Readability testing and bridg​ing

PL is written for the users of the medicinal product. The PL must be of good quality enabling the users to apply the information. Patients who are potential users of the medicinal products have the best ability to answer questions and to give feedback on the readability and usefulness of the package leaflet. User consultation is a method that involves potential patients.

The interview should be conducted in a structured manner. The participants should be able to find the information, to answer in their own words and act approproately in an imagined situation. The patients shall also give specific comments on design and layout.

The patients experience how the PL function in practice . The consultation itself does not improve the PL, but indicates where there are sections which should be rectified. It is important that the interviewer takes the suggestions from the paticipants into consideration and utilise these to improve the quality of the PL.

User-consultation is a requirement for marketing authorisation applications (MA), line extensions, variations concerning change in legal status (OTC/Rx), medicinal product with a new presentation and medicinal products with critical safety issues.

User consultation is not a requirement for veterinary medicinal products.

Results from user test or justification for not performing such consultation is to be included in all new applications for marketing authorisations, variations for change in the legal status from Rx to OTC in the national procedure and other applications where user test is required.

The following is only applicable for MA applications: The application can contain a statement where the applicant states that the user test will be included in the response to the first assessment report

How to achieve a package leaflet easy to read a​​nd with a patient friendly language​
It is crucial that the applicant does a review of the language in the package leaflet. Ensure that the latest QRD template is used and that the language used is active.

Use short words and sentences to achieve a clear leaflet that is easy to read. Make sure that the most important information comes first and avoid long paragraphs. Bullet points are recommended where suitable (preferably not more than 5-6).​

Use terms and expressions that people in general understand. Alternatively, terms that are easy to understand can be followed by the advanced medical term, for example in brackets.

The package leaflet shall be user friendly. Make sure that the information is sufficiently detailed for the user to recognise possible adverse effects and make the appropriate measures and actions.

Applicant has to choose a font that is easily read. Make sure that i, l, and 1 are easily distinguished from each other. Do not usenarrowed fonts as they are difficult to read.

Large font size makes the text easy to read Times New Roman does not qualify as an easily read font, however, a font size of 9 points as measured in font Times New Roman is considered as a minimum.​

Bold font may be used for headlines and subheadings. Do not use underlining. Italics shall only be considered when using Latin terms. Avoid excessive use of capital letters.​

The space between lines shall be minimum 3 mm.

The meaning of the pictogram shall be clear and aid correct use of the medicine. Pictograms must be accompanied by a text.

Before the test, applicant has to decide how to recruite participants in addition to describe inclusion- and exclusion criterias.

Recruit participants who are relevant users (age, gender) of the particular medicine. The participants should neither have too high educatuion level, a profession where they use written material on a daily basis nor have used the medicine in the past. Be sure to exclude people who are directly involved with medicines such as doctors, nurses and pharmacists.

Before the questions are made, review the package leaflet and identify the information considered crucial for safe use. The questions should be open, hence not yes/no questions. Further, the questions should not have long answers.

Assure that the questions covers crucial safety information. The PL should include general information regarding what the patient should do if a dose is missed or a specific adverse event occurs. A user test should also focus on the instructions on adminitration and dosing. The questions should also consider pictograms if applicable. Also make sure to receive feedback on th PL’s layout and design.

Generally, 12-15 questions will be sufficient. In certain instances when comprehensive information is necessary to ensure safe use, additional questions might be needed.

It is recommended to perfom a pilot before the user test. The main purpose of a pilot is to review whether the questions can be considered suitable. If the pilot test indicates that the language or design aren’t pasient friendly, the Applicant should consider the feedback to improve the package leaflet.​

The participants are given mock-ups of the package leaflet and read this.

The interviewer asks the questions orally. For each question, the participant shall locate the information in the package leaflet and answer in their own words.

• Register if the participant is able to find the information. Note down the time the participant used to find the information for each question. (More than 2 minutes is often categorized as not found).
• Record if the paticipant is able to understand the information. Note down the participant`s answer to each question. The answers is usually separated in categories as for example correct answer, wrong answer or incomplete answer.

It is important to have questions to prove that the particant is able to use the information i.e. question about how the participant will act in an imagined situation.

There should be clear instructions for the interviewer. An instruction should decribe what the interviewer should do if the participant does not find the answer. For example the interviewer can be allowed to read the question again, but not help the participant to find the answer.

A total of 10 persons in the first round is usual. Review the results and make use of the participant`s feedback to improve the package leaflet before the next round.

The second round should verify the result from the first round.

Describe the recruitment of the target patient group and present demographic data of participants.

Present results of each round separately. The number of participants able to find the information and the number of participants who have understood the information, should be presented. The aim of the user test is to ensure that the package leaflet is legible and easy to use. The applicant should discuss the results, and suggestions from the partcipants shoud be taken into considerations. Any weaknesses inditified, should be addressed in an approriate way to improve the readability for the user.

The criteria is that 90% of test participants can find the information , of whom 90% can show that they understand it, i.e. each and every question meets criterion of 81 % correct answers. This means to have 16 out of 20 participants should been able to find the information and have answered each question correctly and shown that they can use the information.

The user test is valid until a new is required, cf. question 2.

Is it required to perform a user consultation for package leaflets that were approved before the requirement on user consultation was implemented in the regulation?

Many medicinal products were approved before the requirements on user consultation came into force. The Norwegian Medical Products Agency has not required user consultation of the package leaflet for those products.

If a company applies for a line extension, i.e. a new strength or a new presentation of the medicinal product, if they apply for a change in the legal status from Rx to OTC or a major safety variation, a user consultation is required.

Many medicinal products were approved before the requirements on user consultation came into force. The Norwegian Medical Products Agency has not required user consultation of the package leaflet for those products. 

If a company applies for a line extension, i.e. a new strength or a new presentation of the medicinal product, if they apply for a change in the legal status from Rx to OTC or a major safety variation, a user consultation is required. 

If a package leaflet are sufficiently similar both in content and layout to another package leaflet that have gone thru a successful user consultation a “bridging” may be done to demonstrate that the requirements for user consultation are met.

Use the QRD form for submission and assessment of user testing bridging proposal.

For centrally authorised medicinal products, you will find the QRD form on the European Medicines Agencies (EMA) homepage. The QRD form for the decentralised and mutual recognitinal procedure the form are published on the CMDhs homepage.

For purely national authorised medicinal product, please use the QRD form published on the CMDhs homepage.

A focus test isa “focused” user test, only addressing certain aspect of the package leaflet crucial for safe use of the medicinal product. Often, only a couple of questions may be sufficient for a focus test. Design the questions to make sure that the user can find, understand and use new and important information.