Profile_R4B_SubstanceDefinition_R5 - Extensions for Using Data Elements from FHIR R4B in FHIR R5 v0.1.0

A set of rules under which this content was created

0..1

Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional Bindings

Purpose

0..1

Narrative

Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

contained

0..*

Resource

Contained, inline Resources

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored
Constraints: ext-1

0..*

Identifier by which this substance is known

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:identifier

0..*

R4B: identifier
URL: http://hl7.org/fhir/StructureDefinition/artifact-identifier
Constraints: ext-1

use

?!Σ

0..1

usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

0..1

Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

system

0..1

The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient

ΣC

0..1

The value that is unique
Example General: 123456

period

0..1

Period

Time period when id is/was valid for use

assigner

0..1

Organization that issued id (may be just text)

version

0..1

A business level version identifier of the substance

0..1

xml:id (or equivalent in JSON)

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:version

0..1

R4B: version
URL: http://hl7.org/fhir/StructureDefinition/artifact-version
Constraints: ext-1

0..1

Primitive value for string
Max Length:1048576

0..1

Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:status

0..1

R4B: status
URL: http://hl7.org/fhir/StructureDefinition/artifact-status
Binding: PublicationStatus (required): The lifecycle status of an artifact.
Constraints: ext-1

coding

0..*

Coding

Code defined by a terminology system

0..1

Plain text representation of the concept

classification

0..*

A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity

0..1

If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

grade

0..*

The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies

0..1

Textual description of the substance

0..1

xml:id (or equivalent in JSON)

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:description

0..1

R4B: description
URL: http://hl7.org/fhir/StructureDefinition/artifact-description
Constraints: ext-1

0..1

Primitive value for markdown

informationSource

0..*

Reference(Citation)

Supporting literature

0..*

Textual comment about the substance's catalogue or registry record

manufacturer

0..*

The entity that creates, makes, produces or fabricates the substance

supplier

0..*

An entity that is the source for the substance. It may be different from the manufacturer

moiety

0..*

Moiety, for structural modifications

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

role

0..1

Role that the moiety is playing

0..1

Identifier by which this moiety substance is known

0..1

Textual name for this moiety substance

0..1

Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

0..1

Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

0..1

Molecular formula for this moiety (e.g. with the Hill system)

0..1

Quantitative value for this moiety

amountQuantity

amountString

0..1

The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

characterization

0..*

General specifications for this substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

form

0..1

Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)

0..1

The description or justification in support of the interpretation of the data file

file

0..*

Attachment

The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis

property

0..*

General specifications for this substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

1..1

Reference(SubstanceReferenceInformation)

A code expressing the type of property
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

value[x]

0..1

A value for the property

valueCodeableConcept

valueQuantity

valueDate

valueBoolean

valueAttachment

0..1

General information detailing this substance

0..*

The average mass of a molecule of a compound

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

method

0..1

The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

0..1

Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

amount

1..1

Quantity

Used to capture quantitative values for a variety of elements

structure

0..1

Structural information

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

0..1

Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

0..1

An expression which states the number and type of atoms present in a molecule of a substance

molecularFormulaByMoiety

0..1

Specified per moiety according to the Hill system

See molecularWeight (SubstanceDefinition)

0..1

The molecular weight or weight range

0..*

The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.

sourceDocument

0..*

Source of information for the structure

0..*

A depiction of the structure of the substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

0..1

The structural representation as a text string in a standard format

format

0..1

The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

document

0..1

An attachment with the structural representation e.g. a structure graphic or AnIML file

0..*

Codes associated with the substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

The specific code

0..1

Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

statusDate

0..1

The date at which the code status was changed

0..*

Any comment can be provided in this field

0..*

Supporting literature

0..*

Names applicable to this substance

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:name

0..*

R4B: name
URL: http://hl7.org/fhir/StructureDefinition/artifact-name
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

