Release 4 5 Snapshot #1

This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU ) in it's permanent home (it will always be available at this URL). (v5.0.0-snapshot1: R5 Snapshot #1). 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 Resource Substance - Content

Orders Biomedical Research and Observations Regulation Work Group Maturity Level : 2   Trial Use Security Category : Business Compartments : Not linked to any defined compartments

A homogeneous material with a definite composition.

8.17.1 Scope and Usage

This resource allows for is a material to be represented. The base resource can be that represents raw materials used to represent either a kind of a substance - e.g. a formulation commonly used for treating patients, packaged or it can be used to describe a particular package measured amount of a known substance (e.g. bottle, jar, packet). 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.

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 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.

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.

8.17.3 References

This resource is referenced by ActivityDefinition , AdverseEvent , BiologicallyDerivedProduct , CarePlan , ChargeItem , ChargeItemDefinition , ClinicalUseDefinition , ClinicalUseIssue , Contract , DiagnosticReport , Group , ImagingSelection , Medication , MedicationKnowledge , MedicinalProductContraindication NutritionIntake , MedicinalProductIndication NutritionProduct , MedicinalProductInteraction Observation , Procedure , ResearchSubject , Specimen , SpecimenDefinition , itself, SubstanceSpecification , SupplyDelivery and SupplyRequest .

This resource does not implement any patterns.

8.17.3 8.17.4 Resource Content

Structure

instance Σ 0..* BackboneElement If this describes a specific package/container of the substance
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
. . . instance ?! Σ 1..1 boolean Is this an instance of a substance or a kind of one
... status ?! Σ 0..1 code active | inactive | entered-in-error
FHIRSubstanceStatus ( Required )
. . . code Σ 1..1 CodeableConcept CodeableReference ( SubstanceDefinition ) What substance this is
Substance Code ( Example )
. . . description Σ 0..1 string Textual description of the 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
Substance Code ( Example )
. . . . . substanceCodeableConcept CodeableConcept
. . . . . substanceReference Reference ( Substance )

doco Documentation for this format

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 DataType [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 [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>

 <code><!-- 1..1 CodeableReference(SubstanceDefinition) What substance this is --></code>

 <description value="[string]"/><!-- 0..1 Textual description of the substance, comments -->
 <
  <</identifier>
  <
  <</quantity>
 </instance>

 <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:Substance.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:Substance.instance [ boolean ]; # 1..1 Is this an instance of a substance or a kind of one

  fhir:Substance.status [ code ]; # 0..1 active | inactive | entered-in-error
  fhir:Substance.category [ CodeableConcept ], ... ; # 0..* What class/type of substance this is
  fhir:

  fhir:Substance.code [ CodeableReference(SubstanceDefinition) ]; # 1..1 What substance this is

  fhir:Substance.description [ string ]; # 0..1 Textual description of the substance, comments
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;

  fhir:Substance.expiry [ dateTime ]; # 0..1 When no longer valid to use
  fhir:Substance.quantity [ Quantity(SimpleQuantity) ]; # 0..1 Amount of substance in the package

  fhir:Substance.ingredient [ # 0..* Composition information about the substance
    fhir:Substance.ingredient.quantity [ Ratio ]; # 0..1 Optional amount (concentration)
    # Substance.ingredient.substance[x] : 1..1 A component of the substance. One of these 2
      fhir:Substance.ingredient.substanceCodeableConcept [ CodeableConcept ]
      fhir:Substance.ingredient.substanceReference [ Reference(Substance) ]
  ], ...;
]

Changes since R3

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.status
  • Change code system for extensibly bound codes value set from "http://hl7.org/fhir/substance-category" http://hl7.org/fhir/ValueSet/substance-status|4.0.0 to "http://terminology.hl7.org/CodeSystem/substance-category" http://hl7.org/fhir/ValueSet/substance-status|5.0.0-snapshot1
Substance.code
  • Type changed from CodeableConcept to CodeableReference
Substance.expiry
  • Added Element
Substance.quantity
  • Added Element
Substance.instance.identifier
  • deleted
Substance.instance.expiry
  • deleted
Substance.instance.quantity
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

