by Valeria Quintily – Sr. Scientific Project Manager at LS Academy
In the dynamic and ever-evolving pharmaceutical industry, staying updated with the latest technological advancements is crucial. One significant shift currently underway is the move from traditional paper-based product information to electronic Product Information (ePI).
This transformation not only modernizes how information is delivered but also offers numerous benefits for the industry and patients alike.
This blog will delve into what ePI is, its impact on the pharmaceutical industry, its benefits for patients, and the tools available to support its implementation.
What is ePI?
Electronic Product Information (ePI) is a digital format for delivering essential information about medications, replacing the conventional paper leaflets included with pharmaceutical products. ePI encompasses documents such as the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labeling information. These documents are made available electronically, ensuring that they are accessible, up-to-date, and easy to understand for both healthcare professionals and patients.
The European Medicines Agency (EMA) and other regulatory bodies have been actively promoting the adoption of ePI. The implementation of ePI standards like Fast Healthcare Interoperability Resources (FHIR) aims to improve patient safety, establish data interoperability, and enhance healthcare outcomes. In July 2024 EMA concluded a pilot with ePI based on an online editor. At this moment, there are 23 published ePI documents available for browsing in the PLM Portal.
Impact of ePI on the Pharmaceutical Industry
The shift to ePI has several profound advantages for the pharmaceutical industry:
- Enhanced Regulatory Compliance: ePI facilitates better compliance with regulatory requirements by enabling real-time updates and seamless integration with regulatory systems. This ensures that the most current information is always available, reducing the risk of non-compliance.
- Cost Efficiency: Transitioning to ePI reduces the costs associated with printing and distributing paper leaflets. This shift also aligns with environmental sustainability goals by minimizing paper use and waste.
- Improved Data Management: ePI allows for better data management and integration with other digital systems. Pharmaceutical companies can efficiently manage updates and ensure consistency across various platforms, reducing errors and enhancing the quality of product information, especially when data is used as a basis for ePI authoring (e.g. Structured Content Authoring).
- Global Accessibility: Digital information can be accessed globally, ensuring that healthcare professionals and patients have the necessary information at their fingertips, regardless of location. This is particularly beneficial in remote or underserved areas where paper leaflets may not be readily available, or when reliable translations are needed.
However, the transition to ePI is not without its challenges. The pharmaceutical industry will need to rethink how it manages version control, particularly when considering the differences between versions in internal systems and those at regulatory authorities. There is also the complexity of integrating various tools into existing authoring processes, including both internal tools and potential connections to regulator user interfaces. Additionally, pharmaceutical companies must navigate the differences in regulatory requirements across regions and countries, which can lead to discrepancies between local versions of ePI. Aligning ePI content with physical labeling is another critical aspect, requiring careful coordination to ensure consistency.
The Role of Standardized Data in ePI
As ePI continues to evolve, the role of standardized data becomes increasingly important. In the current EMA approach, there is only limited metadata that is standardized, but this is expected to grow as the maturity of ePI advances. This is where integration with regulatory systems becomes even more critical, enabling pharmaceutical companies to supply standardized data with the ePI in an automated and efficient manner. Standardized data not only facilitates smoother regulatory submissions but also ensures that the information provided is consistent, accurate, and easily accessible across different platforms.
The Impact of ePI on Patients
The primary goal of ePI is to enhance patient outcomes by providing better access to medication information. Here are some key benefits for patients:
- Informed Decision-Making: ePI empowers patients by providing easy access to comprehensive information about their medications. This helps them make more informed decisions regarding their treatment, leading to better adherence and outcomes.
- Enhanced Safety: The ability to update ePI in real-time ensures that patients always have the most current safety information, such as new contraindications or changes in usage instructions. This reduces the risk of medication errors and improves overall patient safety.
- Accessibility and Inclusivity: ePI can be provided in various formats, including audio and interactive digital formats, making it accessible to patients with visual impairments or literacy challenges. This inclusivity ensures that all patients can understand and act upon the information provided.
- Convenience: ePI can be integrated into digital health tools, such as mobile apps or patient portals, providing a convenient way for patients to access information anytime, anywhere. These tools can also offer additional support, such as medication reminders or alerts about updates to their medications.
Tools Available to Support ePI Management
Implementing ePI requires robust tools and platforms to manage the creation, updating, and dissemination of electronic product information. Here are some key tools available:
- Digital Platforms for ePI Creation and Management: These platforms offer comprehensive solutions for creating, updating, and managing ePI. They ensure that the information is structured according to regulatory standards and can be easily accessed and updated.
- Content Management Systems (CMS): A CMS designed for pharmaceutical information allows for efficient management of ePI content. It ensures consistency, accuracy, and compliance with regulatory requirements, making it easier to handle large volumes of information.
- Integration with Regulatory Systems: Tools that facilitate integration with regulatory submission systems ensure that updates to ePI are promptly submitted and approved by regulatory bodies. This seamless integration reduces the administrative burden and ensures timely dissemination of information.
- Patient-Centric Applications: Mobile apps and patient portals that provide access to ePI offer additional functionalities, such as medication reminders, interaction checks, and personalized health information. These applications enhance patient engagement and support better health outcomes.
Conclusion
The adoption of electronic Product Information represents a significant advancement in the pharmaceutical industry, offering numerous benefits for both the industry and patients. By embracing ePI, pharmaceutical companies can improve regulatory compliance, reduce costs, and enhance data management, while patients gain access to more accurate, up-to-date, and accessible information. The tools available to support ePI management further streamline the process, ensuring a smooth and effective transition.
As professionals in the pharmaceutical field, it is crucial to recognize and address the challenges that come with ePI implementation, such as version control, tool integration, and regional differences in regulatory requirements. Additionally, understanding the growing importance of standardized data in ePI will be key to leveraging technology effectively in this space. Embracing ePI is not just about meeting regulatory requirements; it is about leveraging technology to improve patient care and drive innovation in our industry. By understanding and adopting ePI, we can contribute to a future where information is more accessible, accurate, and impactful for all stakeholders involved.
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