1..1

The actual name

0..1

Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

0..1

The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

preferred

0..1

If this is the preferred name for this substance

0..*

Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional Bindings

Purpose

0..*

The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

jurisdiction

0..*

The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

synonym

0..*

A synonym of this particular name, by which the substance is also known

translation

0..*

A translation for this name into another human language

official

0..*

Details of the official nature of this name

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

authority

0..1

Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

0..1

The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

date

0..1

Date of official name change

0..*

Supporting literature

relationship

0..*

A link between this substance and another

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Reference(SubstanceDefinition)

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

substanceDefinition[x]

0..1

A pointer to another substance, as a resource or a representational code

substanceDefinitionReference

substanceDefinitionCodeableConcept

1..1

For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

isDefining

0..1

For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships

0..1

A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other

amountQuantity

amountRatio

amountString

0..1

For use when the numeric has an uncertain range

comparator

0..1

An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

0..*

Reference(SubstanceNucleicAcid)

Supporting literature

nucleicAcid

0..1

Data items specific to nucleic acids

polymer

0..1

Reference(SubstancePolymer)

Data items specific to polymers

protein

0..1

Reference(SubstanceProtein)

Data items specific to proteins

sourceMaterial

0..1

Material or taxonomic/anatomical source

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material.

genus

0..1

The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

species

0..1

The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

part

0..1

An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

countryOfOrigin

0..*

Documentation for this format

The country or countries where the material is harvested
Binding: CountryValueSet (required): Jurisdiction codes

