SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient | Version: 0.2.1 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SubmittedMedicinalProductIngredient | ||
Details around the ingredients of a submitted medicinal product.
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 |
Ingredient | |||
  status |
1..1 | code | draft | active | retired | unknown Required Pattern: active | |
 for |
S | 1..1 | Reference(SubmittedManufacturedItem) | The product which this ingredient is a constituent part of |
| role |
S | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) |
 substance |
S | 1..1 | BackboneElement | The substance that comprises this ingredient |
 code |
S | 1..1 | CodeableReference(SubmittedIngredientDefinition) | A code or full resource that represents the ingredient substance |
| strength |
S | 0..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
 presentation[x] |
S | 1..1 | Ratio | The quantity of substance in the unit of presentation |
| referenceStrength |
S | 0..1 | BackboneElement | Strength expressed in terms of a reference substance |
 substance |
S | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance |
 concept |
S | 1..1 | CodeableConcept | Reference to a concept (by class) |
 reference |
0..0 | |||
| strength[x] |
S | 1..1 | Ratio | Strength expressed in terms of a reference substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.role | required | RoleClassIngredientEntityhttp://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active |
| for |
SΣ | 1..1 | Reference(SubmittedManufacturedItem) | The product which this ingredient is a constituent part of |
| role |
SΣ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) |
| substance |
SΣC | 1..1 | BackboneElement | The substance that comprises this ingredient |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
SΣC | 1..1 | CodeableReference(SubmittedIngredientDefinition) | 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. |
| strength |
SΣ | 0..1 | 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 |
| presentation[x] |
SΣ | 1..1 | Ratio | The quantity of substance in the unit of presentation |
| referenceStrength |
SΣ | 0..1 | BackboneElement | Strength expressed in terms of a reference substance |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substance |
SΣ | 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. |
| concept |
SΣ | 1..1 | CodeableConcept | Reference to a concept (by class) |
| strength[x] |
SΣ | 1..1 | Ratio | Strength expressed in terms of a reference substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Ingredient.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | RoleClassIngredientEntityhttp://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard |
| 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 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 | ||||
| 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. Required Pattern: active | ||||
| for |
SΣ | 1..1 | Reference(SubmittedManufacturedItem) | The product which this ingredient is a constituent part of | ||||
| role |
SΣ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) | ||||
| 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 |
SΣC | 1..1 | BackboneElement | The substance that comprises this ingredient | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code |
SΣC | 1..1 | CodeableReference(SubmittedIngredientDefinition) | 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. | ||||
| strength |
SΣ | 0..1 | 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] |
SΣ | 1..1 | Ratio | The quantity of substance in the unit of presentation | ||||
| textPresentation |
Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
 concentration[x] |
Σ | 0..1 | The strength per unitary volume (or mass) | |||||
| concentrationRatio |
Ratio | |||||||
| concentrationRatioRange |
RatioRange | |||||||
| concentrationCodeableConcept |
CodeableConcept | |||||||
| concentrationQuantity |
Quantity | |||||||
| textConcentration |
Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
| basis |
Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
| measurementPoint |
Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
| country |
Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
| referenceStrength |
SΣ | 0..1 | 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 |
SΣ | 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. | ||||
| 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 |
SΣ | 1..1 | CodeableConcept | Reference to a concept (by class) | ||||
| strength[x] |
SΣ | 1..1 | Ratio | Strength expressed in terms of a reference substance | ||||
| 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 / Code | URI |
| Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Ingredient.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | RoleClassIngredientEntityhttp://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity | |
| Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-functionfrom the FHIR Standard | |
| Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0from the FHIR Standard | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard |
| 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 |
This structure is derived from Ingredient
Summary
Mandatory: 1 element(2 nested mandatory elements)
Must-Support: 10 elements
Prohibited: 1 element
Structures
This structure refers to these other structures:
Maturity: 1
Differential View
This structure is derived from Ingredient
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Ingredient |
Ingredient | |||
| status |
1..1 | code | draft | active | retired | unknown Required Pattern: active | |
| for |
S | 1..1 | Reference(SubmittedManufacturedItem) | The product which this ingredient is a constituent part of |
