ePI - Electronic Medicinal Product Information FHIR IG

Background

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.

ePI is often presented in three forms:

1. Information for healthcare professionals
2. Information for patients
3. Information on the package label

ePI, also sometimes called a drug product label, goes by different names depending on the region of the world. For example,

• USA - Prescription Drug Label or Patient Package Insert (USPI)
• Europe - Summary of Product Characteristics (SmPC) or Package Leaflet
• Japan - Package Insert (JPI)

Since these documents are often based on PDF, they are unstructured electronic paper. As a result, they are difficult to search, difficult to find, and the content does not meet patient needs (e.g., larger fonts, accessibility support, multimedia, multiple languages, always current).

It is known that current procedures based on PDF are not adequate to support electronic initiatives. To support new programs, the international community is adopting a new technology for exchanging medicinal product information between computer systems based on FHIR.

Adoption of FHIR for ePI is anticipated to stimulate the delivery of healthcare applications from innovative 3rd parties. A common standard for ePI exchange will allow the creation of aggregated cross-industry content which is a foundational element for creation of more personalized ePIs directing patients to the most relevant content; facilitating integration with other datasets such as Electronic Health Records (EHR); and data from wearable devices and diagnostics which will ultimately lead to a step-change in patient centric solutions.

Scope

In Scope

• ePI document types (Information for healthcare practitioners, Information for patients, Package labels.
• Human pharmaceutical, radiopharmaceutical and biologic medicinal products (prescription and physician-administered).
• Over the counter (non-prescription) drugs
• Investigational and authorized medicinal products
• Medical devices co-packed with a biopharmaceutical product (e.g., pre-filled syringe).

Out of Scope

• Self-care products
• Natural health products
• Medical devices
• Food
• Veterinary drugs.

Project Status

• ACTIVE  (Status Date: 2022-08)

Approved as a HL7 Vulcan sponsored project by Vulcan Steering Committee on 2021-08-16

Approved as a BR&R sponsored project on 2022-07-12 (2022-07-12 Conference Call meeting minutes)

Approved by HL7 TSC on 2022-08-29 (2022-08-29 TSC Agenda/Minutes)

[PSS-2090] Electronic Product Information FHIR Implementation Guide - Jira (hl7.org)

[PSS-2102] Electronic Product Information FHIR Implementation Guide - Jira (hl7.org)

IG Build Link

HL7/emedicinal-product-info: Gravitate Health Project (github.com)

HL7.FHIR.UV.EMEDICINAL-PRODUCT-INFO\Table of Contents - FHIR v5.0.0-ballot

Meetings

Thursday, weekly, 6AM EST  

Microsoft Teams: Click here to join the meeting

Upcoming Events or Milestones

FHIR Resources (Draft)

1. List
2. Bundle
3. Composition
4. Organization
5. RegulatedAuthorization
6. MedicinalProductDefinition
7. AdministrableProductDefinition
8. ManufacturedItemDefinition
9. Ingredient
10. SubstanceDefinition
11. PackagedProductDefinition
12. ClinicalUseDefinition
13. Binary