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
SubstanceDefinition.language	Base	required	All Languages	📍5.0.0	FHIR Std.
SubstanceDefinition.identifier.use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
SubstanceDefinition.identifier.type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
SubstanceDefinition.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
SubstanceDefinition.domain	Base	example	Medicinal Product Domain	📍5.0.0	FHIR Std.
SubstanceDefinition.grade	Base	example	Substance Grade	📍5.0.0	FHIR Std.
SubstanceDefinition.moiety.stereochemistry	Base	example	Stereochemistry	📍5.0.0	FHIR Std.
SubstanceDefinition.moiety.opticalActivity	Base	example	Optical Activity	📍5.0.0	FHIR Std.
SubstanceDefinition.moiety.measurementType	Base	example	Substance Amount Type	📍5.0.0	FHIR Std.
SubstanceDefinition.characterization.technique	Base	example	Structure Technique	📍5.0.0	FHIR Std.
SubstanceDefinition.characterization.form	Base	example	Substance Form	📍5.0.0	FHIR Std.
SubstanceDefinition.property.type	Base	example	Product Characteristic	📍5.0.0	FHIR Std.
SubstanceDefinition.molecularWeight.method	Base	example	Weight Method	📍5.0.0	FHIR Std.
SubstanceDefinition.molecularWeight.type	Base	example	Weight Type	📍5.0.0	FHIR Std.
SubstanceDefinition.structure.stereochemistry	Base	example	Stereochemistry	📍5.0.0	FHIR Std.
SubstanceDefinition.structure.opticalActivity	Base	example	Optical Activity	📍5.0.0	FHIR Std.
SubstanceDefinition.structure.technique	Base	example	Structure Technique	📍5.0.0	FHIR Std.
SubstanceDefinition.structure.representation.type	Base	example	Substance Representation Type	📍5.0.0	FHIR Std.
SubstanceDefinition.structure.representation.format	Base	example	Substance Representation Format	📍5.0.0	FHIR Std.
SubstanceDefinition.code.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
SubstanceDefinition.name.type	Base	example	Substance Name Type	📍5.0.0	FHIR Std.
SubstanceDefinition.name.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
SubstanceDefinition.name.language	Base	required	All Languages	📍5.0.0	FHIR Std.
SubstanceDefinition.name.domain	Base	example	Substance Name Domain	📍5.0.0	FHIR Std.
SubstanceDefinition.name.jurisdiction	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
SubstanceDefinition.name.official.authority	Base	preferred	Substance Name Authority	📍5.0.0	FHIR Std.
SubstanceDefinition.name.official.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
SubstanceDefinition.relationship.type	Base	example	Substance Relationship Type	📍5.0.0	FHIR Std.
SubstanceDefinition.relationship.comparator	Base	example	Substance Amount Type	📍5.0.0	FHIR Std.
SubstanceDefinition.sourceMaterial.type	Base	example	Source Material Type	📍5.0.0	FHIR Std.
SubstanceDefinition.sourceMaterial.genus	Base	example	Source Material Genus	📍5.0.0	FHIR Std.
SubstanceDefinition.sourceMaterial.species	Base	example	Source Material Species	📍5.0.0	FHIR Std.
SubstanceDefinition.sourceMaterial.part	Base	example	Source Material Part	📍5.0.0	FHIR Std.
SubstanceDefinition.sourceMaterial.countryOfOrigin	Base	required	Country ValueSet	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	SubstanceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	SubstanceDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().ofType(canonical) \| %resource.descendants().ofType(uri) \| %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	SubstanceDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	SubstanceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	SubstanceDefinition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	SubstanceDefinition.meta, SubstanceDefinition.implicitRules, SubstanceDefinition.language, SubstanceDefinition.text, SubstanceDefinition.extension, SubstanceDefinition.modifierExtension, SubstanceDefinition.identifier, SubstanceDefinition.identifier.extension, SubstanceDefinition.identifier.extension:identifier, SubstanceDefinition.identifier.use, SubstanceDefinition.identifier.type, SubstanceDefinition.identifier.system, SubstanceDefinition.identifier.value, SubstanceDefinition.identifier.period, SubstanceDefinition.identifier.assigner, SubstanceDefinition.version, SubstanceDefinition.version.extension, SubstanceDefinition.version.extension:version, SubstanceDefinition.status, SubstanceDefinition.status.extension, SubstanceDefinition.status.extension:status, SubstanceDefinition.status.coding, SubstanceDefinition.status.text, SubstanceDefinition.classification, SubstanceDefinition.domain, SubstanceDefinition.grade, SubstanceDefinition.description, SubstanceDefinition.description.extension, SubstanceDefinition.description.extension:description, SubstanceDefinition.informationSource, SubstanceDefinition.note, SubstanceDefinition.manufacturer, SubstanceDefinition.supplier, SubstanceDefinition.moiety, SubstanceDefinition.moiety.extension, SubstanceDefinition.moiety.modifierExtension, SubstanceDefinition.moiety.role, SubstanceDefinition.moiety.identifier, SubstanceDefinition.moiety.name, SubstanceDefinition.moiety.stereochemistry, SubstanceDefinition.moiety.opticalActivity, SubstanceDefinition.moiety.molecularFormula, SubstanceDefinition.moiety.amount[x], SubstanceDefinition.moiety.measurementType, SubstanceDefinition.characterization, SubstanceDefinition.characterization.extension, SubstanceDefinition.characterization.modifierExtension, SubstanceDefinition.characterization.technique, SubstanceDefinition.characterization.form, SubstanceDefinition.characterization.description, SubstanceDefinition.characterization.file, SubstanceDefinition.property, SubstanceDefinition.property.extension, SubstanceDefinition.property.modifierExtension, SubstanceDefinition.property.type, SubstanceDefinition.property.value[x], SubstanceDefinition.referenceInformation, SubstanceDefinition.molecularWeight, SubstanceDefinition.molecularWeight.extension, SubstanceDefinition.molecularWeight.modifierExtension, SubstanceDefinition.molecularWeight.method, SubstanceDefinition.molecularWeight.type, SubstanceDefinition.molecularWeight.amount, SubstanceDefinition.structure, SubstanceDefinition.structure.extension, SubstanceDefinition.structure.modifierExtension, SubstanceDefinition.structure.stereochemistry, SubstanceDefinition.structure.opticalActivity, SubstanceDefinition.structure.molecularFormula, SubstanceDefinition.structure.molecularFormulaByMoiety, SubstanceDefinition.structure.molecularWeight, SubstanceDefinition.structure.technique, SubstanceDefinition.structure.sourceDocument, SubstanceDefinition.structure.representation, SubstanceDefinition.structure.representation.extension, SubstanceDefinition.structure.representation.modifierExtension, SubstanceDefinition.structure.representation.type, SubstanceDefinition.structure.representation.representation, SubstanceDefinition.structure.representation.format, SubstanceDefinition.structure.representation.document, SubstanceDefinition.code, SubstanceDefinition.code.extension, SubstanceDefinition.code.modifierExtension, SubstanceDefinition.code.code, SubstanceDefinition.code.status, SubstanceDefinition.code.statusDate, SubstanceDefinition.code.note, SubstanceDefinition.code.source, SubstanceDefinition.name, SubstanceDefinition.name.extension, SubstanceDefinition.name.extension:name, SubstanceDefinition.name.modifierExtension, SubstanceDefinition.name.name, SubstanceDefinition.name.type, SubstanceDefinition.name.status, SubstanceDefinition.name.preferred, SubstanceDefinition.name.language, SubstanceDefinition.name.domain, SubstanceDefinition.name.jurisdiction, SubstanceDefinition.name.synonym, SubstanceDefinition.name.translation, SubstanceDefinition.name.official, SubstanceDefinition.name.official.extension, SubstanceDefinition.name.official.modifierExtension, SubstanceDefinition.name.official.authority, SubstanceDefinition.name.official.status, SubstanceDefinition.name.official.date, SubstanceDefinition.name.source, SubstanceDefinition.relationship, SubstanceDefinition.relationship.extension, SubstanceDefinition.relationship.modifierExtension, SubstanceDefinition.relationship.substanceDefinition[x], SubstanceDefinition.relationship.type, SubstanceDefinition.relationship.isDefining, SubstanceDefinition.relationship.amount[x], SubstanceDefinition.relationship.ratioHighLimitAmount, SubstanceDefinition.relationship.comparator, SubstanceDefinition.relationship.source, SubstanceDefinition.nucleicAcid, SubstanceDefinition.polymer, SubstanceDefinition.protein, SubstanceDefinition.sourceMaterial, SubstanceDefinition.sourceMaterial.extension, SubstanceDefinition.sourceMaterial.modifierExtension, SubstanceDefinition.sourceMaterial.type, SubstanceDefinition.sourceMaterial.genus, SubstanceDefinition.sourceMaterial.species, SubstanceDefinition.sourceMaterial.part, SubstanceDefinition.sourceMaterial.countryOfOrigin	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	SubstanceDefinition.extension, SubstanceDefinition.modifierExtension, SubstanceDefinition.identifier.extension, SubstanceDefinition.identifier.extension:identifier, SubstanceDefinition.version.extension, SubstanceDefinition.version.extension:version, SubstanceDefinition.status.extension, SubstanceDefinition.status.extension:status, SubstanceDefinition.description.extension, SubstanceDefinition.description.extension:description, SubstanceDefinition.moiety.extension, SubstanceDefinition.moiety.modifierExtension, SubstanceDefinition.characterization.extension, SubstanceDefinition.characterization.modifierExtension, SubstanceDefinition.property.extension, SubstanceDefinition.property.modifierExtension, SubstanceDefinition.molecularWeight.extension, SubstanceDefinition.molecularWeight.modifierExtension, SubstanceDefinition.structure.extension, SubstanceDefinition.structure.modifierExtension, SubstanceDefinition.structure.representation.extension, SubstanceDefinition.structure.representation.modifierExtension, SubstanceDefinition.code.extension, SubstanceDefinition.code.modifierExtension, SubstanceDefinition.name.extension, SubstanceDefinition.name.extension:name, SubstanceDefinition.name.modifierExtension, SubstanceDefinition.name.official.extension, SubstanceDefinition.name.official.modifierExtension, SubstanceDefinition.relationship.extension, SubstanceDefinition.relationship.modifierExtension, SubstanceDefinition.sourceMaterial.extension, SubstanceDefinition.sourceMaterial.modifierExtension	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`

