Creating Effective Patient Information Leaflets: Guidelines and Examples

Patient Information Leaflets (PILs) included in the package with medicine are the primary source of information about the product and provide guidance for a patient on how to use/consume the medicine. This simple and straightforward document has the potential to inform, educate, and reassure users, helping them use their medication safely and effectively. However, creating a PIL that resonates with various patient populations while meeting strict regulatory standards is quite challenging for various reasons including the complexity of the product, the condition that it’s aimed to treat, and the regulatory framework that it is subjected to.??

A well-crafted PIL is crucial in providing patient-centered care. From addressing common concerns to clarifying complex instructions, every element of the leaflet must be clear, accessible, and actionable.?

Guidelines for Creating Effective PILs?

Creating a Patient Information Leaflet (PIL) that resonates with patients involves adhering to regulatory standards and requirements while focusing on a patient-centric design and language that is easy for the common public to understand. Here are some critical guidelines that should be followed:?

1. Regulatory Frameworks?

Each region has specific guidelines for PILs, such as the EMA’s readability requirements in the EU or the FDA's guidance in the US. These frameworks mandate:?

• Structured information with clear section headings as per the desired format.?

• Accurate descriptions of benefits and risks.?

• Inclusion of contraindications, side effects, and dosage instructions.?

2. Readability and Clarity?

Medical terminologies can confuse readers. Instead, adopt simple, every day or “layman” language to ensure accessibility across diverse patient populations.??

For example:?

• Replace "contraindicated" with "should not be taken if."?

• Use bullet points or numbered lists for clarity.?

3. Design?

A well-designed leaflet is as important as the content itself. Follow the given principles for effective design:??

• Font Size and Style- Use legible fonts specified by each regulatory agency.
• Layout- Organize information logically, with ample white space.?

• Contrast- Ensure high contrast between text and background for easy readability.?

4. Visual Aids?

Visual elements like icons, diagrams, and tables can help explain complex instructions. For example:?

• Diagrams illustrating the correct way to administer an inhaler.?

• Tables summarizing possible side effects and their severity.?

5. Multilingual Options?

For regions with diverse linguistic populations, offering PILs in multiple languages can significantly enhance patient comprehension and adherence. This is typically a requirement of certain regulatory agencies where they necessitate a PIL to be developed in English and in the local language.??

6. Feedback from User-testing??

User-testing of PILs is an essential step, followed by many regulatory agencies like EMA, FDA, MHRA. ?The PIL must reflect the results of consultations with target patient groups.??

For example, In EU, User testing involves testing the readability of a PIL specimen with a group of selected participants who represent the target patient population. The testing procedure is typically carried out by the marketing authorisation holder or by an external company contracted for this purpose through interviews and surveys.?

Collect feedback on the clarity, layout, and overall effectiveness of the leaflet. This step ensures that the PIL meets the intended audience's needs.?

Examples of Well-Crafted PILs?

1-Simplified Language for Antihistamines?

An over-the-counter antihistamine PIL replaced complex phrases like "may cause drowsiness" with "This medicine might make you feel sleepy. Do not drive or use machines after taking it."2- Visual Instructions for an EpiPen?

A PIL for an EpiPen included step-by-step illustrations of how to use the device, along with concise text instructions. This approach ensured clarity even in emergencies.?

3- Multilingual PILs in Canada?

A pharmaceutical firm catering to Canada’s bilingual population provided English and French PILs, with QR codes linking to audio versions for visually impaired patients.?

Conclusion?

Creating effective Patient Information Leaflets by adhering to the principles of clarity, accessibility, and patient-centricity, pharmaceutical manufacturers can transform their PILs into powerful tools for health empowerment.?

Are your PILs meeting the mark? If you’re looking for expert guidance in regulatory requirements and patient communication strategies, reach out to DDReg today.??

Missed our last blog? Catch it here: Ultimate Guide to Streamlining Regulatory Document Archiving for Maximum Efficiency