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Drug Model Implementation Guide

Introduction

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Use Cases

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Content Development

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Information Models and Terminology Bindings

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Technical Application

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SNOMED CT Implementation Guide for the Drug Model

This guide provides practical guidance for implementing the SNOMED CT drug model for medicinal products. It explains how medicinal products are represented within the SNOMED CT Pharmaceutical and Biologic Product hierarchy, including the different levels of abstraction such as ingredient-based medicinal products, medicinal product forms, clinical drugs, and real clinical drugs.

The guide describes how the internationally consistent SNOMED CT drug model is used alongside National SNOMED CT Drug Extensions to represent jurisdiction-specific information such as authorized product names, packaging, and locally marketed medicines. It also outlines best practices developed through collaboration within the Drug Extension User Group (DEUG) and supports implementers, National Release Centers, and regulators in creating, maintaining, and using SNOMED CT drug concepts in clinical and administrative systems.



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Introduction
Use Cases
Content Development
Information Models and Terminology Bindings
Technical Application

Drug Extension Authoring

Model-Driven and Scalable Authoring

Drug extension content is not typically authored manually on a concept-by-concept basis. Instead, it is derived from existing national drug dictionaries using a structured and scalable process.

This approach is comparable to the development of terminologies such as LOINC, where content is generated based on combinations of well-defined attributes.

Process

1

Mapping Atomic Components

The process begins with mapping the atomic elements of the local drug dictionary to SNOMED CT and related standards. These include:

  • substances (active ingredients)

  • dose forms

  • units of measure

  • strength representations

SNOMED CT aligns with EDQM (European Directorate for the Quality of Medicines) standards for dose forms. Where local dictionaries also use EDQM, this significantly facilitates mapping and interoperability.

2

Once atomic elements are mapped, higher-level drug concepts are generated based on combinations identified in the local dictionary.

These include:

  • Medicinal Products (MP)

  • Medicinal Product Forms (MPF)

3

During concept generation:

  • Existing concepts in the International Edition (MP, MPF, CD) should be reused wherever available

  • Missing concepts are created in the national extension

  • These missing concepts may later be submitted for promotion to the International Edition

4

The generation process is typically implemented as:

  • an automated bulk creation process

  • followed by manual review and quality assurance

This hybrid approach balances scalability with clinical and terminological accuracy.

Drug extension development involves several common challenges, including:

  • Variations in ingredient representation across local dictionaries

  • Limited granularity in source data (e.g. missing strength or form details)

  • Rounding rules for strength normalization

  • Non-normalized strength expressions, including numerator/denominator inconsistencies

Addressing these challenges requires careful normalization and alignment with the SNOMED CT concept model.

Clinical Drugs (CD)
  • Real Clinical Drugs (RCD)

  • Packaged Clinical Drugs (PCD)

  • Real Packaged Clinical Drugs (RPCD)

  • Concepts are typically created algorithmically, using rules derived from the SNOMED CT concept model.

    This ensures consistency while allowing extensions to meet immediate national requirements.

    Differences in units of measure and representation conventions

    Deriving Drug Concepts

    Reuse and Gap Filling

    Validation and Refinement

    Typical Authoring Challenges

    Provide Feedback

    Terminology Services

    Terminology services provide the core infrastructure for accessing, querying, and validating SNOMED CT drug content. They enable systems to use the SNOMED CT Drug Model in a computable and scalable way, supporting both clinical workflows and analytical use cases.

    A terminology service acts as the intermediary between:

    • the RF2 terminology content (International + Drug Extension)

    • the applications and APIs that consume drug data

    Core Capabilities

    A terminology service used for SNOMED CT drug content should support the following capabilities:

    • Concept lookup

      Retrieve details of a concept (e.g. term, status, relationships)

    • Hierarchy traversal

      Navigate parent–child relationships across the drug hierarchy (e.g. MP → CD → RCD)

    • Subsumption testing

      Determine whether one concept is a subtype of another (e.g. whether a product contains a given ingredient)

    • Value set expansion

      Generate a set of concepts based on defined criteria (e.g. all drugs containing a substance)

    • Expression Constraint Language (ECL) execution

      Perform dynamic, logic-based queries over SNOMED CT content

    These capabilities are essential to support:

    • clinical decision support

    • product selection and substitution

    • reporting and analytics

    • interoperability between systems

    Terminology services are particularly important for the SNOMED CT Drug Model because they enable:

    • navigation across abstraction levels

      (e.g. linking CD → RCD → RPCD)

    • dynamic grouping of drugs

      (e.g. all products containing an ingredient)

    • clinical reasoning

      (e.g. interaction checking, dose validation)

    FHIR-based terminology services provide standardized APIs for accessing SNOMED CT content. These APIs enable consistent use of drug terminology across systems.

    Key operations include:

    • $expand

      Expands a value set into a list of SNOMED CT concepts

      (e.g. all drugs containing a specific ingredient)

    • $validate-code

      Validates whether a code is valid within a given value set or system

      (e.g. checking if a selected drug is a valid Clinical Drug)

    When implementing terminology services for drug content, systems should ensure:

    • support for ECL queries involving attributes (ingredient, dose form, strength)

    • efficient handling of large extension datasets

    • alignment between terminology services and FHIR APIs

    • consistent use of value sets across workflows

    Because drug data is both hierarchical and highly structured, terminology services are not optional—they are a core dependency for safe and effective implementation of the SNOMED CT Drug Model.

    interoperability across systems

    (e.g. consistent interpretation of medication data in FHIR workflows)

    $subsumes

    Determines hierarchical relationships between concepts

    (e.g. whether a dispensed product is a subtype of a prescribed drug)

    Role of Terminology Services in the Drug Model

    FHIR Terminology Services

    Implementation Considerations

    Provide Feedback

    Overall Implementation Considerations

    Overall Consideration

    Drug extensions introduce additional complexity compared to other SNOMED CT domains.

    They are often aligned with national regulatory sources and pharmaceutical product registries, which may result in:

    • more frequent updates

    • changes in product availability

    • variation in modeling granularity

    Because extension content depends on the International Edition, updates to international content may require corresponding updates in the extension. For example:

    • new substances or Clinical Drugs may become available

    • existing extension concepts may need to be revised or aligned

    • concepts created in extensions may later be promoted to the International Edition

    Implementations must therefore support ongoing synchronization between international and extension content, ensuring that both layers remain semantically aligned.

    In addition, systems should be prepared to handle situations where concepts move between modules (e.g. from extension to international), while preserving identifier continuity and mappings.

    Deploying the SNOMED CT Drug Model requires a robust technical approach that supports:

    • layered loading of international and extension content

    • consistent version management and update processes

    • handling of concept inactivation and replacement

    • preservation of historical meaning

    Because drug data is both clinically critical and operationally dynamic, terminology updates must be carefully managed to ensure that they are safely integrated into clinical workflows and do not compromise data integrity or interoperability.

    Introduction

    Background

    Medicinal products are a fundamental component of healthcare information systems. Accurate and interoperable representation of medications supports a wide range of healthcare activities, including prescribing, dispensing, medication administration, pharmacovigilance, reimbursement, supply chain management, analytics, and research.

    SNOMED CT provides a structured terminology model for representing medicinal products within the Pharmaceutical and Biologic Product hierarchy. This model represents medicines at multiple levels of abstraction, including ingredient-based medicinal products, medicinal product forms, clinical drugs defined by ingredient, strength, and dose form, and real-world authorized products and packages.

    The SNOMED CT International Release provides concepts describing medicinal products in a manner that is internationally consistent and independent of national regulatory environments. However, many aspects of drug representation; such as authorized product names, proprietary dose forms, packaging characteristics, and locally marketed products, are specific to individual jurisdictions. These are represented through National SNOMED CT Drug Extensions.

    The development and harmonization of national drug extensions is supported by the Drug Extension User Group (DEUG). The DEUG is a collaborative community of National Release Centers, regulators, and domain experts that defines best practices for representing medicinal products in SNOMED CT and promotes alignment between national drug extensions and the international drug model.

    Together, the International drug model and national drug extensions enable consistent representation of medicinal products across healthcare systems while supporting national regulatory requirements and clinical workflows.

    Objective

    The objective of this implementation guide is to support the effective and consistent use of the SNOMED CT Drug Model in real-world settings, including both the International medicinal product model and national drug extensions.

    Specifically, this guide aims to:

    • Enable implementers to understand how the SNOMED CT Drug Model supports clinical, administrative, and analytic use cases

    • Provide practical guidance for selecting and using appropriate drug concept classes in different contexts

    • Support the alignment of national drug representations with the SNOMED CT International model

    • Facilitate the implementation of interoperable drug data using SNOMED CT across systems and jurisdictions

    This guide covers the implementation and use of the SNOMED CT Drug Model, including:

    • The structure of the SNOMED CT medicinal product hierarchy

    • The different drug concept classes (e.g. Medicinal Product, Medicinal Product Form, Clinical Drug, Real Clinical Drug) and their roles in implementation

    • The relationship between the International drug model and National Drug Extensions

    • Typical use cases for drug concepts in clinical, administrative, and analytic workflows

    This guide does not cover:

    • Detailed clinical modeling of medication-related concepts

    • Terminology authoring processes or maintenance of SNOMED CT content, which are addressed in the SNOMED CT Editorial Guide and related authoring documentation

    This guide is intended for stakeholders involved in the development, management, and implementation of SNOMED CT drug extensions.

    National Release Centers are responsible for managing SNOMED CT content within their jurisdictions, including the development and maintenance of national extensions.