This structure is derived from SubstanceDefinition

Summary

Extensions

This structure refers to these extensions:

Maturity: 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
SubstanceDefinition		0..*	SubstanceDefinition(5.0.0)	The detailed description of a substance, typically at a level beyond what is used for prescribing
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	SubstanceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	SubstanceDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().ofType(canonical) \| %resource.descendants().ofType(uri) \| %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	SubstanceDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	SubstanceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	SubstanceDefinition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	SubstanceDefinition.implicitRules, SubstanceDefinition.modifierExtension	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	SubstanceDefinition.modifierExtension	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`

Differential View

This structure is derived from SubstanceDefinition

Name	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
SubstanceDefinition	0..*	SubstanceDefinition(5.0.0)	The detailed description of a substance, typically at a level beyond what is used for prescribing
identifier
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:identifier	0..*	Identifier	R4B: identifier URL: http://hl7.org/fhir/StructureDefinition/artifact-identifier
version
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:version	0..1	string	R4B: version URL: http://hl7.org/fhir/StructureDefinition/artifact-version
status
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:status	0..1	code	R4B: status URL: http://hl7.org/fhir/StructureDefinition/artifact-status Binding: PublicationStatus (required): The lifecycle status of an artifact.
description
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:description	0..1	markdown	R4B: description URL: http://hl7.org/fhir/StructureDefinition/artifact-description
name
Slices for extension	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:name	0..*	string	R4B: name URL: http://hl7.org/fhir/StructureDefinition/artifact-name
Documentation for this format

Snapshot View

Description & Constraints Filter: Filters

SubstanceDefinition

0..*

SubstanceDefinition(5.0.0)

The detailed description of a substance, typically at a level beyond what is used for prescribing

0..1

Logical id of this artifact

Meta

Metadata about the resource

implicitRules

?!Σ

0..1

A set of rules under which this content was created

0..1

Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional Bindings

Purpose

0..1

Narrative

Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

contained

0..*

Resource

Contained, inline Resources

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored
Constraints: ext-1

0..*

Identifier by which this substance is known

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:identifier

0..*

R4B: identifier
URL: http://hl7.org/fhir/StructureDefinition/artifact-identifier
Constraints: ext-1

use

?!Σ

0..1

usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

0..1

Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

system

0..1

The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient

ΣC

0..1

The value that is unique
Example General: 123456

period

0..1

Period

Time period when id is/was valid for use

assigner

0..1

Organization that issued id (may be just text)

version

0..1

A business level version identifier of the substance

0..1

xml:id (or equivalent in JSON)

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:version

0..1

R4B: version
URL: http://hl7.org/fhir/StructureDefinition/artifact-version
Constraints: ext-1

0..1

Primitive value for string
Max Length:1048576

0..1

Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:status

0..1

R4B: status
URL: http://hl7.org/fhir/StructureDefinition/artifact-status
Binding: PublicationStatus (required): The lifecycle status of an artifact.
Constraints: ext-1

coding

0..*

Coding

Code defined by a terminology system

0..1

Plain text representation of the concept

classification

0..*

A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity

0..1

If the substance applies to human or veterinary use
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

grade

0..*

0..1

Textual description of the substance

0..1

xml:id (or equivalent in JSON)

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:description

0..1

R4B: description
URL: http://hl7.org/fhir/StructureDefinition/artifact-description
Constraints: ext-1

0..1

Primitive value for markdown

informationSource

0..*

Reference(Citation)

Supporting literature

0..*

Textual comment about the substance's catalogue or registry record

manufacturer

0..*

The entity that creates, makes, produces or fabricates the substance

supplier

0..*

An entity that is the source for the substance. It may be different from the manufacturer

moiety

0..*

Moiety, for structural modifications

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

role

0..1

Role that the moiety is playing

0..1

Identifier by which this moiety substance is known

0..1

Textual name for this moiety substance

0..1

Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

0..1

Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

0..1

Molecular formula for this moiety (e.g. with the Hill system)

0..1

Quantitative value for this moiety

amountQuantity

amountString

0..1

The measurement type of the quantitative value
Binding: SubstanceAmountType (example): The relationship between two substance types.

characterization

0..*

General specifications for this substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

The method used to find the characterization e.g. HPLC
Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance.

form

0..1

Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: SubstanceForm (example)

0..1

The description or justification in support of the interpretation of the data file

file

0..*

Attachment

The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis

property

0..*

General specifications for this substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

1..1

Reference(SubstanceReferenceInformation)

A code expressing the type of property
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

value[x]

0..1

A value for the property

valueCodeableConcept

valueQuantity

valueDate

valueBoolean

valueAttachment

0..1

General information detailing this substance

0..*

The average mass of a molecule of a compound

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

method

0..1

The method by which the weight was determined
Binding: WeightMethod (example): The method by which the substance weight was measured.

