SafeMeds Index Specification

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SafeMeds Index Specification

Powering insight across the world of medicine.

Overview

SafeMeds Index is an open-source global pharmaceutical intelligence platform designed to provide transparent, searchable, and continuously updated information about medicines, pharmaceutical pricing, manufacturing, distribution, recalls, safety developments, and therapeutic alternatives.

SafeMeds Index is designed to help individuals, researchers, healthcare professionals, journalists, policymakers, and organizations understand the global pharmaceutical market and identify meaningful differences in medication availability, pricing, provenance, safety, and therapeutic options.

Mission

The mission of SafeMeds Index is to make pharmaceutical information more transparent and accessible by connecting fragmented global data into a unified intelligence system.

Design Principles

Open Source

The platform shall be developed and distributed as open-source software under the GNU Affero General Public License v3.0 or later (AGPL-3.0+), including the applicable Section 7 attribution requirement.

Global Coverage

The system shall support pharmaceutical data from countries and jurisdictions worldwide while accounting for differences in naming conventions, currencies, regulatory systems, availability, pricing structures, and data formats.

Modular Architecture

The platform shall use modular components with clearly defined interfaces. Core capabilities shall remain independent from optional integrations and extensions.

Local First

The system should support local processing, local data storage, self-hosted deployments, and operation without mandatory dependence on a single commercial cloud provider.

Vendor Neutrality

The platform shall avoid unnecessary vendor lock-in and support interchangeable databases, AI models, search engines, storage systems, data providers, and deployment environments.

Evidence and Provenance

Information shall retain source provenance whenever possible. The system shall distinguish verified information from inferred, estimated, incomplete, outdated, or conflicting information.

Human Oversight

AI-generated classifications, summaries, recommendations, and risk assessments shall remain reviewable and traceable to their underlying sources.

Safety

SafeMeds Index shall present pharmaceutical information as informational intelligence rather than a substitute for professional medical diagnosis, prescribing, or treatment decisions.

Core Modules

Pharmaceutical Identity Module

The Pharmaceutical Identity Module shall create standardized identities for medications and pharmaceutical products across international markets.

Features shall include:

Generic and active ingredient names
Brand names
International and regional names
Active pharmaceutical ingredients
Strength and concentration
Dosage form
Route of administration
Package size
Product identifiers
Regulatory identifiers
Anatomical Therapeutic Chemical classifications
Synonyms and spelling variations
Country-specific product names
Ingredient normalization
Combination medication identification
Product status tracking

The module shall establish canonical medication identities that other SafeMeds Index modules can reference.

Global Price Intelligence Module

The Global Price Intelligence Module shall collect, normalize, compare, and analyze pharmaceutical prices across countries and markets.

Features shall include:

Country-specific medication prices
Pharmacy pricing
Distributor pricing
Manufacturer pricing where publicly available
Retail and wholesale pricing where available
Insurance and reimbursement information where available
Package-size normalization
Dosage normalization
Currency conversion
Purchasing-power comparisons
Historical price tracking
Price change detection
Geographic price comparisons
Price anomaly detection
Availability and price correlation
Lowest identified price indicators
Data freshness indicators

The system shall distinguish between listed prices, observed prices, estimated prices, negotiated prices, reimbursed prices, and other pricing categories.

Manufacturer Intelligence Module

The Manufacturer Intelligence Module shall maintain structured information about companies and organizations responsible for pharmaceutical production.

Features shall include:

Manufacturer identity
Parent company relationships
Subsidiaries
Production facilities
Manufacturing countries
Manufacturing locations
Active pharmaceutical ingredient manufacturers
Finished-product manufacturers
Contract manufacturers
Packaging facilities
Regulatory registrations
Product relationships
Manufacturing history
Regulatory actions
Recall history
Source provenance

The module shall distinguish between the brand owner, marketing authorization holder, manufacturer, contract manufacturer, API manufacturer, packaging facility, and distributor where the available data supports those distinctions.

Distribution Intelligence Module

The Distribution Intelligence Module shall map pharmaceutical movement through available distribution networks.

Features shall include:

Distributors
Wholesalers
Importers
Exporters
Pharmacies
Healthcare providers where appropriate
Distribution territories
Import and export relationships
Product distribution relationships
Country-specific availability
Supply chain relationships
Distribution changes
Source documentation

The system shall represent known relationships without presenting inferred supply chains as verified facts.

