Release 4 5

This page is part of the FHIR Specification (v4.0.1: R4 (v5.0.0: R5 - Mixed Normative and STU ) ). This is the current published version in it's permanent home (it will always be available at this URL). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

8.17 8.19 Resource Substance - Content

Orders Biomedical Research and Observations Regulation icon Work Group Maturity Level : 2   Trial Use Security Category : Business Compartments : Not linked to any No defined compartments

A homogeneous material with a definite composition.

8.17.1 8.19.1 Scope and Usage

This is a base resource allows 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 material to be represented. medication that are not yet in an administrable form.

The resource can be used to represent either a kind of a substance - e.g. a formulation commonly used for treating patients, patients (a "definitional" use of Substance), or it can be used to describe a particular package of a known substance (e.g. bottle, jar, packet). (an "instance" use of Substance).

The composition of the material can be specified in terms of a mix of other materials, including with precise amounts if required.

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.

8.17.2 8.19.2 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 can represent an instance of a substance or a definition (type, kind) of one. See also the SubstanceDefinition resource, which is referenced by 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.

8.19.3 References to this Resource

8.17.3 8.19.4 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 instance ?! Σ 0..1 1..1 code boolean active | inactive | entered-in-error Is this an instance of a substance or a kind of one
FHIRSubstanceStatus ( Required )
. . category . status ?! Σ 0..* 0..1 CodeableConcept code What class/type of substance this is active | inactive | entered-in-error
Substance Category Codes Binding: FHIRSubstanceStatus ( Extensible Required )
. . description . code Σ 0..1 1..1 string CodeableReference ( SubstanceDefinition ) Textual description of the substance, comments What substance this is
Binding: Substance Code ( Example )
. . instance . description Σ 0..* 0..1 BackboneElement markdown If this describes a specific package/container Textual description of the substance substance, comments
. . identifier . expiry Σ 0..1 Identifier Identifier of the package/container expiry Σ 0..1 dateTime When no longer valid to use
. . . quantity Σ 0..1 SimpleQuantity Amount of substance in the package
. . . ingredient Σ 0..* BackboneElement Composition information about the substance

. . . . quantity Σ 0..1 Ratio Optional amount (concentration)
. . . . substance[x] Σ 1..1 A component of the substance
Binding: Substance Code ( Example )
. . . . . substanceCodeableConcept CodeableConcept
. . . . . substanceReference Reference ( Substance )

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

Substance ( DomainResource ) Unique identifier for the substance substance. For an instance, an identifier associated with the package/container (usually a label affixed directly) identifier : Identifier [0..*] A code boolean to indicate if the this an instance of a substance is actively used or a kind of one (a definition) (this element modifies the meaning of other elements) status instance : code boolean [0..1] « [1..1] A code to indicate if the substance is actively used. used (this element modifies the meaning of other elements) status : code [0..1] « null (Strength=Required) FHIRSubstanceStatus ! » A code that classifies the general type of substance. This is used for searching, sorting and display purposes category : CodeableConcept [0..*] « Category or classification of substance. null (Strength=Extensible) SubstanceCategoryCodes + » A code (or set of codes) that identify this substance code : CodeableConcept CodeableReference [1..1] « SubstanceDefinition ; Substance codes. null (Strength=Example) SubstanceCode ?? » A description of the substance - its appearance, handling requirements, and other usage notes description : string [0..1] Instance Identifier associated with the package/container (usually a label affixed directly) identifier : Identifier markdown [0..1] When the substance is no longer valid to use. For some substances, a single arbitrary date is used for expiry expiry : dateTime [0..1] The amount of the substance quantity : Quantity ( SimpleQuantity ) [0..1] Ingredient The amount of the ingredient in the substance - a concentration ratio quantity : Ratio [0..1] Another substance that is a component of this substance substance[x] : Type DataType [1..1] « CodeableConcept | Reference ( Substance ); Substance Ingredient codes. null (Strength=Example) SubstanceCode ?? » Substance may be used to describe a kind of substance, or a specific package/container of the substance: an instance instance [0..*] A substance can be composed of other substances ingredient [0..*]

XML Template 

<Substance xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>

 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <instance value="[boolean]"/><!-- 1..1 Is this an instance of a substance or a kind of one -->

