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15.9 Resource SubstanceDefinition - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: No 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 icon or chat.fhir.org icon.

 

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. SubstanceDefinition TU DomainResource The 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 Σ 0..* Identifier Identifier by which this substance is known

... version Σ 0..1 string A business level version identifier of the substance
... status Σ 0..1 CodeableConcept Status of substance within the catalogue e.g. active, retired
Binding: PublicationStatus (Preferred)
... domain Σ 0..1 CodeableConcept If the substance applies to human or veterinary use
Binding: Medicinal Product Domain (Example)
... grade Σ 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
Binding: Substance Grade (Example)

... description Σ 0..1 markdown Textual description of the substance
... informationSource Σ 0..* Reference(Citation) Supporting literature

... note Σ 0..* Annotation Textual comment about the substance's catalogue or registry record

... manufacturer Σ 0..* Reference(Organization) The entity that creates, makes, produces or fabricates the substance

... supplier Σ 0..* Reference(Organization) An entity that is the source for the substance. It may be different from the manufacturer

... moiety Σ 0..* BackboneElement Moiety, for structural modifications

.... role Σ 0..1 CodeableConcept Role that the moiety is playing
.... identifier Σ 0..1 Identifier Identifier by which this moiety substance is known
.... name Σ 0..1 string Textual name for this moiety substance
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (Example)
.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: Optical Activity (Example)
.... molecularFormula Σ 0..1 string Molecular formula for this moiety (e.g. with the Hill system)
.... amount[x] Σ 0..1 Quantitative value for this moiety
..... amountQuantity Quantity
..... amountString string
.... measurementType Σ 0..1 CodeableConcept The measurement type of the quantitative value
Binding: Substance Amount Type (Example)
... characterization Σ 0..* BackboneElement General specifications for this substance

.... technique Σ 0..1 CodeableConcept The method used to find the characterization e.g. HPLC
Binding: Structure Technique (Example)
.... form Σ 0..1 CodeableConcept Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Binding: Substance Form (Example)
.... description Σ 0..1 markdown The description or justification in support of the interpretation of the data file
.... file Σ 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 Σ 0..* BackboneElement General specifications for this substance

.... type Σ 1..1 CodeableConcept A code expressing the type of property
Binding: Product Characteristic (Example)
.... value[x] Σ 0..1 A value for the property
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment
... referenceInformation Σ 0..1 Reference(SubstanceReferenceInformation) General information detailing this substance
... molecularWeight Σ 0..* BackboneElement The average mass of a molecule of a compound

.... method Σ 0..1 CodeableConcept The method by which the weight was determined
Binding: Weight Method (Example)
.... type Σ 0..1 CodeableConcept Type of molecular weight e.g. exact, average, weight average
Binding: Weight Type (Example)
.... amount Σ 1..1 Quantity Used to capture quantitative values for a variety of elements
... structure Σ 0..1 BackboneElement Structural information
.... stereochemistry Σ 0..1 CodeableConcept Stereochemistry type
Binding: Stereochemistry (Example)
.... opticalActivity Σ 0..1 CodeableConcept Optical activity type
Binding: Optical Activity (Example)
.... molecularFormula Σ 0..1 string An expression which states the number and type of atoms present in a molecule of a substance
.... molecularFormulaByMoiety Σ 0..1 string Specified per moiety according to the Hill system
.... molecularWeight Σ 0..1 see molecularWeight The molecular weight or weight range
.... technique Σ 0..* CodeableConcept The method used to find the structure e.g. X-ray, NMR
Binding: Structure Technique (Example)

.... sourceDocument Σ 0..* Reference(DocumentReference) Source of information for the structure

.... representation Σ 0..* BackboneElement A depiction of the structure of the substance

..... type Σ 0..1 CodeableConcept The kind of structural representation (e.g. full, partial)
Binding: Substance Representation Type (Example)
..... representation Σ 0..1 string The structural representation as a text string in a standard format
..... format Σ 0..1 CodeableConcept The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
Binding: Substance Representation Format (Example)
..... document Σ 0..1 Reference(DocumentReference) An attachment with the structural representation e.g. a structure graphic or AnIML file
... code Σ 0..* BackboneElement Codes associated with the substance

