0.1.0 - ci-build

AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Ingredient

Official URL: https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-ingredient Version: 0.1.0
Draft as of 2024-05-27 Computable Name: AT_MedicinalProduct_Ingredient

Defines the strength and composition parts of a medicinal product

Usage:

  • This Resource Profile is not used by any profiles in this Implementation Guide

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
... identifier 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
.... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.ages.at/fhir/referenceNumber
... for 1..1 Reference(Manufactured item definition | Administrable product definition) The product which this ingredient is a constituent part of
... role 1..1 AT_MedicinalProduct_CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive (ingredient role)
Binding: The Ingredient Role Value Set (required)
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 100000072072
.... code
..... concept 1..1 AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
...... Slices for coding 1..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by value:system
....... coding:substancePharos 1..1 AT_MedicinalProduct_Coding Substance
........ system 1..1 uri Identity of the terminology system
Required Pattern: https://www.ages.at/fhir/GRZ
....... coding:substanceSMS 0..1 AT_MedicinalProduct_Coding Active ingredient
........ system 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
.... strength C 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit)
atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
..... referenceStrength
...... substance 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance (reference ingredient)
...... strength[x] 1..1 Ratio, RatioRange, Quantity Strength expressed in terms of a reference substance (reference ingredient strength & unit)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet / CodeURI
Ingredient.rolerequiredPattern: 100000072072
https://ema.europa.eu/fhir/vs/ingredientRole
from this IG

Constraints

IdGradePath(s)DetailsRequirements
atLeastOnePresentationOrOneConcentrationInvarianterrorIngredient.substance.strengthThere must be at least one presentation or one concentration.
: presentation.count() >=1 or concentration.count() >=1
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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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
Required Pattern: https://www.ages.at/fhir/referenceNumber
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 1..1 Reference(Manufactured item definition | Administrable product definition) The product which this ingredient is a constituent part of
... role 1..1 AT_MedicinalProduct_CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive (ingredient role)
Binding: The Ingredient Role Value Set (required)
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 100000072072
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

..... concept 1..1 AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
...... Slices for coding C 1..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by value:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
....... coding:substancePharos C 1..1 AT_MedicinalProduct_Coding Substance
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ Slices for extension Content/Rules for all slices
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.ages.at/fhir/GRZ
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
....... coding:substanceSMS C 0..1 AT_MedicinalProduct_Coding Active ingredient
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ Slices for extension Content/Rules for all slices
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
.... strength ΣC 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit)
atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Ingredient.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolerequiredPattern: 100000072072
https://ema.europa.eu/fhir/vs/ingredientRole
from this IG
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
atLeastOnePresentationOrOneConcentrationInvarianterrorIngredient.substance.strengthThere must be at least one presentation or one concentration.
: presentation.count() >=1 or concentration.count() >=1
cod-1warningIngredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMSA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
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()
ident-1warningIngredient.identifierIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier C 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
.... 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
Required Pattern: https://www.ages.at/fhir/referenceNumber
.... 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)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 1..1 Reference(Manufactured item definition | Administrable product definition) The product which this ingredient is a constituent part of
... role 1..1 AT_MedicinalProduct_CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive (ingredient role)
Binding: The Ingredient Role Value Set (required)
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 100000072072
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 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: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).


... 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 ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept 1..1 AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... Slices for coding C 1..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by value:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
....... coding:substancePharos C 1..1 AT_MedicinalProduct_Coding Substance
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ 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
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.ages.at/fhir/GRZ
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... coding:substanceSMS C 0..1 AT_MedicinalProduct_Coding Active ingredient
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ 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
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
.... strength ΣC 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit)
atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
..... 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 Σ 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 (reference ingredient)
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 (reference ingredient strength & unit)
....... 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

PathConformanceValueSet / CodeURI
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Ingredient.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Ingredient.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolerequiredPattern: 100000072072
https://ema.europa.eu/fhir/vs/ingredientRole
from this IG
Ingredient.functionexampleIngredientFunction
http://hl7.org/fhir/ValueSet/ingredient-function
from the FHIR Standard
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
atLeastOnePresentationOrOneConcentrationInvarianterrorIngredient.substance.strengthThere must be at least one presentation or one concentration.
: presentation.count() >=1 or concentration.count() >=1
cod-1warningIngredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMSA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
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()
ident-1warningIngredient.identifierIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: 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

