Readability Test of Package Leaflet for
Patients
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« Guideline on the Readability of the Labelling and Package
Leaflet of Medicinal Product for Human Use » (12.01.2009)
Sossane Nourestani
M2 AREIPS
Monday 14th November 2016
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Summary
I. Definition and Legal Framework
II. Recommandations on the Readability of the package leaflet
and the labelling
III. Leading of the Readability Test
I. Definition and Legal Framework
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1. Principle of the Readibility Test
15-20 Questions
Localisation
Comprehension
Leaflet v1
Analyse
answers
Modifications
Group 1
10
Analyse
answers
Results
Leaflet
v2
Group 2
10
15-20 Questions
Localisation
Comprehension
Final
Leaflet
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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
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I. Definition and Legal Framework
3. 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)
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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.”
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I. Definition and Legal Framework
3. 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
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I. Definition and Legal Framework
3. 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
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I. Definition and Legal Framework
3. Legal Framework
 For what kind of dossier ?
 Every New applications of MA dossiers
 Applications of Variations dossiers
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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)
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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
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III. Leading of the Readability Test
1. Different types of Readability Test
a. The Complete Test
 Testing the leaflet with 20 participants
 2 rounds (10 subjects each time)
1) Identifying the part of the PL ↔ difficulties for
comprehension
2) Ckecking the previous modifications ↔ improved
readability of the PL
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III. Leading of the Readability Test
1. 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
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III. Leading of the Readability Test
2. Different steps
a. Preparation of the interview
b. Leading of the interview
c. Analyses of the results
d. Final Report
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III. Leading of the Readability Test
2. Different steps
a. 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
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III. Leading of the Readability Test
2. Different steps
a. Preparation of the interview
Can you specify two Side
effects which can require to
stop taking this medicine ?
Can you specify two cases
when you can never take this
medicine ?
Number of patients who find
easily the information on the
PL
Number of patients who
understood completely and
correctly the question
10/10
10/10
10/10
10/10
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III. Leading of the Readability Test
2. Different steps
a. 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
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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
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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)
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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.
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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
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Thank you for your attention
Questions ?
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References
 European Commission. Guideline on the readability of the labelling and package leaflet of
medicinal products for human use. [En ligne] 2009. [Cité le 04 Novembre 2016]. Disponible:
http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm
 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:
http://ansm.sante.fr/searchengine/general_search?SearchText=conseils+pour+%C3%A9labor
ation+notices&ok=Valider
 DIRECTIVE 2001/83/CE DU PARLEMENT EUROPÉEN ET DU CONSEIL du 6 novembre 2001
instituant un code communautaire relatif aux médicaments à usage humain.
 Code de la santé publique – Article R5121-148 [En ligne]. Code de la Santé Publique.
https://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArtic
le=LEGIARTI000006914900&dateTexte=&categorieLien=cid
 Code de la Santé Publique – Article R5121-25 [En ligne]. Code de la Santé Publique.
https://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArtic
le=LEGIARTI000006914748&dateTexte=&categorieLien=cid