One of the latest initiatives being spearheaded by EMA is publishing ePI, or electronic product information. In some respects, the pharma industry has lagged behind other major industries in terms of how documentation and critical information is relayed to the end patient. Due to regulations, pharma still heavily relies on traditional Microsoft Word-based documentation for labeling that is managed with track changes and then ultimately printed. Besides not leveraging the latest technologies for patient benefit, the current process makes for a cumbersome translation process to provide the PI in the required 25 languages. The introduction of ePI will facilitate more effective and faster change management, version control, translation, and use of advanced translation tools.
What is ePI?
The EU common standard for electronic product information (ePI) has been developed with the goal of expanding public access to accurate and up-to-date information on medicines, labeling, and package leaflets. The ePI itself highlights technical features, such as controlled vocabulary, mark-up language, and interoperability specifications. It is semi-structured for electronic handling and distribution, as well as readable by automated text-to-speech systems for increased accessibility. Through consultations between stakeholders and the EMA, a guide has been developed to outline the use of ePI within the EU in the interest of public health, regulatory efficiencies, and effective multilingual communications.
What is the current landscape of ePI?
In the EU, there are more than 500,000 human medicines in circulation, with several member states, such as Spain, already leveraging electronic formats. Most, however, continue to use PDF formats. The ePI was developed with the goal of disseminating unbiased, accurate information across patient-accessible electronic channels. The current state aims to harmonize this information with an end-goal of improving patient education and enabling more informed decision-making.
What areas is it targeting?
· Package Leaflets (PLs)
One action item for the EMA is improving patient comprehension and readability of PLs. Existing content is considered overly complex and inaccessible across patient groups, including children and the elderly, and those with lower literacy. As content is changed in PLs, the EMA recommends the same changes be applied in parallel to summary of product characteristics (SmPC), in which they identified fewer problem areas.
· Guidelines & Quality Review of Documents
Connected in part to the changes implemented in PLs and SmPCs as far as content and layout are concerned, proposed amendments to the Guidelines and Quality Review of Documents (QRDs) aim to reconcile issues of readability and information quality. The guidance specifically addresses the Readability Guideline, Packaging Information Guideline, and SmPC Guideline, recommending the addition of good design, public consultation, and the introduction of user-tested lay-language to reduce complexities and content length. It also recommends that these principles be equally applied to translated content to ensure simplification across all versions.
· Patient Input in PL Development & Testing
This would afford more power to patients during the PL process with the goal of adapting content for easy comprehension. The intended action is to integrate user-testing into the existing assessment process to maximize results and avoid delays. The current process relies heavily on patient volunteers, which is unsustainable for iterative user testing. Conversely, this proposed amendment would tap into an EMA database of patient-experts to strengthen patient input on PL content.
· SmPC/PL Formats
There is potential to leverage electronic media as a future source of information for the SmPC and PL processes, complementing paper PLs to maximize information access for individual EU citizens.
Benefits for public health
Centralizing and standardizing the information in one electronic format increases immediate access to critical medicines information. In addition to efficiencies and reducing manual, administrative burdens, this process will aid patients in making fully informed decisions about their medicines in the case of rapidly evolving information. It is also easily adaptable for users with print impairments, learning disabilities, or physical disabilities.
For example, the rollout of COVID-19 vaccines and therapeutics in the EU created an information overload regarding rollout, efficacy, symptoms, and dosage requirements.
In this case, the use of a QR code with a direct link to ePI in the patient’s language enables timely access to the most recent, accurate information regarding COVID-19-related medicines, mitigating the risk of confusion or misinformation.
Other such use cases include immediate access to comprehensive instructions on how to properly administer medications, targeted ePI search for particular medical conditions and treatments, and alerts for updates to safety information.
Benefits for regulatory authorities
Quicker and efficient medicine-sharing between EU countries is facilitated through ePI and eliminates redundant information and mitigates the risk of human error. Automation can rapidly identify or implement changes, enabling access to accurate information as soon as it is available.
Additionally, ePI facilitates medicine trend analysis. Researches can leverage ePI in medicinal studies, adverse event research, patient populations and behaviors, etc. In cases where changes are detected with implications for multiple products, this system allows for simultaneous change implementation for all affected entities. This harmonizes the information that is available to patients and providers.
Component content management and ePI
Pharma companies can use component content management systems to author, manage, translate, and publish PIs to increase content reuse, control the way reused material is updated, provide a rich level of traceability, and automate output with no post-translation formatting or DTP. Ultimately, this could reduce cycle times by 30–40% and translation costs by 30%.
This process can be directly integrated with the translation process to manage all language versions and eliminate the need for manual file transfers or tracking. Changes made to the source content can also quickly and effectively be applied to the corresponding translated versions.
A shift to component content management offers multiple benefits for pharma companies, including the ability to quickly and efficiently provide up-to-date product information to patients and healthcare providers.
These are exciting times! While still in discussion, ePI as an emerging mode of delivering product information is great progress and a step for pharma to catch up. We hope and expect this move will impact other content—not only in the way it is submitted to health authorities, but also how it is accessible to patients and healthcare providers.
Curious to discover how you can keep up to date with the evolving regulatory landscape and the future of ePI? Connect with us today to learn more!