.... code Σ 0..1 CodeableConcept The specific code
.... status Σ 0..1 CodeableConcept Status of the code assignment, for example 'provisional', 'approved'
Binding: PublicationStatus (Preferred)
.... statusDate Σ 0..1 dateTime The date at which the code status was changed
.... note Σ 0..* Annotation Any comment can be provided in this field

.... source Σ 0..* Reference(DocumentReference) Supporting literature

... name Σ 0..* BackboneElement Names applicable to this substance

.... name Σ 1..1 string The actual name
.... type Σ 0..1 CodeableConcept Name type e.g. 'systematic', 'scientific, 'brand'
Binding: Substance Name Type (Example)
.... status Σ 0..1 CodeableConcept The status of the name e.g. 'current', 'proposed'
Binding: PublicationStatus (Preferred)
.... preferred Σ 0..1 boolean If this is the preferred name for this substance
.... language Σ 0..* CodeableConcept Human language that the name is written in
Binding: All Languages (Required)
Additional BindingsPurpose
Common Languages Starter Set


.... domain Σ 0..* CodeableConcept The use context of this name e.g. as an active ingredient or as a food colour additive
Binding: Substance Name Domain (Example)

.... jurisdiction Σ 0..* CodeableConcept The jurisdiction where this name applies
Binding: Jurisdiction ValueSet (Example)

.... synonym Σ 0..* see name A synonym of this particular name, by which the substance is also known

.... translation Σ 0..* see name A translation for this name into another human language

.... official Σ 0..* BackboneElement Details of the official nature of this name

..... authority Σ 0..1 CodeableConcept Which authority uses this official name
Binding: Substance Name Authority (Preferred)
..... status Σ 0..1 CodeableConcept The status of the official name, for example 'draft', 'active'
Binding: PublicationStatus (Preferred)
..... date Σ 0..1 dateTime Date of official name change
.... source Σ 0..* Reference(DocumentReference) Supporting literature

... relationship Σ 0..* BackboneElement A link between this substance and another

.... substanceDefinition[x] Σ 0..1 A pointer to another substance, as a resource or a representational code
..... substanceDefinitionReference Reference(SubstanceDefinition)
..... substanceDefinitionCodeableConcept CodeableConcept
.... type Σ 1..1 CodeableConcept For example "salt to parent", "active moiety"
Binding: Substance Relationship Type (Example)
.... isDefining Σ 0..1 boolean For 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] Σ 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 Quantity
..... amountRatio Ratio
..... amountString string
.... ratioHighLimitAmount Σ 0..1 Ratio For use when the numeric has an uncertain range
.... comparator Σ 0..1 CodeableConcept An operator for the amount, for example "average", "approximately", "less than"
Binding: Substance Amount Type (Example)
.... source Σ 0..* Reference(DocumentReference) Supporting literature

... nucleicAcid Σ 0..1 Reference(SubstanceNucleicAcid) Data items specific to nucleic acids
... polymer Σ 0..1 Reference(SubstancePolymer) Data items specific to polymers
... protein Σ 0..1 Reference(SubstanceProtein) Data items specific to proteins
... sourceMaterial Σ 0..1 BackboneElement Material or taxonomic/anatomical source
.... type Σ 0..1 CodeableConcept Classification of the origin of the raw material. e.g. cat hair is an Animal source type
Binding: Source Material Type (Example)
.... genus Σ 0..1 CodeableConcept The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
Binding: Source Material Genus (Example)
.... species Σ 0..1 CodeableConcept The species of an organism e.g. the Latin epithet of the species of the plant/animal
Binding: Source Material Species (Example)
.... part Σ 0..1 CodeableConcept An anatomical origin of the source material within an organism
Binding: Source Material Part (Example)
.... countryOfOrigin Σ 0..* CodeableConcept The country or countries where the material is harvested
Binding: Country ValueSet (Required)


doco Documentation for this format icon

See the Extensions for this resource

 

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
SubstanceDefinition.status PublicationStatus Preferred

The lifecycle status of an artifact.

