PACIO Sample Data Depot
0.1.0 - draft

PACIO Sample Data Depot, published by MITRE. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/paciowg/sample-data-fsh/ and changes regularly. See the Directory of published versions

## Violet Gartner - Medication Risk Evaluation Use Case

### Background

This use case was used to test a REMS scenario using Transitions of Care (ToC) and Standardized Medication Profile (SMP) IGs.

### Scene 5: Violet Gartner Vignette

The REMS program is a critical part of medication safety in the US. The REMS drug safety program required by the United States Food and Drug Administration (FDA) is for medications with serious safety concerns. REMS are designed to reinforce medication use behaviors and actions that support the safe use of the medication. A FHIR-enabled system for the administration of REMS, including the submission of the necessary information by the prescriber, is under development. The cross collaboration of REMS and PACIO’s Standardized Medication Profile (SMP) IG is intended to show how these systems can support one another to create a seamless drug safety environment.

Violet Gartner is a 17 year old patient who lives in Detroit. Violet has been prescribed Isotretinoin (Accutane) for the treatment of severe recalcitrant nodular acne.

Violet suffered a fall and went to the emergency department (ED). She is being transferred to a skilled nursing facility (SNF) to receive physical therapy.

The Isotrentinoin prescription requires prescriber management and monitoring of monthly pregnancy testing. As such, the prescription will be transferred to a provider at the post-acute care facility.

In order to ensure that they have the correct medication list and that there are no contraindications that could be dangerous to the patient, the SNF queries the ED’s FHIR server to pull a Transitions of Care (TOC) bundle, which has relevant information including medication-related information and Violet’s medication list as of ED discharge.

After the SNF EHR receives the TOC bundle and loads Violet’s current medications, a Prescriber and REMS administrator interact to review the medications for safety within the REMS framework. Violet’s provider at the SNF also uses a SMART on FHIR app to connect with the REMS administrator. After risk mitigation is completed, Violet’s provider is able to submit eScripts to the SNF-affiliated pharmacy to fill Violet’s medications.

#### Scene 5 FHIR Resources

- Bundle: VioletGartner01-SMP-Bundle-ED-01
- Bundle: VioletGartner01-SMP-Bundle-Home-01
- CarePlan: VioletGartner01-ED-discharge-01
- Condition: VioletGartner01-condition-RightArmPain-01
- Condition: VioletGartner01-condition-RightFemurBreak-01
- Condition: VioletGartner01-condition-RightHumerusBreak-01
- Condition: VioletGartner01-condition-RightLegPain-01
- List: VioletGartner01-smp-medListED-01
- List: VioletGartner01-smp-medListHome-01
- MedicationRequest: VioletGartner01-smp-medrx-hydrocodoneacetaminophen-01
- MedicationRequest: VioletGartner01-smp-medrx-sennas-01
- MedicationStatement: VioletGartner01-smp-medstmt-hydrocodoneacetaminophen-01
- MedicationStatement: VioletGartner01-smp-medstmt-isotretinoin-01
- MedicationStatement: VioletGartner01-smp-medstmt-sennas-01
- Observation: VioletGartner01-observation-NonWeightBearing-01
- Observation: VioletGartner01-Risk-AssistanceNeeded-01
- Observation: VioletGartner01-Risk-FallRisk-01
- Patient: patient-VioletGartner01
- ServiceRequest: VioletGartner01-servicerequest-OT-01
- ServiceRequest: VioletGartner01-servicerequest-PT-01

### FHIR Actors and Organization Resources

- Location: org-Loc-ED-Metro-Hospital
- Location: org-Loc-Michigan-Primary-Health-Care-A
- Location: org-Loc-Motor-City-Skilled-Nursing-Facility
- Location: org-Loc-Renaissance-Pharmacy
- Organization: org-ED-Metro-Hospital
- Organization: org-HH-Sky-Harbor-Home-Health
- Organization: org-Michigan-Primary-Health-Care-A
- Organization: org-Motor-City-Skilled-Nursing-Facility
- Organization: org-Renaissance-Pharmacy
- Practitioner: Practitioner-AnitaChu
- Practitioner: Practitioner-PriyaSarkar
- Practitioner: Practitioner-RichardRisto
- Practitioner: Practitioner-KevinJames
- PractitionerRole: Role-IMMD-AnitaChu
- PractitionerRole: PractitionerRole-Physician-PriyaSarkar
- PractitionerRole: PractitionerRole-RN-RichardRisto
- PractitionerRole: PractitionerRole-Pharm-KevinJames