Batch and Lot Intelligence Module

The Batch and Lot Intelligence Module shall provide traceability for pharmaceutical batches and lots.

Features shall include:

Batch numbers
Lot numbers
Expiration dates
Manufacturing dates where available
Production facilities
Product identifiers
Packaging information
Recall relationships
Safety alert relationships
Distribution relationships
Geographic distribution
Batch status
Source records

The module shall allow users to determine whether a specific batch or lot has been associated with a recall, warning, contamination event, manufacturing defect, or other regulatory action.

Recall and Regulatory Safety Module

The Recall and Regulatory Safety Module shall aggregate pharmaceutical recalls, safety alerts, regulatory actions, warnings, withdrawals, restrictions, and related notices from jurisdictions around the world.

Features shall include:

Recall identification
Recall dates
Affected products
Affected batches
Affected manufacturers
Recall classifications
Recall reasons
Geographic scope
Regulatory authority
Regulatory notices
Product withdrawals
Safety warnings
Manufacturing violations
Import alerts
Distribution restrictions
Historical recall records

The module shall preserve the originating regulatory source whenever possible.

Global News Intelligence Module

The Global News Intelligence Module shall monitor worldwide news and publicly available reporting concerning medications, manufacturers, pharmaceutical products, and relevant safety issues.

Features shall include:

Global news ingestion
Medication entity recognition
Manufacturer entity recognition
Safety event detection
Recall event detection
Litigation monitoring
Regulatory reporting
Research reporting
Manufacturing incidents
Contamination reporting
Shortage reporting
Pricing reporting
Supply chain reporting
Adverse event reporting
International language processing
Duplicate story detection
Source credibility metadata
Publication date tracking
Event timeline construction

The system shall preserve links and source information for material claims.

Scientific and Clinical Evidence Module

The Scientific and Clinical Evidence Module shall collect and organize scientific literature and clinical evidence associated with medications and therapeutic alternatives.

Features shall include:

Clinical trials
Systematic reviews
Meta-analyses
Peer-reviewed research
Regulatory evidence
Pharmacological studies
Comparative effectiveness studies
Safety studies
Drug interaction studies
Outcome data
Evidence quality indicators
Publication dates
Research provenance

The module shall distinguish between established evidence, emerging evidence, conflicting evidence, and insufficient evidence.

Generic Equivalence Module

The Generic Equivalence Module shall identify generic products associated with the same active ingredient, strength, dosage form, and applicable regulatory equivalence criteria.

Features shall include:

Generic product identification
Active ingredient matching
Strength matching
Dosage-form matching
Regulatory equivalence information
Bioequivalence information where available
Brand-to-generic relationships
Country-specific generic availability
Manufacturer comparisons
Price comparisons
Evidence links

The system shall not automatically represent a product as interchangeable when regulatory or clinical evidence does not support that conclusion.

Therapeutic Alternatives Module

The Therapeutic Alternatives Module shall identify medications that may be used for the same or related therapeutic purposes while clearly distinguishing therapeutic alternatives from pharmaceutical equivalents.

Features shall include:

Therapeutic class comparisons
Active ingredient comparisons
Indication matching
Clinical evidence comparisons
Effectiveness evidence
Safety evidence
Contraindication information
Interaction information
Country-specific availability
Price comparisons
Evidence quality
Clinical uncertainty indicators

The module shall avoid presenting therapeutic alternatives as universally interchangeable.

Medication Safety Intelligence Module

The Medication Safety Intelligence Module shall combine information from recalls, regulatory actions, scientific literature, news, and other validated sources to create medication safety intelligence.

Features shall include:

Safety event aggregation
Risk categorization
Event timelines
Manufacturer risk history
Product risk history
Batch risk history
Geographic risk mapping
Source confidence
Evidence strength
Conflicting evidence detection
Safety trend detection

Safety assessments shall remain transparent and traceable to their underlying evidence.

Drug Shortage and Availability Module

The Drug Shortage and Availability Module shall track medication availability across countries and markets.

Features shall include:

Drug shortages
Supply interruptions
Manufacturing disruptions
Distribution interruptions
Geographic availability
Shortage duration
Shortage severity
Alternative availability
Historical shortages
Manufacturer availability
Regulatory shortage notices

Currency and Market Normalization Module

The Currency and Market Normalization Module shall make international pharmaceutical pricing comparable.

Features shall include:

Currency conversion
Historical exchange rates
Purchasing-power comparisons
Unit-price normalization
Package-size normalization
Dosage normalization
Regional market classification
Price-date tracking
Exchange-rate provenance

The system shall preserve the original price and currency alongside normalized values.

