Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: Ingredient (ePI)

Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/Ingredient-uv-epi Version: 0.1.0
Active as of 2022-09-02 Computable Name: IngredientUvEpi

Ingredient (ePI)

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..*IngredientAn ingredient of a manufactured item or pharmaceutical product
... identifier 0..1IdentifierAn identifier or code by which the ingredient can be referenced.
... status 1..1codedraft|active|retired|unknown
... for 0..*Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI))The product which this ingredient is a constituent part of
... allergenicIndicator 0..1booleanIf the ingredient is a known or suspected allergen.
... manufacturer
.... role 0..1Codingallowed|possible|actual
.... manufacturer 1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance
.... code
..... concept 1..1CodeableConceptReference to a concept (by class)
Example UNII example: {"coding":[{"system":"https://gsrs.ncats.nih.gov/ginas/app/beta","code":"2ZM8CX04RZ","display":"Insulin glargine"}]}
..... reference 0..1Reference(SubstanceDefinition (ePI))Reference to a resource (by instance)
.... strength 0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... presentation[x] 0..1Ratio, RatioRange, CodeableConcept, QuantityThe quantity of substance in the unit of presentation.
..... presentationText 0..1Ratio, RatioRange, CodeableConcept, QuantityText of either the whole presentation strength or a part of it
..... concentrationText 0..1Ratio, RatioRange, CodeableConcept, QuantityText of either the whole concentration strength or a part of it
..... basis 0..1CodeableConceptA 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).
..... referenceStrength 0..*BackboneElementStrength expressed in terms of a reference substance.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..*IngredientAn ingredient of a manufactured item or pharmaceutical product
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierAn identifier or code by which the ingredient can be referenced.
... status ?!Σ1..1codedraft|active|retired|unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ0..*Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI))The product which this ingredient is a constituent part of
... role Σ1..1CodeableConceptA classification of the ingredient identifying its purpose within the product, e.g. active, inactive
Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"00000072072","display":"active"}]}
... function Σ0..*CodeableConceptA 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 Σ0..1CodeableConceptA 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 Σ0..1booleanIf the ingredient is a known or suspected allergen.
... manufacturer Σ0..*BackboneElementAn organization that manufactures this ingredient
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1Coding​allowed|possible|actual
Binding: ingredient-manufacturer-role|5.0.0-snapshot1 (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance Σ1..1BackboneElementThe substance that comprises this ingredient
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ1..1CodeableConceptReference to a concept (by class)
Example UNII example: {"coding":[{"system":"https://gsrs.ncats.nih.gov/ginas/app/beta","code":"2ZM8CX04RZ","display":"Insulin glargine"}]}
..... reference Σ0..1Reference(SubstanceDefinition (ePI))Reference to a resource (by instance)
.... strength Σ0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... presentation[x] Σ0..1The quantity of substance in the unit of presentation.
Slice: Unordered, Open by type:$this
...... presentationRatioRatio
...... presentationRatioRangeRatioRange
...... presentationCodeableConceptCodeableConcept
...... presentationQuantityQuantity
..... presentation[x] Σ0..1Text of either the whole presentation strength or a part of it
...... presentationRatioRatio
...... presentationRatioRangeRatioRange
...... presentationCodeableConceptCodeableConcept
...... presentationQuantityQuantity
..... presentationText Σ0..1stringA textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio
..... concentration[x] Σ0..1Text of either the whole concentration strength or a part of it
Slice: Unordered, Open by type:$this
...... concentrationRatioRatio
...... concentrationRatioRangeRatioRange
...... concentrationCodeableConceptCodeableConcept
...... concentrationQuantityQuantity
..... concentrationText Σ0..1stringA textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio
..... basis Σ0..1CodeableConceptA 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 Σ0..1stringFor when strength is measured at a particular point or distance
..... country Σ0..*CodeableConceptThe country or countries for which the strength range applies
..... referenceStrength Σ0..*BackboneElementStrength expressed in terms of a reference substance.
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... substance Σ0..1CodeableReference(SubstanceDefinition)Relevant reference substance
...... strength[x] Σ1..1Strength expressed in terms of a reference substance
....... strengthRatioRatio
....... strengthRatioRangeRatioRange
....... strengthQuantityQuantity
...... measurementPoint Σ0..1stringFor when strength is measured at a particular point or distance
...... country Σ0..*CodeableConceptThe country or countries for which the strength range applies

