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8.20 Resource Substance - Content

Biomedical Research and Regulation icon

Work Group

Maturity Level: 2

Trial Use

Security Category: Business

Compartments: No defined compartments

A homogeneous material with a definite composition.

8.20.1 Scope and Usage

This is a base resource that represents raw materials used to represent a packaged or measured amount of a known substance (e.g. bottle, jar, packet, drum) that is not in a consumable form nor associated directly with a patient. For example, the materials used for a medication that are not yet in an administrable form.

This resource is used for "instances" of substances. The resource is not used to represent a kind of a substance - e.g. a formulation commonly used for treating patients (a "definitional" use). For that use see SubstanceDefinition resource.

A Substance may be identifiable as precise as the specific container it is stored in, while more commonly it would be based on a combination of lot number, quantity, and package type.

8.20.2 Boundaries and Relationships

A medication is a substance that is packaged and used as an administered medication. The medication resource uses the substance resource to represent the actual ingredients of a medication.

This resource represents an instance of a substance. For definitions (type, kind) see the SubstanceDefinition resource, which is purely definitional. A SubstanceDefinition describes the common characteristics of the substance, including those needed for regulatory agencies.

A NutritionProduct distinguishes from a Substance in that a nutrition product is primary consumable purpose is for its nutritional effect.

A BiologicallyDerivedProduct distinguishes from a Substance in that a BiologicallyDerivedProduct has its origins in a biological entity and needs to carry the source’s characteristics to enable matching and compatibility with the biological target to which it will be transfused or implanted, as well as traceability to the source.

8.20.3 References to this Resource

8.20.4 Resource Content

Structure

Name	Flags	Card.	Type	Description & Constraints
Substance	TU		DomainResource	A homogeneous material with a definite composition Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
status	?!Σ	0..1	code	active \| inactive \| entered-in-error Binding: FHIRSubstanceStatus (Required)
category	Σ	0..*	CodeableConcept	What class/type of substance this is Binding: Substance Category Codes (Extensible)
code	Σ	1..1	CodeableReference(SubstanceDefinition)	What substance this is Binding: Substance Code (Example)
description	Σ	0..1	markdown	Textual description of the substance, comments
expiry	Σ	0..1	dateTime	When no longer valid to use
quantity	Σ	0..1	SimpleQuantity	Amount of substance in the package
Documentation for this format

See the Extensions for this resource

XML Template

<Substance xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error -->
 <category><!-- 0..* CodeableConcept What class/type of substance this is --></category>
 <code><!-- 1..1 CodeableReference(SubstanceDefinition) What substance this is --></code>
 <description value="[markdown]"/><!-- 0..1 Textual description of the substance, comments -->
 <expiry value="[dateTime]"/><!-- 0..1 When no longer valid to use -->
 <quantity><!-- 0..1 Quantity(SimpleQuantity) Amount of substance in the package --></quantity>
</Substance>

JSON Template

{
  "resourceType" : "Substance",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "status" : "<code>", // active | inactive | entered-in-error
  "category" : [{ CodeableConcept }], // What class/type of substance this is
  "code" : { CodeableReference(SubstanceDefinition) }, // R!  What substance this is
  "description" : "<markdown>", // Textual description of the substance, comments
  "expiry" : "<dateTime>", // When no longer valid to use
  "quantity" : { Quantity(SimpleQuantity) } // Amount of substance in the package
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:Substance;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Unique identifier
  fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* What class/type of substance this is
  fhir:code [ CodeableReference(SubstanceDefinition) ] ; # 1..1 What substance this is
  fhir:description [ markdown ] ; # 0..1 Textual description of the substance, comments
  fhir:expiry [ dateTime ] ; # 0..1 When no longer valid to use
  fhir:quantity [ Quantity(SimpleQuantity) ] ; # 0..1 Amount of substance in the package
]

