Medicine information design and regulation in Australia have developed together leading to a high standard of consumer medicine information (CMI) and packaging. This presentation is anl account of these developments by one of the leading researchers in the field and gives an insight into the underlying methods, findings, and dangers for the future.
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David sless cri medicine labelling @ arcs 2015
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CRI
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established 1985
not-for-pro鍖t
200 + organisations helped
international reputation
research
publishing
training
advocacy
advice
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
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Medicine labelling regulation: a brief history
19th Century USA control substance quality
UK control access
20th Century control marketing
control public health
21st Century help consumers
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control
help!!
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 鍖nd 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 鍖nd 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 e鍖ects
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 usedfor
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
di鍖erentiating between
products in a brand
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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
e鍖cient 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 dont know nobody asks
respectful dont know nobody asks
attractive no poor pharm. technology
physically appropriate no poor pharm. technology
socially appropriate sometimes not in鍖exible
usable yes tested
e鍖cient no poor pharm. technology
productive dont 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
consumer
medicine
information
CRIXIVAN
(indinavir sulfate)
速 Registered Trademark of Merck & Co. Inc.Whitehouse Station NJ USA
crixivan
how to take
crixivan
how to take
continued continued
If you need to eat within a dose window make sure its
only small amounts of light food. crixivan is absorbed
well enough with small amounts of light food.
Examples of light food are dry toast
with jam,juice (exceptgrapefruit) and
co&ee with skim-milk and sugar, or
cornflakes with skim-milk and sugar.
Taking crixivan with a meal that is high
in calories, fat and protein reduces your
bodys ability to absorb the medicine
and in turn reduces its effectiveness.
You can indulge in high energy foods
outside the 3-hour dose window.
However, taking crixivan on an empty
stomach improves absorption.
This means noteating during the 3-hour
dose window.
ideal practice do noteat for two hours before and one
hour after taking your dose.
good practice if you need to eat during a 3-hour dose
window make sure its only small
amounts of light food.
unacceptable do noteat heavy food
what to take with it
The period around taking your capsules is the
dose windowwhen you must watch what
you eat and drink. Remember 3-2-1:
3 hour period made up of:
2 hours before each dose
1 hour after each dose
Swallow crixivan with a full glass of water or
other liquid.
Swallowing crixivan with water ensures
maximum absorption and effectiveness.
However, if you do notlike water,
crixivan can be swallowed with skim
milk,juice (exceptgrapefruit), coffee
or tea.
Do notdrink grapefruitjuice within a dose window.
Grapefruitjuice signi鍖cantly reduces the
absorption of crixivan, therefore
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.
X
The fate of pharmacy CMI?
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Packaging: some measurable improvements
<B >0 9 0 2 6 9 E XP AP R 0 4
HOW TO USE PARACOL
Tablets How often
712 1/2 1 every 4 hours with water
maximum 4 in 24 hours
12Adults 1 2 every 4 hours with water
maximum 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 TABLETS
USE PARACOL FOR
Fast effective temporary relief of pain and
discomfort associated with:
Headache
Toothache
Cold & Flu
Migraine
Muscular Aches
Tension headache
Arthritis/Osteoarthritis
Backache
Period pain
Reduces fever
AFTER USE
Store below 30 C
DO NOT USE PARACOL
For 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 broken
If the package use-by date above has expired
DO NOT USE PARACOL
EACH TABLET CONTAINS
500mg Paracetamol No glucose, lactose, or sugar
QUESTIONS/COMMENTS?
Call 1800 028 533
Freecall (Aus only)
Gallina & Dickinson
Pharmaceuticals
38 Works Road,
North Ryde
NSW 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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Child Resistance with Senior Needs
Available in non-proprietary heat seal materials
from multiple vendors
Ability to incorporate patient assistance options
Repeated success in F-1
unit dose testing
2010 HCPC Compliance
Package of the Year
ogy
aging
Reality
& Development to
on
rotocol
ns for:
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 shows
what
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/
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thank you
david sless
d.sless@communication.org.au