine containers
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Medicine labelling is regulated and includes:
Medicine containers
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Consumer medicine information (CMI)
Packaging
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Medicine labelling is regulated and includes:
Medicine containers
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Consumer medicine information (CMI)
Packaging
Appendices 19
Appendix 5 – Codral Cold & Flu + Sore Throat Image
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Medicine labelling regulation: a brief history
19th Century USA – control substance qualityUK – control access
20th Century control marketingcontrol public health
21st Century help consumers
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controlhelp!!
Regulators know a lot about control but very little about helping people.
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1991 – Baume Report A question of balance
1992 – DHHC Quality use of medicines (QUM) policy
1994 – Writing about medicines for people: CMI
2004 – ASMI labelling code of practice: Packaging
2015 – ?
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Medicine labelling in Australia
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Brief Develop guidelines to enable
industry to help consumers
exercise their right to information
about medicines.
Guidelines and CMI must be highly
usable.
CMI available at pharmacy printer.
1994 – Writing about medicine for people
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1994 – Writing about medicine for people
Main outcomes:
comprehensive listing of stakeholder-agreed tasks using CMI (chapter 12 WAMFP)
lead to CMI in which 80% of literate users can find and use over 80% of what they look for
used as de facto standard
widely copied overseas
won awards.
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1994 – Writing about medicine for people
Main outcomes:
comprehensive listing of stakeholder-agreed tasks using CMI (chapter 12 WAMFP)
lead to CMI in which 80% of literate users can find and use over 80% of what they look for
used as de facto standard
widely copied overseas
won awards.
performance-based
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1994 – Writing about medicine for people
1. The name of the medicine and the active ingredients
2. what it is used for and how it works
3. factors to be considered before taking the medicine
4. how to use the medicine properly
5. other information that may be important
6. unwanted effects 7. in case of overdose 8. storage conditions 9. where to go for further
information 10.sponsor of the product 11.date of information
Topic order in regulations
1. What is in this leaflet
2. What medicine is used for
3. Before you take it
4. How to use it
5. While you are using it
6. Side effects
7. After taking it
8. Product description
Guidelines top headings order
Strict temporal order gave best test results
Note that the position of ingredients has changed
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Brief
collaborate with all stakeholders
set performance requirements
set a high usability level
congruent with regulations
baseline measurement.
2004 – ASMI labelling code of practice
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Outcomes
Stakeholder agreement
performance requirements set
baseline measurement ≈ 40%
set a high usability level
congruent with regulations.
2004 – ASMI labelling code of practice
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Labelling performance requirements
highlighted text shows tasks concerned with differentiating between products in a brand
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Labelling regulations TGO 69A 2004
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avoiding the rubbish bin
satisfying the reader.
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Designing for reading
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credible to reader
respectful of reader
attractive to reader
physically appropriate for reader
socially appropriate for the reader.
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Avoiding the rubbish bin
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appropriately usable by the reader
efficient to use
leads to a productive outcome.
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Satisfying the reader
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How do pharmacy CMI perform?
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criterion pharmacy cmi why?
credible don’t know nobody asks
respectful don’t know nobody asks
attractive no poor pharm. technology
physically appropriate no poor pharm. technology
socially appropriate sometimes not inflexible usable yes tested
efficient no poor pharm. technology
productive don’t know nobody asks
How do pharmacy CMI perform?
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These CMI met all the criteria and were used
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consumer
medicine
informat ion
CRIXIVAN
consumermedicineinformationC R I X I V A N(indinavir sulfate)
® Registered Trademark of Merck & Co. Inc. Whitehouse Station NJ USA
c r i x i va nh o w t o t a k e c r i x i va nh o w t o t a k eco nt i n u e d co nt i n u e d
If you need to eat within a dose window make sure it’sonly small amounts of light food. crixivan is absorbed well enough with small amounts of light food.