    For NRCs, this guide provides guidance on:

    • The benefits of using SNOMED CT to represent medicinal products

    • The principles of the SNOMED CT drug model

    • The steps involved in creating and maintaining National SNOMED CT Drug Extensions

    • Harmonizing existing national drug dictionaries with the SNOMED CT drug model

    Implementers include organizations deploying SNOMED CT drug extensions within healthcare systems such as:

    • Electronic Health Records (EHRs)

    • Pharmacy systems

    • ePrescribing platforms

    • Clinical decision support systems

    For implementers, this guide provides guidance on:

    • Deploying and using SNOMED CT drug extensions in clinical systems

    • Implementation best practice principles

    • Understanding the role of the different drug model classes and their relationship to specific use cases

    • Selecting appropriate drug concept levels for different workflows

    This implementation guide is organized into the following sections:

    Provides background information on the SNOMED CT Drug Model, the objectives and scope of the guide, and the intended audience. It also introduces the role of the Drug Extension User Group (DEUG) and the relationship between the International drug model and national drug extensions.

    Describes the main clinical, administrative, and analytic use cases supported by the SNOMED CT drug model. These use cases illustrate how the different drug model concept classes (e.g. Medicinal Product, Medicinal Product Form, Clinical Drug, Real Clinical Drug) are used across healthcare workflows such as prescribing, dispensing, administration, pharmacovigilance, procurement, and reporting.

    Provides an overview of how medicinal products are represented in SNOMED CT. This section explains the structure of the Pharmaceutical / Biologic Product hierarchy, the different concept classes in the drug model, and the relationship between the International medicinal product model and national drug extensions.

    Describes how SNOMED CT drug concepts are used within healthcare information models. This section explains how drug concepts are bound to data elements in clinical systems and how they support interoperability across workflows such as prescribing, dispensing, medication administration, and reporting.

    Provides implementation guidance for using SNOMED CT drug concepts in healthcare systems. This includes best practices for storing and querying SNOMED CT drug data, integrating national drug extensions, mapping national drug dictionaries, and supporting analytics and reporting

    Querying the Drug Model

    Querying SNOMED CT drug content is a fundamental capability for supporting clinical workflows, product selection, and analytics.

    Because drug concepts are defined using structured attributes, effective querying depends on understanding both the hierarchy and the concept model.

    The SNOMED CT Drug Model is designed to enable flexible querying across:

    • hierarchical relationships (e.g. ingredient → product → package)

    • defining attributes (e.g. ingredient, dose form, strength)

    Deployment and Versioning

    SNOMED CT drug content is distributed using Release Format 2 (RF2), the standard format for both the International Edition and all SNOMED CT extensions.

    More information

    SNOMED CT Drug Model

    The SNOMED CT Drug Model provides a comprehensive framework for representing medicinal products across healthcare systems. It is composed of two complementary components:

    • the SNOMED CT International Drug Model, which defines medicinal products in a jurisdiction-independent and clinically focused manner

    • the SNOMED CT Drug Extension Model, which represents real-world medicinal products authorized and available within specific jurisdictions

    Together, these components support consistent representation of medicines across clinical, operational, and regulatory workflows, while enabling interoperability across systems and countries.

    The international model provides the clinical definition of medicinal products, focusing on characteristics such as:

    Implementation Implications

    Provide Feedback

    Practical approaches for representing, storing, querying, and exchanging drug data encoded with SNOMED CT

  • Best practices for integrating national drug dictionaries with SNOMED CT drug extensions

  • Semi-automated and automated approaches for mapping national drug dictionaries to SNOMED CT drug concepts

  • Ensuring interoperability between national drug extensions and the SNOMED CT International Release

  • Regulatory systems
  • Analytics and reporting platforms

  • Efficient storage, retrieval, and querying of SNOMED CT encoded drug data

  • Supporting interoperability across prescribing, dispensing, administration, and reporting workflows

  • Scope

    Audience

    National Release Centers (NRCs)

    Implementers

    Guide Overview

    1. Introduction

    2. Use Cases

    3. SNOMED CT and Drug Representation

    4. Information Model and Terminology Bindings

    5. Technical Application

    Provide Feedback
    The same format is used for both international content and national drug extensions, ensuring that they can be combined into a single, coherent terminology dataset.

    Drug extensions are typically distributed as RF2 packages that are explicitly aligned to a specific version of the SNOMED CT International Edition. This dependency must be respected when deploying and updating terminology content.

    Implementations of the SNOMED CT Drug Model require loading a combined dataset consisting of:

    • the SNOMED CT International Edition, which provides the clinical backbone (MP, MPF, CD)

    • the National Drug Extension, which provides real-world product and packaging concepts (RCD, CDP, RPCD)

    • associated terminology derivatives, e.g. mappings to local drug dictionaries (this may be part of a reference set in the Drug Extension)

    Drug extensions are not standalone. They depend on the International Edition and extend it by adding product identity and packaging information. As a result, implementations must treat the terminology as a layered model, where extension concepts build directly on international concepts.

    To ensure correct resolution of dependencies, content should be loaded in the following order:

    • International Edition

    • National Drug Extension

    • Derivatives

    Key considerations include:

    • maintaining clear module separation between international and extension content

    • ensuring version alignment between the extension and its dependent International Edition

    • validating that all referenced concepts (e.g. substances, dose forms) are present

    • building indexes to support efficient querying across the drug hierarchy

    SNOMED CT drug content evolves continuously due to:

    • introduction of new medicinal products

    • regulatory changes

    • updates to substances, dose forms, and strengths

    • refinement of the concept model

    RF2 uses an append-only versioning mechanism, where each change to a component results in a new version identified by its effective time and active status. Previous versions are retained, enabling full historical traceability.

    Implementations should support:

    • regular ingestion of updated releases

    • identification of new, modified, and inactivated concepts

    • reclassification and reindexing after updates

    Concepts may be inactivated due to product withdrawal, modeling changes, or replacement by more accurate representations. Systems must detect inactive concepts and, where available, use historical association reference sets to identify replacement concepts. This is particularly important for maintaining continuity in longitudinal data.

    Historical traceability allows systems to:

    • interpret past medication records correctly

    • support audit and regulatory requirements

    • perform time-based analytics

    Reference sets are also versioned and must be updated alongside core terminology content. This is especially important for:

    • language refsets, which determine preferred terms for display

    • mapping refsets, which link SNOMED CT concepts to local drug dictionaries

    Provide Feedback

    Distribution and Access

    Content Representation
    SNOMED CT Release File Specification
    SNOMED CT Extension Guide

    Approach

    Version Management

    levels of abstraction (MP, MPF, CD, RCD, RPCD)

    Effective querying relies on the use of Expression Constraint Language (ECL), which allows both hierarchical and attribute-based constraints to be combined. More information, see SNOMED CT Expression Constraint Language

    Hierarchical queries use subtype relationships to retrieve groups of related concepts. These are particularly useful for aggregation and broad filtering.

    Example: Aggregate by ingredient

    Explanation:

    Retrieves all medicinal products containing amoxicillin, across all levels of the drug model (MP, MPF, CD, RCD, RPCD).

    Typical use cases:

    • drug interaction checking

    • allergy alerts

    • population-level reporting

    Example: Retrieve all capsule drugs

    Explanation:

    Retrieves all medicinal products that have of capsule, regardless of ingredient or strength.

    Typical use cases:

    • filtering drug lists in prescribing systems

    • form-specific clinical rules

    Attribute-based queries refine results using specific characteristics of medicinal products.

    Example: Dose-specific Clinical Drugs

    The following expression constraint is satisfied by oral medicinal products, which contain amoxicillin and have a presentation strength greater than or equal to 250 mg.

    Retrieves Clinical Drugs containing amoxicillin at a strength of 250 mg.

    Typical use cases:

    • dose validation

    • prescribing decision support

    A key feature of the SNOMED CT Drug Model is the ability to move between levels of abstraction.

    Upward navigation (aggregation)

    • RCD → CD → MP

    Used to:

    • aggregate dispensing or administration data

    • support reporting and analytics

    Downward navigation (product identification)

    • MP → CD → RCD → RPCD

    Used to:

    • identify available products for a given clinical definition

    • support substitution and dispensing workflows

    Selecting specific drug model classes is essential for accurate data entry and meaningful analytics. This can be achieved using ECL expressions that constrain content based on hierarchical structure, as well as the presence or absence of relevant attributes.

    The following table shows the ECLs required to query specific Drug model classes.

    Class
    ECL

    Medicinal product (MP)

    << 763158003 |Medicinal product| : [0..0] 1142139005 |Count of base of active ingredient| = *, [0..0] 411116001 |Has manufactured dose form| = *, [0..0] 774158006 |Has product name| = *

    Medicinal product only (MPO)

    << 763158003 |Medicinal product| : 1142139005 |Count of base of active ingredient| = *, [0..0] 411116001 |Has manufactured dose form| = *, [0..0] 774158006 |Has product name| = *

    Medicinal product form (MPF)

    These ECLs can be tested live in this demonstrator:

    https://ihtsdo.github.io/sct-implementation-demonstrator/#/medicinal-product-classes

    The appropriate query pattern depends on the use case and required level of detail.

    Uses ingredient-level aggregation to ensure that all relevant products are included.

    Targets Clinical Drugs to ensure precise matching of strength and formulation.

    Retrieves all products containing a given ingredient, supporting dispensing and inventory workflows.

