Medication Risk Evaluation and Mitigation Strategies (REMS) FHIR Implementation Guide (Jira PSS-2295)

Description

The aim of this effort is to develop a FHIR Implementation Guide focused on the US jurisdiction for integrating medication-related Risk Evaluation and Mitigation Strategies (REMS) into provider workflows. A REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) requires for certain medications with serious safety concerns - to reinforce medication use behaviors and other actions that support the safe use of the medication. REMS programs may include steps such as provider certification, patient registration and education, and ongoing patient monitoring.

The IG focus is on provider workflows during patient encounters and drug ordering - and the supporting information exchanges between the prescriber, patient and the REMS Administrator that manages the associated program.

This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will follow the Cross Group Projects WG's variance request process, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.

The work will also align where possible with guidance included in related FHIR implementation guides such as the Da Vinci Coverage Requirements Discovery (CRD) and Documentation Templates and Rules (DTR) IGs.

Misc Notes
2025 March: Patrick LaRocque and Pharmacy Work Group: We plan to make a few key changes to the IG: - Add an intermediary between the Provider EHR system and the REMS Administrator for the CDS Hooks calls. - This will alleviate the burden in registering every REMS admin with every EHR. - We have tested this in the January Connectathon. - Add a new FHIR Operation on GuidanceResponse that will allow for checking the ETASU (Elements to Assure Safe Use) for the specific REMS case at any point in time, not just during the normal CDS Hooks workflow. - This was also tested at the January Connectathon. - Align with work from a team at NCPDP that is developing a guide and is testing a solution through a NCPDP Foundation Grant that will handle much of the pharmacy interactions with the REMS Administrator. - We will at least be linking to their guide in our IG and may come up with a few use cases that exchange data between our intermediary and theirs or by sending them some information earlier in the process. - This work will be tested in a Connectathon with the NCPDP group at a later date and before the September ballot. 2024 July: TSC approved STU Publication Request for US Medication Risk Evaluation and Mitigation Strategies (REMS) FHIR IG Stakeholders: Healthcare IT Vendors, Healthcare Provider/user, Regulatory Agency, Vendor/Manufacturer