| role |
S | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) |
| substance |
S | 1..1 | BackboneElement | The substance that comprises this ingredient |
| code |
S | 1..1 | CodeableReference(SubmittedIngredientDefinition) | A code or full resource that represents the ingredient substance |
| strength |
S | 0..1 | BackboneElement | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
| presentation[x] |
S | 1..1 | Ratio | The quantity of substance in the unit of presentation |
| referenceStrength |
S | 0..1 | BackboneElement | Strength expressed in terms of a reference substance |
| substance |
S | 1..1 | CodeableReference(SubstanceDefinition) | Relevant reference substance |
| concept |
S | 1..1 | CodeableConcept | Reference to a concept (by class) |
| reference |
0..0 | |||
| strength[x] |
S | 1..1 | Ratio | Strength expressed in terms of a reference substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Ingredient.role | required | RoleClassIngredientEntityhttp://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active |
| for |
SΣ | 1..1 | Reference(SubmittedManufacturedItem) | The product which this ingredient is a constituent part of |
| role |
SΣ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) |
| substance |
SΣC | 1..1 | BackboneElement | The substance that comprises this ingredient |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
SΣC | 1..1 | CodeableReference(SubmittedIngredientDefinition) | 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. |
| strength |
SΣ | 0..1 | 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 |
| presentation[x] |
SΣ | 1..1 | Ratio | The quantity of substance in the unit of presentation |
| referenceStrength |
SΣ | 0..1 | BackboneElement | Strength expressed in terms of a reference substance |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substance |
SΣ | 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. |
| concept |
SΣ | 1..1 | CodeableConcept | Reference to a concept (by class) |
| strength[x] |
SΣ | 1..1 | Ratio | Strength expressed in terms of a reference substance |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Ingredient.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | RoleClassIngredientEntityhttp://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard |
| 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 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 | ||||
| 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. Required Pattern: active | ||||
| for |
SΣ | 1..1 | Reference(SubmittedManufacturedItem) | The product which this ingredient is a constituent part of | ||||
| role |
SΣ | 1..1 | CodeableConcept | Purpose of the ingredient within the product, e.g. active, inactive Binding: RoleClassIngredientEntity (required) | ||||
| 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 |
SΣC | 1..1 | BackboneElement | The substance that comprises this ingredient | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code |
SΣC | 1..1 | CodeableReference(SubmittedIngredientDefinition) | 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. | ||||
| strength |
SΣ | 0..1 | 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] |
SΣ | 1..1 | Ratio | The quantity of substance in the unit of presentation | ||||
| textPresentation |
Σ | 0..1 | string | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) | ||||
| concentration[x] |
Σ | 0..1 | The strength per unitary volume (or mass) | |||||
| concentrationRatio |
Ratio | |||||||
| concentrationRatioRange |
RatioRange | |||||||
| concentrationCodeableConcept |
CodeableConcept | |||||||
| concentrationQuantity |
Quantity | |||||||
| textConcentration |
Σ | 0..1 | string | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) | ||||
| basis |
Σ | 0..1 | CodeableConcept | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) | ||||
| measurementPoint |
Σ | 0..1 | string | When strength is measured at a particular point or distance | ||||
| country |
Σ | 0..* | CodeableConcept | Where the strength range applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
| referenceStrength |
SΣ | 0..1 | 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 |
SΣ | 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. | ||||
| 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 |
SΣ | 1..1 | CodeableConcept | Reference to a concept (by class) | ||||
| strength[x] |
SΣ | 1..1 | Ratio | Strength expressed in terms of a reference substance | ||||
| 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 / Code | URI |
| Ingredient.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Ingredient.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| Ingredient.role | required | RoleClassIngredientEntityhttp://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity | |
| Ingredient.function | example | IngredientFunctionhttp://hl7.org/fhir/ValueSet/ingredient-functionfrom the FHIR Standard | |
| Ingredient.manufacturer.role | required | IngredientManufacturerRolehttp://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0from the FHIR Standard | |
| Ingredient.substance.code | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.substance | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| Ingredient.substance.strength.referenceStrength.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard |
| 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 |
This structure is derived from Ingredient
Summary
Mandatory: 1 element(2 nested mandatory elements)
Must-Support: 10 elements
Prohibited: 1 element
Structures
This structure refers to these other structures:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.1 based on FHIR 5.0.0. Generated 2024-10-26
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