    Provide Feedback

    Overview

    << 372687004 |Amoxicillin (substance)|
    << 763158003 |Medicinal product| : 
    763032000 |Has unit of presentation (attribute)| = 732937005 |Capsule (unit of presentation)|
    < 763158003 |Medicinal product (product)| :
      411116001 |Has manufactured dose form (attribute)| = << 385268001 |Oral dose form (dose form)| ,
      {
        << 127489000 |Has active ingredient (attribute)| = << 372687004 |Amoxicillin (substance)|,
        1142135004 |Has presentation strength numerator value (attribute)| >= #250,
        732945000 |Has presentation strength numerator unit (attribute)| = 258684004 |milligram (qualifier value)|
      }
    Example to be added
    Example to be added
    Example to be added

    Hierarchical Queries

    Attribute-Based Queries

    Cross-Level Navigation

    ECLs for Selecting Drug Model Classes

    Querying by Use Case

    Drug interaction checking (MP level)

    Dose validation (CD level)

    Product selection (RCD level)

    active ingredient(s)

  • dose form

  • strength

  • It defines a set of concept classes that represent medicines at increasing levels of detail:

    • Medicinal Product (MP) – ingredient only

    • Medicinal Product Form (MPF) – ingredient + dose form

    • Clinical Drug (CD) – ingredient + dose form + strength

    These concepts are:

    • independent of brand and packaging

    • consistent across jurisdictions

    • used for clinical decision support, prescribing, and analytics

    Examples:

    • Product containing amoxicillin (MP)

    • Product containing amoxicillin in oral capsule dose form (MPF)

    • Product containing precisely amoxicillin 500 mg oral capsule (CD)

    The drug extension model builds on the international model to represent actual medicinal products available in a country, including product identity and packaging.

    It introduces additional concept classes:

    • Real Clinical Drug (RCD) – a specific authorized product

    • Clinical Drug Package (CDP) – a generic packaged form

    • Real Clinical Drug Package (RPCD) – a specific packaged product

    These concepts are required for workflows that involve real products rather than abstract clinical definitions, such as:

    • dispensing and administration

    • inventory and supply chain management

    • reimbursement and regulatory processes

    Examples:

    • Brand X amoxicillin 500 mg oral capsule (RCD)

    • Amoxicillin 500 mg oral capsule box of 24 (CDP)

    • Brand X amoxicillin 500 mg oral capsule box of 24 (RPCD)

    The international and extension models form a single, integrated structure, where extension concepts build directly on international concepts.

    This structure reflects two complementary perspectives:

    • a clinical perspective, which defines what the medicine is

    • a real-world perspective, which defines how the medicine is supplied and identified

    The SNOMED CT Drug Model can be understood as a progression from abstract to concrete representations:

    • MP – What substance is involved?

    • MPF – In what form is it administered?

    • CD – What is the precise clinical definition (including strength)?

    • RCD – Which specific product is used?

    • RPCD – Which specific packaged product is supplied?

    In parallel:

    • CDP represents packaging at a generic level, without reference to a specific product

    This layered approach allows systems to select the appropriate level of detail depending on the use case.

    The model is based on a structured set of characteristics that define medicinal products. At a high level:

    • the international model defines clinical characteristics

    • the extension model adds product identity and packaging characteristics

    This separation ensures that:

    • clinical meaning remains consistent across all products

    • real-world products can be represented without redefining clinical concepts

    • systems can move between levels (e.g. from product to ingredient) for aggregation and analysis

    By combining a shared international foundation with flexible national extensions, the SNOMED CT Drug Model enables:

    • consistent representation of medicines across systems

    • safe and precise clinical workflows

    • accurate identification of real-world products

    • interoperability across jurisdictions

    It allows healthcare systems to represent both:

    • what a medicine is (clinical definition)

    • what product is used in practice (real-world product and packaging)

    For clarity, the SNOMED CT drug model distinguishes several levels of abstraction. Each level supports different clinical or administrative workflows.

    Concept Level
    Description
    Example

    MP (Medicinal Product)

    Drug defined by active ingredient(s) only

    Product containing amoxicillin

    MPF (Medicinal Product Form)

    Drug defined by ingredient and dose form

    Provide Feedback

    The Two-Layer Model

    International Drug Model (Clinical Foundation)

    MP → MPF → CD → RCD → RPCD
                   └→ CDP

    Drug Extension Model (Real-World Representation)

    How the Models Work Together

    A Framework Based on Increasing Specificity

    Attribute-Based Modeling (Conceptual View)

    Why This Model Matters

    Summary of Drug Model Levels

    SNOMED International Drug Model
    SNOMED Drug Extension Model

    Drug Extension Development Principles

    Introduction

    National drug extensions enable the representation of real-world medicinal products within the SNOMED CT drug model, complementing the international semantic backbone with country-specific content such as authorized products and packaged medicines.

    The development of a drug extension requires adherence to a set of principles that ensure:

    • alignment with the SNOMED CT concept model

    • consistency across international and national content

    • scalability through semi-automated processes

    • interoperability with local drug dictionaries and regulatory sources

    This chapter outlines the key principles for both overall extension strategy and authoring processes.

    Drug extensions are built on top of the SNOMED CT International Edition and must align with its concept model and hierarchy. The international model provides the core semantic structure through concepts such as:

    • substances

    • medicinal products (MP)

    • medicinal product forms (MPF)

    • clinical drugs (CD)

    In some cases, national extensions may need to create concepts that logically belong to the international model, such as:

    • new substances

    • MPs, MPFs, or CDs not yet present

    These concepts may subsequently be promoted to the International Edition following review by SNOMED International.

    The creation of international-level concepts by National Release Centers (NRCs) introduces coordination challenges, particularly where multiple countries may require the same concepts.

    To reduce duplication and competition:

    • SNOMED International is taking a more proactive role in creating substance concepts, for example by aligning with regulatory sources such as the European Medicines Agency (EMA)

    • The creation of Medicinal Products (MPs) is also planned centrally

    • Requests for MPFs and CDs can be submitted by NRCs and incorporated into the International Edition

    This approach supports consistency, reduces duplication of effort, and ensures a shared foundation across extensions.

    A clear distinction should be maintained between:

    • International content: abstract, reusable concepts supporting interoperability

    • National extension content: real-world products, packages, and regulatory-specific information

    National extensions should:

    • reuse international concepts wherever possible

    • only create new concepts when necessary

    • ensure that extension concepts are logically aligned with the international model

    Product containing amoxicillin in oral capsule dose form

    CD (Clinical Drug)

    Drug defined by ingredient, strength, and dose form

    Amoxicillin 500 mg oral capsule

    RCD (Real Clinical Drug)

    Authorized or branded medicinal product

    BrandX amoxicillin 500 mg capsule

    CDP (Clinical Drug Package)

    Generic description of package

    Amoxicillin 500 mg capsule box of 24

    RPCD (Real Clinical Drug Package)

    Actual packaged product available in supply chain

    Brand X amoxicillin 500 mg capsule box of 24

    Overall Principles

    Alignment with the International Model

    Managing Concept Creation Across NRCs

    Separation of International and National Responsibilities

    Provide Feedback

    << 763158003 |Medicinal product| : [0..0] 1142139005 |Count of base of active ingredient| = *, 411116001 |Has manufactured dose form| = *, [0..0] 774158006 |Has product name| = *

    Medicinal product form only (MPFO)

    << 763158003 |Medicinal product| : 1142139005 |Count of base of active ingredient| = *, 411116001 |Has manufactured dose form| = *, [0..0] 732943007 |Has basis of strength substance (attribute)| = *, [0..0] 774158006 |Has product name| = *

    Medicinal product precisely (MPP)

    << 763158003 |Medicinal product| : 762949000 |Has precise active ingredient (attribute)| = *, 1142139005 |Count of base of active ingredient| = *, [0..0] 732943007 |Has basis of strength substance (attribute)| = *, [0..0] 774158006 |Has product name| = *

    Real medicinal product (RMP)

    << 763158003 |Medicinal product| : [0..0] 411116001 |Has manufactured dose form| = *, 774158006 |Has product name| = *

    Clinical drug (CD)

    << 763158003 |Medicinal product| : 732943007 |Has basis of strength substance (attribute)| = *, [0..0] 774158006 |Has product name| = *

    Real clinical drug (RCD)

    << 763158003 |Medicinal product| : 732943007 |Has basis of strength substance (attribute)| = *, 774158006 |Has product name| = *

    Packaged clinical drug (PCD)

    << 781405001 |Medicinal product package|: [0..0] 774158006 |Has product name| = *

    Real packaged clinical drug (RPCD)

    << 781405001 |Medicinal product package|: 774158006 |Has product name| = *

    SNOMED International Drug Model

    Overview

    The SNOMED CT International Drug Model provides a standardized framework for representing medicinal products in a manner that is consistent across countries and healthcare systems. The model is part of the Pharmaceutical / Biologic Product hierarchy and defines a set of concept classes that represent medicinal products at different levels of abstraction.

    The international model focuses on representing the clinical characteristics of medicinal products, including:

    • active ingredient(s)

    • dose form

    • strength

    These characteristics allow medicines to be represented in a way that is independent of local brand names, packaging, or regulatory authorizations.

    The international drug model defines several concept classes that represent medicinal products at different levels of abstraction. These concept classes allow systems to represent medications with the level of detail required for different clinical and administrative workflows.

    A Medicinal Product represents a medicinal product defined only by its active ingredient(s). It does not specify dose form or strength.

    This level is commonly used for:

    • ingredient-based decision support rules

    • drug interaction checking

    • pharmacovigilance analysis

    • high-level reporting and analytics

    Concept Class
    Description
    Example

    A Medicinal Product Form represents a medicinal product defined by active ingredient(s) and dose form, but without specifying strength.

    This level allows grouping of products that share the same ingredient and pharmaceutical form.

    Typical uses include:

    • prescribing templates

    • clinical decision support rules specific to dose form

    • reporting and aggregation

    Concept Class
    Description
    Example

    A Clinical Drug represents a medicinal product defined by:

    • active ingredient(s)

    • strength

    • manufactured dose form

    This level provides the detail required for most clinical workflows such as prescribing and medication administration.

    Concept Class
    Description
    Example

    Clinical Drug concepts represent generic clinical specifications of medicines, independent of brand names or manufacturers.

    The concept classes of the international drug model form a hierarchy that supports aggregation and semantic reasoning.