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

Structure

instance Σ 0..* BackboneElement If this describes a specific package/container of the substance
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
. . . instance ?! Σ 1..1 boolean Is this an instance of a substance or a kind of one
... status ?! Σ 0..1 code active | inactive | entered-in-error
FHIRSubstanceStatus ( Required )
. . . code Σ 1..1 CodeableConcept CodeableReference ( SubstanceDefinition ) What substance this is
Substance Code ( Example )
. . . description Σ 0..1 string Textual description of the 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
Substance Code ( Example )
. . . . . substanceCodeableConcept CodeableConcept
. . . . . substanceReference Reference ( Substance )

doco Documentation for this format

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 DataType [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 [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>

 <code><!-- 1..1 CodeableReference(SubstanceDefinition) What substance this is --></code>

 <description value="[string]"/><!-- 0..1 Textual description of the substance, comments -->
 <
  <</identifier>
  <
  <</quantity>
 </instance>

 <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:Substance.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:Substance.instance [ boolean ]; # 1..1 Is this an instance of a substance or a kind of one

  fhir:Substance.status [ code ]; # 0..1 active | inactive | entered-in-error
  fhir:Substance.category [ CodeableConcept ], ... ; # 0..* What class/type of substance this is
  fhir:

  fhir:Substance.code [ CodeableReference(SubstanceDefinition) ]; # 1..1 What substance this is

  fhir:Substance.description [ string ]; # 0..1 Textual description of the substance, comments
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;

  fhir:Substance.expiry [ dateTime ]; # 0..1 When no longer valid to use
  fhir:Substance.quantity [ Quantity(SimpleQuantity) ]; # 0..1 Amount of substance in the package

  fhir:Substance.ingredient [ # 0..* Composition information about the substance
    fhir:Substance.ingredient.quantity [ Ratio ]; # 0..1 Optional amount (concentration)
    # Substance.ingredient.substance[x] : 1..1 A component of the substance. One of these 2
      fhir:Substance.ingredient.substanceCodeableConcept [ CodeableConcept ]
      fhir:Substance.ingredient.substanceReference [ Reference(Substance) ]
  ], ...;
]

Changes since Release 3

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.status
  • Change code system for extensibly bound codes value set from "http://hl7.org/fhir/substance-category" http://hl7.org/fhir/ValueSet/substance-status|4.0.0 to "http://terminology.hl7.org/CodeSystem/substance-category" http://hl7.org/fhir/ValueSet/substance-status|5.0.0-snapshot1
Substance.code
  • Type changed from CodeableConcept to CodeableReference
Substance.expiry
  • Added Element
Substance.quantity
  • Added Element
Substance.instance.identifier
  • deleted
Substance.instance.expiry
  • deleted
Substance.instance.quantity
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

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

 

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

8.17.3.1 8.17.4.1 Terminology Bindings

Path Definition Type Reference
Substance.status A code to indicate if the substance is actively used. Required FHIRSubstanceStatus
Substance.category Category or classification of substance. Extensible SubstanceCategoryCodes
Substance.code Substance codes. Example SubstanceCode
Substance.ingredient.substance[x] Substance Ingredient codes. Example SubstanceCode

8.17.4 8.17.5 Search Parameters

Search parameters for 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 D token The code of the substance or ingredient Substance.code Substance.code.concept | (Substance.ingredient.substance as CodeableConcept)
container-identifier code-reference D token reference Identifier of A reference to the package/container defining substance Substance.instance.identifier Substance.code.reference
expiry N 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 N token active | inactive | entered-in-error Substance.status
substance-reference reference A component of the substance (Substance.ingredient.substance as Reference)
( Substance )