{ "resourceType": "StructureDefinition", "id": "AdministrableProductDefinition", "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/AdministrableProductDefinition", "version": "4.6.0", "name": "AdministrableProductDefinition", "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": "A medicinal product in the final form which is suitable for administering to a patient (after any mixing of multiple components, dissolution etc. has been performed).", "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": "AdministrableProductDefinition", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "AdministrableProductDefinition", "path": "AdministrableProductDefinition", "short": "A medicinal product in the final form, suitable for administration - after any mixing of multiple components", "definition": "A medicinal product in the final form which is suitable for administering to a patient (after any mixing of multiple components, dissolution etc. has been performed).", "alias": [ "Pharmaceutical Product" ], "min": 0, "max": "*", "constraint": [ { "key": "apd-1", "severity": "error", "human": "RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)", "expression": "(AdministrableProductDefinition.routeOfAdministration.code.count() + AdministrableProductDefinition.formOf.resolve().route.count()) < 2", "xpath": "count(f:AdministrableProductDefinition/f:routeOfAdministration/f:code|//f:MedicinalProductDefinition[f:id/@value=current()/ancestor::f:AdministrableProductDefinition/f:formOf/f:reference/@value]/f:route) < 2", "source": "http://hl7.org/fhir/StructureDefinition/AdministrableProductDefinition" } ], "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product" }, { "identity": "w5", "map": "administrative.medication" } ] }, { "id": "AdministrableProductDefinition.identifier", "path": "AdministrableProductDefinition.identifier", "short": "An identifier for the administrable product", "definition": "An identifier for the administrable product.", "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "AdministrableProductDefinition.status", "path": "AdministrableProductDefinition.status", "short": "draft | active | retired | unknown", "definition": "The status of this administrable product. Enables tracking the life-cycle of the content.", "comment": "Allows filtering of administrable products 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": "AdministrableProductDefinition.formOf", "path": "AdministrableProductDefinition.formOf", "short": "References a product from which one or more of the constituent parts of that product can be prepared and used as described by this administrable product", "definition": "References a product from which one or more of the constituent parts of that product can be prepared and used as described by this administrable product. If this administrable product describes the administration of a crushed tablet, the 'formOf' would be the product representing a distribution containing tablets and possibly also a cream. This is distinct from the 'producedFrom' which refers to the specific components of the product that are used in this preparation, rather than the product as a whole.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(link to Medicinal Product)" } ] }, { "id": "AdministrableProductDefinition.administrableDoseForm", "path": "AdministrableProductDefinition.administrableDoseForm", "short": "The dose form of the final product after necessary reconstitution or processing", "definition": "The dose form of the final product after necessary reconstitution or processing. Contrasts to the manufactured dose form (see ManufacturedItemDefinition). If the manufactured form was 'powder for solution for injection', the administrable dose form could be 'solution for injection' (once mixed with another item having manufactured form 'solvent for solution for injection').", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdministrableDoseForm" } ], "strength": "example", "description": "Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.", "valueSet": "http://hl7.org/fhir/ValueSet/administrable-dose-form" }, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product.Administrable Dose Form" } ] }, { "id": "AdministrableProductDefinition.unitOfPresentation", "path": "AdministrableProductDefinition.unitOfPresentation", "short": "The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'", "definition": "The presentation type in which this item is given to a patient. e.g. for a spray - 'puff' (as in 'contains 100 mcg per puff'), or for a liquid - 'vial' (as in 'contains 5 ml per vial').", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "UnitOfPresentation" } ], "strength": "example", "description": "The presentation type in which an administrable medicinal product is given to a patient.", "valueSet": "http://hl7.org/fhir/ValueSet/unit-of-presentation" }, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product.Unit of Presentation" } ] }, { "id": "AdministrableProductDefinition.producedFrom", "path": "AdministrableProductDefinition.producedFrom", "short": "Indicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form", "definition": "Indicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form. In some cases, an administrable form might use all of the items from the overall product (or there might only be one item), while in other cases, an administrable form might use only a subset of the items available in the overall product. For example, an administrable form might involve combining a liquid and a powder available as part of an overall product, but not involve applying the also supplied cream.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a (this is the link from Pharmaceutical Product to the Manufactured Item(s))" } ] }, { "id": "AdministrableProductDefinition.ingredient", "path": "AdministrableProductDefinition.ingredient", "short": "The ingredients of this administrable medicinal product. This is only needed if the ingredients are not specified either using ManufacturedItemDefiniton, or using by incoming references from the Ingredient resource", "definition": "The ingredients of this administrable medicinal product. This is only needed if the ingredients are not specified either using ManufacturedItemDefiniton (via AdministrableProductDefinition.producedFrom) to state which component items are used to make this, or using by incoming references from the Ingredient resource, to state in detail which substances exist within this. This element allows a basic coded ingredient to be used.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "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": "Pharmaceutical Product.Ingredient (see also FHIR Ingredient resource)" } ] }, { "id": "AdministrableProductDefinition.device", "path": "AdministrableProductDefinition.device", "short": "A device that is integral to the medicinal product, in effect being considered as an \"ingredient\" of the medicinal product", "definition": "A device that is integral to the medicinal product, in effect being considered as an \"ingredient\" of the medicinal product. This is not intended for devices that are just co-packaged.