    For example:

    This hierarchical structure allows:

    • aggregation of detailed data for reporting

    • decision support rules defined at the ingredient level to apply to all related products

    • consistent interpretation of medication data across systems

    The international drug model uses a set of defining attributes to describe medicinal products. These attributes allow drug concepts to be formally defined and classified within the SNOMED CT hierarchy.

    Common attributes include:

    Attribute
    Description
    Example

    These attributes enable consistent modeling and automated classification of medicinal product concepts.

    The international drug model provides the clinical foundation for representing medicinal products, but it does not represent jurisdiction-specific details such as:

    • brand names

    • authorized products

    • packaging information

    • pack sizes

    These concepts are represented in National SNOMED CT Drug Extensions, which extend the international model to support local regulatory and clinical requirements.

    For example:

    Model Level
    Example

    The international model therefore provides the semantic backbone for national drug extensions, ensuring that medicines can be represented consistently across jurisdictions.

    Integration with Local Drug Dictionaries

    Overview

    Most countries maintain a national drug dictionary or medicinal product registry, which serves as the authoritative source for:

    • authorized medicinal products

    • brand names and manufacturers

    • packaging and presentation

    • regulatory and reimbursement information

    These national dictionaries are typically used operationally in:

    • prescribing systems

    • pharmacy and dispensing systems

    • reimbursement and regulatory workflows

    To enable interoperability and alignment with SNOMED CT, it is necessary to establish systematic mappings between the national drug dictionary and SNOMED CT drug concepts.

    In addition, the SNOMED CT drug model is aligned with the ISO IDMP family of standards. As a result, national drug dictionaries that are structured according to IDMP, or that adopt compatible standards, can be mapped more efficiently and consistently to SNOMED CT. This is particularly relevant for key elements such as substances, strengths, and dose forms. For example, the use of dose forms aligned with European Directorate for the Quality of Medicines & HealthCare standard terms facilitates direct or near-direct mapping to SNOMED CT concepts, reducing ambiguity and improving interoperability across systems.

    In most jurisdictions, national drug dictionaries are:

    • maintained by regulatory or national bodies

    • updated regularly based on product authorizations and withdrawals

    • structured according to national pharmaceutical standards

    The integration with SNOMED CT is therefore not a one-time activity, but part of an ongoing synchronization process between:

    • the national drug dictionary

    • the SNOMED CT International Edition

    • the SNOMED CT national extension (if implemented)

    This process is typically managed by the National Release Center (NRC) or an equivalent authority.

    Mapping from a national drug dictionary to SNOMED CT is typically performed as a semi-automated, systematic process, rather than manual concept-by-concept mapping.

    The process generally includes:

    • mapping atomic elements

      such as substances, dose forms, and units of measure

    • deriving structured drug concepts

      based on combinations of these elements (e.g. ingredient + strength + dose form)

    • linking national product entries to SNOMED CT concepts

      at the appropriate level:

    This approach ensures consistency and scalability across large national datasets.

    Mappings between national drug dictionaries and SNOMED CT may be represented in different ways depending on national infrastructure.

    In many countries, mappings are maintained within national systems or databases, for example:

    • as part of the national drug dictionary

    • within regulatory or reimbursement systems

    • in dedicated mapping tables

    This approach allows tight integration with national workflows but may be less portable across systems.

    Alternatively, mappings may be represented using SNOMED CT reference sets (refsets).

    This approach enables:

    • alignment with SNOMED CT distribution formats (RF2)

    • versioning and traceability of mappings

    • reuse across multiple systems within a country

    • easier sharing between jurisdictions

    For national implementations that publish SNOMED CT extensions, representing mappings as refsets is often the preferred approach.

    National drug dictionaries often contain detailed product information, including:

    • brand names

    • manufacturers

    • packaging

    Mappings should therefore be established at the appropriate level of the SNOMED CT Drug Model, typically:

    • CD (Clinical Drug) for clinical equivalence

    • RCD (Real Clinical Drug) for specific authorized products

    • RPCD (Real Clinical Drug Package) for packaged products

    In some cases, mappings may also be required at more abstract levels (e.g. MP) for aggregation or reporting.

    Mapping between national drug dictionaries and SNOMED CT must be maintained as part of routine national processes.

    This includes:

    • updating mappings when new products are introduced

    • removing or updating mappings when products are withdrawn

    • aligning mappings with updates to SNOMED CT releases

    • ensuring consistency between national data and SNOMED CT content

    Because both national drug dictionaries and SNOMED CT evolve over time, synchronization is an ongoing process rather than a one-time activity.

    Content Representation

    SNOMED CT drug content, whether part of the International Edition or a national drug extension, is distributed using Release Format 2 (RF2). RF2 provides a structured, tabular representation of terminology components, enabling consistent storage, exchange, and processing of SNOMED CT data.

    In RF2, a medicinal product is not represented as a single record, but as a set of coordinated entries across multiple files:

    • the Concept file identifies the drug concept

    • the Description file provides human-readable names

    Clinical Drug (CD) for clinical definitions

  • Real Clinical Drug (RCD) for specific products

  • Real Clinical Drug Package (RPCD) for packaged products

  • Alignment with National Drug Data Processes

    Mapping Approach

    Representation of Mappings

    Proprietary Mapping Representation

    SNOMED CT Reference Set Representation

    Level of Mapping

    Maintenance and Synchronization

    Provide Feedback
    locally marketed products

    Medicinal Product (MP)

    Product defined by active ingredient(s) only

    Product containing amoxicillin

    Medicinal Product Form (MPF)

    Product defined by ingredient(s) and dose form

    Product containing amoxicillin in oral capsule dose form

    Clinical Drug (CD)

    Product defined by ingredient(s), strength, and dose form

    Amoxicillin 500 mg oral capsule

    Medicinal Product
        Product containing amoxicillin
            ↓
    Medicinal Product Form
        Product containing amoxicillin in oral capsule dose form
            ↓
    Clinical Drug
        Amoxicillin 500 mg oral capsule

    Has active ingredient

    Specifies the active substance(s) in the medicinal product

    Amoxicillin

    Has basis of strength substance

    Identifies the substance used to express the strength

    Clinical Drug (International)

    Amoxicillin 500 mg capsule

    Real Clinical Drug (National Extension)

    Brand X Amoxicillin 500 mg capsule

    Real Clinical Drug Package (National Extension)

    Core Concept Classes in the International Drug Model

    Medicinal Product (MP)

    Medicinal Product Form (MPF)

    Clinical Drug (CD)

    Relationship Between Concept Classes

    Key Attributes Used in the Drug Model

    Relationship to National Drug Extensions

    Provide Feedback
    the Relationship file defines the meaning of the drug
  • Reference sets (refsets) provide additional context such as language preferences and mappings

  • Each row in these files represents a single component, and together they form a computable definition of a medicinal product.

    Consider the following real-world product:

    Brand X amoxicillin 500 mg oral capsule (real clinical drug)

    In RF2, this product is reconstructed from multiple components across files.

    The Concept file contains one row per concept. For a drug, this row represents the existence of the medicinal product.

    In drug context:

    • This row represents the Real Clinical Drug (RCD) concept

    • The concept itself has no meaning without descriptions and relationships

    • It acts as the anchor identifier for all related information

    The Description file provides the human-readable terms associated with the concept.

    In drug context:

    • The Fully Specified Name (FSN) provides a precise and unambiguous description of the medicinal product

    • Synonyms provide alternative terms used in prescribing, dispensing, and user interfaces

    The acceptability of synonyms (e.g. which term is preferred for display) is not defined in the Description file itself. Instead, it is specified in a Language Reference Set, which indicates:

    • which synonym is the preferred term

    • which synonyms are acceptable alternatives

    The Relationship file represent the defining properties (the definition) of the drug using structured relationships.

    Each row represents a single relationship between concepts.

    In drug context:

    These relationships define the clinical meaning of the drug:

    • what substance it contains

    • how it is administered

    • how strong it is

    In drug context:

    These relationships distinguish this concept as a Real Clinical Drug (RCD):

    • same clinical definition as other amoxicillin 500 mg capsules

    • but a specific branded and authorized product

    Now consider:

    BrandX amoxicillin 500 mg oral capsule box of 24 (real clinical drug package)

    This concept includes additional packaging relationships:

    In drug context:

    • These relationships describe how the product is packaged and supplied

    • Combined with product identity, this forms a Real Clinical Drug Package (RPCD)

    In addition to SNOMED CT content, extensions often include mapping artifacts that link SNOMED CT concepts to local drug dictionary identifiers.

    These mappings support:

    • interoperability between systems

    • migration from legacy terminologies

    • integration with national regulatory and reimbursement systems

    Reference sets provide additional, non-defining information.

    In drug context:

    • Links the SNOMED CT concept to a local drug dictionary or regulatory identifier

    • Supports integration with pharmacy, billing, and regulatory systems

    SNOMED CT Extension Format – Drug Content in RF2

    Overview

    Amoxicillin trihydrate

    Has manufactured dose form

    Specifies the pharmaceutical dose form

    Oral capsule

    Has strength

    Specifies the amount of active substance

    500 mg

    Brand X Amoxicillin 500 mg capsule box of 24

    Example Scenario: Representing a Real Drug

    Concept File – Identifying the Drug

    👉 Think of this as: “This drug exists in the terminology.”

    Description File – Naming the Drug

    👉 This allows different countries or systems to use different preferred terms for the same drug concept, while maintaining a shared underlying identifier and meaning.

    Relationship File – Defining the Drug

    Clinical Definition (Inherited from International Model)

    👉 This corresponds to the Clinical Drug (CD) definition.

    Product Identity (Extension-Specific)

    👉 This is what makes it usable in dispensing and traceability.

    Packaging Example – Moving to RPCD

    👉 This level is used in inventory, logistics, and dispensing systems.

