U.S. Food and Drug Administration

The buyer seeks access to outpatient longitudinal drug utilization data to enhance drug safety monitoring and analysis. The buyer requires real-time, multi-user access to prescription and patient-level data for analyzing drug exposure, usage patterns, and conducting regulatory impact studies. The data should enable national-level and geographical analysis of outpatient prescriptions and patient counts. The buyer aims to improve post-market risk/benefit analyses and expedite regulatory decision-making processes.

• 12/23/2024 - Release Date
• 1/23/2025 - Proposal Due Date

• Provide real-time, multi-user desktop access to outpatient prescription data
• Offer national-level and geographical counts of outpatient prescriptions over time
• Provide patient-level demographic information linked to prescription data
• Enable characterization of drug exposure duration at patient level
• Allow analysis of concomitant use of drug products at patient level
• Provide national-level estimates of drug utilization patterns using projection methodologies
• Offer HIPAA-compliant data access in a multi-user environment
• Enable downloading of large datasets as needed
• Provide prescriptions and medical claims data
• Maintain ownership of the database and access methods