 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error -->
 <category><!-- 0..* CodeableConcept What class/type of substance this is --></category>
 <</code>
 <
 <
  <</identifier>
  <
  <</quantity>
 </instance>

 <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>

 <ingredient>  <!-- 0..* Composition information about the substance -->
  <quantity><!-- 0..1 Ratio Optional amount (concentration) --></quantity>
  <substance[x]><!-- 1..1 CodeableConcept|Reference(Substance) A component of the substance --></substance[x]>
 </ingredient>
</Substance>

Turtle Template 

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


[ 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;
  fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir:) ]
  ], ...;

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Unique identifier
  fhir:instance [ boolean ] ; # 1..1 Is this an instance of a substance or a kind of one
  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
  fhir:ingredient ( [ # 0..* Composition information about the substance
    fhir:quantity [ Ratio ] ; # 0..1 Optional amount (concentration)
    # substance[x] : 1..1 A component of the substance. One of these 2
      fhir:substance [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:substance [  a fhir:Reference ; Reference(Substance) ]
  ] ... ) ;

]

Changes since R3 from both R4 and R4B

Substance
Substance.status Substance.instance
  • Change value set Min Cardinality changed from http://hl7.org/fhir/ValueSet/substance-status 0 to http://hl7.org/fhir/ValueSet/substance-status|4.0.1 1
  • Max Cardinality changed from * to 1
  • Type changed from BackboneElement to boolean
  • Now marked as Modifier
Substance.category Substance.code
  • Change code system for extensibly bound codes Type changed from "http://hl7.org/fhir/substance-category" CodeableConcept to "http://terminology.hl7.org/CodeSystem/substance-category" 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.identifier
  • Deleted (-> Substance.instance.identifier)

See the Full Difference for further information

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

See R3 <--> R4 <--> R5 Conversion Maps (status = 6 tests that all execute ok. All tests pass round-trip testing and 1 r3 resources are invalid (0 errors). ) See Conversions Summary .)

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 instance ?! Σ 0..1 1..1 code boolean active | inactive | entered-in-error Is this an instance of a substance or a kind of one
FHIRSubstanceStatus ( Required )
. . category . status ?! Σ 0..* 0..1 CodeableConcept code What class/type of substance this is active | inactive | entered-in-error
Substance Category Codes Binding: FHIRSubstanceStatus ( Extensible Required )
. . description . code Σ 0..1 1..1 string CodeableReference ( SubstanceDefinition ) Textual description of the substance, comments What substance this is
Binding: Substance Code ( Example )
. . instance . description Σ 0..* 0..1 BackboneElement markdown If this describes a specific package/container Textual description of the substance substance, comments
. . identifier . expiry Σ 0..1 Identifier Identifier of the package/container expiry Σ 0..1 dateTime When no longer valid to use
. . . quantity Σ 0..1 SimpleQuantity Amount of substance in the package
. . . ingredient Σ 0..* BackboneElement Composition information about the substance

. . . . quantity Σ 0..1 Ratio Optional amount (concentration)
. . . . substance[x] Σ 1..1 A component of the substance
Binding: Substance Code ( Example )
. . . . . substanceCodeableConcept CodeableConcept
. . . . . substanceReference Reference ( Substance )

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

Substance ( DomainResource ) Unique identifier for the substance substance. For an instance, an identifier associated with the package/container (usually a label affixed directly) identifier : Identifier [0..*] A code boolean to indicate if the this an instance of a substance is actively used or a kind of one (a definition) (this element modifies the meaning of other elements) status instance : code boolean [0..1] « [1..1] A code to indicate if the substance is actively used. used (this element modifies the meaning of other elements) status : code [0..1] « null (Strength=Required) FHIRSubstanceStatus ! » A code that classifies the general type of substance. This is used for searching, sorting and display purposes category : CodeableConcept [0..*] « Category or classification of substance. null (Strength=Extensible) SubstanceCategoryCodes + » A code (or set of codes) that identify this substance code : CodeableConcept CodeableReference [1..1] « SubstanceDefinition ; Substance codes. null (Strength=Example) SubstanceCode ?? » A description of the substance - its appearance, handling requirements, and other usage notes description : string [0..1] Instance Identifier associated with the package/container (usually a label affixed directly) identifier : Identifier markdown [0..1] When the substance is no longer valid to use. For some substances, a single arbitrary date is used for expiry expiry : dateTime [0..1] The amount of the substance quantity : Quantity ( SimpleQuantity ) [0..1] Ingredient The amount of the ingredient in the substance - a concentration ratio quantity : Ratio [0..1] Another substance that is a component of this substance substance[x] : Type DataType [1..1] « CodeableConcept | Reference ( Substance ); Substance Ingredient codes. null (Strength=Example) SubstanceCode ?? » Substance may be used to describe a kind of substance, or a specific package/container of the substance: an instance instance [0..*] A substance can be composed of other substances ingredient [0..*]

XML Template 

<Substance xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>

 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <instance value="[boolean]"/><!-- 1..1 Is this an instance of a substance or a kind of one -->

 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error -->
 <category><!-- 0..* CodeableConcept What class/type of substance this is --></category>
 <</code>
 <
 <
  <</identifier>
  <
  <</quantity>
 </instance>

 <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>

 <ingredient>  <!-- 0..* Composition information about the substance -->
  <quantity><!-- 0..1 Ratio Optional amount (concentration) --></quantity>
  <substance[x]><!-- 1..1 CodeableConcept|Reference(Substance) A component of the substance --></substance[x]>
 </ingredient>
</Substance>

Turtle Template 

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


[ 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;
  fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir:) ]
  ], ...;

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Unique identifier
  fhir:instance [ boolean ] ; # 1..1 Is this an instance of a substance or a kind of one
  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
  fhir:ingredient ( [ # 0..* Composition information about the substance
    fhir:quantity [ Ratio ] ; # 0..1 Optional amount (concentration)
    # substance[x] : 1..1 A component of the substance. One of these 2
      fhir:substance [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:substance [  a fhir:Reference ; Reference(Substance) ]
  ] ... ) ;

]

Changes since Release 3 from both R4 and R4B

Substance
Substance.status Substance.instance
  • Change value set Min Cardinality changed from http://hl7.org/fhir/ValueSet/substance-status 0 to http://hl7.org/fhir/ValueSet/substance-status|4.0.1 1
  • Max Cardinality changed from * to 1
  • Type changed from BackboneElement to boolean
  • Now marked as Modifier
Substance.category Substance.code
  • Change code system for extensibly bound codes Type changed from "http://hl7.org/fhir/substance-category" CodeableConcept to "http://terminology.hl7.org/CodeSystem/substance-category" 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.identifier
  • Deleted (-> Substance.instance.identifier)

See the Full Difference for further information

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

See R3 <--> R4 <--> R5 Conversion Maps (status = 6 tests that all execute ok. All tests pass round-trip testing and 1 r3 resources are invalid (0 errors). ) See Conversions Summary .)

 

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

8.17.3.1 8.19.4.1 Terminology Bindings

Path Definition ValueSet Type Reference Documentation
Substance.status A code to indicate if the substance is actively used. FHIRSubstanceStatus Required FHIRSubstanceStatus

A code to indicate if the substance is actively used.

Substance.category Category or classification of substance. SubstanceCategoryCodes Extensible SubstanceCategoryCodes

Substance category codes

Substance.code Substance codes. SubstanceCode Example SubstanceCode

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

Substance.ingredient.substance[x] Substance Ingredient codes. SubstanceCode Example SubstanceCode

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

8.17.4 8.19.5 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 or ingredient Substance.code Substance.code.concept | (Substance.ingredient.substance as CodeableConcept) (Substance.ingredient.substance.ofType(CodeableConcept))
container-identifier code-reference token reference Identifier of A reference to the package/container defining substance Substance.instance.identifier Substance.code.reference
expiry date Expiry date of package or container of substance Substance.instance.expiry Substance.expiry
identifier token Unique identifier for the substance Substance.identifier
quantity quantity Amount of substance in the package Substance.instance.quantity Substance.quantity
status token active | inactive | entered-in-error Substance.status
substance-reference reference A component of the substance (Substance.ingredient.substance as Reference) (Substance.ingredient.substance.ofType(Reference))
( Substance )