    Mapping to Local Drug Dictionaries

    Reference Sets – Adding Context

    Example: Mapping to a National Drug Code

    Provide Feedback
    id        effectiveTime  active  moduleId     definitionStatusId
    999001234 20250131       1       EXT_MODULE   Fully defined
    id      conceptId   typeId   term
    888001  999001234   FSN      Brand X amoxicillin 500 mg oral capsule (real clinical drug)
    888002  999001234   Synonym  Brand X amoxicillin 500 mg capsule
    sourceId   typeId                      destinationId
    999001234  Has active ingredient      Amoxicillin
    999001234  Has dose form              Oral capsule
    999001234  Has strength               500 mg
    sourceId   typeId                 destinationId
    999001234  Has product name      Brand X
    999001234  Has manufacturer      Company Y
    sourceId   typeId                  destinationId
    999009999  Has pack size           24
    999009999  Has unit of presentation Capsule
    999009999  Is a                    Real clinical drug package
    referencedComponentId   mapTarget
    999001234               AMOX500_BRANDX

    FHIR and HL7 Terminology Binding Examples

    Introduction

    HL7® FHIR® (Fast Healthcare Interoperability Resources) is widely used to exchange medication information between healthcare systems. The SNOMED CT Drug Model can be used as a terminology for representing medications within FHIR resources, enabling interoperable and semantically consistent medication workflows.

    This section provides examples of how SNOMED CT drug concepts are bound to key FHIR resources across common use cases, including prescribing, dispensing, administration, and medication history.

    The examples illustrate:

    • how different SNOMED CT drug model concept levels (MP, MPF, CD, RCD, RPCD) are used

    • how these concepts are represented in FHIR resources

    • how terminology bindings support interoperability and traceability across workflows

    When using the SNOMED CT Drug Model in FHIR resources, terminology bindings should be carefully aligned with the role of each resource within the medication workflow.

    The following principles should be applied:

    • Use Clinical Drug (CD) for prescribing to ensure a precise and interoperable definition of the intended medication, including ingredient, strength, and dose form

    • Use Real Clinical Drug (RCD) for dispensing and administration to capture the exact product supplied or administered

    • Use SNOMED CT consistently across all medication-related resources to support traceability across prescribing, dispensing, and administration workflows

    In FHIR, SNOMED CT drug concepts are typically bound to CodeableConcept elements, such as medicationCodeableConcept. The selection of the appropriate SNOMED CT concept level for these elements is critical, as it determines the level of clinical detail and supports safe, consistent interpretation of medication data across systems.

    Although the same data element may be used across multiple FHIR resources, its meaning depends on the context in which it is used:

    • In MedicationRequest, .medicationCodeableConcept represents the prescribed medication and is therefore typically bound to a Clinical Drug (CD)

    • In MedicationDispense and MedicationAdministration, the same element represents the actual product supplied or administered and is therefore bound to a Real Clinical Drug (RCD)

    • In MedicationStatement, the element may be bound to either a CD or an RCD, depending on the level of detail available

    Clearly identifying both the specific FHIR data element and its role within the workflow is essential to ensure that terminology bindings are applied consistently, safely, and interoperably across implementations.

    The FHIR Medication resource represents a medication definition that can be referenced by other resources. It provides a reusable representation of a medicinal product across systems.

    In prescribing workflows, the Medication resource is typically populated using a Clinical Drug (CD) concept. This represents the intended medication independently of any specific brand or manufacturer, supporting consistency in prescribing and enabling substitution during dispensing.

    • Concept level: Clinical Drug (CD)

    • Use case: Generic prescribing, reusable medication definition

    The MedicationRequest resource represents a prescription issued by a clinician and captures the clinical intent, including the medication and dosage instructions.

    For prescribing, the medication is represented using a Clinical Drug (CD) to ensure that the prescription clearly specifies the active ingredient, strength, and dose form, while remaining independent of any specific brand. This allows pharmacists to safely substitute equivalent products during dispensing.

    • Concept level: Clinical Drug (CD)

    • Rationale: Provides a precise and interoperable definition of the prescribed medication

    The MedicationDispense resource records the medication actually supplied by the pharmacy.

    At this stage, it is important to capture the exact product dispensed, including brand and manufacturer where applicable. Therefore, a Real Clinical Drug (RCD) concept is used. This ensures traceability between what was prescribed and what was dispensed, and supports pharmacovigilance and reimbursement processes.

    • Concept level: Real Clinical Drug (RCD)

    • Rationale: Captures the exact product supplied to the patient

    The MedicationAdministration resource records the medication actually administered to the patient, typically in a clinical setting.

    At this stage, it is critical to record the exact product administered, as this directly impacts patient safety, auditing, and clinical outcomes. Therefore, the medication is represented using a Real Clinical Drug (RCD).

    In addition, the route of administration is captured using SNOMED CT qualifier values to ensure consistent and interoperable representation.

    • Concept level: Real Clinical Drug (RCD)

    • Additional binding: Route represented using SNOMED CT qualifier values

    • Rationale: Ensures accurate recording of both the administered product and the route of administration

    The MedicationStatement resource represents medications that a patient is taking or has taken, based on patient report, clinical records, or other sources.

    The level of detail available in medication history may vary. In some cases, only the generic drug is known, while in others the exact product may be recorded. Therefore, both Clinical Drug (CD) and Real Clinical Drug (RCD) concepts may be used.

    This flexibility allows medication history to be recorded accurately while still supporting clinical decision support and analytics.

    • Concept level: Clinical Drug (CD) or Real Clinical Drug (RCD)

    • Rationale: Supports varying levels of detail depending on available information

    FHIR Resource
    FHIR Data Element
    Recommended Concept Level
    Example

    Drug Concept Classes Across Workflows

    Different healthcare workflows require the use of different SNOMED CT drug model concept levels, depending on whether the focus is on clinical intent, real-world products, packaging, or aggregation.

    This section summarizes how SNOMED CT concepts are typically bound to data elements across common use cases, ensuring consistent and safe interpretation of medication data.

    Prescribing

    Prescribing is typically based on Clinical Drugs (CD) to represent the intended medication. In some cases, prescribing may specify a brand (RCD) or a package (CDP/RPCD), depending on clinical or regulatory requirements.

    Concept Class
    Role
    Example

    Dispensing translates the prescribed drug into a specific product (RCD) or packaged product (RPCD), reflecting what is actually supplied.

    Concept Class
    Role
    Example

    Administration records the actual product (RCD) given to the patient. The Clinical Drug (CD) may be used for equivalence checks or clinical reasoning. The route is captured separately, typically using SNOMED CT qualifier values.

    Concept Class
    Role
    Example

    Inventory systems operate primarily at the package level (RPCD/CDP), while CD supports aggregation and reporting across products.

    Concept Class
    Role
    Example

    Procurement processes typically specify requirements using CDs, allowing suppliers to respond with RCDs and associated packaged products (RPCDs).

    Concept Class
    Role
    Example

    Reimbursement rules may apply at different levels of abstraction, from ingredient (MP) to form (MPF) to specific strength (CD).

    Concept
    Role
    Example

    Clinical decision support operates across multiple levels, depending on the rule:

    • MP for interactions

    • MPF for form-specific logic

    • CD for dose validation

    Concept Class
    Role
    Example

    Adverse event reporting may require different levels of detail, from specific product (RCD) to generic drug (CD) or ingredient (MP), depending on data availability and reporting requirements.

    Concept Class
    Role
    Example

    Analytics typically uses MP and MPF for aggregation, with CD enabling more detailed analysis when needed.

    Concept Class
    Role
    Example

    Terminology Binding for Drug Content

    Terminology bindings for drug content must align with both the data element and the clinical or operational workflow in which it is used. The selected SNOMED CT concept level should provide sufficient detail to support safe and accurate use of medications, while also enabling interoperability, aggregation, and traceability across systems.

    A key aspect of terminology binding is that drug concepts are not used in isolation; they are always bound to structured data elements within an information model. The meaning of the data element determines the appropriate level of abstraction in the SNOMED CT drug model.

    Terminology binding ensures that:

    • the appropriate drug model concept level is used for each data element

    • medication data is represented consistently across systems

    RPCD

    Dispensed package

    Brand X amoxicillin box of 24

    Route

    Administration route

    Intravenous route

    CD

    Aggregation

    Amoxicillin 500 mg capsule

    RPCD

    Packaged offer

    Brand X amoxicillin box

    CD

    Strength coverage

    Metformin 500 mg tablet

    CD

    Dose rules

    Paracetamol 500 mg

    MP

    Ingredient

    Amoxicillin

    CD

    Detailed analysis

    Insulin glargine

    CD

    Generic prescribing

    Amoxicillin 500 mg capsule

    RCD

    Brand prescribing

    Brand X amoxicillin 500 mg capsule

    CDP / RPCD

    Package prescribing

    Brand X amoxicillin box of 24

    CD

    Prescribed drug

    Amoxicillin 500 mg capsule

    RCD

    Dispensed product

    RCD

    Product administered

    Morphine injection BrandX

    CD

    Clinical equivalence

    RPCD

    Stock package

    Brand X amoxicillin box of 24

    CDP

    Generic package

    CD

    Tender requirement

    Amoxicillin 500 mg capsule

    RCD

    Supplier product

    MP

    Ingredient coverage

    Metformin

    MPF

    Form coverage

    MP

    Interaction rules

    Warfarin

    MPF

    Form-specific rules

    RCD

    Specific product

    Brand X amoxicillin

    CD

    Generic drug

    MP

    Aggregation

    Insulin

    MPF

    Form analysis

    Dispensing

    Medication Administration

    Inventory and Logistics

    Procurement

    Reimbursement

    Clinical Decision Support

    Adverse Drug Reaction Reporting

    Analytics and Reporting

    Provide Feedback

    Brand X amoxicillin 500 mg capsule

    Morphine injection 10 mg/mL

    Amoxicillin box of 24

    Brand X amoxicillin capsule

    Metformin tablet

    Insulin injectable

    Amoxicillin 500 mg

    Injectable insulin

    MedicationRequest.medicationCodeableConcept

    CD

    Product containing precisely amoxicillin 500 milligram oral capsule (clinical drug)

