R5 Final QA
AdministrationThis page is part of the FHIR Specification (v5.0.0-draft-final: Final QA Preview for R5 - see ballot notes). 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
| Biomedical Research and 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.
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.
The resource can be used to represent either a kind of a substance - e.g. a formulation commonly used for treating patients (a "definitional" use of Substance), or it can be used to describe a particular package of a known substance (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.
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 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.
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 |
 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 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 |
  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) | |||
| 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> <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><!-- 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>
JSON Template
{
"resourceType" : "Substance",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Unique identifier
"instance" : <boolean>, // R! Is this an instance of a substance or a kind of one
"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
"ingredient" : [{ // Composition information about the substance
"quantity" : { Ratio }, // Optional amount (concentration)
// substance[x]: A component of the substance. One of these 2:
"substanceCodeableConcept" : { CodeableConcept },
"substanceReference" : { Reference(Substance) }
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since R4
| Substance | |
| Substance.instance |
|
| Substance.code |
|
| Substance.description |
|
| Substance.expiry |
|
| Substance.quantity |
|
| Substance.instance.identifier |
|
| Substance.instance.expiry |
|
| Substance.instance.quantity |
|
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
| 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 |
| 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 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 |
| 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) | |||
| Documentation for this format | ||||
See the Extensions for this resource
XML Template
<Substance xmlns="http://hl7.org/fhir">
JSON Template
{
"resourceType" : "Substance",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Unique identifier
"instance" : <boolean>, // R! Is this an instance of a substance or a kind of one
"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
"ingredient" : [{ // Composition information about the substance
"quantity" : { Ratio }, // Optional amount (concentration)
// substance[x]: A component of the substance. One of these 2:
"substanceCodeableConcept" : { CodeableConcept },
"substanceReference" : { Reference(Substance) }
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since Release 4
| Substance | |
| Substance.instance |
|
| Substance.code |
|
| Substance.description |
|
| Substance.expiry |
|
| Substance.quantity |
|
| Substance.instance.identifier |
|
| Substance.instance.expiry |
|
| Substance.instance.quantity |
|
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).)
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
| 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 |
| Substance.ingredient.substance[x] | SubstanceCode | Example | This value set contains concept codes for specific substances. It includes codes from SNOMED |
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.concept | (Substance.ingredient.substance.ofType(CodeableConcept)) | |
| 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 | |
| substance-reference | reference | A component of the substance | (Substance.ingredient.substance.ofType(Reference)) (Substance) |
FHIR ®© HL7.org 2011+. FHIR R5 hl7.fhir.core#5.0.0-draft-final generated on Wed, Mar 1, 2023 23:07+1100.
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