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David sless cri medicine labelling @ arcs 2015

David Sless
David Sless

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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slide of 28 息 CRI 2015 CRI 1 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
slide of 28 息 CRI 2015 CRI 2 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
slide of 28 息 CRI 2015 CRI 3 Labelling lessons from communication research
slide of 28 息 CRI 2015 CRI Medicine labelling is regulated and includes: Medicine containers 4
slide of 28 息 CRI 2015 CRI Medicine labelling is regulated and includes: Medicine containers 5 Consumer medicine information (CMI) Packaging
slide of 28 息 CRI 2015 CRI Medicine labelling is regulated and includes: Medicine containers 6 Consumer medicine information (CMI) Packaging
slide of 28 息 CRI 2015 CRI 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 7 control help!! Regulators know a lot about control but very little about helping people.
slide of 28 息 CRI 2015 CRI 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
slide of 28 息 CRI 2015 CRI 9 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
slide of 28 息 CRI 2015 CRI 10 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.
slide of 28 息 CRI 2015 CRI 11 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
slide of 28 息 CRI 2015 CRI 12 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
slide of 28 息 CRI 2015 CRI 13 Brief collaborate with all stakeholders set performance requirements set a high usability level congruent with regulations baseline measurement. 2004 ASMI labelling code of practice
slide of 28 息 CRI 2015 CRI 14 Outcomes Stakeholder agreement performance requirements set baseline measurement 40% set a high usability level congruent with regulations. 2004 ASMI labelling code of practice
slide of 28 息 CRI 2015 CRI 15 Labelling performance requirements highlighted text shows tasks concerned with di鍖erentiating between products in a brand
slide of 28 息 CRI 2015 CRI 16 Labelling regulations TGO 69A 2004
slide of 28 息 CRI 2015 CRI avoiding the rubbish bin satisfying the reader. 17 Designing for reading
slide of 28 息 CRI 2015 CRI credible to reader respectful of reader attractive to reader physically appropriate for reader socially appropriate for the reader. 18 Avoiding the rubbish bin
slide of 28 息 CRI 2015 CRI appropriately usable by the reader e鍖cient to use leads to a productive outcome. 19 Satisfying the reader
slide of 28 息 CRI 2015 CRI 20 How do pharmacy CMI perform?
slide of 28 息 CRI 2015 CRI 21 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?
slide of 28 息 CRI 2015 CRI These CMI met all the criteria and were used 22 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?
slide of 28 息 CRI 2015 CRI 23 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?
slide of 28 息 CRI 2015 CRI 24 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
slide of 28 息 CRI 2015 CRI Overall improvements across OTC products 25 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
slide of 28 息 CRI 2015 CRI Thinking into the future: merging container, cmi & packaging 26 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
slide of 28 息 CRI 2015 CRI 27 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/
slide of 28 息 CRI 2015 CRI 28 thank you david sless d.sless@communication.org.au

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David sless cri medicine labelling @ arcs 2015

  • 1. slide of 28 息 CRI 2015 CRI 1 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
  • 2. slide of 28 息 CRI 2015 CRI 2 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
  • 3. slide of 28 息 CRI 2015 CRI 3 Labelling lessons from communication research
  • 4. slide of 28 息 CRI 2015 CRI Medicine labelling is regulated and includes: Medicine containers 4
  • 5. slide of 28 息 CRI 2015 CRI Medicine labelling is regulated and includes: Medicine containers 5 Consumer medicine information (CMI) Packaging
  • 6. slide of 28 息 CRI 2015 CRI Medicine labelling is regulated and includes: Medicine containers 6 Consumer medicine information (CMI) Packaging
  • 7. slide of 28 息 CRI 2015 CRI 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 7 control help!! Regulators know a lot about control but very little about helping people.
  • 8. slide of 28 息 CRI 2015 CRI 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
  • 9. slide of 28 息 CRI 2015 CRI 9 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
  • 10. slide of 28 息 CRI 2015 CRI 10 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.
  • 11. slide of 28 息 CRI 2015 CRI 11 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
  • 12. slide of 28 息 CRI 2015 CRI 12 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
  • 13. slide of 28 息 CRI 2015 CRI 13 Brief collaborate with all stakeholders set performance requirements set a high usability level congruent with regulations baseline measurement. 2004 ASMI labelling code of practice
  • 14. slide of 28 息 CRI 2015 CRI 14 Outcomes Stakeholder agreement performance requirements set baseline measurement 40% set a high usability level congruent with regulations. 2004 ASMI labelling code of practice
  • 15. slide of 28 息 CRI 2015 CRI 15 Labelling performance requirements highlighted text shows tasks concerned with di鍖erentiating between products in a brand
  • 16. slide of 28 息 CRI 2015 CRI 16 Labelling regulations TGO 69A 2004
  • 17. slide of 28 息 CRI 2015 CRI avoiding the rubbish bin satisfying the reader. 17 Designing for reading
  • 18. slide of 28 息 CRI 2015 CRI credible to reader respectful of reader attractive to reader physically appropriate for reader socially appropriate for the reader. 18 Avoiding the rubbish bin
  • 19. slide of 28 息 CRI 2015 CRI appropriately usable by the reader e鍖cient to use leads to a productive outcome. 19 Satisfying the reader
  • 20. slide of 28 息 CRI 2015 CRI 20 How do pharmacy CMI perform?
  • 21. slide of 28 息 CRI 2015 CRI 21 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?
  • 22. slide of 28 息 CRI 2015 CRI These CMI met all the criteria and were used 22 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?
  • 23. slide of 28 息 CRI 2015 CRI 23 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?
  • 24. slide of 28 息 CRI 2015 CRI 24 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
  • 25. slide of 28 息 CRI 2015 CRI Overall improvements across OTC products 25 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
  • 26. slide of 28 息 CRI 2015 CRI Thinking into the future: merging container, cmi & packaging 26 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
  • 27. slide of 28 息 CRI 2015 CRI 27 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/
  • 28. slide of 28 息 CRI 2015 CRI 28 thank you david sless d.sless@communication.org.au