Patient Friendly Labelling - the Way Forward

1. Patient Friendly Labelling - the Way Forward Jane Nicholson

2. Patient Friendly Labelling

3. The Patient Friendly Pack -Factors Affecting Legibility Font size and style Use of colour Orientation of labelling information, i.e. design / layout

9. THE LABELTEXT • Use “sans serif” types, as it is easier to read.

10. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals).

11. Use of “tall” letters VinBLAStine VinCRIStine Seroquel SerZONE as recommended by the Institute of Safe Medication Practices.

12. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals). • Use “bold” type face to emphasise.

13. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals). • Use “bold” type face to emphasise. • Critical warnings should be in red.

14. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals). • Use “bold” type face to emphasise. • Critical warnings should be in red. • Numbers should have no trailing zeros, e.g. 5 mg, not 5.0 mg.

15. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals). • Use “bold” type face to emphasise. • Critical warnings should be in red. • Numbers should have no trailing zeros, e.g. 5 mg, not 5.0 mg. • Distinguish decimal points from full stops. Commas should not be used in decimal numbers.

16. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals). • Use “bold” type face to emphasise. • Critical warnings should be in red. • Numbers should have no trailing zeros, e.g. 5 mg, not 5.0 mg. • Distinguish decimal points from full stops. Commas should not be used in decimal numbers. • Maximise contrast of text and background.

17. Use “sans serif” types, as easier to read. • Use upper and lower case (not all capitals). • Use “bold” type face to emphasise. • Critical warnings should be in red. • Numbers should have no trailing zeros, e.g. 5 mg, not 5.0 mg. • Distinguish decimal points from full stops. Commas should not be used in decimal numbers. • Maximise contrast of text and background. • Use appropriate spacing of text.

18. Use appropriate spacing of text. • Lower case print size should normally not be less than 2 mm in height, but optimum, not minimum, should be used.

19. Use appropriate spacing of text. • Lower case print size should normally not be less than 2 mm in height, but optimum, not minimum, should be used. • Visual impairment and use by the elderly need consideration.

20. Use appropriate spacing of text. • Lower case print size should normally not be less than 2 mm in height, but optimum, not minimum, should be used. • Visual impairment and use by the elderly need consideration. • Abbreviations should not be used.

21. Use appropriate spacing of text. • Lower case print size should normally not be less than 2 mm in height, but optimum, not minimum, should be used. • Visual impairment and use by the elderly need consideration. • Abbreviations should not be used. • Avoid names (both trade and generic) similar to those of other medicines on the market.

22. Use appropriate spacing of text. • Lower case print size should normally not be less than 2 mm in height, but optimum, not minimum, should be used. • Visual impairment and use by the elderly need consideration. • Abbreviations should not be used. • Avoid names (both trade and generic) similar to those of other medicines on the market. • Machine readable coding (e.g. bar coding) will be used by the future pharmacist.

23. Text critical for the safe use of medicines • Strength • Registered name followed by generic name (given due prominence • Route of administration • Dosage instructions for self-medication products • Any special warnings - should appear in as large a font as possible on the pack, in the same field of view and should not be broken up by additional information, logos, other text or graphics. For prescription medicines, the name of the patient, dosage instructions and indication or intended use should be added at the time of dispensing.

24. The full name, strength and, if appropriate, the route of administration should appear on three non-opposing pack faces.

25. Patient Information Leaflets Leaflets designed to go in the manufacturer’s pack

26. 50% of medicines are not taken as directed Marshall Marinker (1997)

28. Method of Testing ReadabilityUsability Guidelines for Consumer Medicine InformationWHAT TO TEST? • Can the consumer find the information quickly and easily? EASE OF LOCATION • Having found it, can they understand and act on it ? USER FRIENDLINESS David Sless & Rob Wiseman, Communications Institute of Australia

29. 20 subjects each asked the same 15 questionsfirst question about product name to establish literacy then 14 safety related questions

30. The European Guideline suggests 16 of 20 subjects should be able to answer all questions correctly.

31. Results 12 out of the 15 questions met the targetQuestion 1:What is the name of the medicine?Only 15 /20 got it right ( the 5 wrong answers were mis-pronounciations)Question 4: Suppose you went red in the face whilst taking this medicine?Only 11/20 got it right ( the wrong answers all went for caution to consult a doctor and stop medication- the right answer was to continue taking the medicine)Question 9:Suppose you were prescribed the medicine before an operation?Only 12/20 got it right ( most of the wrong answers were because people could not find it )

32. Overall Results On 41 occasions (14%) people could not find the informationOn 42 occasions (14%) the incorrect answer was given One rogue subject , a nervous interviewee could read and find information well, as he correctly answered 7 questions but for the other 8, he was a complete blank

33. Remarks made by Subjects* The leaflet is too long* Its hard going - there is a lot of stuff at the beginning you don’t need* Most people don’t read the whole thing so put “when and how to take” the medicine up front* Is it really necessary to have these contact addresses?

35. Remarks made by Subjects • Size of print is not good when you are old. This one is not too bad as it happens- I can read it • Size of print is not good when you are old. This one is not too bad as it happens- I can read it • Sometimes I need a magnifying glass- this is OK • Its for high blood pressure - right ?-by the picture of the arm - that’s how I know where to look • Nice to have diastolic and systolic blood pressure explained - I always wanted to know that • Its for high blood pressure- right by the picture of the arm-that’s how I know where to look • Nice to have diastolic and systolic blood pressure explained- I always wanted to know that

36. Remarks made about Side-effects • That’s the bit I don’t like reading- I think” oh dear!” • For me, the more information, the better - there is more fear in not knowing • Must be quite strong these tablets! • Same old boring rubbish • Well if you get a swollen tongue and rash, you would feel a bit worried too ! • If I feel dodgy, I get down to the old Doc’s straight away!

37. Remark on Storage I store all my medicines in the fridge- then I know where to find them

38. Conclusions 1. Patients need to be “informed” not overwhelmed with information 2. The European legislation on leaflets should be changed 3. Pictograms are helpful in finding and informing

40. Conclusions 4. Flexibility is needed as it is important that information on different products can have a different emphasis

42. Patient Friendly Informationand the Internet

44. Zerit - Stavudine - d4T - HIV infections In 1999, 4,000 sites on Internet mentioned d4T Proposed users for U.K. site: - • Doctors, pharmacists, nurses involved in HIV healthcare (Factual information, pharmacology, safety, efficacy, tolerability of product) • Patients (Factual information with links to disease specific sites) Not placed on any search engines.

45. Zerit - Stavudine - d4T - HIV infections • Proposed U.K. site ruled in breach of our Advertising Code because trade name and logo for Zerit was mentioned and statements: • “A foundation of anti-HIV therapy” • and • “B.M.S. is a leading manufacturer of HIV related treatments” • - in open access on health professionals’ site. • This could raise unfounded hopes in patients of successful treatment.

47. Internet websites for Patients on Prescription or non-Prescription Products should contain: 1. Company identity (sponsor of website)

50. 2. Health education information - methods of disease prevention, screening advice on public health Internet websites for Patients on Prescription or non-Prescription Products should contain: 1. Company identity (sponsor of website)