FAERS + Real-World Drug Interaction Surveillance

What it is

Drug Interaction Surveillance is a real-world signal-detection layer over FDA's FAERS database. FAERS is the canonical adverse event reporting system, but its signal detection is slow, voluntarily reported, and famously misses drug-drug interactions and polypharmacy patterns until the harm is large enough to make the news.

Branmoor runs continuous disproportionality analysis over FAERS combined with state PDMP aggregate data, Medicare Part D claims polypharmacy patterns, and published case reports indexed from PubMed and FDA Adverse Event Reporting System case narratives. Emerging interaction signals are flagged with effect-size estimates and the cohort characteristics that drive them (elderly, polypharmacy, renal impairment, etc.).

The free public surface serves prescribing clinicians, patient advocates, and journalists. The paid surface serves pharma pharmacovigilance teams (defensive use — knowing what FDA may flag about your product before they flag it), payer pharmacy benefit management, and malpractice carriers underwriting prescriber risk.

Primary data sources

• FDA FAERS Public Dashboard and quarterly extracts — Adverse event reports
• State PDMP aggregate data (where public) — Prescribing pattern surveillance
• Medicare Part D Public Use Files — Polypharmacy and co-prescription patterns
• PubMed case report indexing — Published case literature
• FDA drug labeling (Structured Product Labeling) — Current labeling baseline for new-signal detection

Buyers

• Clinicians and prescribing pharmacists (free)
• Patient advocacy groups (free)
• Pharma pharmacovigilance teams
• PBM clinical operations
• Malpractice carriers underwriting prescriber liability
• Medical journalists and academic researchers

Methodology

Disproportionality analysis follows established pharmacovigilance methodology (Information Component, EBGM). New-signal definitions and false-positive controls are disclosed.