Optimising Your Patient Information.
With PharmaLex the emphasis is on patient
choice and safety.
PIL User Testing
Do your patients understand your leaflet?
Sections of the Patient Information Leaflet are often difficult for the patient to understand. Information is often given in scientific language in order to fulfil regulatory requirements. It is more appropriate for medical staff and the authorities rather than the patient. It is the patient who needs to know and understand the benefits as well as the risks of their medical treatment. Therefore providing accurate and understandable information to the patients becomes an ethical matter.
It’s the LAW.
- Legislation has been passed to make Patient Information readability tests a legal requirement under Directive 2001/83/EC of the European Parliament.
- The national implementation of this directive is finalised in most EU member states.
- It is required that “The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use” and that “The results of assessments carried out in cooperation with target patients groups shall also be provided to the competent authority.”
- Volunteers from the potential patient population take part in a PIL User Test to assess the readability of the proposed Patient Information Leaflet.
What has to be done?
| All PILs- new or existing - have to be revised to be "readable" and easy to understand for the patient. | The format for the text has to be according to the current QRD-Templates. | An appropriate sample population from the target group has to be chosen and submitted to a validated test procedure. | Test results have to be analysed. An executed summary has to be prepared and submitted to the Authorities. |
Where are the problems?
| The preferences of each national authority has to be considered. | The balance between legal requirements and a user friendly wording presents a challenge. |
What PharmaLex can do for you.
PharmaLex International offers a full service to ensure that your patient information leaflet is fully revised and updated in accordance with current guidelines. We can provide innovative suggestions to improve your leaflet.In addition:
- PharmaLex International provides the whole range of regulatory support for marketing authorisation of medicinal products.
- Our registration experts have broad experience in the pharmaceutical industry.
- We are specialists in the Life Cycle management of products.
- We have a network of partners across Europe to advice on national preferences that may affect the acceptance of your PIL.
PIL review
Depending on your requirements we will generate your PIL or review an existing PIL-text, paying attention to EU guidelines and national requirements. We will liaise with relevant company departments as necessary.
Need for user test
It may not be necessary to test all PILs. We will evaluate the possibility of an exemption from readability testing.
User test
The PharmaLex User Test will be conducted according to the relevant EU guidelines and all results together with an executive summary will be provided to support submission to the Competent Authorities.