Short Description

This track is the latest in an ongoing series, spanning multiple Connectathons, to test the creation, exchange and display of electronic Product information (ePI) and the International Patient Summary (IPS).

Each phase strives to make a more robust and implementable FHIR solution for electronic medicinal product information. 

In this series, SPL on FHIR, UNICOM, and GIDWG scenarios for the implementation of the ISO IDMP standards for the Identification of Medicinal Product (IDMP) will be incorporated into the testing plan.  

Track Objective is to test and gather feedback on the following: 

  1. Test scenario #1: Confirm how to make connections between the Vulcan ePI and SPL-FHIR by manually transforming an ePI to a SPL-FHIR.
  2. Test scenario #2: A patient travels from Europe to US and has to find the similar US medicinal product to their European prescription.
  3. Test scenario #3: A patient travels from Japan to US and has to find the similar US medicinal product to their Japanese prescription.
  4. Test scenario #4: Incorporate IDMP identifiers into the ePIs to facilitate international connections. Focus on the PhPID generation; lookup and usage; and matching identifiers cross-border to support the relevant test scenarios above.

The track is supported by the Innovative Medicines Initiative (IMI) Gravitate-Health Project; HL7’s Vulcan Accelerator; and the EU’s funded project UNICOM. The track also supports the European Medicines Agency’s ePI pilot project, the GIDWG initiative, and HL7 BR&R’s SPL on FHIR project.

Long Description

Problem Statements 

The lack of international harmonization on the adoption and implementation of the ISO IDMP standards for the unique identification of medicinal products is leading to a divergence of approaches for structured product and substance information and the related terminologies. Differing standards are developing internationally, e.g., HL7 SPL in North America, FHIR in HL7, FHIR in the European Union; and multiple custom XML standards developing in Asia and the Middle East. 

 Vision 

The vision of the Gravitate-Health/Vulcan ePI project is to define a common structure for medicinal product information that improves the patient experience and supports semantic interoperability across the international healthcare clinical and regulatory environment.  

ePI Track Phase 7 builds towards this vision by incorporating lessons learned from the previous connectathons. Also, by testing more complex real-world scenarios and more advanced product label data, we expect to make FHIR a more robust solution for medicinal product information.

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 use. 

ePI includes three primary forms:

  1. Information adapted for healthcare professionals.
  2. Information for patients/consumers.
  3. Packaging label.

These documents are currently mostly based on PDF. As a result, they are difficult to search, difficult to find, and the content does not always meet patient needs lacking e.g., large fonts, accessibility support, multimedia, multiple languages, up-to-date information. 

Only a few regions/countries have XML ePI’s, but the number and interest is growing. For example, US FDA uses HL7’s SPL; Japan’s PMDA uses custom XML; EU’s EMA is developing a FHIR XML ePI. Without harmonization, there is a high risk of divergence. 

Hence the need to transition to a dynamic structured format that can be used as an international standard, i.e., FHIR documents.

Type

FHIR Design, FHIR Testing, Test Implementation Guides

Related Tracks?

TBD

Call for participants

Gravitate Health members; HL7 Vulcan Members; FDA; EMA; PMDA; GIDWG members; Project UNICOM; adopters; implementers; ePI and IPS data consumers

Track Prerequisites

  1. Have read the Electronic Medicinal Product Information (ePI) Implementation Guide
  2. Have watched the IDMP Demonstrator video (https://bit.ly/IDMP_Demonstrator)

Track Lead(s)

Track Leads

Gravitate-Health/Vulcan: Craig Anderson, Catherine Chronaki

US FDA: Scott Gordon


Global IDMP Working Group (GIDWG) Members

US FDA: Ron Fitzmartin, TJ Chen

EMA (Europe): Panagiotis Telonis, Rik Smithies, Robert Stegwee, Giorgio Cangioli, Achilleas Voutsas, and Andrei Idu

UMC: Magnus Wallberg, Malin Fladvad

Track Lead Email(s)

