Surveillance

Overview

VIGIA’s Surveillance module provides comprehensive monitoring of global pharmacovigilance databases and regulatory agencies, enabling early detection of safety signals and regulatory actions.

Multi-Source Monitoring

FDA, EMA, DIGEMID Peru, VigiAccess WHO

Scheduled Scraping

Automated data collection with configurable CRON schedules

Smart Filtering

Filter by severity, medication, date ranges, and keywords

Automated Reports

Weekly email reports in PDF, CSV, XLSX, or HTML

Surveillance Scopes

VIGIA separates surveillance into two scopes:

Scope	Description	Sources
National	Domestic regulatory monitoring	DIGEMID (Peru), national health authorities
External	International monitoring	FDA, EMA, VigiAccess, Health Canada, MHRA

Each scope has independent configuration for sources, schedules, and recipients.

Data Sources

Configuring Sources

GET /api/v1/surveillance/sources?scope=national

Response:

{
  "sources": [
    {
      "id": "uuid-1234",
      "name": "DIGEMID Alertas",
      "url": "https://www.digemid.minsa.gob.pe/alertas",
      "enabled": true
    },
    {
      "id": "uuid-5678",
      "name": "DIGEMID RAM",
      "url": "https://www.digemid.minsa.gob.pe/ram",
      "enabled": false
    }
  ]
}

Update Sources

POST /api/v1/surveillance/sources?scope=external
Content-Type: application/json

{
  "sources": [
    {
      "name": "FDA Drug Safety",
      "url": "https://www.fda.gov/drugs/drug-safety-and-availability",
      "enabled": true
    },
    {
      "name": "EMA Safety Updates",
      "url": "https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance",
      "enabled": true
    },
    {
      "name": "VigiAccess",
      "url": "http://www.vigiaccess.org/",
      "enabled": true
    }
  ]
}

When updating sources, the entire list is replaced. Include all sources you want to keep active.

Automated Scraping

Scraping Schedule

Configure CRON-based automatic scraping:

GET /api/v1/surveillance/schedule?scope=national

Response:

{
  "cron": "0 9 * * MON",
  "next_run_iso": "2024-03-11T09:00:00+00:00"
}

Update Schedule

POST /api/v1/surveillance/schedule?scope=external
Content-Type: application/json

{
  "cron": "0 9 * * MON,THU",
  "next_run_iso": "2024-03-07T09:00:00-05:00"
}

Common CRON Patterns:

0 9 * * MON: Every Monday at 9:00 AM
0 9 * * MON,THU: Monday and Thursday at 9:00 AM
0 */6 * * *: Every 6 hours
0 9 1 * *: First day of each month at 9:00 AM

Timezone: Schedules run in America/Lima timezone by default.

Manual Run

Trigger immediate scraping:

POST /api/v1/surveillance/run?scope=national

Scrapes all enabled sources and returns:

{
  "ok": true,
  "results": {
    "uuid-1234": {
      "items_found": 15,
      "items_new": 3,
      "source": "DIGEMID Alertas"
    },
    "uuid-5678": {
      "error": "Connection timeout"
    }
  }
}

Surveillance Items

Each scraped item contains:

# Model: backend/app/models/surveillance.py:20-34
class SurveillanceItem:
    - fuente: Source name (FDA, EMA, etc.)
    - titulo: Alert/announcement title
    - medicamento: Drug/product name
    - evento: Adverse event or safety issue
    - severidad: Severity (Alta, Media, Baja)
    - tendencia: Trend (Aumentando, Estable, Disminuyendo)
    - url: Source URL
    - fecha: Item date/time
    - fecha_publicada: Published date
    - scope: national or external

Severity Levels

Severidad	Criteria	Example
Alta	Death, hospitalization, recall	”FDA recalls drug due to contamination”
Media	Serious ADR, label change	”New black box warning for hepatotoxicity”
Baja	Minor ADR, information update	”Updated administration guidelines”

Querying Results

Basic Search

GET /api/v1/surveillance/results?scope=external&limit=20&offset=0

Advanced Filtering

GET /api/v1/surveillance/results?
  scope=national&
  query=paracetamol&
  severity=Alta&
  medicamento=PARACETAMOL&
  date_from=2024-01-01&
  date_to=2024-03-31&
  limit=50

Filter Parameters:

query: Full-text search across title, medication, event
severity: Filter by severity level
medicamento: Exact or partial medication name
date_from / date_to: Date range (ISO 8601 format)
scope: national or external

Response:

{
  "items": [
    {
      "id": "item-uuid-1",
      "fuente": "FDA",
      "titulo": "FDA warns of liver injury risk with acetaminophen",
      "medicamento": "Acetaminophen",
      "evento": "Hepatotoxicity",
      "severidad": "Alta",
      "tendencia": "Aumentando",
      "url": "https://www.fda.gov/...",
      "fecha": "2024-03-01T14:30:00Z",
      "fecha_publicada": "2024-03-01T10:00:00Z"
    }
  ],
  "total": 145,
  "page": 1,
  "page_size": 50
}

Automated Reports

Send Weekly Reports

Generate and email surveillance reports:

POST /api/v1/surveillance/send-reports
Content-Type: application/json

{
  "scope": "external",
  "recipients": [
    "[email protected]",
    "[email protected]"
  ],
  "inline": true,
  "pdf": true,
  "csv": false,
  "xlsx": true,
  "filters": {
    "severity": "Alta",
    "date_from": "2024-02-26",
    "date_to": "2024-03-03"
  },
  "title": "VIGIA - Vigilancia Internacional Semanal"
}

Options:

inline: Include HTML table in email body
pdf: Attach PDF report
csv: Attach CSV export
xlsx: Attach Excel spreadsheet
filters: Apply filters (optional, defaults to last week)

Response:

{
  "ok": true,
  "sent_to": ["[email protected]", "[email protected]"],
  "attachments": ["surveillance_report.pdf", "surveillance_report.xlsx"],
  "inline": true,
  "count": 23,
  "applied_filters": {
    "severity": "Alta",
    "date_from": "2024-02-26T05:00:00+00:00",
    "date_to": "2024-03-03T04:59:59+00:00",
    "defaulted_to_last_week": false,
    "scope": "external"
  }
}

Default behavior: If no date filters provided, reports default to the previous ISO week (Monday-Sunday).

Integration with ICSR

Surveillance items can trigger ICSR creation:

Detect Signal

Surveillance identifies new safety signal from FDA

Review Alert

Pharmacovigilance team reviews the alert details

Create ICSR (if applicable)

If the signal affects company products, create ICSR for investigation

Document in IPS

Include surveillance finding in next IPS report under “Regulatory Actions”

VigiAccess Integration

Special integration with WHO VigiAccess database:

# VigiAccess specific endpoints
GET /api/v1/vigiaccess/search?drug=paracetamol&reaction=hepatotoxicity

GET /api/v1/vigiaccess/dashboard?product_id=123

Features:

Global ADR statistics from 150+ countries
Comparative analysis across regions
Temporal trend analysis
Dashboard visualization

Source: backend/app/routers/vigiaccess.py, backend/app/routers/vigiaccess_dashboard.py

API Endpoints Summary

Configuration

# Get sources
GET /api/v1/surveillance/sources?scope={national|external}

# Update sources
POST /api/v1/surveillance/sources?scope={national|external}

# Get schedule
GET /api/v1/surveillance/schedule?scope={national|external}

# Update schedule
POST /api/v1/surveillance/schedule?scope={national|external}

Scraping

# Run now
POST /api/v1/surveillance/run?scope={national|external}

Results

# Get filtered results
GET /api/v1/surveillance/results?
  scope={scope}&
  limit={int}&
  offset={int}&
  query={text}&
  severity={Alta|Media|Baja}&
  medicamento={name}&
  date_from={YYYY-MM-DD}&
  date_to={YYYY-MM-DD}

Reports

# Send email reports
POST /api/v1/surveillance/send-reports

Code References

Feature	Implementation
Models	`backend/app/models/surveillance.py:11-44`
Router	`backend/app/routers/surveillance.py:1-300`
Scraper Service	`backend/app/services/scraper.py`
Report Generation	`backend/app/services/reports.py`
Filters	`backend/app/services/report_filters.py`
VigiAccess	`backend/app/routers/vigiaccess.py`

Best Practices

Source Management

Enable only reliable, official sources
Test new sources with manual run first
Monitor scraper errors and adjust URLs
Review source list quarterly

Alert Management

Set up severity-based email filters
Review high-severity alerts within 24h
Document signal evaluation decisions
Link alerts to ICSRs when creating reports

ICSR Management - Create cases from surveillance signals
IPS Reports - Include regulatory actions in PSUR
Adverse Event Reporting - Document signal-related events

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

Surveillance

Overview

Multi-Source Monitoring

Scheduled Scraping

Smart Filtering

Automated Reports

Surveillance Scopes

Data Sources

Configuring Sources

Update Sources

Automated Scraping

Scraping Schedule

Update Schedule

Manual Run

Surveillance Items

Severity Levels

Querying Results

Basic Search

Advanced Filtering

Automated Reports

Send Weekly Reports

Integration with ICSR

VigiAccess Integration

API Endpoints Summary

Configuration

Scraping

Results

Reports

Code References

Best Practices

Source Management

Alert Management

Build docs developers (and LLMs) love

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

​Overview

Multi-Source Monitoring

Scheduled Scraping

Smart Filtering

Automated Reports

​Surveillance Scopes

​Data Sources

​Configuring Sources

​Update Sources

​Automated Scraping

​Scraping Schedule

​Update Schedule

​Manual Run

​Surveillance Items

​Severity Levels

​Querying Results

​Basic Search

​Advanced Filtering

​Automated Reports

​Send Weekly Reports

​Integration with ICSR

​VigiAccess Integration

​API Endpoints Summary

​Configuration

​Scraping

​Results

​Reports

​Code References

​Best Practices

Source Management

Alert Management

​Related Features

Build docs developers (and LLMs) love

Overview

Surveillance Scopes

Data Sources

Configuring Sources

Update Sources

Automated Scraping

Scraping Schedule

Update Schedule

Manual Run

Surveillance Items

Severity Levels

Querying Results

Basic Search

Advanced Filtering

Automated Reports

Send Weekly Reports

Integration with ICSR

VigiAccess Integration

API Endpoints Summary

Configuration

Scraping

Results

Reports

Code References

Best Practices

Related Features