Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi | Version: 1.0.0 | |||
Standards status: Trial-use | Maturity Level: 2 | Computable Name: SubstanceDefinitionUvEpi |
SubstanceDefinition (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from SubstanceDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | SubstanceDefinition | |||
identifier | 1..* | Identifier | Identifier by which this substance is known | |
system | 1..1 | uri | The namespace for the identifier value | |
value | 1..1 | string | The value that is unique | |
status | 0..1 | CodeableConcept | draft|active|retired|unknown | |
domain | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) | |
description | 0..1 | markdown | Textual description of the substance. | |
manufacturer | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance | |
molecularWeight | ||||
amount | 1..1 | Quantity | The molecular weight. | |
value | 0..1 | decimal | numerical value. | |
unit | 0..1 | string | Unit of measure. | |
code | 0..1 | code | coded form of the unit of measure. | |
structure | ||||
molecularFormula | 0..1 | string | Molecular formula (e.g. using the Hill system). | |
code | 0..* | BackboneElement | Codes associated with the substance. | |
code | 0..1 | CodeableConcept | The specific code Binding: Substances (example) | |
name | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. | |
type | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
SubstanceDefinition.code.code | example | VsSubstancehttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/substance from this IG |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | 0..* | SubstanceDefinition | 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 |
identifier | Σ | 1..* | Identifier | Identifier by which this substance is known |
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) |
description | Σ | 0..1 | markdown | Textual description of the substance. |
manufacturer | Σ | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance |
code | Σ | 0..* | BackboneElement | Codes associated with the substance. |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) |
name | Σ | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
name | Σ | 1..1 | string | The actual name |
type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
Documentation for this format |
Path | Conformance | ValueSet | URI |
SubstanceDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
SubstanceDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
SubstanceDefinition.code.code | example | VsSubstancehttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/substance from this IG | |
SubstanceDefinition.name.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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 | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 1..* | Identifier | Identifier by which this substance is known | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
type | Σ | 0..1 | CodeableConcept | 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 | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
version | Σ | 0..1 | string | A business level version identifier of the substance | ||||
status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
classification | Σ | 0..* | CodeableConcept | 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 | ||||
domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) | ||||
grade | Σ | 0..* | CodeableConcept | 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 | ||||
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 (ePI)) | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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): The optical rotation type of a substance. | ||||
opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
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: SubstanceAmountType (example): The relationship between two substance types. | ||||
characterization | Σ | 0..* | BackboneElement | General specifications for this substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
technique | Σ | 0..1 | CodeableConcept | 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 | 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: SubstanceForm (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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 1..1 | CodeableConcept | 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] | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
method | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: WeightMethod (example): The method by which the substance weight was measured. | ||||
type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: WeightType (example): The type of substance weight measurement. | ||||
amount | Σ | 1..1 | Quantity | The molecular weight. | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | numerical value. | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | Σ | 0..1 | string | Unit of measure. | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | ΣC | 0..1 | code | coded form of the unit of measure. | ||||
structure | Σ | 0..1 | BackboneElement | Structural information | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. | ||||
opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
molecularFormula | Σ | 0..1 | string | Molecular formula (e.g. using the Hill system). | ||||
molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system | ||||
molecularWeight | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range | ||||
technique | Σ | 0..* | CodeableConcept | 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 | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure | ||||
representation | Σ | 0..* | BackboneElement | A depiction of the structure of the substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 0..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: SubstanceRepresentationType (example): A format of a substance representation. | ||||
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: SubstanceRepresentationFormat (example): A format of a substance representation. | ||||
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. | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) | ||||
status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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 | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
name | Σ | 1..1 | string | The actual name | ||||
type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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: AllLanguages (required): IETF language tag for a human language
| ||||
domain | Σ | 0..* | CodeableConcept | 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 | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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: SubstanceRelationshipType (example): The relationship between two substance types. | ||||
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: SubstanceAmountType (example): The relationship between two substance types. | ||||
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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 0..1 | CodeableConcept | 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 | Σ | 0..1 | CodeableConcept | 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 | Σ | 0..1 | CodeableConcept | 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 | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism. | ||||
countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: CountryValueSet (required): Jurisdiction codes | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
SubstanceDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
SubstanceDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
SubstanceDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
SubstanceDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
SubstanceDefinition.grade | example | SubstanceGradehttp://hl7.org/fhir/ValueSet/substance-grade from the FHIR Standard | |
SubstanceDefinition.moiety.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistry from the FHIR Standard | |
SubstanceDefinition.moiety.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activity from the FHIR Standard | |
SubstanceDefinition.moiety.measurementType | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-type from the FHIR Standard | |
SubstanceDefinition.characterization.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique from the FHIR Standard | |
SubstanceDefinition.characterization.form | example | SubstanceFormhttp://hl7.org/fhir/ValueSet/substance-form from the FHIR Standard | |
SubstanceDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
SubstanceDefinition.molecularWeight.method | example | WeightMethodhttp://hl7.org/fhir/ValueSet/substance-weight-method from the FHIR Standard | |
SubstanceDefinition.molecularWeight.type | example | WeightTypehttp://hl7.org/fhir/ValueSet/substance-weight-type from the FHIR Standard | |
SubstanceDefinition.molecularWeight.amount.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
SubstanceDefinition.structure.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistry from the FHIR Standard | |
SubstanceDefinition.structure.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activity from the FHIR Standard | |
SubstanceDefinition.structure.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique from the FHIR Standard | |
SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type from the FHIR Standard | |
SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-format from the FHIR Standard | |
SubstanceDefinition.code.code | example | VsSubstancehttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/substance from this IG | |
SubstanceDefinition.code.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.name.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type from the FHIR Standard | |
SubstanceDefinition.name.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.name.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
SubstanceDefinition.name.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domain from the FHIR Standard | |
SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authority from the FHIR Standard | |
SubstanceDefinition.name.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.relationship.type | example | SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-type from the FHIR Standard | |
SubstanceDefinition.relationship.comparator | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-type from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.type | example | SourceMaterialTypehttp://hl7.org/fhir/ValueSet/substance-source-material-type from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenushttp://hl7.org/fhir/ValueSet/substance-source-material-genus from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecieshttp://hl7.org/fhir/ValueSet/substance-source-material-species from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialParthttp://hl7.org/fhir/ValueSet/substance-source-material-part from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSethttp://hl7.org/fhir/ValueSet/country|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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 | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from SubstanceDefinition
Summary
Mandatory: 3 elements
Structures
This structure refers to these other structures:
Maturity: 2
Differential View
This structure is derived from SubstanceDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | SubstanceDefinition | |||
identifier | 1..* | Identifier | Identifier by which this substance is known | |
system | 1..1 | uri | The namespace for the identifier value | |
value | 1..1 | string | The value that is unique | |
status | 0..1 | CodeableConcept | draft|active|retired|unknown | |
domain | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) | |
description | 0..1 | markdown | Textual description of the substance. | |
manufacturer | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance | |
molecularWeight | ||||
amount | 1..1 | Quantity | The molecular weight. | |
value | 0..1 | decimal | numerical value. | |
unit | 0..1 | string | Unit of measure. | |
code | 0..1 | code | coded form of the unit of measure. | |
structure | ||||
molecularFormula | 0..1 | string | Molecular formula (e.g. using the Hill system). | |
code | 0..* | BackboneElement | Codes associated with the substance. | |
code | 0..1 | CodeableConcept | The specific code Binding: Substances (example) | |
name | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. | |
type | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
SubstanceDefinition.code.code | example | VsSubstancehttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/substance from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | 0..* | SubstanceDefinition | 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 |
identifier | Σ | 1..* | Identifier | Identifier by which this substance is known |
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) |
description | Σ | 0..1 | markdown | Textual description of the substance. |
manufacturer | Σ | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance |
code | Σ | 0..* | BackboneElement | Codes associated with the substance. |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) |
name | Σ | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
name | Σ | 1..1 | string | The actual name |
type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
Documentation for this format |
Path | Conformance | ValueSet | URI |
SubstanceDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
SubstanceDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
SubstanceDefinition.code.code | example | VsSubstancehttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/substance from this IG | |
SubstanceDefinition.name.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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 | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 1..* | Identifier | Identifier by which this substance is known | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
type | Σ | 0..1 | CodeableConcept | 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 | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
version | Σ | 0..1 | string | A business level version identifier of the substance | ||||
status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
classification | Σ | 0..* | CodeableConcept | 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 | ||||
domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) | ||||
grade | Σ | 0..* | CodeableConcept | 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 | ||||
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 (ePI)) | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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): The optical rotation type of a substance. | ||||
opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
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: SubstanceAmountType (example): The relationship between two substance types. | ||||
characterization | Σ | 0..* | BackboneElement | General specifications for this substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
technique | Σ | 0..1 | CodeableConcept | 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 | 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: SubstanceForm (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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 1..1 | CodeableConcept | 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] | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
method | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: WeightMethod (example): The method by which the substance weight was measured. | ||||
type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: WeightType (example): The type of substance weight measurement. | ||||
amount | Σ | 1..1 | Quantity | The molecular weight. | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
value | Σ | 0..1 | decimal | numerical value. | ||||
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. | ||||
unit | Σ | 0..1 | string | Unit of measure. | ||||
system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
code | ΣC | 0..1 | code | coded form of the unit of measure. | ||||
structure | Σ | 0..1 | BackboneElement | Structural information | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. | ||||
opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. | ||||
molecularFormula | Σ | 0..1 | string | Molecular formula (e.g. using the Hill system). | ||||
molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system | ||||
molecularWeight | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range | ||||
technique | Σ | 0..* | CodeableConcept | 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 | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure | ||||
representation | Σ | 0..* | BackboneElement | A depiction of the structure of the substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 0..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: SubstanceRepresentationType (example): A format of a substance representation. | ||||
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: SubstanceRepresentationFormat (example): A format of a substance representation. | ||||
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. | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) | ||||
status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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 | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
name | Σ | 1..1 | string | The actual name | ||||
type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. | ||||
status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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: AllLanguages (required): IETF language tag for a human language
| ||||
domain | Σ | 0..* | CodeableConcept | 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 | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known | ||||
translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language | ||||
official | Σ | 0..* | BackboneElement | Details of the official nature of this name | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. | ||||
status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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: SubstanceRelationshipType (example): The relationship between two substance types. | ||||
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: SubstanceAmountType (example): The relationship between two substance types. | ||||
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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 0..1 | CodeableConcept | 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 | Σ | 0..1 | CodeableConcept | 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 | Σ | 0..1 | CodeableConcept | 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 | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism. | ||||
countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: CountryValueSet (required): Jurisdiction codes | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
SubstanceDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
SubstanceDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
SubstanceDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
SubstanceDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
SubstanceDefinition.grade | example | SubstanceGradehttp://hl7.org/fhir/ValueSet/substance-grade from the FHIR Standard | |
SubstanceDefinition.moiety.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistry from the FHIR Standard | |
SubstanceDefinition.moiety.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activity from the FHIR Standard | |
SubstanceDefinition.moiety.measurementType | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-type from the FHIR Standard | |
SubstanceDefinition.characterization.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique from the FHIR Standard | |
SubstanceDefinition.characterization.form | example | SubstanceFormhttp://hl7.org/fhir/ValueSet/substance-form from the FHIR Standard | |
SubstanceDefinition.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard | |
SubstanceDefinition.molecularWeight.method | example | WeightMethodhttp://hl7.org/fhir/ValueSet/substance-weight-method from the FHIR Standard | |
SubstanceDefinition.molecularWeight.type | example | WeightTypehttp://hl7.org/fhir/ValueSet/substance-weight-type from the FHIR Standard | |
SubstanceDefinition.molecularWeight.amount.comparator | required | QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard | |
SubstanceDefinition.structure.stereochemistry | example | Stereochemistryhttp://hl7.org/fhir/ValueSet/substance-stereochemistry from the FHIR Standard | |
SubstanceDefinition.structure.opticalActivity | example | OpticalActivityhttp://hl7.org/fhir/ValueSet/substance-optical-activity from the FHIR Standard | |
SubstanceDefinition.structure.technique | example | StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique from the FHIR Standard | |
SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type from the FHIR Standard | |
SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormathttp://hl7.org/fhir/ValueSet/substance-representation-format from the FHIR Standard | |
SubstanceDefinition.code.code | example | VsSubstancehttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/substance from this IG | |
SubstanceDefinition.code.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.name.type | example | SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type from the FHIR Standard | |
SubstanceDefinition.name.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.name.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
SubstanceDefinition.name.domain | example | SubstanceNameDomainhttp://hl7.org/fhir/ValueSet/substance-name-domain from the FHIR Standard | |
SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthorityhttp://hl7.org/fhir/ValueSet/substance-name-authority from the FHIR Standard | |
SubstanceDefinition.name.official.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
SubstanceDefinition.relationship.type | example | SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-type from the FHIR Standard | |
SubstanceDefinition.relationship.comparator | example | SubstanceAmountTypehttp://hl7.org/fhir/ValueSet/substance-amount-type from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.type | example | SourceMaterialTypehttp://hl7.org/fhir/ValueSet/substance-source-material-type from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenushttp://hl7.org/fhir/ValueSet/substance-source-material-genus from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecieshttp://hl7.org/fhir/ValueSet/substance-source-material-species from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.part | example | SourceMaterialParthttp://hl7.org/fhir/ValueSet/substance-source-material-part from the FHIR Standard | |
SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSethttp://hl7.org/fhir/ValueSet/country|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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 | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from SubstanceDefinition
Summary
Mandatory: 3 elements
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron