Release 4B

This page is part of the FHIR Specification (v4.3.0: R4B - STU). This is a downloaded version of the specification. For a full list of available versions, see the Directory of published versions

15.9 Resource SubstanceDefinition - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

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

For an overview of this resource and others in the Medication Definition domain, also see the module page

SubstanceDefinition is used for rich descriptions of substances, of any type, to support the detailed definition of medications, and in particular their ingredients (see Ingredient) and manufacturing.

This is a definitional resource describing types of substances, to a varying degree of specificity. It can cover the substance in the abstract (properties that this substance always has), or a particular variety of it, such as one manufacturer's version, or a certain presentation (e.g. "granulated"). However it is always a type and does not represent an actual physical instance of a substance. By contrast the Substance resource can act as either a concise definition (a subset of SubstanceDefinition) or as an instance (an actual batch).

SubstanceDefinition is not generally used directly to represent an ingredient, nor as a product that is given to a patient. When acting as an ingredient, the Ingredient resource gives the context necessary (strength, role etc.) and, within it, uses this resource to describe the substance. Any substance that is to be used as medication would be considered a medicinal product (even a plain one such as water) and as such would be described using MedicinalProductDefinition or for a concise summary suitable for day-to-day prescribing, Medication.

This resource is undergoing review for which elements are core and which may be suitable as extensions.

Implementer feedback is welcome on the issue tracker or chat.fhir.org .

 

This resource is referenced by ClinicalUseDefinition, Ingredient, MedicinalProductDefinition, PlanDefinition, RegulatedAuthorization and itself.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition TUDomainResourceThe detailed description of a substance, typically at a level beyond what is used for prescribing
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierIdentifier by which this substance is known
... version Σ0..1stringA business level version identifier of the substance
... status Σ0..1CodeableConceptStatus of substance within the catalogue e.g. active, retired
PublicationStatus (Preferred)
... domain Σ0..1CodeableConceptIf the substance applies to human or veterinary use
MedicinalProductDomain (Example)
... grade Σ0..*CodeableConceptThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
SubstanceGrade (Example)
... description Σ0..1markdownTextual description of the substance
... informationSource Σ0..*Reference(Citation)Supporting literature
... note Σ0..*AnnotationTextual comment about the substance's catalogue or registry record
... manufacturer Σ0..*Reference(Organization)The entity that creates, makes, produces or fabricates the substance
... supplier Σ0..*Reference(Organization)An entity that is the source for the substance. It may be different from the manufacturer
... moiety Σ0..*BackboneElementMoiety, for structural modifications
.... role Σ0..1CodeableConceptRole that the moiety is playing
.... identifier Σ0..1IdentifierIdentifier by which this moiety substance is known
.... name Σ0..1stringTextual name for this moiety substance
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
Stereochemistry (Example)
.... opticalActivity Σ0..1CodeableConceptOptical activity type
OpticalActivity (Example)
.... molecularFormula Σ0..1stringMolecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ0..1Quantitative value for this moiety
..... amountQuantityQuantity
..... amountStringstring
.... measurementType Σ0..1CodeableConceptThe measurement type of the quantitative value
SubstanceAmountType (Example)
... property Σ0..*BackboneElementGeneral specifications for this substance
.... type Σ1..1CodeableConceptA code expressing the type of property
SNOMEDCTCharacteristicCodes (Example)
.... value[x] Σ0..1A value for the property
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
... molecularWeight Σ0..*BackboneElementThe molecular weight or weight range
.... method Σ0..1CodeableConceptThe method by which the weight was determined
WeightMethod (Example)
.... type Σ0..1CodeableConceptType of molecular weight e.g. exact, average, weight average
WeightType (Example)
.... amount Σ1..1QuantityUsed to capture quantitative values for a variety of elements
... structure Σ0..1BackboneElementStructural information
.... stereochemistry Σ0..1CodeableConceptStereochemistry type
Stereochemistry (Example)
.... opticalActivity Σ0..1CodeableConceptOptical activity type
OpticalActivity (Example)
.... molecularFormula Σ0..1stringMolecular formula (e.g. using the Hill system)
.... molecularFormulaByMoiety Σ0..1stringSpecified per moiety according to the Hill system
.... molecularWeight Σ0..1see molecularWeightThe molecular weight or weight range
.... technique Σ0..*CodeableConceptThe method used to find the structure e.g. X-ray, NMR
StructureTechnique (Example)
.... sourceDocument Σ0..*Reference(DocumentReference)Source of information for the structure
.... representation Σ0..*BackboneElementA depiction of the structure or characterization of the substance
..... type Σ0..1CodeableConceptThe kind of structural representation (e.g. full, partial)
SubstanceRepresentationType (Example)
..... representation Σ0..1stringThe structural representation or characterization as a text string in a standard format
..... format Σ0..1CodeableConceptThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
SubstanceRepresentationFormat (Example)
..... document Σ0..1Reference(DocumentReference)An attachment with the structural representation e.g. a structure graphic or AnIML file
... code Σ0..*BackboneElementCodes associated with the substance
.... code Σ0..1CodeableConceptThe specific code
.... status Σ0..1CodeableConceptStatus of the code assignment, for example 'provisional', 'approved'
PublicationStatus (Preferred)
.... statusDate Σ0..1dateTimeThe date at which the code status was changed
.... note Σ0..*AnnotationAny comment can be provided in this field
.... source Σ0..*Reference(DocumentReference)Supporting literature
... name Σ0..*BackboneElementNames applicable to this substance
.... name Σ1..1stringThe actual name
.... type Σ0..1CodeableConceptName type e.g. 'systematic', 'scientific, 'brand'
SubstanceNameType (Example)
.... status Σ0..1CodeableConceptThe status of the name e.g. 'current', 'proposed'
PublicationStatus (Preferred)
.... preferred Σ0..1booleanIf this is the preferred name for this substance
.... language Σ0..*CodeableConceptHuman language that the name is written in
Common Languages (Preferred but limited to AllLanguages)
.... domain Σ0..*CodeableConceptThe use context of this name e.g. as an active ingredient or as a food colour additive
SubstanceNameDomain (Example)
.... jurisdiction Σ0..*CodeableConceptThe jurisdiction where this name applies
Jurisdiction (Example)
.... synonym Σ0..*see nameA synonym of this particular name, by which the substance is also known
.... translation Σ0..*see nameA translation for this name into another human language
.... official Σ0..*BackboneElementDetails of the official nature of this name
..... authority Σ0..1CodeableConceptWhich authority uses this official name
SubstanceNameAuthority (Preferred)
..... status Σ0..1CodeableConceptThe status of the official name, for example 'draft', 'active'
PublicationStatus (Preferred)
..... date Σ0..1dateTimeDate of official name change
.... source Σ0..*Reference(DocumentReference)Supporting literature
... relationship Σ0..*BackboneElementA link between this substance and another
.... substanceDefinition[x] Σ0..1A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReferenceReference(SubstanceDefinition)
..... substanceDefinitionCodeableConceptCodeableConcept
.... type Σ1..1CodeableConceptFor example "salt to parent", "active moiety"
SubstanceRelationshipType (Example)
.... isDefining Σ0..1booleanFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
.... amount[x] Σ0..1A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
..... amountQuantityQuantity
..... amountRatioRatio
..... amountStringstring
.... ratioHighLimitAmount Σ0..1RatioFor use when the numeric has an uncertain range
.... comparator Σ0..1CodeableConceptAn operator for the amount, for example "average", "approximately", "less than"
SubstanceAmountType (Example)
.... source Σ0..*Reference(DocumentReference)Supporting literature
... sourceMaterial Σ0..1BackboneElementMaterial or taxonomic/anatomical source
.... type Σ0..1CodeableConceptClassification of the origin of the raw material. e.g. cat hair is an Animal source type
SourceMaterialType (Example)
.... genus Σ0..1CodeableConceptThe genus of an organism e.g. the Latin epithet of the plant/animal scientific name
SourceMaterialGenus (Example)
.... species Σ0..1CodeableConceptThe species of an organism e.g. the Latin epithet of the species of the plant/animal
SourceMaterialSpecies (Example)
.... part Σ0..1CodeableConceptAn anatomical origin of the source material within an organism
SourceMaterialPart (Example)
.... countryOfOrigin Σ0..*CodeableConceptThe country or countries where the material is harvested
Country (Required)

