Short Description | This track is Phase 3 of an ongoing series, spanning multiple Connectathons, to test the exchange and display of electronic Product information (ePI) and the International Patient Summary (IPS) as FHIR documents. Each phase will include increased levels of product information and increasingly complex healthcare/life scenarios. Track Objective is to test and gather feedback on the following
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Long Description | Problem Statements
Vision The vision of Gravitate Health/Vulcan accelerator is to define a common structure for medicinal product information that improves the patient experience and supports interoperability across the international healthcare community. ePI Track Phase 2 builds towards this vision by incorporating lessons learned from connectathon 28. Also, by testing more complex real-world scenarios; additional FHIR resources; and more advanced product label data. 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 is often presented in two forms: Information for healthcare professionals and/or information for patients. Since these documents are currently 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). Only a few 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 that Hence the need to transition to a dynamic structured format that can be used as an international standard; i.e., FHIR documents. |
Type | Test the design of a set of resources. |
Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group | HL7 Vulcan Accelerator and Gravitate Health |
Track Lead(s) | Craig Anderson, Catherine Chronaki, Jens Villadsen |
Track Lead Email(s) | Craig.Anderson2@pfizer.com; jvi@trifork.com; chronaki@gmail.com |
Related Tracks | No direct relationships at this time |
FHIR Version | |
Specification(s) this track uses | Vulcan/Gravitate Health ePI IG |
Artifacts of focus | FHIR Resources
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Expected participants | Gravitate Health members, HL7 Vulcan Members, FDA, EMA, Project UNICOM, adopters and implementers |
Zulip stream | https://chat.fhir.org/#narrow/stream/296557-Vulcan.2FePI #europe#GH |
| Supporting Artifacts | |
| Track Schedule | Day #1 May 2, 2022 7:00 AM to 9:00 AM EST Track Kick Off Track kick off Day #2 May 3, 2022 7:00 AM to 8:00 AM EST LinkedIn Event (Outside of the connectathon) Discuss FHIR standard for Patient Information Leaflets of Medicines https://www.linkedin.com/events/6924779635935244288 Day #2 May 3, 2022 8:00 AM to 9:30 AM EST Touchpoint Touchpoint 1 - Discuss sample data and scenario walkthrough 9:30 AM to 12:00 PM EST Build/Test/Validate Work offline Session 1- Build/test/validate (teams work on their own, mentors available) 12:00 PM to 1:00 PM EST Touchpoint Touchpoint 2 - Review developments from offline work 1:00 PM to 3:00 PM EST Build/Test/Validate Work offline session 2 - Build/test/validate (teams work on their own, mentors available) 3:00 PM to 4:00 PM EST Touchpoint Touchpoint 3 - Recap of the day Day #3 May 4, 2022 8:00 AM to 9:00 AM EST Touchpoint Touchpoint 4 - Review plan for the day 9:00 AM to 10:30 AM EST Build/Test/Validate Work Offline Session 4 - Build/test/validate (teams work on their own, mentors available) 10:30 AM to 12:00 PM EST Touchpoint Touchpoint 5 - Review work session, discuss feedback, results, IG changes 1:00 PM to 2:00 PM EST Track Highlight Wrap up session 5 |
Track Details | Servers See ConMan for full connectathon track and testing details Connectathon (clinfhir.com) See ePI Server for the Humalog, Monuril and Exemestane samples See the following links for the servers meant to mimic a Medicinal Product Dictionary:
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. Humalog sample data
Monuril sample data
Exemestane sample data
International Patient Summary (IPS) Bundle - Helen Bundle - Maria EMA Test Scenarios Test #1 = Alert that PL section 4 was updated A patient is watching section 4 of the package leaflet for updates to possible side effect information. They receive an alert to say new information has been added in this section. Test #2 = Compare two pregnancy sections side by side A patient taking 2 medicines and planning a pregnancy wants to look at the pregnancy sections of her 2 medicines side by side. Test #3 = Find all ePI's that contain the excipient lactose A patient with a lactose intolerance wants to search all medicines with a particular ATC code to find which ones contain/do not contain lactose as an excipient. Test #4 = search a List of ePIs There is a List with several ePI documents (e.g., Multiple versions of a Package Leaflet; multiple languages) and they want to search from the list to find individual ePI documents. UNICOM Test Scenario This scenario is meant as a demonstrator to show how the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) can be used to:
This use case will show how various systems can be interconnected by using IDMP identifiers. Particularly with the global Pharmaceutical Product Identifier (PhPID) which establishes the connection between national identifiers for medicinal products; i.e., Medicinal Product Identifier (MPID) and Packaged Medicinal Product Identifier (PCID). The PhPID functions as the ‘glue’ between medicinal product dictionaries (MPD’s) and other databases like those governed by the European Medicines Agency (EMA )or the US Food and Drug Administration's (FDA) Substance Registration System (SRS) and healthcare provider IT-systems. We will also use IDMP identifiers to make connections between the IPS and the ePI in a digital format to help improve patient experience. The scenario is built around the Helen persona. A UK resident who travels to Europe and is prevented from receiving the wrong medication as a result of the above mentioned systems, processes and standards. See below for more detail on the Helen scenario:
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