Changes from both R4 and R4B

Substance

Substance.code

Type changed from CodeableConcept to CodeableReference

Substance.description

Type changed from string to markdown

Substance.expiry

Moved from Substance.instance to Substance

Substance.quantity

Moved from Substance.instance to Substance

Substance.instance

Deleted

Substance.ingredient

Deleted

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
Substance	TU		DomainResource	A homogeneous material with a definite composition Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
status	?!Σ	0..1	code	active \| inactive \| entered-in-error Binding: FHIRSubstanceStatus (Required)
category	Σ	0..*	CodeableConcept	What class/type of substance this is Binding: Substance Category Codes (Extensible)
code	Σ	1..1	CodeableReference(SubstanceDefinition)	What substance this is Binding: Substance Code (Example)
description	Σ	0..1	markdown	Textual description of the substance, comments
expiry	Σ	0..1	dateTime	When no longer valid to use
quantity	Σ	0..1	SimpleQuantity	Amount of substance in the package
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<Substance xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error -->
 <category><!-- 0..* CodeableConcept What class/type of substance this is --></category>
 <code><!-- 1..1 CodeableReference(SubstanceDefinition) What substance this is --></code>
 <description value="[markdown]"/><!-- 0..1 Textual description of the substance, comments -->
 <expiry value="[dateTime]"/><!-- 0..1 When no longer valid to use -->
 <quantity><!-- 0..1 Quantity(SimpleQuantity) Amount of substance in the package --></quantity>
</Substance>

JSON Template

{
  "resourceType" : "Substance",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "status" : "<code>", // active | inactive | entered-in-error
  "category" : [{ CodeableConcept }], // What class/type of substance this is
  "code" : { CodeableReference(SubstanceDefinition) }, // R!  What substance this is
  "description" : "<markdown>", // Textual description of the substance, comments
  "expiry" : "<dateTime>", // When no longer valid to use
  "quantity" : { Quantity(SimpleQuantity) } // Amount of substance in the package
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:Substance;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Unique identifier
  fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* What class/type of substance this is
  fhir:code [ CodeableReference(SubstanceDefinition) ] ; # 1..1 What substance this is
  fhir:description [ markdown ] ; # 0..1 Textual description of the substance, comments
  fhir:expiry [ dateTime ] ; # 0..1 When no longer valid to use
  fhir:quantity [ Quantity(SimpleQuantity) ] ; # 0..1 Amount of substance in the package
]

Changes from both R4 and R4B

Substance

Substance.code

Type changed from CodeableConcept to CodeableReference

Substance.description

Type changed from string to markdown

Substance.expiry

Moved from Substance.instance to Substance

Substance.quantity

Moved from Substance.instance to Substance

Substance.instance

Deleted

Substance.ingredient

Deleted

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

8.20.4.1 Terminology Bindings

Path	ValueSet	Type	Documentation
Substance.status	FHIRSubstanceStatus	Required	A code to indicate if the substance is actively used.
Substance.category	SubstanceCategoryCodes	Extensible	Substance category codes
Substance.code	SubstanceCode	Example	This value set contains concept codes for specific substances. It includes codes from SNOMED where concept is-a 105590001 (Substance (substance))

Path

ValueSet

Type

Documentation

Substance.status

FHIRSubstanceStatus

Required

A code to indicate if the substance is actively used.

Substance.category

SubstanceCategoryCodes

Extensible

Substance category codes

Substance.code

SubstanceCode

Example

This value set contains concept codes for specific substances. It includes codes from SNOMED icon where concept is-a 105590001 (Substance (substance))

8.20.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
category	token	The category of the substance	Substance.category
code	token	The code of the substance	Substance.code.concept
code-reference	reference	A reference to the defining substance	Substance.code.reference
expiry	date	Expiry date of package or container of substance	Substance.expiry
identifier	token	Unique identifier for the substance	Substance.identifier
quantity	quantity	Amount of substance in the package	Substance.quantity
status	token	active \| inactive \| entered-in-error	Substance.status