Search and Discovery Module

The Search and Discovery Module shall provide a unified interface for locating pharmaceutical intelligence.

Features shall include:

Medication search
Brand search
Generic search
Manufacturer search
Distributor search
Batch search
Recall search
Country search
Price search
Safety search
News search
Alternative search
Full-text search
Multilingual search
Synonym matching
Fuzzy matching
Advanced filtering

Data Provenance Module

The Data Provenance Module shall track where information originated and how it was transformed.

Features shall include:

Source identification
Source URLs
Publication dates
Retrieval dates
Data provider identification
Transformation history
Import history
Confidence indicators
Verification status
Data freshness
Conflict identification
Version history

Every significant data point should be traceable to its source whenever technically and legally possible.

Data Quality Module

The Data Quality Module shall evaluate incoming and existing pharmaceutical data.

Features shall include:

Validation rules
Duplicate detection
Contradiction detection
Missing-field detection
Stale-data detection
Invalid-identifier detection
Currency validation
Unit validation
Source validation
Confidence scoring
Human review queues

AI Intelligence Module

The AI Intelligence Module shall provide machine-assisted analysis across the SafeMeds Index data ecosystem.

Features shall include:

Named entity recognition
Pharmaceutical entity matching
Multilingual classification
Document classification
News event extraction
Recall detection
Safety event extraction
Price anomaly detection
Relationship extraction
Summarization
Translation
Semantic search
Evidence clustering
Alternative discovery
Duplicate detection
Conflict detection

AI-generated results shall include provenance and confidence information whenever possible.

Alert and Notification Module

The Alert and Notification Module shall allow users to monitor medications, manufacturers, batches, prices, recalls, and safety developments.

Features shall include:

Price alerts
Recall alerts
Batch alerts
Safety alerts
Manufacturer alerts
Shortage alerts
News alerts
Regulatory alerts
Availability alerts
Watchlists
Email notifications
Push notifications
Web notifications
Configurable thresholds

User Intelligence Module

The User Intelligence Module shall provide personalized monitoring without requiring unnecessary personal information.

Features shall include:

Saved medications
Saved manufacturers
Saved countries
Saved pharmacies
Saved searches
Watchlists
Price targets
Safety monitoring
Notification preferences
Data export
Account deletion

API Module

The API Module shall provide programmatic access to SafeMeds Index data and intelligence.

Features shall include:

Medication endpoints
Pricing endpoints
Manufacturer endpoints
Distribution endpoints
Batch endpoints
Recall endpoints
Safety endpoints
News endpoints
Evidence endpoints
Alternative endpoints
Search endpoints
Provenance endpoints
Authentication
Authorization
Rate limiting
API versioning
Documentation

Internationalization Module

The Internationalization Module shall support global deployment.

Features shall include:

Multilingual interfaces
Multilingual search
Pharmaceutical name localization
Local currency support
Country-specific regulatory terminology
Regional date formats
Regional measurement conventions
Translation workflows
Language-aware NLP

Governance and Audit Module

The Governance and Audit Module shall maintain transparency around system operations.

Features shall include:

Audit logs
Data change history
Model version tracking
Administrative actions
Source changes
Moderation history
Verification history
User reports
Correction requests
Governance records

Optional Plugin Modules

Pharmacy Integration Plugin

Connects SafeMeds Index to participating pharmacies and pharmacy data providers for current pricing and availability information.

Government Data Plugin

Connects to national and regional government pharmaceutical databases, regulatory systems, pricing databases, and public health datasets.

Regulatory Authority Plugin

Provides jurisdiction-specific integrations for regulatory agencies and safety authorities.

News Provider Plugin

Adds additional news feeds and licensed news sources to the Global News Intelligence Module.

Scientific Literature Plugin

Connects additional scientific literature databases and research repositories.

Trade and Customs Plugin

Adds international pharmaceutical import and export information where legally available.

Supply Chain Plugin

Provides additional pharmaceutical manufacturing and distribution intelligence.

Barcode and Product Identifier Plugin

Supports scanning and interpretation of pharmaceutical barcodes, package identifiers, serialization information, and related product identifiers where available.

OCR Plugin

Extracts structured pharmaceutical information from product packaging, labels, regulatory documents, invoices, and other permitted documents.

Translation Plugin

Adds external or locally hosted translation models for pharmaceutical terminology and international sources.

