{ "resourceType": "StructureDefinition", "id": "Ingredient", "meta": { "lastUpdated": "2020-12-30T20:32:20.021+00:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Specialized.Medication Definition" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 1 }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "anonymous" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status", "valueCode": ".status=entered-in-error" } ], "url": "http://hl7.org/fhir/StructureDefinition/Ingredient", "version": "4.6.0", "name": "Ingredient", "status": "draft", "date": "2020-12-30T20:32:20+00:00", "publisher": "Health Level Seven International (Biomedical Research and Regulation)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" } ] }, { "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim/index.cfm" } ] } ], "description": "An ingredient of a manufactured item or pharmaceutical product.", "fhirVersion": "4.6.0", "mapping": [ { "identity": "idmp", "uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products", "name": "IDMP Mapping" }, { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" } ], "kind": "resource", "abstract": false, "type": "Ingredient", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "Ingredient", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "0,100" } ], "path": "Ingredient", "short": "An ingredient of a manufactured item or pharmaceutical product", "definition": "An ingredient of a manufactured item or pharmaceutical product.", "min": 0, "max": "*", "constraint": [ { "key": "ing-1", "severity": "error", "human": "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", "expression": "(Ingredient.allergenicIndicator.where(value='true').count() + Ingredient.substance.code.reference.count()) < 2", "xpath": "count(f:Ingredient.f:allergenicIndicator[@value='true']|f:Ingredient.f:substance.f:code.f:reference) < 2", "source": "http://hl7.org/fhir/StructureDefinition/Ingredient" } ], "mapping": [ { "identity": "idmp", "map": "Ingredient" }, { "identity": "w5", "map": "administrative.medication" } ] }, { "id": "Ingredient.identifier", "path": "Ingredient.identifier", "short": "An identifier or code by which the ingredient can be referenced", "definition": "The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.", "min": 0, "max": "1", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.status", "path": "Ingredient.status", "short": "draft | active | retired | unknown", "definition": "The status of this ingredient. Enables tracking the life-cycle of the content.", "comment": "Allows filtering of ingredient that are appropriate for use versus not.", "min": 1, "max": "1", "type": [ { "code": "code" } ], "isModifier": true, "isModifierReason": "This is labeled as \"Is Modifier\" because applications should not use a retired {{title}} without due consideration", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PublicationStatus" }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", "valueBoolean": true } ], "strength": "required", "description": "The lifecycle status of an artifact.", "valueSet": "http://hl7.org/fhir/ValueSet/publication-status|4.6.0" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.for", "path": "Ingredient.for", "short": "The product which this ingredient is a constituent part of", "definition": "The product which this ingredient is a constituent part of.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "http://hl7.org/fhir/StructureDefinition/AdministrableProductDefinition", "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.role", "path": "Ingredient.role", "short": "Purpose of the ingredient within the product, e.g. active, inactive", "definition": "A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "IngredientRole" } ], "strength": "example", "description": "A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.", "valueSet": "http://hl7.org/fhir/ValueSet/ingredient-role" }, "mapping": [ { "identity": "idmp", "map": "Ingredient.Ingredient Role" } ] }, { "id": "Ingredient.function", "path": "Ingredient.function", "short": "Precise action within the drug product, e.g. antioxidant, alkalizing agent", "definition": "A 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.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "IngredientFunction" } ], "strength": "example", "description": "A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).", "valueSet": "http://hl7.org/fhir/ValueSet/ingredient-function" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.group", "path": "Ingredient.group", "short": "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", "definition": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.allergenicIndicator", "path": "Ingredient.allergenicIndicator", "short": "If the ingredient is a known or suspected allergen", "definition": "If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here.", "min": 0, "max": "1", "type": [ { "code": "boolean" } ], "meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made", "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Ingredient.Allergenic Indicator" } ] }, { "id": "Ingredient.manufacturer", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "160,280" } ], "path": "Ingredient.manufacturer", "short": "An organization that manufactures this ingredient", "definition": "The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Ingredient.manufacturer" } ] }, { "id": "Ingredient.manufacturer.role", "path": "Ingredient.manufacturer.role", "short": "allowed | possible | actual", "definition": "The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.", "min": 0, "max": "1", "type": [ { "code": "code" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "IngredientManufacturerRole" }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", "valueBoolean": true } ], "strength": "required", "description": "The way in which this manufacturer is associated with the ingredient.", "valueSet": "http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role" }, "mapping": [ { "identity": "idmp", "map": "Ingredient.Manufacturer / Establishment (Organisation)" } ] }, { "id": "Ingredient.manufacturer.manufacturer", "path": "Ingredient.manufacturer.manufacturer", "short": "An organization that manufactures this ingredient", "definition": "An organization that manufactures this ingredient.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Ingredient.Manufacturer / Establishment (Organisation)" } ] }, { "id": "Ingredient.substance", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "160,0" } ], "path": "Ingredient.substance", "short": "The substance that comprises this ingredient", "definition": "The substance that comprises this ingredient.", "min": 1, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Ingredient.Substance" } ] }, { "id": "Ingredient.substance.code", "path": "Ingredient.substance.code", "short": "A code or full resource that represents the ingredient substance", "definition": "A code or full resource that represents the ingredient's substance.", "min": 1, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition" ] } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTSubstanceCodes" } ], "strength": "example", "description": "This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/substance-codes" }, "mapping": [ { "identity": "idmp", "map": "Substance.Substance" } ] }, { "id": "Ingredient.substance.strength", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "350,106" } ], "path": "Ingredient.substance.strength", "short": "The quantity of substance, per presentation, or per volume or mass, and type of quantity", "definition": "The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Specified Substance.Strength" } ] }, { "id": "Ingredient.substance.strength.presentation[x]", "path": "Ingredient.substance.strength.presentation[x]", "short": "The quantity of substance in the unit of presentation", "definition": "The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').", "min": 0, "max": "1", "type": [ { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "CodeableConcept" }, { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Strength.Strength (Presentation)" } ] }, { "id": "Ingredient.substance.strength.presentationText", "path": "Ingredient.substance.strength.presentationText", "short": "Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)", "definition": "A 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.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.substance.strength.concentration[x]", "path": "Ingredient.substance.strength.concentration[x]", "short": "The strength per unitary volume (or mass)", "definition": "The strength per unitary volume (or mass).", "min": 0, "max": "1", "type": [ { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "CodeableConcept" }, { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Strength.Strength (Concentration)" } ] }, { "id": "Ingredient.substance.strength.concentrationText", "path": "Ingredient.substance.strength.concentrationText", "short": "Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)", "definition": "A 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.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.substance.strength.basis", "path": "Ingredient.substance.strength.basis", "short": "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)", "definition": "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).", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "Ingredient.substance.strength.measurementPoint", "path": "Ingredient.substance.strength.measurementPoint", "short": "When strength is measured at a particular point or distance", "definition": "For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Strength.Measurement Point" } ] }, { "id": "Ingredient.substance.strength.country", "path": "Ingredient.substance.strength.country", "short": "Where the strength range applies", "definition": "The country or countries for which the strength range applies.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Country" } ], "strength": "example", "description": "Jurisdiction codes", "valueSet": "http://hl7.org/fhir/ValueSet/country" }, "mapping": [ { "identity": "idmp", "map": "Strength.Country" } ] }, { "id": "Ingredient.substance.strength.referenceStrength", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "700,117" } ], "path": "Ingredient.substance.strength.referenceStrength", "short": "Strength expressed in terms of a reference substance", "definition": "Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Strength.Reference Strength" } ] }, { "id": "Ingredient.substance.strength.referenceStrength.substance", "path": "Ingredient.substance.strength.referenceStrength.substance", "short": "Relevant reference substance", "definition": "Relevant reference substance.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition" ] } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTSubstanceCodes" } ], "strength": "example", "description": "This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/substance-codes" }, "mapping": [ { "identity": "idmp", "map": "Reference Strength.Reference Substance" } ] }, { "id": "Ingredient.substance.strength.referenceStrength.strength[x]", "path": "Ingredient.substance.strength.referenceStrength.strength[x]", "short": "Strength expressed in terms of a reference substance", "definition": "Strength expressed in terms of a reference substance.", "min": 1, "max": "1", "type": [ { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Reference Strength.Reference Strength" } ] }, { "id": "Ingredient.substance.strength.referenceStrength.measurementPoint", "path": "Ingredient.substance.strength.referenceStrength.measurementPoint", "short": "When strength is measured at a particular point or distance", "definition": "For when strength is measured at a particular point or distance.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Reference Strength.Measurement Point" } ] }, { "id": "Ingredient.substance.strength.referenceStrength.country", "path": "Ingredient.substance.strength.referenceStrength.country", "short": "Where the strength range applies", "definition": "The country or countries for which the strength range applies.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Country" } ], "strength": "example", "description": "Jurisdiction codes", "valueSet": "http://hl7.org/fhir/ValueSet/country" }, "mapping": [ { "identity": "idmp", "map": "Reference Strength.Country" } ] } ] } }