Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: Ingredient (ePI)

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi Version: 1.0.0
Standards status: Trial-use Maturity Level: 2 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
.... manufacturer 1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance
.... code 1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
Binding: Substances (example)
.... strength 0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... textPresentation 0..1stringText of either the whole presentation strength or a part of it
..... textConcentration 0..1stringText of either the whole concentration strength or a part of it
..... referenceStrength
...... substance 1..1CodeableReference(SubstanceDefinition)Relevant reference substance.
...... strength[x] 1..1Ratio, RatioRange, QuantityStrength of the reference substance.

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Ingredient.roleexampleVsIngredientRole
Ingredient.substance.codeexampleVsSubstance
NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C0..*IngredientAn ingredient of a manufactured item or pharmaceutical product
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... 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..1CodeableConceptPurpose of the ingredient within the product, e.g. active, inactive
Binding: Ingredient Role (example)
... allergenicIndicator ΣC0..1booleanIf the ingredient is a known or suspected allergen.
... substance ΣC1..1BackboneElementThe substance that comprises this ingredient
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code ΣC1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
Binding: Substances (example)
.... strength Σ0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... textPresentation Σ0..1stringText of either the whole presentation strength or a part of it
..... textConcentration Σ0..1stringText of either the whole concentration strength or a part of it

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Ingredient.statusrequiredPublicationStatus
Ingredient.roleexampleVsIngredientRole
Ingredient.substance.codeexampleVsSubstance

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 C0..*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 ?!Σ0..*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..1CodeableConceptPurpose of the ingredient within the product, e.g. active, inactive
Binding: Ingredient Role (example)
... function Σ0..*CodeableConceptPrecise 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 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 ΣC0..1booleanIf the ingredient is a known or suspected allergen.
... comment 0..1markdownA place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ0..*BackboneElementAn organization that manufactures this ingredient
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1codeallowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance ΣC1..1BackboneElementThe substance that comprises this ingredient
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code ΣC1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
Binding: Substances (example)
.... strength Σ0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... id 0..1stringUnique 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
...... presentationRatioRatio
...... presentationRatioRangeRatioRange
...... presentationCodeableConceptCodeableConcept
...... presentationQuantityQuantity
..... textPresentation Σ0..1stringText of either the whole presentation strength or a part of it
..... concentration[x] Σ0..1The strength per unitary volume (or mass)
...... concentrationRatioRatio
...... concentrationRatioRangeRatioRange
...... concentrationCodeableConceptCodeableConcept
...... concentrationQuantityQuantity
..... textConcentration Σ0..1stringText of either the whole concentration strength or a part of it
..... 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..1stringWhen strength is measured at a particular point or distance
..... country Σ0..*CodeableConceptWhere the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... referenceStrength Σ0..*BackboneElementStrength expressed in terms of a reference substance
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... substance Σ1..1CodeableReference(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] Σ1..1Strength of the reference substance.
....... strengthRatioRatio
....... strengthRatioRangeRatioRange
....... strengthQuantityQuantity
...... measurementPoint Σ0..1stringWhen strength is measured at a particular point or distance
...... country Σ0..*CodeableConceptWhere the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Ingredient.languagerequiredAllLanguages
Ingredient.statusrequiredPublicationStatus
Ingredient.roleexampleVsIngredientRole
Ingredient.functionexampleIngredientFunction
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
Ingredient.substance.codeexampleVsSubstance
Ingredient.substance.strength.countryexampleCountryValueSet
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet

Constraints

IdGradePath(s)DetailsRequirements
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()

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
.... manufacturer 1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance
.... code 1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
Binding: Substances (example)
.... strength 0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... textPresentation 0..1stringText of either the whole presentation strength or a part of it
..... textConcentration 0..1stringText of either the whole concentration strength or a part of it
..... referenceStrength
...... substance 1..1CodeableReference(SubstanceDefinition)Relevant reference substance.
...... strength[x] 1..1Ratio, RatioRange, QuantityStrength of the reference substance.

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Ingredient.roleexampleVsIngredientRole
Ingredient.substance.codeexampleVsSubstance

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient C0..*IngredientAn ingredient of a manufactured item or pharmaceutical product
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... 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..1CodeableConceptPurpose of the ingredient within the product, e.g. active, inactive
Binding: Ingredient Role (example)
... allergenicIndicator ΣC0..1booleanIf the ingredient is a known or suspected allergen.
... substance ΣC1..1BackboneElementThe substance that comprises this ingredient
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code ΣC1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
Binding: Substances (example)
.... strength Σ0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... textPresentation Σ0..1stringText of either the whole presentation strength or a part of it
..... textConcentration Σ0..1stringText of either the whole concentration strength or a part of it

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Ingredient.statusrequiredPublicationStatus
Ingredient.roleexampleVsIngredientRole
Ingredient.substance.codeexampleVsSubstance

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 C0..*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 ?!Σ0..*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..1CodeableConceptPurpose of the ingredient within the product, e.g. active, inactive
Binding: Ingredient Role (example)
... function Σ0..*CodeableConceptPrecise 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 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 ΣC0..1booleanIf the ingredient is a known or suspected allergen.
... comment 0..1markdownA place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ0..*BackboneElementAn organization that manufactures this ingredient
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... role Σ0..1codeallowed | possible | actual
Binding: IngredientManufacturerRole (required): The way in which this manufacturer is associated with the ingredient.

.... manufacturer Σ1..1Reference(Organization (ePI))An organization that manufactures this ingredient
... substance ΣC1..1BackboneElementThe substance that comprises this ingredient
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code ΣC1..1CodeableReference(SubstanceDefinition)A code or full resource that represents the ingredient substance
Binding: Substances (example)
.... strength Σ0..*BackboneElementThe quantity of substance, per presentation, or per volume or mass, and type of quantity.
..... id 0..1stringUnique 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
...... presentationRatioRatio
...... presentationRatioRangeRatioRange
...... presentationCodeableConceptCodeableConcept
...... presentationQuantityQuantity
..... textPresentation Σ0..1stringText of either the whole presentation strength or a part of it
..... concentration[x] Σ0..1The strength per unitary volume (or mass)
...... concentrationRatioRatio
...... concentrationRatioRangeRatioRange
...... concentrationCodeableConceptCodeableConcept
...... concentrationQuantityQuantity
..... textConcentration Σ0..1stringText of either the whole concentration strength or a part of it
..... 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..1stringWhen strength is measured at a particular point or distance
..... country Σ0..*CodeableConceptWhere the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes


..... referenceStrength Σ0..*BackboneElementStrength expressed in terms of a reference substance
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... substance Σ1..1CodeableReference(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] Σ1..1Strength of the reference substance.
....... strengthRatioRatio
....... strengthRatioRangeRatioRange
....... strengthQuantityQuantity
...... measurementPoint Σ0..1stringWhen strength is measured at a particular point or distance
...... country Σ0..*CodeableConceptWhere the strength range applies
Binding: CountryValueSet (example): Jurisdiction codes



doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Ingredient.languagerequiredAllLanguages
Ingredient.statusrequiredPublicationStatus
Ingredient.roleexampleVsIngredientRole
Ingredient.functionexampleIngredientFunction
Ingredient.manufacturer.rolerequiredIngredientManufacturerRole
Ingredient.substance.codeexampleVsSubstance
Ingredient.substance.strength.countryexampleCountryValueSet
Ingredient.substance.strength.referenceStrength.substanceexampleSNOMEDCTSubstanceCodes
Ingredient.substance.strength.referenceStrength.countryexampleCountryValueSet

Constraints

IdGradePath(s)DetailsRequirements
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()

 

Other representations of profile: CSV, Excel, Schematron