2023 - 01 Vulcan/Gravitate Health - ePI/IPS (Phase 5)

Short Description

This track is Phase 5 of an ongoing series, spanning multiple Connectathons, to test the creation, exchange and display of electronic Product information (ePI) and the International Patient Summary (IPS) as FHIR Documents, as well as potential UNICOM scenario’s for IDMP implementation. 

Each phase will include increased numbers of product information and increasingly complex healthcare/life scenarios. 

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

1. Work with the Core ePI Implementation Guide following ballot 
2. Elaborate Core ePI Profile vs national/regional profiles 
3. G-Lens business rules and its connection to HL7 accelerators besides Vulcan 
4. Gravitate Health Federated Open-Source Platform and Services (FOSPS) a’ version and its support to end-to-end scenarios.
5. Deep dive on interactions and substances
6. Identification of medicinal product (IDMP)
7. Search for ePI and specifically for different types of interaction starting with drug-to-drug interactions.
1. Look for active substances in the medication list and the ePI
2. Search for interactions among active substances included in the ePI
3. Create an interface in the FOPS that allows to search externally for dummy interactions.

The track is supported by the EU IMI Project Gravitate Health, the EU funded project UNICOM and supports the ePI pilot project at the European Medicines Agency. 

Long Description

Problem Statements 

1. Existing ePI formats are not meeting the needs of patients, professionals and developers. 
2. The lack of harmonization is leading to fragmented approaches where multiple differing standards are developing internationally e.g., eLabeling in HL7 SPL in North America, ePI in HL7 FHIR in the European Union; and custom XML standards in Asia. 
3. Expressing rules for G-lens and Persona characteristics in HL7 FHIR to tailor the presentation of ePI highlighting reported interactions.
4. Due to variety in identification of medicinal products it is difficult to match the right information to the right products. This causes confusion and may introduce risks for the patient.  IDMP-standards provide globally consistent identification of medicinal products regarding their substance(s), strength and dose form.

 Vision

The vision of the Gravitate Health ePI /Vulcan accelerator ePI/ eLabeling project is to define a common structure for medicinal product information, including consistent identification by IDMP standards, that improves the patient experience and supports interoperability across the international healthcare clinical and regulatory environment.  

ePI Track Phase 5 builds towards this vision by incorporating lessons learned from the previous 4 connectathons 28-29-30-31. Also, by testing more complex real-world scenarios; additional FHIR resources; and more advanced product label data we expect the IG to be more mature and effective in covering a wider range of products. 

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 two primary forms of Information adapted for healthcare professionals and patients/consumers. Frequently apart from the core ePI, there are additional risk minimization measures like a patient card, videos, pictures, etc. that can act in support of the ePI to support patient understanding and safe use. IDMP-standards are crucial to ensure that any medicinal product can be accurately identified anywhere in the world to improve patient safety.

These documents are currently mostly based on PDF and they are section-formatted, but basically unstructured electronic paper content. As a result, they are difficult to search, difficult to find, and the content does not always meet patient needs as it lacks e.g., large fonts, accessibility support, multimedia, multiple languages, UpToDate (not including latest 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 with an ongoing SPLtoFHIR project; Japan’s PMDA uses custom XML; EU’s EMA is developing a FHIR XML ePI and authoring tool. Without harmonization, alignment and exchange of ideas, there is a high risk of divergence. This divergence won’t allow us to reap the benefits of the digital transformation.

Hence the need to transition to a dynamic structured format that can be used as an international standard, i.e., FHIR documents with the added benefit of tailoring to individual patient/consumer needs. 

Type

Test an Implementation Guide and review ballot comments.

Related Tracks?

Call for participants

Gravitate Health members; HL7 Vulcan Members; FDA; EMA; Project UNICOM; adopters; implementers; ePI and IPS data consumers, HELIOS and Gravity accelerators

Track Prerequisites

Track Lead(s)

Catherine Chronaki, Craig Anderson, Jens Villadsen

Patricia Arbil, Cecilia Vera, Alvaro Belmar, Joao Almeida, Giorgio Cangioli, Erol Hoffman, Evinn Drusys, Adam Kover, Bente Jensen, Alejandro M. Medrano  

Track Lead Email(s)

 chronaki@gmail.com; Craig.Anderson2@pfizer.com; jvi@trifork.com

Specification Information

Vulcan/Gravitate Health Core ePI IG 

Github Repository with sample instances (in FSH)  

IPS IG 

EMA ePI Specification 

Draft SPLtoFHIR specification.

Zulip stream

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

#europe#GH

Track Kick off Call

LinkedIn Event on Tuesday January 10, 2023, 07:00 to 08:00 EDT

https://www.linkedin.com/events/fcat32-letsdiscusshl7fhirforpat7016776177675583488

System Roles

Testing Scenario:

Servers 

ePI Server  

Sample data for use with the testing scenarios noted below 

HTML, XML and JSON versions of the samples can be found in the Implementation Guide or the FHIR Shorthand (FSH) source files can be found in GitHub. 

Electronic Product Information (ePI) 

1. EU/EMA Sample ePI 
2. US/FDA Sample ePI 
3. Japan/PMDA Sample ePI 

International Patient Summary (IPS) 

1. Helen 
2. Maria 
3. Pedro (new Spanish persona with HIV)

ePI Profiles 

1. International Core
2. National/European extensions 
3. Formulation of Glens rules for drug-to-drug interactions.

Test Scenarios 

1. Drug-to-drug interactions in a person’s medication list in the IPS
2. Considering taking a new drug given the medication list in the IPS
3. Textual analysis of ePI sections and formulation of rules for drug classes and annotations

Other Testing Scenarios to be considered as we move closer to FCAT32

1. Core ePI Implementation Guide 
2. Core ePI Profile vs Regional/national profile(s)
3. G-Lens business rules and Gravitate Health Federated Open-Source Platform and Services (FOSPS)