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REMS (Risk Evaluation and Mitigation Strategies) are drug safety programs that the FDA (Food and Drug Administration) can require for certain medications with potential for serious adverse side effects to help ensure the benefits of the medication outweigh its risks. REMS allows the prescribing of drugs that otherwise would not be available because of safety issues. Only a few drugs require REMS. REMS required actions vary with each drug or drug class (e.g., opioid).


FDA is championing and actively exploring innovative technologies to facilitate the completion of REMS requirements, including mandatory education within the prescribers and pharmacists’ workflows. Under the auspices of the public HL7 CodeX FHIR Accelerator Community and through the REMS Integration Use Case, FDA is supporting the use of standardized application programming interfaces (APIs), like the open source and freely available HL7® FHIR® APIs, with pharmacy data standards, i.e., National Council for Prescription Drug Programs (NCPDP), to reduce undue burden on prescribers, pharmacists, and other stakeholders. The use case ultimately aims to advance the provision of timely safety information to patients and health professionals, improve the quality of REMS data for feedback and evaluation, and optimize safe medication use and REMS outcomes.


For more background information about REMS, please see the following resources:


REMS Workflow Diagram


Project Overview

Problem

  • There are a number of key stakeholders (Patients, Prescribers, Nurse/Office Administrators, Pharmacists, REMS Administrators and Pharmaceutical Manufacturers) who play an important role in the REMS workflow of prescribing a drug to the patient. This includes verification of completed REMS requirements and dispensing the drug to the patient. There currently is no unified way to share data between REMS stakeholders.
  • Due to gaps in data interoperability, there is difficulty in communication and coordination of efforts amongst stakeholders in the REMS workflows.
  • REMS are not built into current workflows and the complexity of these programs leads to additional burden on stakeholders and the overall healthcare system.
  • All of these challenges can result in ​delays in therapy for patients, treatment abandonment, limited access to REMS drugs, time taken away from patient care, overwhelmed stakeholders and sub-optimal care for the patient.

Description

  • REMS is integrated into prescriber and pharmacist workflows, allowing them to easily complete the necessary REMS requirements without having to open a separate portal or remember additional steps for handling a REMS
  • REMS integration allows prescribers to be alerted that a drug requires REMS education and training and any additional clinical actions needed (e.g., monthly liver enzyme monitoring, lab tests, etc.) to adhere to the requirements of the REMS program without having to manually look up this information
  • ​Prescribers are able to easily submit the necessary information in their current workflow, allowing them to fulfill or attest to REMS requirements
    • Structured data is used for populating REMS requirements, helping to automate the process and reduce the burden of manual entry
    • Capture of a completed REMS is integrated in a claim and documented in prescriber's clinical notes
  • When a request is received to dispense a REMS drug, pharmacists are able to easily confirm, within their current workflow, that REMS requirements have been met 
    • Pharmacists are able to easily look up data that prescribers submitted and which has been verified for certification by a REMS Administrator
  • ​Patients receive or are administered the REMS drug in a timely manner with minimal effort or burden on their part

Target Outcome

  • Create an integrated, automated, efficient, and effective REMS program by leveraging open data standards and creating the data infrastructure to enable REMS integration into the current workflow and data sharing across REMS stakeholders, reducing undue burden 

Value

  • All REMS stakeholders are able to access the right data at the right time in order to carry out their tasks efficiently and effectively
  • REMS workflow is accurate, timely, and easy for stakeholders, allowing for more time spent with the patient and ultimately an improved experience, improved patient care and outcomes
  • Patients are able to access REMS drugs as part of their care
  • In the future, standardization of REMS data could support REMS assessment reports, along with evaluation and updating of REMS over time in a data driven manner


REMS Proof-of-Concept Prototype

MITRE and FDA are working together to develop an open source proof-of-concept prototype that leverages data standards and technology to integrate REMS into the health care system, with a focus on stakeholder workflows. The aim for this prototype is to demonstrate the art of the possible with technical REMS integration and to help drive conversations with the community around opportunities to enhance REMS.


The current iteration of the prototype builds upon previous prototype releases (prescriber workflow, prescriber/pharmacist interaction, and REMS administrator workflow) and focuses on:

  • Prescriber requirement submission user interface (UI)
  • iPLEDGE Elements to Assure Safe Use (ETASU) support
  • Code cleanup
  • Remaining documentation


 Any and all feedback on the prototype is welcome!


Instructions for setting up the prototype: https://github.com/mcode/REMS/blob/master/SimpleSetupGuide.md


The REMS integration proof-of-concept prototype leverages existing DaVinci burden reduction specifications as a starting point. In particular, the prototype uses the Documentation Templates and Rules (DTR) andCoverage Requirements Discovery (CRD) implementation guides (IGs) as-is. The REMS ecosystem has unique requirements which will drive standards development activities for REMS integration. These may represent new standards, and/or expansions upon existing specifications.