    MedicationDispense

    MedicationDispense.medicationCodeableConcept

    RCD

    Brand X amoxicillin 500 milligram oral capsule (real clinical drug)

    MedicationAdministration

    MedicationAdministration.medicationCodeableConcept

    RCD

    Morphine sulfate 10 milligram per milliliter solution for injection (real clinical drug)

    MedicationAdministration

    MedicationAdministration.route

    SNOMED CT qualifier (route)

    Oral route (qualifier value)

    MedicationStatement

    MedicationStatement.medicationCodeableConcept

    CD / RCD

    Product containing precisely metformin 500 milligram oral tablet (clinical drug)

    {
      "resourceType": "Medication",
      "code": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "CD_CODE",
            "display": "Amoxicillin 500 mg oral capsule"
          }
        ]
      }
    }
    {
      "resourceType": "MedicationRequest",
      "medicationCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "CD_CODE",
            "display": "Amoxicillin 500 mg oral capsule"
          }
        ]
      },
      "dosageInstruction": [
        {
          "text": "Take one capsule three times daily"
        }
      ]
    }
    {
      "resourceType": "MedicationDispense",
      "medicationCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "RCD_CODE",
            "display": "Brand X amoxicillin 500 mg capsule"
          }
        ]
      }
    }
    {
      "resourceType": "MedicationAdministration",
      "medicationCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "RCD_CODE",
            "display": "Morphine sulfate 10 mg/mL solution for injection – BrandX"
          }
        ]
      },
      "route": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "26643006",
            "display": "Oral route"
          }
        ]
      }
    }
    {
      "resourceType": "MedicationStatement",
      "medicationCodeableConcept": {
        "coding": [
          {
            "system": "http://snomed.info/sct",
            "code": "CD_CODE",
            "display": "Metformin 500 mg oral tablet"
          }
        ]
      }
    }

    Medication

    Medication.code

    CD / RCD

    Product containing precisely amoxicillin 500 milligram oral capsule (clinical drug)

    Further details on the FHIR resources referenced in this section can be found in the HL7 FHIR specification

    • Medication: https://hl7.org/fhir/medication.html

    • MedicationDispense: https://hl7.org/fhir/medicationdispense.html

    • MedicationStatement:

    • MedicationAdministration:

    • MedicationRequest:

    Key Considerations for Using SNOMED CT in FHIR

    Examples

    FHIR Medication Resource

    FHIR MedicationRequest (Prescribing)

    FHIR MedicationDispense (Dispensing)

    FHIR MedicationAdministration (Administration)

    FHIR MedicationStatement (Medication History)

    Summary of FHIR Bindings

    Provide Feedback

    MedicationRequest

    clinical and administrative workflows are supported safely and effectively

  • data can be aggregated and reused for analytics, reporting, and research

  • Use the highest level of abstraction that safely supports the use case:

    • MP (Medicinal Product) for ingredient-level use, such as clinical decision support and analytics

    • MPF (Medicinal Product Form) for ingredient and dose form

    • CD (Clinical Drug) for prescribing and other clinically precise definitions

    • RCD (Real Clinical Drug) for dispensing and administration of a specific product

    • RPCD (Real Clinical Drug Package) for inventory, supply, and packaged products

    Different healthcare systems operate at different levels of detail within the SNOMED CT drug model. Some workflows require abstract representations (e.g. ingredient-level analysis), while others require precise identification of specific authorized products or packages.

    Terminology bindings should preserve meaning as medication data moves between systems and workflow stages.

    This includes:

    • traceability from prescribing to dispensing and administration

    • consistent interpretation across clinical and administrative systems

    • aggregation across concept levels for reporting and analytics

    The hierarchical structure of the SNOMED CT drug model supports this by linking abstract and concrete representations of medicinal products.

    SNOMED CT drug concepts should be bound to clearly defined coded fields within an information model. The meaning of the field determines the appropriate concept level.

    Common examples include:

    • medication prescribed

    • medication dispensed

    • medication administered

    • medication held in inventory

    • medication recorded in an adverse event report

    It is essential to distinguish between:

    • the clinical intent (what is prescribed)

    • the supply or administration event (what product is actually used)

    • the analytical or reporting context (how data is aggregated)

    Each of these requires a different level of representation in the drug model.

    Data Element
    Recommended Concept Class
    Role
    Example

    Medication (general)

    MP

    Ingredient-level representation

    Product containing amoxicillin (medicinal product)

    Structured data entry ensures that medication information is captured in a consistent and computable way. This is achieved by binding SNOMED CT drug concepts to specific data elements that reflect the role of the medication within a workflow.

    The following abstract models illustrate how terminology binding aligns with structured data elements.

    • Purpose: Capture clinical intent

    • Context: MedicationRequest

    • Data Element: medicationCode

      • The prescribed medication is represented using a Clinical Drug (CD) to define ingredient, strength, and dose form.

    Additional data elements in example model:

    • dosageInstruction – dose, frequency, duration (essential for safe prescribing)

    • route – route of administration (SNOMED CT qualifier values)

    • indication – reason for prescribing (SNOMED CT clinical findings)

    • substitution – whether generic substitution is allowed

    • Purpose: Capture actual supplied product

    • Context: MedicationDispense

    • Data Element: .medicationCode

      • The dispensed medication is a specific product, requiring a Real Clinical Drug (RCD).

    Additional data elements in example model:

    • quantity – amount dispensed

    • daysSupply – expected duration of supply

    • substitution – indicates if substitution occurred

    • performer – dispensing organization or pharmacist

    • Purpose: Capture actual administered product

    • Context: MedicationAdministration

    • Data Element: .medicationCode

      • The administered medication must reflect the exact product given to the patient.

    Additional data elements in example model:

    • dose – actual dose administered

    • route – route of administration (SNOMED CT)

    • site – anatomical site (SNOMED CT body structure)

    • effectiveDateTime – when administration occurred

    • Purpose: Manage stock and logistics

    • Context: InventoryItem

    • Data Element: .product

      • Inventory systems manage packaged products, requiring representation at the RPCD level to include pack size and packaging details.

    Additional data elements in example model:

    • quantity – number of packages in stock

    • batchNumber – batch/lot tracking

    • expiryDate – product expiration

    • storageCondition – storage requirements

    • Purpose: Reporting and population analysis

    • Context: Analytics Dataset

    • Data Element: .medication

      • For analytics, medications are often aggregated at the ingredient level (MP) to support population-level analysis and reporting.

    Additional data elements in example model:

    • indication – condition being treated (SNOMED CT)

    • outcome – clinical outcomes or adverse events (SNOMED CT / MedDRA)

    • patientContext – demographics, population group

    • timePeriod – time-based analysis

    Provide Feedback

    Introduction

    MedicationRequest
     ├── medicationCode
     │     └── SNOMED CT Clinical Drug (CD)
     ├── dosageInstruction
     ├── route
     ├── indication
     └── substitution
    MedicationDispense
     ├── medicationCode (CodeableConcept)
     │     └── SNOMED CT Real Clinical Drug (RCD)
     ├── quantity
     ├── substitution
     ├── daysSupply
     └── performer
    MedicationAdministration
     ├── medicationCode (CodeableConcept)
     │     └── SNOMED CT Real Clinical Drug (RCD)
     ├── dose
     └── route
           └── << 284009009 |Route of administration value (qualifier value)|
     ├── site
     └── effectiveDateTime
    InventoryItem
     └── product
           └── SNOMED CT Real Clinical Drug Package (RPCD)
     ├── quantity
     ├── batchNumber
     ├── expiryDate
     └── storageCondition
    Analytics Dataset
     └── medication
           └── SNOMED CT Medicinal Product (MP)
     ├── indication
     ├── outcome
     ├── patientContext
     └── timePeriod

    More information on Terminology Bindings can be found in

    Overall Binding Principles

    Use the Appropriate Level of Abstraction

    Maintain Semantic Consistency Across Workflows

    Bind Concepts to Structured Data Elements

    Overview of Terminology Binding by Data Element

    Example Information Models with Bindings

    Model 1: Prescribing

    Model 2: Dispensing

    Model 3: Administration

    Model 4: Inventory and Supply

    Model 5: Analytics and Reporting

    SNOMED CT Drug Model Use Cases

    Introduction

    The SNOMED CT Pharmaceutical / Biologic Product hierarchy provides a structured model for representing medicinal products at multiple levels of abstraction. This hierarchy includes concepts such as Medicinal Product (MP), Medicinal Product Form (MPF), and Clinical Drug (CD), which progressively add detail about ingredients, dose form, and strength.

    For example:

    • A Medicinal Product (MP) represents a medicinal product defined only by its active ingredient(s), without specifying strength or dose form.

    • A Clinical Drug (CD) represents a medicinal product defined by ingredient, strength, and manufactured dose form, making it suitable for use in clinical workflows.

    The International Release focuses on representing medicinal products in a way that is globally consistent, while national extensions may add concepts representing actual authorized products and packaging available in specific jurisdictions, including branded medicines and product packages.

    Together, the International Drug Model and National Drug Extensions support a wide range of healthcare use cases including prescribing, dispensing, logistics, reimbursement, pharmacovigilance, and clinical decision support.

    Administrative use cases support operational and financial aspects of healthcare systems such as procurement, logistics, and reporting.

    Healthcare organizations and national procurement agencies often purchase medicines through competitive tendering processes. In these processes, the purchasing authority defines the medication required using a generic specification, allowing suppliers to compete with their own authorized products.

    The SNOMED CT drug model supports this process by separating generic drug definitions from real products available on the market. Procurement specifications can reference Clinical Drug (CD) concepts, while suppliers offer their products using Real Clinical Drug (RCD) and Real packaged Clinical Drug (RPCD) concepts defined in national extensions.

