tooluniverse-adverse-event-detection

Detects adverse drug event signals using FAERS disproportionality analysis and FDA label data.

1.7k|254|Updated Mar 3, 2025
One-click install
npx skills add https://github.com/mims-harvard/ToolUniverse --skill tooluniverse-adverse-event-detection
Or copy as Structured Prompt for Agent
Please help me install this Agent Skill.
Skill: tooluniverse-adverse-event-detection
Source: https://github.com/mims-harvard/ToolUniverse/tree/main/plugins/tooluniverse/skills/tooluniverse-adverse-event-detection
Command: npx skills add https://github.com/mims-harvard/ToolUniverse --skill tooluniverse-adverse-event-detection

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

Identifying rare or emerging adverse drug events is difficult because clinical trials lack the statistical power to detect them, and manual pharmacovigilance analysis across FAERS reports, FDA labels, and literature is slow and error-prone. This Skill automates quantitative signal detection so safety analysts can assess drug risk with statistical rigor.

Core Features & Use Cases

  • Disproportionality Signal Detection: Calculates PRR, ROR, and IC with 95% confidence intervals for each adverse event from FAERS data, classifying signal strength as Strong, Moderate, Weak, or None.
  • Multi-Source Safety Triangulation: Combines FAERS reports, FDA label sections (boxed warnings, contraindications, interactions), OpenTargets, DrugBank, PharmGKB pharmacogenomics, and PubMed literature into one assessment.
  • Quantitative Safety Signal Score: Produces a 0-100 risk score with T1-T4 evidence grading and a structured markdown report including monitoring recommendations.
  • Use Case: Ask whether pembrolizumab is associated with myocarditis, and receive PRR/ROR/IC statistics, demographic stratification, FDA label cross-checks, and literature evidence in a single report.

Quick Start

Ask the agent to detect adverse event signals for atorvastatin and generate a full pharmacovigilance report with a Safety Signal Score.

Frequently Asked Questions about tooluniverse-adverse-event-detection

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

FAQPage Schema
How do I detect adverse event signals for a drug using FAERS data?

Provide the generic drug name and the skill queries FAERS for top adverse events, then calculates PRR, ROR, and IC with 95% confidence intervals for each event. A signal is detected when PRR is at least 2.0, the lower confidence interval exceeds 1.0, and there are at least 3 cases.

What is disproportionality analysis in pharmacovigilance?

Disproportionality analysis compares the reporting rate of an adverse event for a specific drug against all other drugs in FAERS using metrics like PRR, ROR, and IC. It identifies events reported more often than expected, flagging potential safety signals for investigation.

Can I compare the safety of two drugs for a specific adverse event?

Yes, the skill supports head-to-head comparison using FAERS_compare_drugs, which returns PRR, ROR, and IC side-by-side for both drugs on a given adverse event. It can also aggregate adverse events across an entire drug class to distinguish drug-specific from class-wide signals.

What does the Safety Signal Score mean?

The Safety Signal Score is a 0-100 metric combining FAERS signal strength (0-35 points), serious adverse events (0-30), FDA label warnings (0-25), and literature evidence (0-10). Scores of 75-100 indicate high concern, 50-74 moderate concern, and below 25 low concern.

What happens if a drug has no FAERS reports or no FDA boxed warning?

If no FAERS reports exist, the skill skips FAERS phases and relies on FDA labels, mechanism-based predictions, and literature. A NOT_FOUND error from FDA label tools is normal and simply means that section, such as a boxed warning, does not exist for the drug.

What are the limitations of FAERS-based signal detection?

FAERS data is subject to reporting biases and confounding by indication, since patients taking a drug often have the underlying disease. The skill mitigates this through drug class comparison, demographic stratification, and Naranjo causality reasoning, but signals indicate association rather than proven causation.