Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: AdministrableProductDefinition (ePI)

Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/AdministrableProductDefinition-uv-epi Version: 0.1.0
Active as of 2022-09-02 Computable Name: AdministrableProductDefinitionUvEpi

AdministrableProductDefinition (ePI)

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from AdministrableProductDefinition

Summary

Mandatory: 3 elements (1 nested mandatory element)
Prohibited: 1 element

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element AdministrableProductDefinition.property is sliced based on the value of value:type
  • The element AdministrableProductDefinition.property.value[x] is sliced based on the value of type:$this

This structure is derived from AdministrableProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA 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)
... identifier 1..*IdentifierAn identifier for the administrable product
.... system 1..1uriThe namespace for the identifier value
Binding: AdministrableProductDefinition identifier systems (extensible)
.... value 1..1stringThe value that is unique
... status 1..1codedraft | active | retired |unknown
... formOf 0..*Reference(MedicinalProductDefinition (ePI))The medicinal product that this is a prepared administrable form of. This element is not a reference to the item(s) that make up this administrable form (for which see AdministrableProductDefinition.producedFrom). It is medicinal product as a whole, which may have several components (as well as packaging, devices etc.), that are given to the patient in this final administrable form. A single medicinal product may have several different administrable products (e.g. a tablet and a cream), and these could have different administrable forms (e.g. tablet as oral solid, or tablet crushed)
... unitOfPresentation 0..1CodeableConceptThe 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')
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000002145","display":"Spoonful"}]}
... producedFrom 0..*Reference(ManufacturedItemDefinition (ePI))The constituent manufactured item(s) that this administrable product is produced from. Either a single item, or several that are mixed before administration (e.g. a power item and a solvent item, to make a consumable solution). Note the items this is produced from are not raw ingredients (see AdministrableProductDefinition.ingredient), but manufactured medication items (ManufacturedItemDefinitions), which may be combined or prepared and transformed for patient use. The constituent items that this administrable form is produced from are all part of the product (for which see AdministrableProductDefinition.formOf)
... Slices for property 0..*BackboneElementCharacteristics e.g. a products onset of action
Slice: Unordered, Open by value:type
.... property:colour 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: color
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:flavour 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/gravitate
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: flavor
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:score 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: scoring
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:shape 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: shape
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:size 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: size
..... value[x] 0..1QuantityA value for the characteristic
.... property:image 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: image
..... value[x] 0..1AttachmentA value for the characteristic
.... property:imprint 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: imprintcd
..... value[x] 0..1A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConceptCodeableConcept
...... valueAttachmentAttachment
..... valueCodeableConcept 0..1CodeableConceptA value for the characteristic
...... coding 0..0
...... text 1..1stringPlain text representation of the concept
... routeOfAdministration 1..*BackboneElementThe 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
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073578","display":"Gingival use"}]}

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA 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)
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierAn identifier for the administrable product
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Binding: AdministrableProductDefinition identifier systems (extensible)
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... status ?!Σ1..1codedraft | active | retired |unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf Σ0..*Reference(MedicinalProductDefinition (ePI))The medicinal product that this is a prepared administrable form of. This element is not a reference to the item(s) that make up this administrable form (for which see AdministrableProductDefinition.producedFrom). It is medicinal product as a whole, which may have several components (as well as packaging, devices etc.), that are given to the patient in this final administrable form. A single medicinal product may have several different administrable products (e.g. a tablet and a cream), and these could have different administrable forms (e.g. tablet as oral solid, or tablet crushed)
... administrableDoseForm Σ0..1CodeableConceptThe 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')
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073646","display":"Oral solution"}]}
... unitOfPresentation Σ0..1CodeableConceptThe 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')
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000002145","display":"Spoonful"}]}
... producedFrom Σ0..*Reference(ManufacturedItemDefinition (ePI))The constituent manufactured item(s) that this administrable product is produced from. Either a single item, or several that are mixed before administration (e.g. a power item and a solvent item, to make a consumable solution). Note the items this is produced from are not raw ingredients (see AdministrableProductDefinition.ingredient), but manufactured medication items (ManufacturedItemDefinitions), which may be combined or prepared and transformed for patient use. The constituent items that this administrable form is produced from are all part of the product (for which see AdministrableProductDefinition.formOf)
... ingredient Σ0..*CodeableConceptThe 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
... device Σ0..1Reference(DeviceDefinition)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
... Slices for property Σ0..*BackboneElementCharacteristics e.g. a products onset of action
Slice: Unordered, Open by value:type
.... property:All Slices Content/Rules for all slices
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueAttachmentAttachment
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:colour Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: color
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:flavour Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/gravitate
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: flavor
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:score Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: scoring
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:shape Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: shape
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:size Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: size
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1QuantityA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:image Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: image
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1AttachmentA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:imprint Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: imprintcd
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... Slices for value[x] Σ0..1A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConceptCodeableConcept
...... valueAttachmentAttachment
...... value[x]:valueCodeableConcept Σ0..1CodeableConceptA value for the characteristic
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... text Σ1..1stringPlain text representation of the concept
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
... routeOfAdministration Σ1..*BackboneElementThe 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

Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073578","display":"Gingival use"}]}
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptCoded expression for the route
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
.... maxDosePerDay Σ0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which an Investigational Medicinal Product can be administered
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... code Σ1..1CodeableConceptCoded expression for the species
..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... tissue Σ1..1CodeableConceptCoded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
...... value Σ1..1QuantityA value for the time
...... supportingInformation Σ0..1stringExtra information about the withdrawal period

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA 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)

doco Documentation for this format

This structure is derived from AdministrableProductDefinition

Summary

Mandatory: 3 elements (1 nested mandatory element)
Prohibited: 1 element

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element AdministrableProductDefinition.property is sliced based on the value of value:type
  • The element AdministrableProductDefinition.property.value[x] is sliced based on the value of type:$this

Differential View

This structure is derived from AdministrableProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA 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)
... identifier 1..*IdentifierAn identifier for the administrable product
.... system 1..1uriThe namespace for the identifier value
Binding: AdministrableProductDefinition identifier systems (extensible)
.... value 1..1stringThe value that is unique
... status 1..1codedraft | active | retired |unknown
... formOf 0..*Reference(MedicinalProductDefinition (ePI))The medicinal product that this is a prepared administrable form of. This element is not a reference to the item(s) that make up this administrable form (for which see AdministrableProductDefinition.producedFrom). It is medicinal product as a whole, which may have several components (as well as packaging, devices etc.), that are given to the patient in this final administrable form. A single medicinal product may have several different administrable products (e.g. a tablet and a cream), and these could have different administrable forms (e.g. tablet as oral solid, or tablet crushed)
... unitOfPresentation 0..1CodeableConceptThe 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')
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000002145","display":"Spoonful"}]}
... producedFrom 0..*Reference(ManufacturedItemDefinition (ePI))The constituent manufactured item(s) that this administrable product is produced from. Either a single item, or several that are mixed before administration (e.g. a power item and a solvent item, to make a consumable solution). Note the items this is produced from are not raw ingredients (see AdministrableProductDefinition.ingredient), but manufactured medication items (ManufacturedItemDefinitions), which may be combined or prepared and transformed for patient use. The constituent items that this administrable form is produced from are all part of the product (for which see AdministrableProductDefinition.formOf)
... Slices for property 0..*BackboneElementCharacteristics e.g. a products onset of action
Slice: Unordered, Open by value:type
.... property:colour 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: color
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:flavour 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/gravitate
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: flavor
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:score 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: scoring
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:shape 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: shape
..... value[x] 0..1CodeableConceptA value for the characteristic
.... property:size 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: size
..... value[x] 0..1QuantityA value for the characteristic
.... property:image 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: image
..... value[x] 0..1AttachmentA value for the characteristic
.... property:imprint 0..*BackboneElementCharacteristics e.g. a products onset of action
..... type 1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: imprintcd
..... value[x] 0..1A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConceptCodeableConcept
...... valueAttachmentAttachment
..... valueCodeableConcept 0..1CodeableConceptA value for the characteristic
...... coding 0..0
...... text 1..1stringPlain text representation of the concept
... routeOfAdministration 1..*BackboneElementThe 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
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073578","display":"Gingival use"}]}

