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
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Ingredient
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product | |
identifier | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced. | |
status | 1..1 | code | draft|active|retired|unknown | |
for | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | The product which this ingredient is a constituent part of | |
role | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Ingredient Role (example) | |
allergenicIndicator | 0..1 | boolean | If the ingredient is a known or suspected allergen. | |
manufacturer | ||||
manufacturer | 1..1 | Reference(Organization (ePI)) | An organization that manufactures this ingredient | |
substance | ||||
code | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (example) | |
strength | 0..* | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity. | |
textPresentation | 0..1 | string | Text of either the whole presentation strength or a part of it | |
textConcentration | 0..1 | string | Text of either the whole concentration strength or a part of it | |
referenceStrength | ||||
substance | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance. | |
strength[x] | 1..1 | Ratio, RatioRange, Quantity | Strength of the reference substance. | |
Documentation for this format |
Path | Conformance | ValueSet |
Ingredient.role | example | VsIngredientRole |
Ingredient.substance.code | example | VsSubstance |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 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 (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | 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: Ingredient Role (example) |
allergenicIndicator | ΣC | 0..1 | boolean | If the ingredient is a known or suspected allergen. |
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: Substances (example) |
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 |
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it |
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it |
Documentation for this format |
Path | Conformance | ValueSet |
Ingredient.status | required | PublicationStatus |
Ingredient.role | example | VsIngredientRole |
Ingredient.substance.code | example | VsSubstance |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ing-1 | error | Ingredient | 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 : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product |
id | Σ | 0..1 | id | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 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 (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | 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: Ingredient Role (example) |
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 (ePI)) | 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: Substances (example) |
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 |
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 |
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. 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 of the 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 |
Documentation for this format |
Path | Conformance | ValueSet |
Ingredient.language | required | AllLanguages |
Ingredient.status | required | PublicationStatus |
Ingredient.role | example | VsIngredientRole |
Ingredient.function | example | IngredientFunction |
Ingredient.manufacturer.role | required | IngredientManufacturerRole |
Ingredient.substance.code | example | VsSubstance |
Ingredient.substance.strength.country | example | CountryValueSet |
Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodes |
Ingredient.substance.strength.referenceStrength.country | example | CountryValueSet |
Id | Grade | Path(s) | Details | Requirements |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
Maturity: 2
Differential View
This structure is derived from Ingredient
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product | |
identifier | 0..1 | Identifier | An identifier or code by which the ingredient can be referenced. | |
status | 1..1 | code | draft|active|retired|unknown | |
for | 0..* | Reference(MedicinalProductDefinition (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | The product which this ingredient is a constituent part of | |
role | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: Ingredient Role (example) | |
allergenicIndicator | 0..1 | boolean | If the ingredient is a known or suspected allergen. | |
manufacturer | ||||
manufacturer | 1..1 | Reference(Organization (ePI)) | An organization that manufactures this ingredient | |
substance | ||||
code | 1..1 | CodeableReference(SubstanceDefinition) | A code or full resource that represents the ingredient substance Binding: Substances (example) | |
strength | 0..* | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity. | |
textPresentation | 0..1 | string | Text of either the whole presentation strength or a part of it | |
textConcentration | 0..1 | string | Text of either the whole concentration strength or a part of it | |
referenceStrength | ||||
substance | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance. | |
strength[x] | 1..1 | Ratio, RatioRange, Quantity | Strength of the reference substance. | |
Documentation for this format |
Path | Conformance | ValueSet |
Ingredient.role | example | VsIngredientRole |
Ingredient.substance.code | example | VsSubstance |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 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 (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | 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: Ingredient Role (example) |
allergenicIndicator | ΣC | 0..1 | boolean | If the ingredient is a known or suspected allergen. |
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: Substances (example) |
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 |
textPresentation | Σ | 0..1 | string | Text of either the whole presentation strength or a part of it |
textConcentration | Σ | 0..1 | string | Text of either the whole concentration strength or a part of it |
Documentation for this format |
Path | Conformance | ValueSet |
Ingredient.status | required | PublicationStatus |
Ingredient.role | example | VsIngredientRole |
Ingredient.substance.code | example | VsSubstance |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Ingredient | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Ingredient | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | Ingredient | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Ingredient | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ing-1 | error | Ingredient | 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 : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Ingredient | C | 0..* | Ingredient | An ingredient of a manufactured item or pharmaceutical product |
id | Σ | 0..1 | id | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
contained | 0..* | Resource | Contained, inline Resources | |
extension | 0..* | Extension | Additional content defined by implementations | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | Σ | 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 (ePI) | AdministrableProductDefinition (ePI) | ManufacturedItemDefinition (ePI)) | 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: Ingredient Role (example) |
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 (ePI)) | 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: Substances (example) |
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 |
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 |
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. 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 of the 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 |
Documentation for this format |
Path | Conformance | ValueSet |
Ingredient.language | required | AllLanguages |
Ingredient.status | required | PublicationStatus |
Ingredient.role | example | VsIngredientRole |
Ingredient.function | example | IngredientFunction |
Ingredient.manufacturer.role | required | IngredientManufacturerRole |
Ingredient.substance.code | example | VsSubstance |
Ingredient.substance.strength.country | example | CountryValueSet |
Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodes |
Ingredient.substance.strength.referenceStrength.country | example | CountryValueSet |
Id | Grade | Path(s) | Details | Requirements |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Ingredient
Summary
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron