In response to the evolving landscape of electronic Product Information (ePI) and the currently ongoing revision of the EU General Pharma Legislation, the ePI Roundtable Series was launched as a collaborative initiative by AstraZeneca, Bayer, and Chiesi. The series seeks to inspire a new dialogue around the potential of ePI to improve how Product Information is shared and its impact on health outcomes. Through a structured, progressive format of three moderated roundtables, the initiative brings together a diverse group of stakeholders, including patients, healthcare professionals, regulators, and researchers, for open, solutions-oriented and patient-centric discussions.

To ensure the discussion was anchored in patient perspectives, the first roundtable brought together patient representatives and patient safety organizations. The discussion focused on identifying patient needs, information gaps, and the challenges and opportunities associated with a new way of providing medicines information, such as through ePI.

Patient needs and the Product Information Leaflet (PIL)

As health conditions and innovative treatments become more complex, patients are increasingly prescribed multiple, and often unfamiliar, medications, sometimes taken simultaneously, without the benefit of prior personal experience.

The discussion during the roundtable led to the identification of patient information needs and preferences across various aspects. There was unanimous agreement over the basic requirements for Product Information Leaflets, such as usage and dosage instructions, safety, and side effects information. However, certain aspects of the leaflets were identified as insufficient, such as the content available to patients regarding the types and severities of interactions between medications, and detrimental to the user experience, such as small font sizes.

Gaps identified in today’s Product Information Leaflets

The organizations present in the discussion identified various gaps and areas for improvement in the way information is currently provided to patients. These include communication gaps by healthcare professionals, limitations of today’s Product Information Leaflet, and the differing roles of and expectations from paper and digital information.

It’s important to note that the human aspect of Product Information was highlighted as one of the most important ways that patients receive their information: healthcare professionals (HCPs) form a cornerstone of health literacy. However, today’s pressured healthcare systems face time and resource limitations, and while HCPs aim to do their best, in-depth conversations can sometimes prove difficult. Also, patients have different levels of understanding, with some being satisfied with basic information and others seeking a more scientific understanding. Those with lower health literacy often find themselves at a disadvantage when reading PILs.

Patient perspectives on potential upgrades

Paper leaflets are currently the most readily available resource for information, and the discussion highlighted the convenience of the paper format and its importance as an analog system. However, will the paper leaflet still meet safety and performance standards as the primary source of information over the next decade? And how would it cope with the increasingly complex medical needs?

Whatever form the future system takes, any changes to the paper PILs must be gradual, allowing for sufficient time for all demographics to adapt. In the discussion, patient organisations stressed the importance of having paper and ePI complement each other for a period that cannot yet be clearly defined. In the future, whether the paper format is phased out or not should entirely be dependent on evidence-based decision making that maintains patient safety and health as the top priority.

But what form could this future digital format take on? Participants were asked to imagine potential benefits of the digital format and agreed that it could provide various groups with much needed support. Some of the simplest benefits include allowing patients living with disabilities to access information more easily, allow patients to quickly change languages while ensuring the trustworthiness of the content, providing easy access to critical information and the ability to compare it across medicines through, for example, AI tools, reducing the reliance on information from internet sources, and contributing to the improvement of health outcomes of patients by supporting therapeutic adherence and the correct use of medication. Take, for example, a reminder function that prompts patients to take their medication on time, and videos demonstrating the correct use of tools like inhalers for optimal results. A more advanced version of ePI could eventually become a comprehensive, personalized and real-time solution designed to provide each individual patient with tailored information adapted specifically to their needs.

There are, of course, some areas of concern that must be addressed for a truly successful ePI system. Equity is essential and relevant to both paper and digital formats, as no group must be put at a disadvantage no matter what format is being used. Cybersecurity is another concern, and the cybersecurity of ePI must be of utmost importance because it must be considered as an individual’s health data. Finally, the issue of printing on demand arises: printing on demand could be employed as a phasing in/out tool throughout the transition. However, it is not expected to be a popular choice as patients are unlikely to take the extra step to print the paper or ask for its printing when acquiring their medication, especially if this is not provided by pharmacists.

Conclusion

Digitalization can offer many benefits if done in a socially inclusive manner. The participants indicated clear enthusiasm for a secure digital ecosystem with smart, tailored information. Such a tool would, after all, have the potential to improve patient safety and empowerment, and complement the work done by HCPs with the potential of reducing their workload rather than overburdening them. Finally, the roundtable reaffirmed the importance of ensuring that patients are actively involved in the development of Product Information, whether digital or not, as they are the group most impacted and served by its objectives. It will now be important to further discuss these learnings during the next two roundtables with further stakeholders including Health Care Professionals and Regulators.