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA 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)
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierAn identifier for the administrable product
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Binding: AdministrableProductDefinition identifier systems (extensible)
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... status ?!Σ1..1codedraft | active | retired |unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf Σ0..*Reference(MedicinalProductDefinition (ePI))The medicinal product that this is a prepared administrable form of. This element is not a reference to the item(s) that make up this administrable form (for which see AdministrableProductDefinition.producedFrom). It is medicinal product as a whole, which may have several components (as well as packaging, devices etc.), that are given to the patient in this final administrable form. A single medicinal product may have several different administrable products (e.g. a tablet and a cream), and these could have different administrable forms (e.g. tablet as oral solid, or tablet crushed)
... administrableDoseForm Σ0..1CodeableConceptThe 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')
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073646","display":"Oral solution"}]}
... unitOfPresentation Σ0..1CodeableConceptThe 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')
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000002145","display":"Spoonful"}]}
... producedFrom Σ0..*Reference(ManufacturedItemDefinition (ePI))The constituent manufactured item(s) that this administrable product is produced from. Either a single item, or several that are mixed before administration (e.g. a power item and a solvent item, to make a consumable solution). Note the items this is produced from are not raw ingredients (see AdministrableProductDefinition.ingredient), but manufactured medication items (ManufacturedItemDefinitions), which may be combined or prepared and transformed for patient use. The constituent items that this administrable form is produced from are all part of the product (for which see AdministrableProductDefinition.formOf)
... ingredient Σ0..*CodeableConceptThe 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
... device Σ0..1Reference(DeviceDefinition)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
... Slices for property Σ0..*BackboneElementCharacteristics e.g. a products onset of action
Slice: Unordered, Open by value:type
.... property:All Slices Content/Rules for all slices
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueAttachmentAttachment
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:colour Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: color
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:flavour Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/gravitate
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: flavor
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:score Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: scoring
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:shape Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: shape
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1CodeableConceptA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:size Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: size
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1QuantityA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:image Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: image
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... value[x] Σ0..1AttachmentA value for the characteristic
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
.... property:imprint Σ0..*BackboneElementCharacteristics e.g. a products onset of action
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Required Pattern: At least the following
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
....... id0..1stringUnique id for inter-element referencing
....... extension0..*ExtensionAdditional content defined by implementations
....... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/medicationknowledge-characteristic
....... version0..1stringVersion of the system - if relevant
....... code1..1codeSymbol in syntax defined by the system
Fixed Value: imprintcd
....... display0..1stringRepresentation defined by the system
....... userSelected0..1booleanIf this coding was chosen directly by the user
...... text0..1stringPlain text representation of the concept
..... Slices for value[x] Σ0..1A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConceptCodeableConcept
...... valueAttachmentAttachment
...... value[x]:valueCodeableConcept Σ0..1CodeableConceptA value for the characteristic
....... id 0..1stringUnique id for inter-element referencing
....... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... text Σ1..1stringPlain text representation of the concept
..... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
... routeOfAdministration Σ1..*BackboneElementThe 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

Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073578","display":"Gingival use"}]}
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptCoded expression for the route
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
.... maxDosePerDay Σ0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which an Investigational Medicinal Product can be administered
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... code Σ1..1CodeableConceptCoded expression for the species
..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... id 0..1idUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... tissue Σ1..1CodeableConceptCoded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
...... value Σ1..1QuantityA value for the time
...... supportingInformation Σ0..1stringExtra information about the withdrawal period

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
AdministrableProductDefinition.languagepreferredCommonLanguages
Max Binding: AllLanguages
AdministrableProductDefinition.identifier.userequiredIdentifierUse
AdministrableProductDefinition.identifier.typeextensibleIdentifier Type Codes
AdministrableProductDefinition.identifier.systemextensibleVsAdmProductIdSystems
AdministrableProductDefinition.statusrequiredPublicationStatus