Craig.Anderson2@pfizer.com; chronaki@gmail.com; Gideon.Gordon@fda.hhs.gov

Specification Information

Electronic Medicinal Product Information (ePI) IG 

IPS IG 

EMA ePI Specification 

SPL Mapping FHIR Implementation Guide 

Zulip stream

https://chat.fhir.org/#narrow/stream/296557-Vulcan.2FePI 

#europe#GH 

Track Kick off Call

Virtual kick-off event on the 34th HL7 FHIR CONNECTATHON - ePI Track

Date and Time: Sep 5, 2023 13:00 (CEST) or 07:00 (EST)

Follow this link to register for the event: 05.09.2023 | Gravitate Health Webinar Ahead of HL7 FHIR Connecthathon 34 in Phoenix | | REGISTER NOW! - Gravitate Health

Testing Scenario:

Servers (ePI/IPS and SPL-FHIR Repositories)

  • TBD

System Roles

  • Generator of ePI and SPL documents
  • Receiver of ePI and SPL documents
  • Requester of cross-border MP identification
  • Matcher of cross-border MP identifications

Sample data for use with the testing scenarios: 

ePI

  • EU/EMA Sample ePI 
  • US/FDA Sample ePI 
  • Japan/PMDA Sample ePI 

SPL-FHIR

  • Sample Product Information in SPL-FHIR format

IPS/EU PS

  • Sample PS-s with appropriately IDMP identified medication list
  • Sample IPS with appropriately IDMP identified medication list


Scenario #1: Connections between ePI to SPL-FHIR

Action

  • Manually transform ePI to SPL-FHIR and note any gaps or differences
  • Submit the manually transformed ePI to the SPL-FHIR server via API and take note of the validation results
  • Manually transform SPL-FHIR to ePI and note any gaps or differences

Success Criteria

  • ePI is successfully converted to SPL on FHIR
  • Acquired validation results from the SPL-FHIR server for the ePI converted to SPL-FHIR
  • SPL-FHIR is successfully converted to ePI


Scenario #2: Patient travels from Europe to US

Action

  • Retrieve patient’s European ePI.
  • Retrieve the US SPL for the similar medicinal product for which the European ePI was retrieved.

Success Criteria

  • Retrieved the US SPL for the similar medicinal product for which the European ePI was retrieved.


Scenario #3: Patient travels from Japan to US

Action

  • Retrieve patient’s Japanese ePI.
  • Retrieve the US SPL for the similar medicinal product for which the Japanese ePI was retrieved.

Success Criteria

  • Retrieved the US SPL for the similar medicinal product for which the Japanese ePI was retrieved.


Scenario #4: Incorporate IDMP’s identifiers into the ePIs and, where possible, into the SPL-FHIR

Goal: Demonstrate how substance identifiers and PhPID (for ePI) can facilitate cross-border search and prescriptions.

Action-1: MP look-up

  • Submit  to the PhPID maintenance organization(s) (e.g. Uppsala WHO UMC)

    • country of origin MPID, or

    • Substance, Administrable Dose form, Strength or

    • PhPID
    • plus the target jurisdiction (supported by the maintenance organization)

  • Receive a list of Medical Products (MP) for the target jurisdiction

Action-2: PhPID look-up

  • Submit to the PhPID maintenance organization(s) (e.g. Uppsala WHO UMC)

    • Substance, Administrable Dose form, Strength

    • and possibly the country of origin MPID

  • Receive the matching PhPID (levels)

Action-3: Decode PhPID

  • Submit to the PhPID maintenance organization(s) (e.g. Uppsala WHO UMC)

    • PhPID

  • Receive for the provided PhPID the corresponding

    • Substance, Administrable Dose form, Strength (as used for generating the PhPID)

Action-4: Translate PhPID  (out of scope for this FCAT)

  • Submit to the PhPID maintenance organization(s) (e.g. Uppsala WHO UMC)

    • decentralized administrable product identifier (e.g. RxNorm) 
    • plus the source jurisdiction (supported by the maintenance organization)

  • Receive for the provided administrable product identifier the corresponding

    • PhPID

  Discussion capture

Slide reference #1 - Test scenario 2 and 3

Slide reference #2 - Test scenario 2 and 3

Slide reference #3 - Test scenario 2 and 3

Slide reference #4 - Test scenario 4

Slide reference #5 - Test scenario summary

Scenario results

Scenario Results.zip

This zip file contains the html and json files that are the result of the calls documented in the Scenario Details PDF.