• Multiple key stakeholders that are impacted (Patient, Prescriber, Nurse/Office Administrator, Pharmacist and REMS Administrator/pharmaceutical manufacturers)
• No unified way to share data between REMS stakeholders​
• Gaps in data interoperability
• Workflow challenges - communication and coordination amongst stakeholders 
  • REMS are not built into current workflows and the complexity of these programs leads to additional burden on prescribers, patients, pharmacists, and the healthcare system overall
• 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​

• Leverage Open Data Standards
• Create an integrated, automated, efficient, and effective REMS programs
• Fluid data sharing
• Create data infrastructure
• Integration into current workflow
• Reduce undue burden
• Expedite access of needed therapies to the patient

• 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 improved experience/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

Brainstorming conversations:

1. Stakeholders - Who else should be in partnership with this use case endeavor?  
2. Have we defined the minimum stakeholder representation? (data senders, receivers, other important contributors/actors)
3. What is the level of impact of REMS on your organization and support to change how REMS functions today?

4. Does the use case fill a compelling and urgent need that leads to better, safer, faster care, and lower burden and cost?

5. What steps must we take to establish a flexible seamless platform inclusive for use by the prescriber, patient, care organizations, payer, pharmacist and intermediaries?
6. How can FHIR/APIs be leveraged to achieve standardization for things like Initial REMS Identification and prescriber processes?
7. How can we assure the API/FHIR work in the upstream processes (EHR, etc.) are harmonized downstream with the pharmacy process and pharmacy existing standards (Harmonization)?
8. Is there anything we have missed in the problem statement?

1. Challenge with other IT and regulatory priorities competing for resources to focus on REMS improvement
2. Lack of regulatory requirements

FDA representatives provided the following details related to their plan:  

• Seeks to integrate REMS into the healthcare system, with a current focus on prescriber system integration, by using contemporary data standards such as FHIR to reduce undue RMEs program implementation burden and advance REMS implementation and evaluation
• Advance this integration through a proof-of-concept prototype and seek collaboration through a stakeholder drive use case under HL7/CodeX FHIR Accelerator that can be piloted and scaled relatively rapidly
• Build on FDA’s work in recent years to standardize REMS and a Prescription Drug Use Fee Act (PDUFA) VI mandate
• Build on this foundational work in future years.

Michele Davidson (Walgreens) mentioned their support and interest of the REMS upstream use case and that the pharmacy SDO (

Critical to have upstream improvement to enhance the transactions and improve automation.  If the information is present - then little to know intervention 

Interaction between the NCPDP Task group and this use case would create greater efficiencies

Kevin Holman - Janssen - 60 some odd individual and distinct programs to feed a data pipeline through the EHRs. Independent data bases, independently held within their databases and through their vendors.  How will those connections take place?  How manufacturers are involved (owned by the individual companies).  How would this use case create that connectivity.  API (central)

Lauren (MITRE) - in order to reduce the number of integrations, difficult with a diverse set of programs.  Understand the interfaces is a big part of the process.  

Kevin - universal API or 

May (BMS) - In light of the comments on many different sponsors.  Is there an example of what success looks like for this? Understanding how we can accomplish from a program and element perspective. What can be established based on particular tasks, in a therapeutic area.  Oncology practice - needing and wanting access to all REMS products.  How can they have comprehensive access?

Lauren - helpful to look at phase descriptions.  Piloting new technologies.  The phase descriptions found on confluence can be utilized.

Mike Menkhaus - Pro Rx - multiple REMS -  prescribers cannot know which product the pharmacy is going to dispense,  is there appetite for the FDA to create their own REMS administration program and funding based on the own dispensations from each manufacturer.

Ed - great comment.  Internally well aware of the point Mike made.  FHIR standard could open the opportunity for consideration of what Mike is notating. Not agreeing

Chat Michael Cheung - To build off what Kevin mentioned regarding the number of individual programs using their own databases, the Sponsors may use different vendors with several different databases which adds to the complexity. I would be interested to understanding how the data would be migrated.

Sherice Mills (jazz) - have there been any outreaches discussions with the EHR vendors who already have a framework that can be leveraged.  Lauren - yes absolutely.  EHRs are using FHIR, within that context can we leverage those existing standards that can be leveraged for the REMS process, enrollment forms for example- certain lab tests detail for example.  Starting point.

Pooja - great idea - created IGs, NCPDP's eRX specialty enrollment process, we could leverage.  As we start digging into this more, what is already created, what are EHRs already doing and can we leverage.  Link to Specialty IG: https://build.fhir.org/ig/HL7/fhir-specialty-rx/

Kishore - TEVA - look from multiple use case scenarios - how does the product flow through from the supply chain, from pharmacist how does this use case integrate and harmonize with their workflow.  So many stakeholders - how does it integrate with their own current workflows.

Kal Elhoregy - alignments among stakeholders - key component for success.  Different REMS programs  difficult to find alignment. Nicole Ng - community buy-in is key.  Reason for convening the codeX REMS case and public engagement.  

Ed - this is why we are holding the public calls - input - work on this as a whole - community involvement.

Jennifer Chapman - When we first had preliminary conversations with prescribers about this topic a few years ago, they had data privacy/security concerns.  They feared linking to a manufacturer and worried that we would have access to their non-REMS patients as well.

• Evaluate the intelligence gathered from the community and provide feedback.
• Continue discussion with community (providers, vendors, EHRs, payers) to think and build on REMS improvement, leveraging standards based workflows (FHIR/APIs)
• Provide education to drive awareness of opportunities for improvements or shared learnings