June 19, 2024 

The Product Information (PI) is an approved, legally required document for medicinal products used in humans, containing the summary of product characteristics (SmPC), the package leaflet, and the labelling.  The ePI, its electronic counterpart, offers this content in a semi-structured format based on common EU standards and on the Fast Healthcare Interoperability Resource (FHIR), a technical standard for the exchange of electronic health data. This enables electronic processing and distribution via the Internet, electronic platforms, and printed media with the aim to improve accessibility, searchability and multilingualism. Furthermore, ePIs are intended to be integrated into electronic healthcare systems so that healthcare professionals as well as patients can easily access accurate and up to date information. 

The EMA (European Medicines Agency) and a group of national authorities within the EU have tested the use of ePI in a one-year pilot project that started in July 2023. Based on these results and the feedback the standard will be developed further. However, affected companies should address issue as early as possible, as there are still several challenges to overcome. 

To meet the requirements of the ePI standard, pharmaceutical companies need to master two main skills. First, they need to be able to send the required data to the EMA's PLM portal and the underlying labeling documents must be created in a semi-structured format. This content must be managed throughout the entire product lifecycle from initial market authorization, throughout countless changes, to the termination of marketing and beyond. For this purpose, the introduction of a Structured Content Management (SCM) System has proven its worth. As the introduction of such a system usually entails a major change in labeling processes and methods for employees, organizational change management is crucial for success. Another challenge that needs to be overcome is the transformation and migration of existing labeling documents, which are usually in the form of monolithic Word files, into the new SCM system. To overcome this problem, the use of a dedicated and intelligent tool has proven to be essential to reduce time-consuming manual effort. 

Structured Content Management in Pharma Labeling

SCM (Structured Content Management) forms the focal point in the creation and the provisioning of electronic product information. In these systems semi-structured logical content modules are created instead of documents and managed throughout the entire life cycle. By using a uniform content structure, errors are minimized and inconsistencies between, e.g. global and local ePIs are avoided. System-supported change management, such as "reused from" and "change & deviation management" features, mean that changes in higher-level documents can be tracked and systematically implemented throughout the entire reuse chain. Additionally, label changes for market authorizations in different regions become easier to track and SCM enables companies to find, update and share their product information more easily.

By effectively structuring the content of product information using technologies such as XML or JSON, companies can streamline their content creation process and distribute information more efficiently across different application platforms  such as artwork management, regulatory document management and web content management. This also lays the foundation for the creation and publication of electronic product information in the FHIR standard.

FHIR is a framework that enables the standardized exchange of data in health information systems. This standard was primarily developed to make patient data in an electronic patient record more accessible for doctors, insurance companies and patients and the  transaction of data between institutions faster, more efficient, and therefore more cost-effective.
This standard defines rules and specification for components, data formats, and application interfaces for the data exchange. With it various web standards and technologies such as XML, JSON, HTTP, OAuth and RESTful API are supported.

As part of the ePI project, FHIR has been expanded to include an ePI definition so that pharmaceutical companies can make electronic product information available to the EMA in a structured form. To be able to reuse the unstructured documents, usually available as Word, they must be converted into semi-structured content and enriched with the necessary information, i.e. metadata. The requirements of the EMA's IDMP initiative must also be met. However, this will not be discussed further, as it is beyond the scope of this blog.

Electronic product information includes all product-related information such as product specifications, instructions for use and warnings about side effects, etc. By digitizing this information, pharmaceutical companies can provide patients and authorities with easy, paperless access to comprehensive details about their products. This not only improves the customer experience, but also reduces printing costs and environmental impact. However, it should not be forgotten that the classic paper package leaflet still must be provided to the patient on request. This could be done in the pharmacy, for example, by printing out a PDF version of the package leaflet. This emphasizes that the same product information must be available in different output formats, e.g.,4 FHIR-formatted content for the EMA portal, a PDF document for printing or a dedicated data format for the publication of user information in the GI 4.0 app of Rote Liste Service GmbH. For this purpose, the content and layout need to be separated. This can be provided by an SCM System which recombines the content with different "stylesheets" to achieve the desired formatting. 

Structured Content Management thus serves as the basis for the ePI by providing a framework for organizing and updating product information. With structured content management, companies can ensure that their ePI is consistent, up-to-date and easily accessible to customers. With advances in technologies such as artificial intelligence and advanced data analytics, companies can use ePI to offer personalized results that are tailored to individual needs. Real-time updates and compliance with industry regulations are made possible by SCM in the fastest possible way.

Document Transformation and Migration

Based on the ideal scenario of an established SCM system, the generation of FHIR-compatible ePIs is relatively easy to ensure, if not already offered by the system in use. A suitable content strategy around the correct granularity of the components and the maintenance of relevant metadata at component level are helpful.

In most cases, the relevant documents are still stored as monolithic documents in traditional document management systems. Metadata only exists at document level, if at all. However, when creating an ePI, the same challenges are faced as if it was migrated to a SCM system.

• Document formatting

Word documents can vary significantly in formatting, including styles, fonts, and layout structures. It is critical to ensure consistent interpretation and extraction of content from these documents.

• Accuracy of extraction

Accurate extraction of semi-structured and structured data from Word documents, especially those with complex layouts or nested structures, require robust analysis techniques to avoid errors and inconsistencies.

• Handling tables and lists

Word documents often contain tables, lists and other structured elements that need to be properly identified and converted into compatible formats for structured content management systems.

• Metadata extraction

The extraction of metadata such as document properties, author information and creation data are essential for the organization and management of structured content. In addition, the extraction of metadata at the level of individual components such as indication, dosage or dosage form using Named Entity Recognition is particularly complex.

• Scalability

As the number of Word documents increases, the conversion process must scale efficiently in order to process large volumes of documents without any loss of speed or accuracy.

• Quality control

Implementing quality control measures to detect and correct errors in the converted data is critical to the integrity and reliability of structured content. Automated validation checks and manual checks may be required to ensure the accuracy of converted content.

The use of a content transformation tool is necessary for economically overcoming the challenges listed above. Only the use of AI technologies makes it possible to manage the complexity of SCM transformation effectively and efficiently. By using advanced natural language processing (NLP) algorithms, a content transformation tool (CTT) automates the extraction, structuring, and validation of product information from various sources, including Word documents. By applying semantic understanding and specific subject matter expertise, it ensures the integrity, accuracy, and compliance of converted data to SCM and FHIR standards. In addition, the tool's adaptability and scalability enable organizations to streamline their ePI processes, improve regulatory compliance, and realize the full potential of digital product information management.

Conclusion

The EMA's ePI initiative highlights the path of future pharmaceutical regulation in Europe. As a consequence, the paradigm shift away from monolithic documents towards structured and semi-structured data is vital.

By introducing structured content management and using interoperability standards such as FHIR, pharmaceutical organizations can manage complex and volatile regulatory requirements with greater agility and efficiency. Thus, the introduction of an SCM system not only delivers benefits in meeting the ePI standard, but also major advantages for overall labeling management. The challenge of migrating existing validated labeling documents can be effectively addressed with innovative AI-powered solutions for the transformation of monolithic Word documents and semi-structured content building blocks.

Even though the point at which ePI will be mandatory for pharmaceutical companies is in the future, it is advisable to take the first steps here. In our opinion, they are a boon for the company's labeling management!

The path to the ePI is in front of you, you just have to take it. We will be happy to accompany you. Reach out to Michael Nikel for more information.