• 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

The REMS Prototype will:

• Seek 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 REMS program implementation burden and advance REMS implementation and evaluation
• Advance this integration through a proof-of-concept prototype and seek collaboration through a stakeholder driven 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