FHIR Implementation Guide for Electronic Medicinal Product Information (ePI)

Hi all,

A medicine’s product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe and effective use. Electronic Product Information (ePI) refers to a format adapted for electronic dissemination via the web and via healthcare systems. In Canada, “product information” is referred to as a “Product Monograph”.

In July 2023, Health Level 7 (HL7) published the FHIR Implementation Guide for Electronic Medicinal Product Information (ePI) , a common international standard for exchanging structured medicinal product information. FHIR® (Fast Healthcare Interoperability Resources) is a next-generation standards framework created by HL7. FHIR® leverages the latest web standards and applies a tight focus on implementability. The FHIR ePI standard was developed by Gravitate Health (a public-private partnership funded by the Innovative Medicines Initiative ) and HL7’s Vulcan Accelerator ; in collaboration with the European Medicines Agency .

For more information, read the full announcement on the Gravitate Health website.

Global Adoption and Implementation

This standard is being implemented by health authorities in the European Union, United States, Jordan, Taiwan, and Brazil. Drug compendia in the UK, Sweden, Norway, Denmark, and Finland plan to transition their product information to FHIR ePI this year as well. There is an opportunity for Canadian compendia and eHealth developers to adopt this standard to enhance interoperability with other FHIR-compliant eHealth systems.

Benefits of FHIR ePI

It is known that the current PDF format for medicine product information is not adequate to support patient needs and modern electronic initiatives. To support innovation, the international community adopted FHIR to provide benefits like the following:
• Interoperability: FHIR enables interoperability between ePI and healthcare use cases like ePrescribing and eHealth records, facilitating patient-focused digital tools for safer medicine use.
• Personalization: content can be dynamically tailored to the patient’s need (e.g., show only the applicable strength or dosing regimen) or preference (e.g., language, font size).
• Detail: Provides a highly detailed and machine-readable description of the drug product in its primary packaging or ready for administration to the patient (after transformation); packaging identifiers like GTIN; ingredients list with known allergen flags; encoded clinical details like indication, contraindication, interactions (drug:drug, drug:food, drug:lab).
• Visualization: Increased level of detail, structured format, and encoded images support more patient-friendly presentations; e.g., eHealth apps can use structured dose content to present graphical dosing, reminders, or notifications.

Call to Action

HL7® Vulcan FHIR® Accelerator and Gravitate Health encourage international health authorities, medicinal product compendia, and the biopharmaceutical industry to implement and maintain this standard, driving a transformative future for global healthcare.

Best regards,