Medication Risk Tools and FDA Boundary Analysis for Rx360's Tiering System

Format: PDF

Overview

This document reviews established clinical medication risk frameworks and analyzes the FDA regulatory boundaries relevant to Rx360's medication risk tiering system. It provides a foundation for defensible, evidence-based risk stratification without crossing into clinical decision support requiring regulatory clearance.

Key Topics

• Beers Criteria for potentially inappropriate medications in older adults
• STOPP/START criteria for prescribing optimization
• FORTA (Fit fOR The Aged) classification system
• Anticholinergic Cognitive Burden (ACB) scoring
• FDA regulatory boundaries for software-based medication risk tools
• Risk tiering design considerations for the Rx360 platform