Examples of light food are dry toastwith jam,juice (exceptgrapefruit) andco&ee with skim-milk and sugar, orcornflakes with skim-milk and sugar.Taking crixivan with a meal that is highin calories, fat and protein reduces yourbody’s ability to absorb the medicineand in turn reduces its effectiveness.You can indulge in high ener gy foodsoutside the 3-hour dose window.However, taking crixivan on an emptystomach improves absorption.This means noteating during the 3-hourdose window.
ideal practice do noteat for two hours before and onehour after taking your dose.
good practice if you need to eat during a 3-hour dosewindow make sure it’s only smallamounts of light food.
unacceptable do noteat heavy foodpractice (high-fat,high-protein,high-calorie)
during the 3-hour dose windows.co ntinued ov e r l e a fco nt i n u e d
w h at to take w ith it
The period around taking your capsules is the‘dose window’—when you must watch whatyou eat and drink. Remember 3-2-1:
3 hour period made up of:2 hours before each dose1 hour after each dose
Swallow crixivan with a full glass of water orother liquid.
Swallowing crixivan with water ensuresmaximum absorption and effectiveness.However, if you do notlike water,crixivan can be swallowed with skimmilk,juice (exceptgrapefruit), coffee or tea.
Do notdrink grapefruitjuice within a dose window.Grapefruitjuice significantly reduces theabsorption of crixivan, thereforedecreasing its effectiveness.
How do other CMI perform?
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CMI have not changed since 1994
many consumers do not read them
some pharmacists have never liked them
improve or abandon pharmacy distribution.
XThe fate of pharmacy CMI?
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Packaging: some measurable improvements< B > 0 9 0 2 6 9 E X P A P R 0 4
HOW TO USE PARACOLTablets How often
7–12 1/2 – 1 every 4 hours with watermaximum 4 in 24 hours
12–Adults 1 – 2 every 4 hours with watermaximum 8 in 24 hours
If pain persists, or you exceed these doses, seek medical advice. Over use can cause liver damage.
Suitable for: Asthmatics sensitive to aspirin NSAIDs Breastfeeding mothers People with stomach ulcers
24 TABLETSUSE PARACOL FOR Fast effective temporary relief of pain and discomfort associated with:
HeadacheToothacheCold & FluMigraineMuscular Aches
Tension headacheArthritis/OsteoarthritisBackachePeriod painReduces fever
AFTER USEStore below 30 C
DO NOT USE PARACOLFor children below 7, except on medical advice For a long time without medical supervision. If using other medicines containing paracetamol If any of the seals on this package are brokenIf the package use-by date above has expired
DO NOT USE PARACOL
EACH TABLET CONTAINS500mg Paracetamol No glucose, lactose, or sugar
QUESTIONS/COMMENTS?
Call 1800 028 533Freecall (Aus only)Gallina & DickinsonPharmaceuticals38 Works Road, North RydeNSW 2100, Australia
GD 9 3 6 7 3 0 1 3
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Overall improvements across OTC products
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benchmark proto 1 proto 2 product % N % N % N process used
1 81 21 - - - - followed CRI guidelines
2 42 19 81 21 100 9 followed CRI guidelines
3 - - 80 10 followed CRI guidelines
4 60 10 90 10 90 10 new product, followed CRI guidelines
5 27 15 67 9 followed CRI guidelines
6 - - 100 5 new product, followed CRI guidelines
7 17 6 17 6 did not follow guidelines
8 50 6 0 6 did not follow guidelines
9 83 10 90 10 followed CRI guidelines
10 17 10 83 10 followed CRI guidelines
11 62 8 100 10 followed CRI guidelines
12 - - 100 10 new product, followed CRI guidelines
13 0 8 90 10
average % 49 88 95
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Thinking into the future: merging container, cmi & packaging
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AmerisourceBergen Packaging Group
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Anderson Packaging
Packaging TechnologyCompliance Prompting PackagingIn-house Design – Concept to Reality
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Compliance Packaging solutions for:� Clinical Packaging� Physician Samples� Patient Starter Kits� Trade Packaging� Combination Therapies� Titration Packs
Anderson Packaging
Packaging Technology
Secondary Packaging – MeadWestvaco Dosepak� Seven Years of Experience and Evolution� Capital Investment Exceeding $20 Million� Over 200 Million Dosepacks Produced
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Australian regulators want to go back 30 years & use FDA approach!!
FDA showswhat happens without a QUM policy
A Temporal trip
To see an animation of the temporal trip go to: http://communication.org.au/implications-of-the-big-shift-2/