AI Model Plugin

Allows operators to add, remove, or replace AI models without changing the core application.

Supported model categories may include:

Large language models
Small language models
Medical language models
Multilingual language models
Named entity recognition models
Embedding models
Classification models
Ranking models
Recommendation models
Translation models
Vision-language models

Local AI Plugin

Allows SafeMeds Index to run supported AI models locally or on private infrastructure without requiring external AI services.

Mapping Plugin

Adds geographic visualization of pharmaceutical prices, manufacturers, production facilities, distributors, recalls, shortages, and availability.

Visualization Plugin

Provides advanced charts, graphs, timelines, geographic views, price comparisons, and pharmaceutical relationship visualizations.

Notification Provider Plugin

Adds external notification systems such as email providers, messaging systems, mobile push services, or self-hosted notification infrastructure.

Identity Provider Plugin

Supports optional authentication systems while allowing self-hosted deployments to select their preferred identity provider.

Data Export Plugin

Provides export formats for researchers, journalists, healthcare organizations, governments, and other authorized users.

Supported formats may include:

CSV
JSON
XML
RDF
Parquet
API feeds

Research Plugin

Provides tools for researchers to compare pharmaceutical prices, safety events, manufacturers, clinical evidence, and therapeutic alternatives.

Public Health Plugin

Provides specialized analytics for public health organizations, including shortage monitoring, availability analysis, and geographic medication access.

Accessibility Plugin

Provides additional accessibility capabilities for users with visual, auditory, cognitive, or motor accessibility requirements.

Model Architecture

SafeMeds Index shall support a model-agnostic AI architecture so that models can be evaluated and replaced independently of the core application.

Language Models

Language models may be used for:

Document understanding
Summarization
Question answering
Structured extraction
Research synthesis
Classification
Pharmaceutical intelligence analysis

The system shall support both locally hosted and externally hosted models where compatible with the deployment requirements.

Medical Language Models

Medical and biomedical language models may be used for:

Medical terminology extraction
Drug and disease entity recognition
Clinical document analysis
Biomedical literature analysis
Pharmacological relationship extraction

Embedding Models

Embedding models shall support:

Semantic search
Pharmaceutical entity matching
Multilingual matching
Duplicate detection
Similarity analysis
Evidence clustering

Named Entity Recognition Models

NER models shall identify:

Medications
Active ingredients
Manufacturers
Distributors
Regulatory organizations
Countries
Healthcare organizations
Medical conditions
Clinical events
Safety events
Batch numbers
Product identifiers

Classification Models

Classification models may identify:

Recall events
Safety events
Pricing information
Clinical evidence
Regulatory actions
Manufacturing incidents
Shortages
News categories
Source categories
Evidence quality

Recommendation Models

Recommendation models may assist with:

Generic discovery
Therapeutic alternative discovery
Evidence retrieval
Price comparison
Search ranking

Recommendations must remain evidence-linked and must not imply clinical interchangeability without appropriate supporting evidence.

Anomaly Detection Models

Anomaly detection models may identify:

Unusual price changes
Unusual regional price differences
Suspicious data patterns
Unexpected availability changes
Data quality anomalies
Supply chain anomalies

Knowledge Graph Models

Knowledge graph technologies may represent relationships among:

Medications
Ingredients
Manufacturers
Production facilities
Distributors
Pharmacies
Countries
Batches
Recalls
Safety events
Clinical evidence
Therapeutic alternatives

Computer Vision Models

Computer vision models may optionally process permitted images of:

Medication packaging
Labels
Product identifiers
Regulatory documents
Recall notices

Visual extraction must remain subject to validation and human review when accuracy is uncertain.

Data Sources

SafeMeds Index shall prioritize authoritative and legally accessible sources.

Potential sources include:

Government pharmaceutical databases
National regulatory agencies
International regulatory organizations
Public pharmacy pricing databases
Manufacturer publications
Distributor data
Public procurement databases
Scientific publications
Clinical trial registries
Public recall databases
Public safety notices
Licensed news sources
Publicly accessible pharmaceutical datasets

The platform shall respect applicable terms of use, licensing requirements, copyright restrictions, privacy requirements, robots directives, and data access restrictions.

Data Integrity

SafeMeds Index shall distinguish among:

Verified data
Official data
Reported data
Observed data
Estimated data
AI-inferred data
Community-submitted data
Historical data
Conflicting data
Unverified data

The platform shall never present AI inference as verified pharmaceutical fact.