0..1

Type of molecular weight e.g. exact, average, weight average
Binding: WeightType (example): The type of substance weight measurement.

amount

1..1

Quantity

Used to capture quantitative values for a variety of elements

structure

0..1

Structural information

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

Stereochemistry type
Binding: Stereochemistry (example): The optical rotation type of a substance.

0..1

Optical activity type
Binding: OpticalActivity (example): The optical rotation type of a substance.

0..1

An expression which states the number and type of atoms present in a molecule of a substance

molecularFormulaByMoiety

0..1

Specified per moiety according to the Hill system

See molecularWeight (SubstanceDefinition)

0..1

The molecular weight or weight range

0..*

The method used to find the structure e.g. X-ray, NMR
Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance.

sourceDocument

0..*

Source of information for the structure

0..*

A depiction of the structure of the substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

The kind of structural representation (e.g. full, partial)
Binding: SubstanceRepresentationType (example): A format of a substance representation.

0..1

The structural representation as a text string in a standard format

format

0..1

The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: SubstanceRepresentationFormat (example): A format of a substance representation.

document

0..1

An attachment with the structural representation e.g. a structure graphic or AnIML file

0..*

Codes associated with the substance

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

The specific code

0..1

Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

statusDate

0..1

The date at which the code status was changed

0..*

Any comment can be provided in this field

0..*

Supporting literature

0..*

Names applicable to this substance

0..1

Unique id for inter-element referencing

0..*

Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

extension:name

0..*

R4B: name
URL: http://hl7.org/fhir/StructureDefinition/artifact-name
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

1..1

The actual name

0..1

Name type e.g. 'systematic', 'scientific, 'brand'
Binding: SubstanceNameType (example): The type of a name given to a substance.

0..1

The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

preferred

0..1

If this is the preferred name for this substance

0..*

Human language that the name is written in
Binding: AllLanguages (required): IETF language tag for a human language

Additional Bindings

Purpose

0..*

jurisdiction

0..*

The jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

synonym

0..*

A synonym of this particular name, by which the substance is also known

translation

0..*

A translation for this name into another human language

official

0..*

Details of the official nature of this name

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

authority

0..1

Which authority uses this official name
Binding: SubstanceNameAuthority (preferred): An authority that officates substance names.

0..1

The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

date

0..1

Date of official name change

0..*

Supporting literature

relationship

0..*

A link between this substance and another

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Reference(SubstanceDefinition)

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

substanceDefinition[x]

0..1

A pointer to another substance, as a resource or a representational code

substanceDefinitionReference

substanceDefinitionCodeableConcept

1..1

For example "salt to parent", "active moiety"
Binding: SubstanceRelationshipType (example): The relationship between two substance types.

isDefining

0..1

For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships

0..1

A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other

amountQuantity

amountRatio

amountString

0..1

For use when the numeric has an uncertain range

comparator

0..1

An operator for the amount, for example "average", "approximately", "less than"
Binding: SubstanceAmountType (example): The relationship between two substance types.

0..*

Reference(SubstanceNucleicAcid)

Supporting literature

nucleicAcid

0..1

Data items specific to nucleic acids

polymer

0..1

Reference(SubstancePolymer)

Data items specific to polymers

protein

0..1

Reference(SubstanceProtein)

Data items specific to proteins

sourceMaterial

0..1

Material or taxonomic/anatomical source

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Constraints: ext-1

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Constraints: ext-1

0..1

genus

0..1

species

0..1

The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: SourceMaterialSpecies (example): A species of origin a substance raw material.

part

0..1

An anatomical origin of the source material within an organism
Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism.

countryOfOrigin

0..*