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..*IngredientAn ingredient of a manufactured item or pharmaceutical product

doco Documentation for this format

Differential View

This structure is derived from Ingredient

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..*IngredientAn ingredient of a manufactured item or pharmaceutical product
... identifier 0..1IdentifierAn identifier or code by which the ingredient can be referenced.
... status 1..1codedraft|active|retired|unknown
... for 0..*Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI))The product which this ingredient is a constituent part of
... allergenicIndicator 0..1booleanIf the ingredient is a known or suspected allergen.
... manufacturer
.... role 0..1Codingallowed|possible|actual
.... manufacturer 1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance
.... code
..... concept 1..1CodeableConceptReference to a concept (by class)
Example UNII example: {"coding":[{"system":"https://gsrs.ncats.nih.gov/ginas/app/beta","code":"2ZM8CX04RZ","display":"Insulin glargine"}]}
..... reference 0..1Reference(SubstanceDefinition (ePI))Reference to a resource (by instance)
.... strength 0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... presentation[x] 0..1Ratio, RatioRange, CodeableConcept, QuantityThe quantity of substance in the unit of presentation.
..... presentationText 0..1Ratio, RatioRange, CodeableConcept, QuantityText of either the whole presentation strength or a part of it
..... concentrationText 0..1Ratio, RatioRange, CodeableConcept, QuantityText of either the whole concentration strength or a part of it
..... basis 0..1CodeableConceptA 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).
..... referenceStrength 0..*BackboneElementStrength expressed in terms of a reference substance.

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient 0..*IngredientAn ingredient of a manufactured item or pharmaceutical product
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierAn identifier or code by which the ingredient can be referenced.
... status ?!Σ1..1codedraft|active|retired|unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... for Σ0..*Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI))The product which this ingredient is a constituent part of
... role Σ1..1CodeableConceptA classification of the ingredient identifying its purpose within the product, e.g. active, inactive
Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"00000072072","display":"active"}]}
... function Σ0..*CodeableConceptA 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 Σ0..1CodeableConceptA 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 Σ0..1booleanIf the ingredient is a known or suspected allergen.
... manufacturer Σ0..*BackboneElementAn organization that manufactures this ingredient
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1Coding​allowed|possible|actual
Binding: ingredient-manufacturer-role|5.0.0-snapshot1 (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance Σ1..1BackboneElementThe substance that comprises this ingredient
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ1..1CodeableConceptReference to a concept (by class)
Example UNII example: {"coding":[{"system":"https://gsrs.ncats.nih.gov/ginas/app/beta","code":"2ZM8CX04RZ","display":"Insulin glargine"}]}
..... reference Σ0..1Reference(SubstanceDefinition (ePI))Reference to a resource (by instance)
.... strength Σ0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... presentation[x] Σ0..1The quantity of substance in the unit of presentation.
Slice: Unordered, Open by type:$this
...... presentationRatioRatio
...... presentationRatioRangeRatioRange
...... presentationCodeableConceptCodeableConcept
...... presentationQuantityQuantity
..... presentation[x] Σ0..1Text of either the whole presentation strength or a part of it
...... presentationRatioRatio
...... presentationRatioRangeRatioRange
...... presentationCodeableConceptCodeableConcept
...... presentationQuantityQuantity
..... presentationText Σ0..1stringA textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio
..... concentration[x] Σ0..1Text of either the whole concentration strength or a part of it
Slice: Unordered, Open by type:$this
...... concentrationRatioRatio
...... concentrationRatioRangeRatioRange
...... concentrationCodeableConceptCodeableConcept
...... concentrationQuantityQuantity
..... concentrationText Σ0..1stringA textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio
..... basis Σ0..1CodeableConceptA 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 Σ0..1stringFor when strength is measured at a particular point or distance
..... country Σ0..*CodeableConceptThe country or countries for which the strength range applies
..... referenceStrength Σ0..*BackboneElementStrength expressed in terms of a reference substance.
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... substance Σ0..1CodeableReference(SubstanceDefinition)Relevant reference substance
...... strength[x] Σ1..1Strength expressed in terms of a reference substance
....... strengthRatioRatio
....... strengthRatioRangeRatioRange
....... strengthQuantityQuantity
...... measurementPoint Σ0..1stringFor when strength is measured at a particular point or distance
...... country Σ0..*CodeableConceptThe country or countries for which the strength range applies

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
Ingredient.languagepreferredCommonLanguages
Max Binding: AllLanguages
Ingredient.statusrequiredPublicationStatus
Ingredient.manufacturer.rolerequiredhttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0-snapshot1