    This approach ensures vendor-neutral procurement while maintaining precise definitions of the medicines being purchased.

    Concept
    Role
    Example

    Hospital pharmacies and distribution systems manage inventories of medications across warehouses, pharmacies, and clinical units. Stock management systems track package quantities, expiration dates, and product movement.

    The SNOMED CT drug model supports these workflows by representing product packages using concepts such as Clinical Drug Package (CDP) and Real Clinical Drug Package (RPCD).

    This allows inventory systems to track real packages while maintaining a link to the underlying clinical drug concept, and make this information available during the prescription process when necessary.

    Concept
    Role
    Example

    Health insurance systems and national payers define reimbursement policies for medications based on ingredients, formulations, or specific products.

    The SNOMED CT drug model enables reimbursement rules to be defined at different levels of abstraction. For example, coverage policies may apply to all products containing a given ingredient or may apply only to specific strengths or formulations.

    Concept
    Role
    Example

    Healthcare organizations and public health authorities routinely analyze medication usage data to monitor prescribing patterns, drug costs, and treatment trends, and to support business intelligence activities such as forecasting demand, planning procurement, and optimizing medication supply.

    The hierarchical structure of the SNOMED CT drug model enables aggregation of medication data at different levels of granularity. Data recorded at the clinical drug level can be automatically aggregated at higher levels, such as ingredient or drug class.

    Concept
    Role
    Example

    Clinical use cases focus on the use of medications in patient care workflows.

    Electronic prescribing systems allow clinicians to select medications and send prescriptions electronically to pharmacies. These systems must represent medications with sufficient detail to ensure accurate dispensing.

    SNOMED CT Clinical Drug (CD) concepts provide the appropriate level of detail for prescribing because they specify ingredient, strength, and dose form. In some cases, clinicians may prescribe a specific brand or package using Real Clinical Drug (RCD) or Real Packaged Clinical Drug (RPCD) concepts.

    Concept
    Role
    Example

    When a pharmacy receives a prescription, the pharmacist selects a product that fulfills the prescription. In many healthcare systems, pharmacists are allowed to substitute equivalent generic medicines.

    The SNOMED CT drug model supports this workflow by linking Clinical Drug concepts with Real Clinical Drug concepts, enabling pharmacy systems to match prescriptions with available products.

    Concept
    Role
    Example

    In hospitals and other care settings, nurses administer medications to patients according to physician orders. Medication administration systems must record the exact product administered and verify that it matches the prescribed medication. Clinical decision support systems can support the administration step by checking contraindications, potential drug interactions, and dose appropriateness before the medication is given.

    Closed-loop medication administration systems often use barcode scanning to identify the medication product before administration.

    Concept
    Role
    Example

    Pharmacovigilance systems collect reports of adverse reactions associated with medications. These systems must accurately identify the suspected drug to detect safety signals. If adverse reaction reports are generated directly from medication administration data recorded in the clinical record, the exact product administered can be captured without information loss, ensuring that the same product is reported to pharmacovigilance systems.

    The SNOMED CT drug model allows adverse reactions to be recorded at different levels of specificity depending on available information.

    Concept
    Role
    Example

    Clinical decision support systems analyze medication orders and patient information to provide alerts and guidance to clinicians.

    Typical decision support functions include drug–drug interaction checking, allergy alerts, and dose range validation.

    Concept
    Role
    Example

    The SNOMED CT drug model also supports knowledge management, research, and secondary uses of medication data.

    Healthcare organizations and knowledge provider companies maintain drug knowledge databases containing information about drug interactions, contraindications, dosing guidance, and therapeutic indications.

    The SNOMED CT drug model allows knowledge to be linked to standardized drug concepts, enabling consistent application and simple integration across clinical systems.

    Concept
    Role
    Example

    Electronic health records maintain medication lists representing drugs that a patient is currently taking or has taken previously. These lists support medication reconciliation and continuity of care.

    Medication records may represent drugs at different levels depending on available information.

    Concept
    Role
    Example

    Researchers and public health authorities analyze medication data to study treatment outcomes, safety, and prescribing trends. Current medication use is also commonly used as a criterion for patient selection and eligibility in clinical studies.

    The hierarchical structure of SNOMED CT drug concepts allows researchers to aggregate medication data at different levels.

    Concept
    Role
    Example

    https://hl7.org/fhir/medicationstatement.html
    https://hl7.org/fhir/medicationadministration.html
    https://hl7.org/fhir/medicationrequest.html

    Medication (with form)

    MPF

    Ingredient and dose form

    Product containing amoxicillin in oral capsule dose form (medicinal product form)

    Medication prescribed

    CD

    Clinical specification of intended medication

    Product containing precisely amoxicillin 500 mg oral capsule (clinical drug)

    Medication dispensed

    RCD

    Actual product supplied

    BrandX amoxicillin 500 mg oral capsule (real clinical drug)

    Medication administered

    RCD

    Actual product given

    Morphine sulfate 10 mg/mL solution for injection (real clinical drug)

    Medication package

    RPCD

    Specific packaged product

    Brand X amoxicillin 500 mg oral capsule box of 24 (real clinical drug package)

    Medication package (generic)

    CDP

    Generic packaged clinical drug

    Amoxicillin 500 mg oral capsule box of 24 (clinical drug package)

    Context Representation Implementation Guide

    RPCD

    Represents the specific packaged product offered by suppliers

    Brand X amoxicillin 500 mg capsule, pack of 30 capsules, manufactured by Company Y

    CD

    Aggregated reporting across packages

    Product containing precisely amoxicillin 500 mg capsule

    CD

    Strength-specific reimbursement

    Product containing precisely metformin 500 mg oral tablet

    CD

    Detailed drug usage statistics

    Insulin glargine 100 units/mL solution for injection

    CDP / RPCD

    Prescribing by package

    BrandX amoxicillin 500 mg capsule box of 24

    RPCD

    Dispensed package

    BrandX amoxicillin 500 mg capsule box of 24 capsules

    Route concepts

    Administration route

    Intravenous route (qualifier value)

    MP

    Ingredient-level safety monitoring

    Product containing amoxicillin (medicinal product)

    CD

    Dose validation

    Maximum dose rule for paracetamol 500 mg tablet

    CD

    Strength-specific rules

    Maximum daily dose for paracetamol 500 mg tablet

    CD

    Specific dosage analysis

    Study of atorvastatin 20 mg tablet

    CD

    Defines the medication required in the tender

    Product containing precisely amoxicillin 500 mg oral capsule (clinical drug)

    RCD

    Represents the specific product offered by suppliers

    RPCD

    Actual product package stored in inventory

    BrandX amoxicillin 500 mg capsule box of 24 capsules

    CDP

    Generic package representation

    MP

    Ingredient-level reimbursement rules

    Product containing metformin (medicinal product)

    MPF

    Ingredient + dose form reimbursement

    MP

    Ingredient-level reporting

    Product containing insulin (medicinal product)

    MPF

    Ingredient + dose form analysis

    CD

    Generic prescribing

    Product containing precisely amoxicillin 500 mg oral capsule

    RCD

    Brand-specific prescribing

    CD

    Prescribed drug

    Product containing precisely amoxicillin 500 mg capsule

    RCD

    Dispensed product

    RCD

    Product administered

    Morphine sulfate 10 mg/mL solution for injection – BrandX

    CD

    Clinical equivalence

    RCD

    Specific product causing reaction

    BrandX amoxicillin 500 mg capsule

    CD

    Generic drug reaction reporting

    MP

    Ingredient-based CDS rules

    Interaction rule for warfarin (medicinal product) with NSAIDs

    MPF

    Form-specific rules

    MP

    Ingredient-level knowledge

    Interaction between warfarin and ibuprofen

    MPF

    Form-specific rules

    CD

    Generic medication record

    Metformin 500 mg oral tablet

    RCD

    Exact product taken

    MP

    Population-level studies

    Study of all statin medicinal products

    MPF

    Therapeutic category analysis

    Administrative Use Cases

    UC.1 Procurement and Tendering

    Concept usage

    hexagon

    Example scenario:

    A hospital publishes a tender for amoxicillin 500 mg capsules (CD). Multiple suppliers submit offers for their specific authorized products (RCDs).

    UC.2 Stock Management and Pharmacy Logistics

    Concept usage

    hexagon

    Example scenario:

    A pharmacy stores boxes of 24 capsules of BrandX amoxicillin (RPCD). Inventory reporting aggregates all packages under the amoxicillin 500 mg capsule clinical drug concept.

    UC.3 Financial Coverage and Reimbursement

    Concept usage

    hexagon

    Example scenario:

    An insurer reimburses all oral metformin tablets (MPF) but applies different reimbursement levels depending on tablet strength (CD).

    UC. 4 Business Intelligence and Drug Utilization Reporting

    Concept usage

    hexagon

    Example scenario:

    A national health authority analyzes total insulin usage by aggregating prescriptions recorded at the clinical drug level.

    Clinical Use Cases

    UC.5 Electronic Prescribing

    Concept usage

    hexagon

    Example scenario:

    A physician prescribes amoxicillin 500 mg capsules using a clinical drug concept. The pharmacy system receives the prescription and selects the appropriate product.

    UC.6 Pharmacy Dispensing

    Concept usage

    hexagon

    Example scenario:

    A prescription for amoxicillin 500 mg capsules is filled by dispensing a generic product from manufacturer Y.

    UC.7 Medication Administration

    Concept usage

    hexagon

    Example scenario:

    A nurse administers morphine 2 mg IV and records the administration using the details of the branded product. The decision support system validates the safety against recorded patient data.

    UC.8 Adverse Drug Reaction Reporting

    Concept usage

    hexagon

    Example scenario:

    A patient develops a rash after taking amoxicillin. The adverse reaction report is created with the accurate and appropriate information.