Security

The platform shall implement appropriate security controls including:

Secure authentication
Authorization controls
Encryption in transit
Encryption at rest where appropriate
Secure secrets management
Dependency monitoring
Input validation
API protection
Audit logging
Rate limiting
Security testing
Vulnerability reporting

Privacy

SafeMeds Index shall minimize collection of personally identifiable information.

The platform shall avoid collecting sensitive health information unless explicitly required for a specific deployment and appropriately protected.

Personalized medication monitoring should preferably operate using minimal user information and privacy-preserving identifiers.

Healthcare Safety Disclaimer

SafeMeds Index is an information and pharmaceutical intelligence platform.

Information presented by the platform shall not be represented as a diagnosis, prescription, individualized medical recommendation, or replacement for consultation with a qualified healthcare professional.

Generic products and therapeutic alternatives shall be clearly distinguished. The presence of an alternative in the database shall not mean that it is appropriate for every patient.

Deployment

SafeMeds Index shall support:

Local deployment
Self-hosted deployment
Private infrastructure
Institutional deployment
Public web deployment
Containerized deployment
Distributed deployment

The architecture shall avoid requiring a single hosting provider or proprietary service.

Interoperability

The platform should support widely used standards and interoperable data formats where applicable.

Integration capabilities should support:

REST APIs
GraphQL where useful
JSON
CSV
XML
RDF
Structured pharmaceutical identifiers
Standardized medical terminology
International currency standards
Geographic standards

Transparency

Every major intelligence result should provide enough context for users to understand:

What was found
When it was found
Where it came from
How it was processed
Whether it was verified
How confident the system is
Whether conflicting information exists

Corrections

Users and authorized data contributors should be able to report:

Incorrect prices
Incorrect manufacturer relationships
Incorrect batch information
Incorrect recalls
Incorrect safety information
Incorrect alternatives
Outdated information
Duplicate records
Misclassified information

Corrections should enter a review and audit process rather than silently overwriting historical records.

Specification Branding License (SBL)

Standard

Fully AGPL-3.0+ compliant system
Copyleft enforced for network deployments
Required attribution:
- Roxanne Ardary
- https://www.roxanneardary.com/

Optional

Specification Branding License (SBL)
- Attribution-free commercial deployment
- Pricing based on scale, usage, and deployment scope
- https://roxanneardary.com/safemedsindex/

License & Notice Requirements

SafeMeds Index is released under the GNU Affero General Public License v3.0 or later (AGPL-3.0+).

By contributing to this project, you agree that your contributions will also be released under this license.

Please note the following:

All contributions must comply with the AGPL-3.0+ terms.
Under Section 7 of the license, all redistributions, forks, and derivative works must preserve attribution to Roxanne Ardary and roxanneardary.com.
SafeMeds Index specifications are free to use with attribution. A Specification Branding License can be negotiated upon request.
The project’s notice.md file tracks attribution requirements and contributor acknowledgments. Any update that adds new contributors or modifies attribution should also update notice.md.
When submitting a pull request, ensure that any new files maintain the attribution headers where applicable.
Network-deployed versions of this software must also remain fully AGPL-3.0+ compliant, including exposure of source code modifications when applicable under the license.

For full legal details, please refer to the AGPL-3.0+ license and the project’s notice.md file.

Notice – SafeMeds Index

Attribution Requirement: Under Section 7 of the AGPL 3.0+ license, all redistributions, forks, and derivative works, including network-deployed versions of this project, must provide attribution to Roxanne Ardary and roxanneardary.com.

Contributors

This file tracks contributors and their specific contributions to the project.

Roxanne Ardary, roxanneardary.com – March 20, 2026
Created the repository for SafeMeds Index. Designed and implemented the global pharmaceutical intelligence platform, including price comparison, batch tracking, recall monitoring, and generic alternatives features.
[Add other contributors here] – [Date]
[Describe contribution in one sentence]

License – SafeMeds Index

This repository is licensed under the GNU Affero General Public License v3.0 or later (AGPL-3.0+).

Key Points

You are free to use, modify, and distribute the code.
All redistributions, forks, and derivative works or network-deployed versions must also be licensed under AGPL-3.0+ and must provide attribution to Roxanne Ardary and roxanneardary.com as required under Section 7 of the license.
The software is provided “as is,” without warranty of any kind.

For the full license text, see GNU AGPL-3.0 License.