United BioSource LLC (UBC), a leading provider of Risk Evaluation and Mitigation Strategies for biopharma, recently participated in the Health Level Seven (HL7 ®) International Fast Healthcare Interoperability Resources (FHIR ®) Connectathon, 16 – 18 January 2024.
With a focus on enabling healthcare interoperability through FHIR, Connectathon participants meet several times a year to work alongside vendors, peers, healthcare providers, and administrators, to rapidly learn to implement the standard and validate their conformance to the specification and mature implementation guides.
During Connectathon, UBC successfully implemented the Risk Evaluation and Mitigation Strategies (REMS) administration software, including the CDS Hooks Services and SMART App Launch as described in scenario 1 and 2 against an EHR test system.
“Connectathon participation is a critical component to advancing interoperability, and we are thankful for UBC’s efforts, as we were able to experience the workflows first-hand. The process allows us to fine-tune the standards so we can efficiently integrate REMS into workflows, share data across stakeholders, and reduce burden on staff and patients,” said Kelee Petzelt, REMS Use Case Coordinator, Point of Care Partners/CodeX.
“The business value derived from this technology is best understood from the workflow of a prescriber,” said Natalie O’Donnell, SVP, Head of Safety & Risk Management, UBC. The technology enables the prescriber, within their normal Electronic Health Records (EHR) system workflow, to be notified of a REMS and its applicable elements to assure safe use at the appropriate time – in this use case, when ordering a medication for a REMS covered drug.
In addition to being notified, the prescriber is also presented with an application user interface, still within their EHR and without the need for additional logins, etc., to supply the information required for the Elements to Assure Safe Use (ETASU), in this case a patient enrollment.
“A key component of this use case, championed by the U.S. Food and Drug Administration, is automating interoperable exchange of standardized REMS data,” said Saneel Vasram, Program Director, CodeX. “The shared CodeX vision and community-driven effort to reduce REMS clinical workflow burden, technical implementation effort and improved quality of REMS data is integral to optimizing safe medication use and health outcomes.”
Within the just-in-time prompt and in workflow user interface, most if not all the data can be supplied directly from the EHR to the REMS form and the prescriber data entry will be eliminated or severely reduced. “This creates enormous value for a REMS implementation by reducing burden to prescribers, patients, and indirectly pharmacies, as their patients will be more likely to arrive at the pharmacy with the proper ETASU documentation in place,” said Ms. O’Donnell. The streamlined process will improve compliance and therefore overall safety.
SOURCE: PRNewswire