doco Documentation for this format

 

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

PathDefinitionTypeReference
SubstanceDefinition.status PreferredPublicationStatus
SubstanceDefinition.domain ExampleMedicinalProductDomain
SubstanceDefinition.grade ExampleSubstanceGrade
SubstanceDefinition.moiety.stereochemistry ExampleStereochemistry
SubstanceDefinition.moiety.opticalActivity ExampleOpticalActivity
SubstanceDefinition.moiety.measurementType ExampleSubstanceAmountType
SubstanceDefinition.property.type Examplehttp://hl7.org/fhir/ValueSet/product-characteristic-codes
SubstanceDefinition.molecularWeight.method ExampleWeightMethod
SubstanceDefinition.molecularWeight.type ExampleWeightType
SubstanceDefinition.structure.stereochemistry ExampleStereochemistry
SubstanceDefinition.structure.opticalActivity ExampleOpticalActivity
SubstanceDefinition.structure.technique ExampleStructureTechnique
SubstanceDefinition.structure.representation.type ExampleSubstanceRepresentationType
SubstanceDefinition.structure.representation.format ExampleSubstanceRepresentationFormat
SubstanceDefinition.code.status PreferredPublicationStatus
SubstanceDefinition.name.type ExampleSubstanceNameType
SubstanceDefinition.name.status PreferredPublicationStatus
SubstanceDefinition.name.language Preferred, but limited to AllLanguagesCommonLanguages
SubstanceDefinition.name.domain ExampleSubstanceNameDomain
SubstanceDefinition.name.jurisdiction ExampleJurisdiction ValueSet
SubstanceDefinition.name.official.authority PreferredSubstanceNameAuthority
SubstanceDefinition.name.official.status PreferredPublicationStatus
SubstanceDefinition.relationship.type ExampleSubstanceRelationshipType
SubstanceDefinition.relationship.comparator ExampleSubstanceAmountType
SubstanceDefinition.sourceMaterial.type ExampleSourceMaterialType
SubstanceDefinition.sourceMaterial.genus ExampleSourceMaterialGenus
SubstanceDefinition.sourceMaterial.species ExampleSourceMaterialSpecies
SubstanceDefinition.sourceMaterial.part ExampleSourceMaterialPart
SubstanceDefinition.sourceMaterial.countryOfOrigin RequiredCountry ValueSet

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
classificationtokenHigh or low level categorization, e.g. polymer vs. nucleic acid or linear vs. branch chainSubstanceDefinition.classification
codetokenThe specific codeSubstanceDefinition.code.code
domaintokenIf the substance applies to only human or veterinary useSubstanceDefinition.domain
identifiertokenIdentifier by which this substance is knownSubstanceDefinition.identifier
name NstringThe actual nameSubstanceDefinition.name.name