Limited distribution drugs come with reporting obligations that don't pause for understaffed teams. Asepha automates REMS enrollment verification, patient monitoring touchpoints, and manufacturer reporting workflows. Let your compliance obligations run in the background so your team focuses on patient care.
of REMS-enrolled patients flagged for required monitoring touchpoints
<1 min
to generate manufacturer reports and audit-ready documentation
0
enrollment checks that fall through when someone forgot to follow up
REMS Enrollment Verification
When a specialty prescription arrives for a REMS-restricted drug, Asepha verifies enrollment status for both the patient and prescriber before the prescription moves forward. Unenrolled patients or prescribers are flagged immediately with the required enrollment steps to avoid discovering a REMS gap at the point of dispensing.
For limited distribution drugs and manufacturer hub programs, Asepha generates required reporting automatically. It pulls dispense data, patient outcomes, and adherence metrics into the format each program requires. Reports run on your configured schedule and are available for review before submission. Your team stops manually compiling data across systems at the end of every reporting period.
Asepha supports drug-specific workflow configuration so each REMS program runs on its own defined rules, monitoring intervals, and documentation requirements. New programs can be added without rebuilding your entire workflow.
Every REMS interaction is logged with a timestamp and user ID in an immutable audit trail: enrollment checks, monitoring touchpoints, patient acknowledgment, and dispense confirmations. When a manufacturer audit or FDA inspection comes, your documentation is already organized and export-ready.