    UC.9 Clinical Decision Support

    Concept usage

    hexagon

    Example scenario:

    A CDS rule alerts the physician if a patient with a penicillin allergy is prescribed amoxicillin.

    Knowledge and Secondary Use Cases

    UC.10 Clinical Drug Knowledge Bases

    Concept usage

    hexagon

    Example scenario:

    A drug knowledge base defines an interaction between warfarin and NSAIDs, which is triggered during prescribing.

    UC.11 Medication History and Patient Medication Lists

    Concept usage

    hexagon

    Example scenario:

    A patient’s medication list includes metformin 500 mg tablets as a generic and Tylenol 500mg tablets as a branded product.

    UC.12 Research and Pharmacoepidemiology

    Concept usage

    hexagon

    Example scenario:

    Researchers study cardiovascular outcomes in patients taking atorvastatin 20 mg tablets.

    Provide Feedback

    Brand X amoxicillin 500 mg capsule manufactured by Company Y

    Amoxicillin 500 mg capsule box of 24 (generic package)

    Product containing metformin in oral tablet dose form

    Product containing insulin in injectable solution

    BrandX amoxicillin 500 mg capsule

    BrandX amoxicillin 500 mg capsule

    Product containing precisely morphine sulfate 10 mg/mL solution for injection

    Product containing precisely amoxicillin 500 mg capsule

    Alert for insulin injectable products

    Dosing recommendations for inhaled salbutamol

    BrandX metformin 500 mg tablet

    Analysis of oral statin tablets

    SNOMED Drug Extension Model

    Overview

    The SNOMED CT Drug Extension Model provides a standardized framework for representing real-world medicinal products that are authorized and available within a specific jurisdiction.

    While the SNOMED CT International Drug Model represents medicinal products in a jurisdiction-independent and abstract manner, national healthcare systems require additional information to support operational and regulatory use cases. These include:

    • brand or proprietary names

    • manufacturer or marketing authorization holder

    • packaging and presentation

    • locally authorized and marketed products

    Drug extensions address these requirements by extending the international medicinal product hierarchy with additional concept classes that represent specific products and packages, while maintaining semantic alignment with the International Edition.

    The extension model ensures that real-world medicinal products can be represented in a way that supports clinical use, supply chain processes, and regulatory requirements, without compromising interoperability.

    The drug extension model defines additional concept classes that represent authorized products and their packaging. These concept classes complement the international model and provide the level of detail required for operational workflows.

    A Real Clinical Drug (RCD) represents a medicinal product that is authorized and marketed within a specific jurisdiction.

    An RCD is defined as a specialization of a Clinical Drug (CD) and therefore includes:

    • active ingredient(s)

    • strength

    • manufactured dose form

    In addition, it includes product-specific characteristics such as:

    • brand or proprietary name

    • manufacturer or supplier

    • regulatory authorization

    This level is commonly used for:

    • pharmacy dispensing

    • medication administration

    • pharmacovigilance reporting

    • reimbursement and billing

    Concept Class
    Description
    Example

    Example:

    • Clinical Drug (CD):

      Product containing precisely amoxicillin 500 milligram oral capsule (clinical drug)

    • Real Clinical Drug (RCD):

      BrandX amoxicillin 500 milligram oral capsule (real clinical drug)

    A Clinical Drug Package (CDP) represents a generic packaged medicinal product, defined by packaging characteristics but not tied to a specific branded product.

    A CDP is derived from a Clinical Drug and includes:

    • pack size

    • unit of presentation

    • container type

    This level is commonly used for:

    • procurement specifications

    • logistics planning

    • supply chain management

    Concept Class
    Description
    Example

    Example:

    • Clinical Drug (CD):

      Product containing precisely amoxicillin 500 milligram oral capsule (clinical drug)

    • Clinical Drug Package (CDP):

      Product containing precisely amoxicillin 500 milligram oral capsule box of 24 (clinical drug package)

    A Real Clinical Drug Package (RPCD) represents a specific packaged medicinal product available in the supply chain.

    An RPCD combines:

    • a Real Clinical Drug (RCD)

    • packaging characteristics

    This level is commonly used for:

    • pharmacy inventory systems

    • medication dispensing systems

    • supply chain management

    • regulatory tracking and traceability

    Concept Class
    Description
    Example

    Example:

    • Real Clinical Drug (RCD):

      Brand X amoxicillin 500 milligram oral capsule (real clinical drug)

    • Real Clinical Drug Package (RPCD):

      Brand X amoxicillin 500 milligram oral capsule box of 24 (real clinical drug package)

    The drug extension model extends the international hierarchy by adding concept classes that represent real-world products and packaging.

    The combined model can be illustrated as follows:

    This structure reflects two complementary pathways:

    • a real product pathway (CD → RCD → RPCD)

    • a generic packaging pathway (CD → CDP)

    The Clinical Drug Package (CDP) concept class is not shown in this hierarchical representation because it does not form part of the main vertical specialization pathway from abstract to concrete medicinal products.

    The diagram illustrates a single lineage of increasing specificity, where each concept is a direct specialization of the previous one:

    • MP → MPF → CD → RCD → RPCD

    In this pathway, each step adds additional defining attributes to represent the same medicinal product with increasing specificity, culminating in a specific packaged product (RPCD).

    In contrast, CDP represents a parallel packaging abstraction:

    • A CDP is derived from a Clinical Drug (CD)

    • It introduces packaging attributes (e.g. pack size, container type)

    • However, it does not represent a specific real-world product, as it lacks product identity (e.g. brand, manufacturer)

    Therefore:

    • CDP is not a parent of RCD or RPCD

    • CDP does not sit on the direct specialization path from CD to RPCD

    • CDP exists as a parallel branch used for generic packaging representations

    Conceptually, the structure can be understood as:

    This distinction is important because:

    • The RCD → RPCD pathway supports clinical and operational workflows involving real products

    • The CDP pathway supports administrative and logistical use cases such as procurement and planning

    This layered structure ensures that:

    • clinical meaning is defined internationally, while product-specific details are added nationally

    • clinical rules and decision support defined at the international level apply to extension concepts

    • aggregation across concept levels remains consistent (e.g. RCD → CD → MP)

    • interoperability is preserved across jurisdictions

    Drug extension concepts use additional attributes to represent characteristics specific to real-world medicinal products. These attributes are applied in a structured way according to the concept class.

    Some attributes are used across multiple extension concept classes (particularly RCD and RPCD) to represent product identity and regulatory context.

    These include:

    • Has product name (attribute)

    • Has manufacturer (attribute)

    • Has marketing authorization (attribute)

    • Has intended site / jurisdiction (attribute)

    These attributes ensure that extension concepts represent real-world authorized products, while remaining linked to their clinical definitions.

    All extension concepts ultimately derive from international drug concepts and therefore inherit core defining attributes such as:

    • Has active ingredient (attribute)

    • Has manufactured dose form (attribute)

    • Has presentation strength (attribute)

    • Has concentration strength (attribute) (where applicable)

    These attributes define the clinical meaning of the medicinal product and remain consistent across international and national content.

    RCD concepts extend Clinical Drugs by adding attributes that identify a specific authorized product:

    • Has product name (attribute)

    • Has manufacturer (attribute)

    • Has marketing authorization (attribute)

    These attributes distinguish products that share the same clinical definition but differ in branding or regulatory status.

    CDP concepts add packaging information to a Clinical Drug:

    • Has pack size (attribute)

    • Has unit of presentation (attribute)

    • Has container type (attribute)

    These attributes describe packaging independently of any specific product.

    RPCD concepts combine both product identity and packaging:

    • product-level attributes (inherited from RCD)

    • packaging attributes (as in CDP), including:

      • Has pack size (attribute)

      • Has unit of presentation (attribute)

    This allows full representation of the exact packaged product

    Has container type (attribute)

    Real Clinical Drug (RCD)

    Product defined by ingredient(s), strength, dose form, and product identity

    Brand X amoxicillin 500 mg oral capsule

    Clinical Drug Package (CDP)

    Product defined by ingredient(s), strength, dose form, and packaging (no product identity)

    Amoxicillin 500 mg oral capsule box of 24

    Real Clinical Drug Package (RPCD)

    Product defined by ingredient(s), strength, dose form, product identity, and packaging

    Brand X amoxicillin 500 mg oral capsule box of 24

    Core Concept Classes in the Drug Extension Model

    Real Clinical Drug (RCD)

    Clinical Drug Package (CDP)

    Real Clinical Drug Package (RPCD)

    Relationship Between Concept Classes

    Note on Clinical Drug Package (CDP)

    Implications of the Model

    Attributes Used in Drug Extensions

    Attributes Shared Across Extension Concepts

    Attributes Inherited from the International Model

    Attributes Specific to Real Clinical Drug (RCD)

    Attributes Specific to Clinical Drug Package (CDP)

    Attributes Specific to Real Clinical Drug Package (RPCD)

    Provide Feedback
    Medicinal Product (MP)            [International]
      Product containing amoxicillin
          ↓
    Medicinal Product Form (MPF)      [International]
      Product containing amoxicillin in oral capsule dose form
          ↓
    Clinical Drug (CD)                [International]
      Product containing precisely amoxicillin 500 mg oral capsule
          ↓
          ├── Real Clinical Drug (RCD)          [Extension]
          │     Brand X amoxicillin 500 mg oral capsule
          │         ↓
          │     Real Clinical Drug Package (RPCD) [Extension]
          │     Brand X amoxicillin 500 mg oral capsule box of 24
          │
          └── Clinical Drug Package (CDP)       [Extension]
                Amoxicillin 500 mg oral capsule box of 24
    CD
     ├── RCD → RPCD   (real-world product pathway)
     └── CDP          (generic packaging pathway)
    unit of presentation