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product.Device" } ] }, { "id": "AdministrableProductDefinition.property", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "500,25" } ], "path": "AdministrableProductDefinition.property", "short": "Characteristics e.g. a product's onset of action", "definition": "Characteristics e.g. a product's onset of action.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product Characteristics" } ] }, { "id": "AdministrableProductDefinition.property.type", "path": "AdministrableProductDefinition.property.type", "short": "A code expressing the type of characteristic", "definition": "A code expressing the type of characteristic.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTCharacteristicCodes" } ], "strength": "example", "description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes" }, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product Characteristics.Code System (not a one to one map, the resource is more capable)" } ] }, { "id": "AdministrableProductDefinition.property.value[x]", "path": "AdministrableProductDefinition.property.value[x]", "short": "A value for the characteristic", "definition": "A value for the characteristic.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" }, { "code": "Quantity" }, { "code": "date" }, { "code": "boolean" }, { "code": "Attachment" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product Characteristics.Value (not a one to one map, the resource is more capable)" } ] }, { "id": "AdministrableProductDefinition.property.status", "path": "AdministrableProductDefinition.property.status", "short": "The status of characteristic e.g. assigned or pending", "definition": "The status of characteristic e.g. assigned or pending.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "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" }, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product Characteristics.Status" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "57,205" } ], "path": "AdministrableProductDefinition.routeOfAdministration", "short": "The path by which the product is taken into or makes contact with the body", "definition": "The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa).", "min": 1, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product.Route of Administration" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.code", "path": "AdministrableProductDefinition.routeOfAdministration.code", "short": "Coded expression for the route", "definition": "Coded expression for the route.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTRouteCodes" } ], "strength": "example", "description": "A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.", "valueSet": "http://hl7.org/fhir/ValueSet/route-codes" }, "mapping": [ { "identity": "idmp", "map": "Route of Administration.Route of Administration" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.firstDose", "path": "AdministrableProductDefinition.routeOfAdministration.firstDose", "short": "The first dose (dose quantity) administered can be specified for the product", "definition": "The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement.", "min": 0, "max": "1", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Dosing and Route of Administration.First dose in humans (Investigational Medicinal Product)" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.maxSingleDose", "path": "AdministrableProductDefinition.routeOfAdministration.maxSingleDose", "short": "The maximum single dose that can be administered", "definition": "The maximum single dose that can be administered, specified using a numerical value and its unit of measurement.", "min": 0, "max": "1", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Dosing and Route of Administration.Maximum single dose (Investigational Medicinal Product)" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.maxDosePerDay", "path": "AdministrableProductDefinition.routeOfAdministration.maxDosePerDay", "short": "The maximum dose quantity to be administered in any one 24-h period", "definition": "The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered.", "min": 0, "max": "1", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Dosing and Route of Administration.Maximum dose per day (Investigational Medicinal Product)" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod", "path": "AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod", "short": "The maximum dose per treatment period that can be administered", "definition": "The maximum dose per treatment period that can be administered.", "min": 0, "max": "1", "type": [ { "code": "Ratio" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Dosing and Route of Administration.Maximum dose per treatment period (Investigational Medicinal Product)" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod", "path": "AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod", "short": "The maximum treatment period during which the product can be administered", "definition": "The maximum treatment period during which the product can be administered.", "min": 0, "max": "1", "type": [ { "code": "Duration" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Dosing and Route of Administration.Maximum treatment period (Investigational Medicinal Product)" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.targetSpecies", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "360,239" } ], "path": "AdministrableProductDefinition.routeOfAdministration.targetSpecies", "short": "A species for which this route applies", "definition": "A species for which this route applies.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.code", "path": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.code", "short": "Coded expression for the species", "definition": "Coded expression for the species.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "TargetSpecies" } ], "strength": "example", "description": "A tissue type of an animal.", "valueSet": "http://hl7.org/fhir/ValueSet/target-species" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "620,229" } ], "path": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod", "short": "A species specific time during which consumption of animal product is not appropriate", "definition": "A species specific time during which consumption of animal product is not appropriate.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue", "path": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue", "short": "The type of tissue for which the withdrawal period applies, e.g. meat, milk", "definition": "Coded expression for the type of tissue for which the withdrawal period applies, e.g. meat, milk.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AnimalTissueType" } ], "strength": "example", "description": "A tissue type of an animal.", "valueSet": "http://hl7.org/fhir/ValueSet/animal-tissue-type" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value", "path": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value", "short": "A value for the time", "definition": "A value for the time.", "min": 1, "max": "1", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation", "path": "AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation", "short": "Extra information about the withdrawal period", "definition": "Extra information about the withdrawal period.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] } ] } }