Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. 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/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: Ingredient - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq Version: 1.0.0
Active as of 2024-04-22 Computable Name: IngredientDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.27

This Ingredient profile represents the active ingredient(s) of a drug substance or product. It references one SubstanceDefinition resource and can include the strength or concentration of that substance.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
... suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

.... data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... function 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (example): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.

... substance
.... code S 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
.... strength
..... referenceStrength S 0..* BackboneElement Strength expressed in terms of a reference substance

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Ingredient.rolepreferredIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleVsIngredientFunctionPQ (a valid code from Ingredient Function Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-ingredientFunction-pq
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

.... data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (example): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.


... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... referenceStrength SΣ 0..* BackboneElement Strength expressed in terms of a reference substance
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolepreferredIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleVsIngredientFunctionPQ (a valid code from Ingredient Function Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-ingredientFunction-pq
from this IG
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... 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
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
... suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (example): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.


... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... 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 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... 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 SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... 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
..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
...... concentrationRatio Ratio
...... concentrationRatioRange RatioRange
...... concentrationCodeableConcept CodeableConcept
...... concentrationQuantity Quantity
..... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
..... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
..... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
..... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... referenceStrength SΣ 0..* BackboneElement Strength expressed in terms of a reference 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
...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolepreferredIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleVsIngredientFunctionPQ (a valid code from Ingredient Function Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-ingredientFunction-pq
from this IG
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
from the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Differential View

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
... suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

.... data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... function 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (example): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.

... substance
.... code S 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
.... strength
..... referenceStrength S 0..* BackboneElement Strength expressed in terms of a reference substance

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Ingredient.rolepreferredIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleVsIngredientFunctionPQ (a valid code from Ingredient Function Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-ingredientFunction-pq
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

.... data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (example): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.


... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... referenceStrength SΣ 0..* BackboneElement Strength expressed in terms of a reference substance
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolepreferredIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleVsIngredientFunctionPQ (a valid code from Ingredient Function Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-ingredientFunction-pq
from this IG
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
... 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
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... novel-excipient S 0..1 boolean novel-excipient
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq
... suitability-for-use S 0..1 string suitability-for-use
URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of
... role Σ 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive
Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

.... id 0..1 id Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... data-absent-reason S 0..1 code data-absent-reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (example): A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.


... group Σ 0..1 CodeableConcept A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient
.... 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 code allowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... 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 SΣC 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity
..... 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
..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
...... concentrationRatio Ratio
...... concentrationRatioRange RatioRange
...... concentrationCodeableConcept CodeableConcept
...... concentrationQuantity Quantity
..... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
..... basis Σ 0..1 CodeableConcept A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
..... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
..... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... referenceStrength SΣ 0..* BackboneElement Strength expressed in terms of a reference 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
...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolepreferredIngredientRole
http://hl7.org/fhir/ValueSet/ingredient-role
from the FHIR Standard
Ingredient.functionexampleVsIngredientFunctionPQ (a valid code from Ingredient Function Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-ingredientFunction-pq
from this IG
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0
from the FHIR Standard
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorIngredientIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorIngredientIf 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-4errorIngredientIf 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-5errorIngredientIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceIngredientA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ing-1errorIngredientIf an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
: Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2

 

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