1. Sossane Nourestani M2 AREIPS Monday 14th November 2016
Readability Test of Package Leaflet for Patients « Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Product for Human Use » ( )
Sossane Nourestani
M2 AREIPS
Monday 14th November 2016

2. Summary Definition and Legal Framework
Recommandations on the Readability of the package leaflet and the labelling
Leading of the Readability Test

3. I. Definition and Legal Framework
Principle of the Readibility Test
15-20 Questions
Localisation
Comprehension
Analyse answers
Modifications
Results
Leaflet v2
Final Leaflet
Group 1 10
Group 2 10
Leaflet v1
15-20 Questions
Localisation
Comprehension
Analyse answers

4. I. Definition and Legal Framework
2. Aim of the Readability Test
Demonstrating the weakness of the leaflet
Identifying difficulties to find and understand the information
Improving design and presentation of the leaflet
Improving the Good Use of medicines

5. I. Definition and Legal Framework
Directive 2001/83/EC amended by Directive 2004/27/EC
Requires the Readability test since:
2005 for the Community Procedure (CP,MRP,DP)
2008 for the National Procedure (French Decree N°2008/435)

6. I. Definition and Legal Framework
Article 59(3)
“The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.”
Article 61(1)
“The results of assessments carried out in cooperation with target patient groups
shall also be provided to the competent authority.“
Article 63 (2)
“The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals.”

7. I. Definition and Legal Framework
When is this test required ?
First authorisation of a Medicinal Product with a new AS
MP with change in legal status
MP with a new pharmaceutical form or new route of adm
MP with particular critical safety issues

8. I. Definition and Legal Framework
When is the test not required ?
Extension for the same route of administration
Same safety issues identified
Same class of medicinal products
Reference
To already approved package leaflet

9. I. Definition and Legal Framework
For what kind of dossier ?
Every New applications of MA dossiers
Applications of Variations dossiers

10. II. Recommandations on the Readability of the package leaflet and the labelling
1. Summary of the Main Recommandations
Recommandations
Type size and font
Time New Roman
9 points
Headings
Bold
Using line to seperate diff sections
Print colour
Dark text on lighted background
Lighted text on dark background (warnings)
Synthax
Simple
Short Sentence/Paragraph
▲Order of side effects by frequency of occurrence
Style
Active style instead of passive
Abbreviations and acronyms should not usually be used
Medical terms should be translated
Paper
Weight +++ (reduce transparency)

11. II. Recommandations on the Readability of the package leaflet and the labelling
2. General Considerations
Leaflet package well designed and clearly worded
→ promote the use of information by patients (older children; adolescents; poor literacy; some degree of sight loss )
These recommandations optimize the usability of the package leaflet

12. III. Leading of the Readability Test
Different types of Readability Test
The Complete Test
Testing the leaflet with 20 participants
2 rounds (10 subjects each time)
Identifying the part of the PL ↔ difficulties for comprehension
Ckecking the previous modifications ↔ improved readability of the PL

13. III. Leading of the Readability Test
Different types of Readability Test
b. The Bridging Test
Extension for the same route of adm (e.g IV/IM)
Same class of medicinal product
Comparative table of safety info
PL of reference VS PL tested
Mock up of the PL
Report of the complete Readability Test of the PL of Reference

14. III. Leading of the Readability Test
2. Different steps
Preparation of the interview
Leading of the interview
Analyses of the results
Final Report

15. III. Leading of the Readability Test
2. Different steps
Preparation of the interview
Preparing the questions
Cover any critical safety issues with the medicine;
Cover a balance of general and specific issues;
Be phrased differently from the text of the leaflet:
Appear in a random order:
Cover the preparation/handling instructions for products with complex administration devices

16. III. Leading of the Readability Test
2. Different steps
Preparation of the interview
Number of patients who find easily the information on the PL
Number of patients who understood completely and correctly the question
Can you specify two Side effects which can require to stop taking this medicine ?
10/10
Can you specify two cases when you can never take this medicine ?

17. III. Leading of the Readability Test
2. Different steps
Preparation of the interview
Recruiting participants
Representative of the population to be treated
Young people and older people
New users or people who do not normally use medicines
People who do not use written documents in their working life;
People who find written information difficult

18. III. Leading of the Readability Test
2. Different steps
b. Leading of the interview
Individual interview face to face not more than 45 minutes
Allow the participant to read the whole of the leaflet
Answer into their own words
Observe the way the participants search the information

19. III. Leading of the Readability Test
2. Different steps
c. Analyses of the results
Success criteria
90% of participants find the information requested of whom 90% can show that they understand it
= 16/20 participants able to find and understand the information
(for each question)

20. III. Leading of the Readability Test
2. Different steps
d. Final report
Questions asked,
Responses offered
Interviewer’s written observations
Different versions of the package leaflet tested
Submitted in module 1 (section 3-4) of the application dossier to the competent authority for review.

21. Conclusion
Leaflet can be difficult to understand (Modifications between two round of the test)
Readabality test of the leaflet +++
Improving the good use of medicines

22. Thank you for your attention Questions ?

23. References
European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. [En ligne] [Cité le 04 Novembre 2016]. Disponible:
ANSM. Conseils pour l’élaboration des notices destinées aux patients et la conduite des tests de lisibilité. [En ligne]2014. [cité le 05 Novembre]. Disponible: ation+notices&ok=Valider
DIRECTIVE 2001/83/CE DU PARLEMENT EUROPÉEN ET DU CONSEIL du 6 novembre instituant un code communautaire relatif aux médicaments à usage humain.
Code de la santé publique – Article R [En ligne]. Code de la Santé Publique. le=LEGIARTI &dateTexte=&categorieLien=cid
Code de la Santé Publique – Article R [En ligne]. Code de la Santé Publique. le=LEGIARTI &dateTexte=&categorieLien=cid