SubstanceDefinition.domain MedicinalProductDomain Example

Applicable domain for this product (e.g. human, veterinary)

SubstanceDefinition.grade SubstanceGrade Example

The quality standard, established benchmark, to which a substance complies.

SubstanceDefinition.moiety.stereochemistry Stereochemistry (a valid code from Substance Stereochemistry) Example

The optical rotation type of a substance.

SubstanceDefinition.moiety.opticalActivity OpticalActivity (a valid code from Substance Optical Activity) Example

The optical rotation type of a substance.

SubstanceDefinition.moiety.measurementType SubstanceAmountType Example

The relationship between two substance types.

SubstanceDefinition.characterization.technique StructureTechnique (a valid code from Substance Structure Technique) Example

The method used to elucidate the structure or characterization of the drug substance.

SubstanceDefinition.characterization.form SubstanceForm Example

The substance form, whether it is the base form or a salt.

SubstanceDefinition.property.type ProductCharacteristic Example

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

SubstanceDefinition.molecularWeight.method WeightMethod (a valid code from Substance Weight Method) Example

The method by which the substance weight was measured.

SubstanceDefinition.molecularWeight.type WeightType (a valid code from Substance Weight Type) Example

The type of substance weight measurement.

SubstanceDefinition.structure.stereochemistry Stereochemistry (a valid code from Substance Stereochemistry) Example

The optical rotation type of a substance.

SubstanceDefinition.structure.opticalActivity OpticalActivity (a valid code from Substance Optical Activity) Example

The optical rotation type of a substance.

SubstanceDefinition.structure.technique StructureTechnique (a valid code from Substance Structure Technique) Example

The method used to elucidate the structure or characterization of the drug substance.

SubstanceDefinition.structure.representation.type SubstanceRepresentationType Example

The type of a name given to a substance.

SubstanceDefinition.structure.representation.format SubstanceRepresentationFormat Example

A format of a substance representation.

SubstanceDefinition.code.status PublicationStatus Preferred

The lifecycle status of an artifact.

SubstanceDefinition.name.type SubstanceNameType Example

The type of a name given to a substance.

SubstanceDefinition.name.status PublicationStatus Preferred

The lifecycle status of an artifact.

SubstanceDefinition.name.language AllLanguages (a valid code from Tags for the Identification of Languages icon) Required

This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47)

  Common Languages starter
SubstanceDefinition.name.domain 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.

SubstanceDefinition.name.jurisdiction JurisdictionValueSet Example

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.

SubstanceDefinition.name.official.authority SubstanceNameAuthority Preferred

An authority that officates substance names.

SubstanceDefinition.name.official.status PublicationStatus Preferred

The lifecycle status of an artifact.

SubstanceDefinition.relationship.type SubstanceRelationshipType Example

The relationship between two substance types.

SubstanceDefinition.relationship.comparator SubstanceAmountType Example

The relationship between two substance types.

SubstanceDefinition.sourceMaterial.type SourceMaterialType (a valid code from Substance Source Material Type) Example

A classification that provides the origin of the substance raw material.

SubstanceDefinition.sourceMaterial.genus SourceMaterialGenus (a valid code from Substance Source Material Genus) Example

The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

SubstanceDefinition.sourceMaterial.species SourceMaterialSpecies (a valid code from Substance Source Material Species) Example

A species of origin a substance raw material.

SubstanceDefinition.sourceMaterial.part SourceMaterialPart (a valid code from Substance Source Material Part) Example

An anatomical origin of the source material within an organism.

SubstanceDefinition.sourceMaterial.countryOfOrigin CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code icon) Required

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon.



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
classification token High or low level categorization, e.g. polymer vs. nucleic acid or linear vs. branch chain SubstanceDefinition.classification
code token The specific code SubstanceDefinition.code.code
domain token If the substance applies to only human or veterinary use SubstanceDefinition.domain
identifier token Identifier by which this substance is known SubstanceDefinition.identifier
name string The actual name SubstanceDefinition.name.name