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detecting-pv-signals

Compute disproportionality signals for drug-reaction pairs from FAERS or OpenFDA data.

5.0k|615|Updated Oct 4, 2025
Search Tags:#pharmacovigilance#signal detection#ror#openfda#prr#disproportionality#ebgm
One-click install
npx skills add https://github.com/maziyarpanahi/openmed --skill detecting-pv-signals
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: detecting-pv-signals
Source: https://github.com/maziyarpanahi/openmed/tree/main/skills/detecting-pv-signals
Command: npx skills add https://github.com/maziyarpanahi/openmed --skill detecting-pv-signals

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This Skill identifies drug-reaction pairs reported more often than expected in FAERS or OpenFDA data, helping pharmacovigilance teams prioritize potential safety signals without treating statistical associations as confirmed causal relationships.

Core Features & Use Cases

  • Disproportionality Analysis: Builds 2x2 contingency tables and computes PRR, ROR with confidence intervals, IC, and EBGM/EB05 metrics.
  • OpenFDA Screening: Queries public drug-event data using normalized drug fields and exact MedDRA reaction terms, with guidance for rate limits and empty-result handling.
  • Safety Triage: Applies screening thresholds, addresses small-count instability and reporting bias, and supports follow-up against drug labels and internal de-identified case counts.
  • Use Case: Screen warfarin for over-reported gastrointestinal haemorrhage reports, calculate multiple disproportionality measures, and send flagged associations for expert medical review.

Quick Start

Use the detecting-pv-signals skill to build a 2x2 table and calculate PRR, ROR with a 95% confidence interval, IC, and EB05 for a specified drug-reaction pair in OpenFDA.

Frequently Asked Questions about detecting-pv-signals

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I calculate PRR and ROR for drug-reaction pairs in FAERS data?▼

To calculate disproportionality signals in FAERS data, build a 2x2 contingency table for the drug-reaction pair to compute PRR, ROR with confidence intervals, IC, and EBGM/EB05 shrinkage metrics.

What is pharmacovigilance signal detection using disproportionality analysis?▼

Pharmacovigilance signal detection uses disproportionality analysis to identify drug-reaction pairs reported more often than expected in spontaneous-report data, prioritizing potential safety signals for expert medical review.

Can I use OpenFDA data to screen for adverse event safety signals?▼

Yes, you can query public drug-event data using OpenFDA by applying normalized drug fields and exact MedDRA reaction terms to screen for safety signals, while handling rate limits and empty results.

How do I handle small count instability when computing EBGM shrinkage estimates?▼

To handle small count instability during EBGM shrinkage estimation, apply robust statistical implementations and screening thresholds that address reporting bias and empty results in the 2x2 contingency table.

Does this signal detection approach confirm causal relationships between a drug and reaction?▼

No, disproportionality signal detection does not confirm causal relationships; it identifies statistically associated drug-reaction pairs from spontaneous reports to triage and prioritize safety signals for further review.

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