Xt-EHR
0.1.0 - ci-build

Xt-EHR, published by Xt-EHR. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Xt-EHR/xt-ehr-common/ and changes regularly. See the Directory of published versions

Logical Model: Medicinal product (model)

Official URL: https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSMedication Version: 0.1.0
Active as of 2024-09-18 Computable Name: EHDSMedication

Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile.

Usage:

Formal Views of Profile Content

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

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product (model)
Instances of this logical model are not marked to be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* BackboneElement A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* BackboneElement Ingredients
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..* CodeableConcept Concentration or presentation strength
...... strength 1..1 Ratio Concentration or presentation strength of the precise active ingredient
...... strengthType 0..1 CodeableConcept Type of strength that is expressed
...... strengthSubstance 0..1 CodeableConcept Substance that the strength refers to, if different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

... device 0..* BackboneElement Administration device included in the product
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device (model))
... characteristic 0..* BackboneElement Other features of the product
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value 0..1 ANY Description of the characteristic
... additionalProductInformation 0..1 BackboneElement Additional information about product - for example, a reference to a product catalogue

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.strengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred
NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product (model)
Instances of this logical model are not marked to be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* BackboneElement A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* BackboneElement Ingredients
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..* CodeableConcept Concentration or presentation strength
...... strength 1..1 Ratio Concentration or presentation strength of the precise active ingredient
...... strengthType 0..1 CodeableConcept Type of strength that is expressed
...... strengthSubstance 0..1 CodeableConcept Substance that the strength refers to, if different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

... device 0..* BackboneElement Administration device included in the product
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device (model))
... characteristic 0..* BackboneElement Other features of the product
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value 0..1 ANY Description of the characteristic
... additionalProductInformation 0..1 BackboneElement Additional information about product - for example, a reference to a product catalogue

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.strengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product (model)
Instances of this logical model are not marked to be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* BackboneElement A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* BackboneElement Ingredients
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..* CodeableConcept Concentration or presentation strength
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
...... text Σ 0..1 string Plain text representation of the concept
...... strength 1..1 Ratio Concentration or presentation strength of the precise active ingredient
...... strengthType 0..1 CodeableConcept Type of strength that is expressed
...... strengthSubstance 0..1 CodeableConcept Substance that the strength refers to, if different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

... device 0..* BackboneElement Administration device included in the product
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device (model))
... characteristic 0..* BackboneElement Other features of the product
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value 0..1 ANY Description of the characteristic
... additionalProductInformation 0..1 BackboneElement Additional information about product - for example, a reference to a product catalogue

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.strengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Base

Summary

Mandatory: 0 element(6 nested mandatory elements)

Structures

This structure refers to these other structures:

Differential View

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product (model)
Instances of this logical model are not marked to be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* BackboneElement A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* BackboneElement Ingredients
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..* CodeableConcept Concentration or presentation strength
...... strength 1..1 Ratio Concentration or presentation strength of the precise active ingredient
...... strengthType 0..1 CodeableConcept Type of strength that is expressed
...... strengthSubstance 0..1 CodeableConcept Substance that the strength refers to, if different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

... device 0..* BackboneElement Administration device included in the product
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device (model))
... characteristic 0..* BackboneElement Other features of the product
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value 0..1 ANY Description of the characteristic
... additionalProductInformation 0..1 BackboneElement Additional information about product - for example, a reference to a product catalogue

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.strengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product (model)
Instances of this logical model are not marked to be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* BackboneElement A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* BackboneElement Ingredients
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..* CodeableConcept Concentration or presentation strength
...... strength 1..1 Ratio Concentration or presentation strength of the precise active ingredient
...... strengthType 0..1 CodeableConcept Type of strength that is expressed
...... strengthSubstance 0..1 CodeableConcept Substance that the strength refers to, if different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

... device 0..* BackboneElement Administration device included in the product
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device (model))
... characteristic 0..* BackboneElement Other features of the product
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value 0..1 ANY Description of the characteristic
... additionalProductInformation 0..1 BackboneElement Additional information about product - for example, a reference to a product catalogue

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.strengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. EHDSMedication 0..* Base Medicinal product (model)
Instances of this logical model are not marked to be the target of a Reference
... identifyingCode[x] 0..* Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities.
.... identifyingCodeCodeableConcept CodeableConcept
.... identifyingCodeIdentifier Identifier
... classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
Binding Description (No ValueSet): (preferred): WHO ATC


... productName 0..1 string Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided.
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... organizationName 0..1 string Name of the organisation holding the authorisation for marketing/mahufacturing
.... organizationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location
... doseForm 0..1 CodeableConcept Dose form(s) on a product level. Dose form for a single package item is defined below.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

... packSize 0..* Quantity Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.


... item 0..* BackboneElement A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... doseForm 0..1 CodeableConcept Dose form
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... ingredient 1..* BackboneElement Ingredients
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... isActive 0..1 boolean Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected.
..... substance 1..1 CodeableConcept Substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

..... strengthInfo 0..* CodeableConcept Concentration or presentation strength
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
...... text Σ 0..1 string Plain text representation of the concept
...... strength 1..1 Ratio Concentration or presentation strength of the precise active ingredient
...... strengthType 0..1 CodeableConcept Type of strength that is expressed
...... strengthSubstance 0..1 CodeableConcept Substance that the strength refers to, if different from the main substance
Binding Description (No ValueSet): (preferred): EMA SPOR SMS

.... unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Binding Description (No ValueSet): (preferred): EDQM Standard Terms

.... containedQuantity 0..1 Ratio Manufactured item quantity for liquids (3ml / 1 vial)
.... amount 0..1 Quantity Number of such manufactured items in this product (5 vials)
Binding Description (No ValueSet): (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation.

... device 0..* BackboneElement Administration device included in the product
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceQuantity 1..1 Quantity Number of such devices
.... device[x] 1..1 Device coded
..... deviceCodeableConcept CodeableConcept
..... deviceReference Reference(Device (model))
... characteristic 0..* BackboneElement Other features of the product
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept A code expressing the type of characteristic
.... value 0..1 ANY Description of the characteristic
... additionalProductInformation 0..1 BackboneElement Additional information about product - for example, a reference to a product catalogue

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
EHDSMedication.classificationpreferred
EHDSMedication.doseFormpreferred
EHDSMedication.packSizepreferred
EHDSMedication.item.doseFormpreferred
EHDSMedication.item.ingredient.substancepreferred
EHDSMedication.item.ingredient.strengthInfo.strengthSubstancepreferred
EHDSMedication.item.unitOfPresentationpreferred
EHDSMedication.item.amountpreferred

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Base

Summary

Mandatory: 0 element(6 nested mandatory elements)

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel