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• established 1985

• not-for-profit

• 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

4

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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

7

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 – ?

8

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.

19

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

22

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

Introducing IntuiDose

• Cost effective solutions for any format• Patient Friendly dosing balancesChild Resistance with Senior Needs

• Available in non-proprietary heat seal materialsfrom multiple vendors

• Ability to incorporate patient assistance options• Repeated success in F-1unit dose testing

• 2010 HCPC CompliancePackage of the Year

Anderson Packaging

Packaging TechnologyCompliance Prompting PackagingIn-house Design – Concept to Reality

� Full Service support from Design & Development toline startup and Commercialization

� Extensive experience with CPSCChild Resistant/Senior Friendly protocol

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/

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thank you

david sless

d.sless@communication.org.au