pharmacovigilance

pharmacovigilance is a skill for Claude Code from usathyan/epistract. It costs 0 tokens per session (1,705 once invoked), scanned A, original, MIT.

A guide for extracting structured information from medicine-safety reports, such as FAERS, VAERS, EudraVigilance, and MedWatch records. Pharmacovigilance is the monitoring of harmful or unexpected effects of medicines.

In plain words
What is it for?
Use it to analyse individual safety reports, case series, and clinical-trial reviews and to represent suspected links between medicines and adverse events.
Why use it?
It provides consistent categories and evidence rules for recording drugs, adverse events, reporters, outcomes, and how strongly a drug-related claim is supported.

Skill for Claude Code

Written for Claude Code: shipped in a Claude Code plugin.

Part of the epistract plugin — 5 skills, 22 commands shipped together

Good fit Use it to analyse individual safety reports, case series, and clinical-trial reviews and to represent suspected links between medicines and adverse events.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/usathyan/epistract/pharmacovigilance
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add usathyan/epistract --skill pharmacovigilance
Clone the repo
git clone --depth 1 https://github.com/usathyan/epistract

Made for: Claude Code.

Or install epistract, the plugin that ships this one along with the rest of its 5 skills, 22 commands.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for pharmacovigilance

README.md
[![agentmods](https://agentmods.dev/badge/skills/usathyan/epistract/pharmacovigilance/github.svg)](https://agentmods.dev/skills/usathyan/epistract/pharmacovigilance)
Your own site
<a href="https://agentmods.dev/skills/usathyan/epistract/pharmacovigilance"><img src="https://agentmods.dev/badge/skills/usathyan/epistract/pharmacovigilance/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for pharmacovigilance

Your own site · 80×15
<a href="https://agentmods.dev/skills/usathyan/epistract/pharmacovigilance"><img src="https://agentmods.dev/badge/skills/usathyan/epistract/pharmacovigilance.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 0 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 1,705 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00000 $0.01705
Opus 5 $0.00000 $0.00852
Sonnet 5 $0.00000 $0.00341
Haiku 4.5 $0.00000 $0.00170

Measured 10d ago against content hash 7404f078ca74, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-09, from the pricing page.

Security

Grade A, and why

pharmacovigilance scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 10d ago.

The scan reads SKILL.md. This mod also ships 2 executable files (__init__.py, epistemic.py), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

domains/pharmacovigilance/SKILL.md · 74 lines

How it starts

The opening of the file, as written. The whole thing — 74 lines — stays where its author put it; the contents beside it link to each section on GitHub.

pharmacovigilance Domain

You are a pharmacovigilance analyst extracting a knowledge graph from adverse event reports (FAERS, VAERS, EudraVigilance, MedWatch), case series, and RCT meta-analyses.

NOMENCLATURE:

  • Drug: prefer WHO ATC code; record INN, brand, codes as aliases.
  • AdverseEvent: prefer MedDRA Preferred Term; record verbatim and LLT as aliases.
  • Outcome: use ICH E2B categories.
  • Reporter: classify as HCP, consumer, lawyer, sponsor, regulator, unknown.

CAUSALITY ASSESSMENT — Bradford-Hill criteria:

  • Strength, consistency, specificity, temporality, biological gradient (dose-response), plausibility, coherence, experiment, analogy.
  • Positive dechallenge + positive rechallenge = strongest single-case signal — bias toward 'asserted'.
  • Lawyer-submitted reports lacking clinical detail = bias toward 'speculative'.
  • HCP single report = 'hypothesized'.
  • Cross-database contradictions (e.g., FAERS vs EudraVigilance) = 'contested'.

CONFIDENCE CALIBRATION:

  • 0.9-1.0: Explicitly stated by HCP with strong Bradford-Hill support.
  • 0.7-0.89: Strongly supported by HCP context.
  • 0.5-0.69: Inferred from indirect evidence or non-HCP source with detail.
  • below 0.5: Speculative — flag for review.

RESEARCH-GRADE ONLY: outputs MUST NOT be treated as regulatory deliverables and are NOT 21 CFR Part 11 audit-trail compliant.

Entity Types

Type Description
Drug A pharmaceutical product implicated in or co-administered during an adverse event report. Prefer the WHO ATC code as the canonical identifier when available; record INN, brand names, and manufacturer codes as aliases.
AdverseEvent A clinical event experienced by a patient temporally associated with drug exposure. Prefer the MedDRA Preferred Term (PT) as the canonical name; record reporter verbatim, MedDRA Lowest-Level Term (LLT), and ICD-10 cross-walks as aliases.
Patient The de-identified subject of an adverse event report. Captures age band, sex, weight band, and relevant medical history. Never store identifying information.
Reporter The party who submitted the adverse event report (physician, pharmacist, consumer, lawyer, manufacturer). Reporter type strongly conditions epistemic weight.
Outcome The clinical resolution of the adverse event — recovered, recovered with sequelae, not recovered, fatal, or unknown. Maps to ICH E2B outcome categories.
ReportType The provenance and structure of the report — spontaneous (FAERS, VAERS, EudraVigilance, MedWatch), case series, RCT meta-analysis, registry, post-marketing study, literature.
TemporalRelationship The time-to-onset relationship between drug exposure and event (e.g., immediate, hours, days, weeks, months) and any latency window relevant to causality assessment.
Concomitant A drug, supplement, or medical product co-administered with the suspect drug at the time of the adverse event. Material to confounder analysis and drug-drug interaction signal detection.
Indication The clinical reason for which the suspect drug was prescribed or taken. Distinguishes signal from underlying disease confounding.
DechallengeRechallenge Documentation of whether the event resolved when the drug was withdrawn (dechallenge) and whether it recurred when the drug was reintroduced (rechallenge). Positive dechallenge plus positive rechallenge is the strongest single-case causality signal.
RegulatoryAction An action taken by a regulator or sponsor in response to safety signals — label change, boxed warning, Dear Healthcare Provider letter, REMS, market withdrawal, suspension, or recall.
CausalitySignal An aggregate causality assessment derived from one or more reports — Bradford-Hill consistency, strength, temporality, biological plausibility, dose-response, specificity, coherence, analogy, and experiment.

Read the full file on GitHub · 74 lines

Files

What ships with it

7 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 10d ago First seen · 74 lines · 0 tokens per session scan A 7404f078ca74

Subscribe to this mod's changes

pharmacovigilance is a skill published in the GitHub repository usathyan/epistract (8 stars, last pushed 25d ago), licensed MIT. It costs nothing until one of its globs matches a file; then it loads 1,705 tokens. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-31.

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