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Pharmacovigilance Safety Analyzer Checklist

Pre-delivery verification checklist for drug safety reports.

Report Quality Checklist

Structure & Format

  • Report file created: [DRUG]_safety_report.md
  • All 10 main sections present
  • Executive summary completed (not [Researching...])
  • Data sources section populated

Phase 1: Drug Identification

  • Generic name documented
  • Brand names listed
  • Drug class identified
  • ChEMBL ID or DrugBank ID obtained
  • Mechanism of action stated
  • Approval date noted

Phase 2: FAERS Adverse Event Analysis

  • FAERS data period stated (e.g., "Q1 2020 - Q4 2025")
  • Total report count for drug provided
  • ≥20 adverse events queried
  • PRR calculated with 95% CI for top events
  • Serious case counts included
  • Fatal case counts included
  • Signal thresholds applied (PRR >2, N ≥3)
  • Top events ranked by frequency/signal strength

Phase 3: FDA Label Warnings

  • DailyMed SPL retrieved (or "Not available")
  • Boxed warning extracted (or "None")
  • Contraindications listed with rationale
  • Key warnings and precautions summarized
  • Drug interactions noted
  • Source citation included

Phase 4: Pharmacogenomics

  • PharmGKB queried for drug
  • Actionable variants listed (or "No actionable variants")
  • Evidence levels assigned (1A, 1B, 2A, 2B, 3)
  • Genes and variants specified
  • Clinical recommendations stated
  • CPIC/DPWG guideline status noted

Phase 5: Clinical Trial Safety

  • Phase 3/4 trials searched
  • At least 3 trials summarized (or all available)
  • Sample sizes provided
  • Duration of studies noted
  • Serious AE rates (drug vs placebo)
  • Discontinuation rates compared
  • Common AEs from trials listed

Phase 6: Signal Prioritization

  • Signals scored using formula (PRR × severity × frequency)
  • Critical signals flagged (⚠️⚠️⚠️)
  • Moderate signals identified
  • Known/expected effects categorized
  • Action recommendations for each signal

Phase 7: Risk-Benefit Assessment

  • Overall risk level stated
  • Benefits summarized
  • Risk factors identified
  • Comparison to alternatives (if requested)

Phase 8: Clinical Recommendations

  • ≥3 monitoring recommendations
  • Patient counseling points listed
  • Contraindication checklist provided
  • Pre-treatment assessment items

Citation Requirements

Every Section Must Include

  • Source database name
  • Tool used (in backticks)
  • Data retrieval period (for FAERS)
  • Specific identifiers where applicable

Format Examples

*Source: FAERS via `FAERS_count_reactions_by_drug_event` (Q1 2020 - Q4 2025)*
*Source: DailyMed via `DailyMed_get_spl_by_set_id` (setid: abc123)*
*Source: PharmGKB via `PharmGKB_search_drug` (PA450360)*
*Source: ClinicalTrials.gov via `search_clinical_trials`*

Signal Grading

All Signals Must Have

  • PRR value with 95% CI
  • Case count (N)
  • Serious/fatal breakdown
  • Evidence tier assigned (T1-T4)

Tier Definitions

Tier Symbol Criteria
T1 ⚠️⚠️⚠️ PRR >10, fatal outcomes, or boxed warning
T2 ⚠️⚠️ PRR 3-10, serious outcomes
T3 ⚠️ PRR 2-3, moderate concern
T4 ℹ️ PRR <2, known/expected

Quantified Minimums

Section Minimum Requirement
Adverse events Top 20 events with PRR
Serious AEs All with fatal outcomes listed
Contraindications All from label extracted
PGx variants All level 1-2 variants
Clinical trials ≥3 phase 3/4 trials
Monitoring recs ≥3 specific recommendations

Safety Signal Metrics

Required Calculations

  • PRR (Proportional Reporting Ratio)
  • 95% Confidence Interval for PRR
  • Case count (total reports)
  • Serious case percentage
  • Fatal case count

Signal Detection Criteria

Criterion Threshold Status
PRR >2.0 Signal
Chi-squared >4.0 Signal
N (cases) ≥3 Reportable
Lower 95% CI >1.0 Significant

Output Files

Required

  • [DRUG]_safety_report.md - Main report

Optional (recommended)

  • [DRUG]_adverse_events.csv - All AEs with metrics
  • [DRUG]_pharmacogenomics.csv - PGx variants

CSV Column Requirements

adverse_events.csv:

Adverse_Event,Report_Count,PRR,CI_Lower,CI_Upper,Serious_Count,Fatal_Count,Signal_Tier

pharmacogenomics.csv:

Gene,Variant,rs_ID,Phenotype,Evidence_Level,Recommendation

Final Review

Before Delivery

  • No [Researching...] placeholders remaining
  • All tables properly formatted
  • No empty sections (use "Not available" if needed)
  • Executive summary synthesizes key findings
  • Recommendations are specific and actionable
  • Risk-benefit conclusion stated

Common Issues to Avoid

  • PRR without confidence intervals
  • Signals without case counts
  • Missing serious/fatal breakdown
  • PGx without evidence levels
  • Recommendations without rationale
  • Missing data period for FAERS

Comparative Analysis (if requested)

Drug Comparison Checklist

  • Both drugs identified with same granularity
  • Same FAERS time period used
  • Head-to-head AE comparison table
  • PRR comparison for shared AEs
  • Class effect vs drug-specific noted
  • Clear recommendation stated

Urgent Findings Protocol

If any of these found, flag prominently in executive summary:

  • Boxed warning not widely known
  • Recent safety signal (new in last year)
  • High fatality rate (>5% for serious AEs)
  • Drug-drug interaction causing deaths
  • Newly identified pharmacogenomic risk
  • Recent FDA safety communication

Flagging Format

⚠️ **URGENT SAFETY ALERT** ⚠️

[Description of finding requiring immediate attention]

*First identified: [Date] | Source: [Database/Alert]*