The following are links to the code repositories used in the prototype:

DTR - https://github.com/mcode/dtr/releases/tag/REMSv0.7

PIMS - https://github.com/mcode/pharmacy-information-system/releases/tag/REMSv0.7

CDS-Library - https://github.com/mcode/CDS-Library/releases/tag/REMSv0.7

CRD - https://github.com/mcode/CRD/releases/tag/REMSv0.7

Test-EHR - https://github.com/mcode/test-ehr/releases/tag/REMSv0.7

Crd-request-generator - https://github.com/mcode/crd-request-generator/releases/tag/REMSv0.7

REMS - https://github.com/mcode/REMS/releases/tag/REMSv0.7


The mcode/REMS repository is licensed under Apache License 2.0.


Project Plan

Anchor
rttd public project plan
rttd public project plan

Phase

Milestone

Timeline

Discovery

Use case identification

  • Develop description of REMS problems/challenges and proposed solution/workflow demonstrating an approach for advancing the REMS programs 
  • Identify scope and potential impact of the REMS use case
  • Develop high level timeline for planning phase and initial stages of execution phase

Convening of use case members

  • Identify at least 1 "Champion", who commits to leading concept and planning alignment, engagement of stakeholders, etc.
  • Identify and gain commitment from at least 1 organization for each REMS key stakeholder group (patient, prescriber, nurse/office administrator, pharmacist, REMS administrator/pharmaceutical manufacturers)
  • Engage the community through public CodeX meetings to discuss REMS use case, develop a proposed solution/workflow, and identify end goal

Outcome: Use case identified with consensus on end goal (i.e. live pilot in a real environment)


Planning

Plan out high-level project plan, deliverables, success measures, high level timeline, key stakeholders, etc. 

  • Update use case description, scope, and potential impact as necessary
  • Provide more detailed solution/workflow with alignment from REMS use case members (and those committed to join) 

Growing the REMS CodeX Community 

  • 1 or 2 "Champions", who commit to lead the REMS use case into Executing, including driving work and engaging additional stakeholders to participate
  • Identify and gain commitment from additional organizations 

Outcome: Project plan with phases/objectives defined and timelines with consensus from the REMS CodeX community


Execution

Phase 0

(Notional)

Develop test environment with synthetic patients (sandbox environment developed in house or using vendor test environment)

Outcome: Readiness to integrate with external systems 


Execution

Phase 1 

(Notional)

Begin integrating with a health system/target site

  • Work with the site's actual IT infrastructure
  • Support data exchange (ensure all components are in place and are connected)
  • Run data end to end connection with test patients and test scenarios to check integration and accuracy
  • Engage with clinicians
  • Have all agreements with heath system in place

Outcome: Readiness to pilot



Execution

Phase 2

(Notional)

Execute real world pilot using health system's actual infrastructure, real interface, and real patients

Outcome: Real world pilot results


Execution

Phase 3

(Notional)

Capture lessons learned, ideas for future enhancements, etc. 

Outcome: Roadmap for future enhancements




Info
titleREMS Use Case

Quick Links

CodeX REMS One-Pager

GitHub REMS Code Repository

FDA_REMS_Landscape_Analysis

FDA REMS Drug Safety Program (Patient Context)

Risk Evaluation and Mitigation Strategies - REMS (Member page)

REMS Public Calls

Public webinar: Challenges and Opportunities for REMS Integration, Innovation, and Modernization

  • Hosted by Duke-Margolis and the U.S. Food and Drug Administration (FDA)
  • Recording and slides from the webinar are avaialbe via the link above

REMS Prototype Demos

REMS Engagement Value by Stakeholder

REMS Use Case Page Navigation


Conference Call Information (2023 dates coming soon)

You may register for upcoming Risk Evaluation and Mitigation Strategies (REMS) public use case calls using the links below. 

DateTimeRegistration Link
2February 14, 20231:00 PM ET

Register Here

March 9, 2023 

12:00 PM ET 

Register Here

April 11, 2023 

1:00 PM ET Register Here



Use Case Team

RoleName Organization
ChampionClaudia ManzoFDA
ChampionJose GalvezFDA
ChampionGeorge NeyarapallyFDA
ChampionEd MillikanFDA
Use Case Coordinator

Kelee Petzelt


CodeX 

If you'd like to learn more about this use case, please contact kelee.petzelt@pocp.com

Current Collaborators

Food and Drug Administration (FDA)

MITRE