This structure is derived from Ingredient

Differential View

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product
... identifier 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
.... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.ages.at/fhir/referenceNumber
... for 1..1 Reference(Manufactured item definition | Administrable product definition) The product which this ingredient is a constituent part of
... role 1..1 AT_MedicinalProduct_CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive (ingredient role)
Binding: The Ingredient Role Value Set (required)
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 100000072072
.... code
..... concept 1..1 AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
...... Slices for coding 1..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by value:system
....... coding:substancePharos 1..1 AT_MedicinalProduct_Coding Substance
........ system 1..1 uri Identity of the terminology system
Required Pattern: https://www.ages.at/fhir/GRZ
....... coding:substanceSMS 0..1 AT_MedicinalProduct_Coding Active ingredient
........ system 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
.... strength C 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit)
atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
..... referenceStrength
...... substance 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance (reference ingredient)
...... strength[x] 1..1 Ratio, RatioRange, Quantity Strength expressed in terms of a reference substance (reference ingredient strength & unit)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet / CodeURI
Ingredient.rolerequiredPattern: 100000072072
https://ema.europa.eu/fhir/vs/ingredientRole
from this IG

Constraints

IdGradePath(s)DetailsRequirements
atLeastOnePresentationOrOneConcentrationInvarianterrorIngredient.substance.strengthThere must be at least one presentation or one concentration.
: presentation.count() >=1 or concentration.count() >=1

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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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
Required Pattern: https://www.ages.at/fhir/referenceNumber
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 1..1 Reference(Manufactured item definition | Administrable product definition) The product which this ingredient is a constituent part of
... role 1..1 AT_MedicinalProduct_CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive (ingredient role)
Binding: The Ingredient Role Value Set (required)
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 100000072072
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

..... concept 1..1 AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
...... Slices for coding C 1..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by value:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
....... coding:substancePharos C 1..1 AT_MedicinalProduct_Coding Substance
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ Slices for extension Content/Rules for all slices
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.ages.at/fhir/GRZ
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
....... coding:substanceSMS C 0..1 AT_MedicinalProduct_Coding Active ingredient
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ Slices for extension Content/Rules for all slices
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
.... strength ΣC 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit)
atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Ingredient.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolerequiredPattern: 100000072072
https://ema.europa.eu/fhir/vs/ingredientRole
from this IG
Ingredient.substance.codeexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
atLeastOnePresentationOrOneConcentrationInvarianterrorIngredient.substance.strengthThere must be at least one presentation or one concentration.
: presentation.count() >=1 or concentration.count() >=1
cod-1warningIngredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMSA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
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()
ident-1warningIngredient.identifierIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier C 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
.... 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
Required Pattern: https://www.ages.at/fhir/referenceNumber
.... 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)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ 1..1 Reference(Manufactured item definition | Administrable product definition) The product which this ingredient is a constituent part of
... role 1..1 AT_MedicinalProduct_CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive (ingredient role)
Binding: The Ingredient Role Value Set (required)
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/100000072050
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 100000072072
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 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: IngredientFunction (example): A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).


... 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 ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept 1..1 AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... Slices for coding C 1..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by value:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
....... coding:substancePharos C 1..1 AT_MedicinalProduct_Coding Substance
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ 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
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://www.ages.at/fhir/GRZ
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... coding:substanceSMS C 0..1 AT_MedicinalProduct_Coding Active ingredient
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
........ 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
......... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v3/SubstanceDefinition
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
.... strength ΣC 1..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity (active ingredient strength & unit)
atLeastOnePresentationOrOneConcentrationInvariant: There must be at least one presentation or one concentration.
..... 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 Σ 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 (reference ingredient)
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 (reference ingredient strength & unit)
....... 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

PathConformanceValueSet / CodeURI
Ingredient.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Ingredient.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Ingredient.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Ingredient.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
Ingredient.rolerequiredPattern: 100000072072
https://ema.europa.eu/fhir/vs/ingredientRole
from this IG
Ingredient.functionexampleIngredientFunction
http://hl7.org/fhir/ValueSet/ingredient-function
from the FHIR Standard
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
atLeastOnePresentationOrOneConcentrationInvarianterrorIngredient.substance.strengthThere must be at least one presentation or one concentration.
: presentation.count() >=1 or concentration.count() >=1
cod-1warningIngredient.substance.code.concept.coding, Ingredient.substance.code.concept.coding:substancePharos, Ingredient.substance.code.concept.coding:substanceSMSA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
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()
ident-1warningIngredient.identifierIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: 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

This structure is derived from Ingredient

 

Other representations of profile: CSV, Excel, Schematron