A leaflet may follow the current QRD template, contain the required information and use the correct structure – and still be difficult for patients to use.
Regulatory compliance and real-world readability are not the same thing.
A good leaflet is not simply one in which the required information is present. Patients must also be able to find that information, understand it correctly and know how to act on it.
The QRD template provides structure. It does not tell us how patients will use the leaflet.
The QRD template is a fundamental tool for developing medicinal product information. It defines the structure of the document, required sections, headings and standard wording.
Its role is essential.
But it should not be expected to do something it was not designed to do.
Compliance with the QRD template alone does not tell us whether patients will quickly find the information they need, understand it correctly and know what to do based on it.
That is a question of readability.
Regulatory requirements go beyond the presence of information
This distinction is also reflected in European requirements for patient information leaflets.
Directive 2001/83/EC requires the package leaflet to be written and designed so that it is clear and understandable, enabling users to act appropriately, and to be clearly legible.
That goes considerably further than simply following the correct document structure.
A leaflet may therefore formally contain the correct information, yet the patient may:
fail to find it, understand it differently from what was intended, or remain unsure what the information means for what they should do.
This is where real readability begins.
Patients do not know the document as well as its authors do
Someone who works on a leaflet knows its structure. They know where particular information is located and why it appears in that section.
The patient does not have that knowledge.
They may also reach for the leaflet because they need a specific answer – sometimes at a moment of uncertainty or stress.
In that situation, it is not enough for the information to be somewhere in the document.
Patients need to be able to reach it quickly – precisely when they need it.
That is why asking:
“Is the information in the leaflet?”
is not the same as asking:
“Will the patient be able to find it and use it appropriately?”
Readability begins where “the information is in the leaflet” ends
At PHARMBICON, we capture this distinction in our 3Z Method:
FIND → UNDERSTAND → ACT
FIND – can the patient find the information they need?
UNDERSTAND – do they correctly understand what it means?
ACT – do they know how to act on that information?
Finding the information is only the beginning.
If a patient finds the relevant section but misunderstands it, the information has not fulfilled its purpose.
The same is true if they understand the information but do not know what they should do as a result.
This is why user testing adds something that checking compliance with a template alone cannot provide.
The QRD template itself continues to evolve
It is worth noting that the development of European QRD templates is also moving towards making patient information more understandable and useful.
EMA’s work on the next version of the template takes account of experience relating to how patients use product information.
That sends an important signal.
Compliance with the template and real-world usability are not competing objectives. A good leaflet needs both.
QRD and readability answer different questions
The distinction can be made very simply.
The QRD template helps answer:
Has the document been structured appropriately?
Readability asks:
Can the patient actually use the document effectively?
One does not replace the other.
Compliance with the QRD template is essential.
But on its own, it does not guarantee good readability.
Summary
A well-prepared leaflet needs to bring together two perspectives:
REGULATORY – the document is correct, complete and compliant with the applicable requirements,
and
PATIENT – the information can be found, understood and used appropriately.
Only by bringing these perspectives together can a leaflet both meet regulatory requirements and genuinely fulfil its purpose for the patient.