UnicomIG
0.1.0 - ci-build

UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/hl7-eu/unicom-ig and changes regularly. See the Directory of published versions

Resource Profile: PPL Administrable Product profile

Official URL: http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition Version: 0.1.0
Active as of 2023-02-03 Computable Name: PPLAdministrableProductDefinition

Administrable product profile defines the ISO IDMP Pharmaceutical Product concept

Usage:

Formal Views of Profile Content

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

This structure is derived from AdministrableProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA medicinal product in the final form, suitable for administration - after any mixing of multiple components
... identifier 0..*IdentifierPhPID or other relevant identifier
... formOf 1..*Reference(PPL Medicinal Product profile)Reference to the Medicinal Product
... administrableDoseForm 1..1CodeableConceptDose form of the administrable product (after preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... producedFrom 0..*Reference(PPL Manufactured Item profile)References to manufactured items that are used in the preparation of this administrable product
... ingredient 0..0
... property 0..0
... routeOfAdministration
.... code 1..1CodeableConceptCoded expression for the route
Binding: Routes and Methods of Administration (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
AdministrableProductDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition C0..*AdministrableProductDefinitionA medicinal product in the final form, suitable for administration - after any mixing of multiple components
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierPhPID or other relevant identifier
... formOf Σ1..*Reference(PPL Medicinal Product profile)Reference to the Medicinal Product
... administrableDoseForm Σ1..1CodeableConceptDose form of the administrable product (after preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation Σ0..1CodeableConceptUnit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging.
Binding: Unit of Presentation EMA (required)
... producedFrom Σ0..*Reference(PPL Manufactured Item profile)References to manufactured items that are used in the preparation of this administrable product
... routeOfAdministration Σ1..*BackboneElementThe path by which the product is taken into or makes contact with the body
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptCoded expression for the route
Binding: Routes and Methods of Administration (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdministrableProductDefinition.statusrequiredPublicationStatus
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
AdministrableProductDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)

Constraints

IdGradePath(s)DetailsRequirements
apd-1errorAdministrableProductDefinitionRouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)
: (AdministrableProductDefinition.routeOfAdministration.code.count() + AdministrableProductDefinition.formOf.resolve().route.count()) < 2
dom-2errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdministrableProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
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
.. AdministrableProductDefinition C0..*AdministrableProductDefinitionA medicinal product in the final form, suitable for administration - after any mixing of multiple components
... 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 Σ0..*IdentifierPhPID or other relevant identifier
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf Σ1..*Reference(PPL Medicinal Product profile)Reference to the Medicinal Product
... administrableDoseForm Σ1..1CodeableConceptDose form of the administrable product (after preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation Σ0..1CodeableConceptUnit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging.
Binding: Unit of Presentation EMA (required)
... producedFrom Σ0..*Reference(PPL Manufactured Item profile)References to manufactured items that are used in the preparation of this administrable product
... device Σ0..1Reference(DeviceDefinition)A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
... routeOfAdministration Σ1..*BackboneElementThe path by which the product is taken into or makes contact with the body
.... id 0..1stringUnique 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
Binding: Routes and Methods of Administration (required)
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered can be specified for the product
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered
.... maxDosePerDay Σ0..1QuantityThe maximum dose quantity to be administered in any one 24-h period
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which the product can be administered
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... id 0..1stringUnique 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
Binding: TargetSpecies (example): A tissue type of an animal.

..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... tissue Σ1..1CodeableConceptThe type of tissue for which the withdrawal period applies, e.g. meat, milk
Binding: AnimalTissueType (example): A tissue type of an animal.

...... value Σ1..1QuantityA value for the time
...... supportingInformation Σ0..1stringExtra information about the withdrawal period

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdministrableProductDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdministrableProductDefinition.statusrequiredPublicationStatus
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
AdministrableProductDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
AdministrableProductDefinition.property.statusrequiredPublicationStatus
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
AdministrableProductDefinition.routeOfAdministration.targetSpecies.codeexampleTargetSpecies
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissueexampleAnimalTissueType

Constraints

IdGradePath(s)DetailsRequirements
dom-r4bwarningAdministrableProductDefinition.containedContaining new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
: ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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()

Differential View

This structure is derived from AdministrableProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition 0..*AdministrableProductDefinitionA medicinal product in the final form, suitable for administration - after any mixing of multiple components
... identifier 0..*IdentifierPhPID or other relevant identifier
... formOf 1..*Reference(PPL Medicinal Product profile)Reference to the Medicinal Product
... administrableDoseForm 1..1CodeableConceptDose form of the administrable product (after preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... producedFrom 0..*Reference(PPL Manufactured Item profile)References to manufactured items that are used in the preparation of this administrable product
... ingredient 0..0
... property 0..0
... routeOfAdministration
.... code 1..1CodeableConceptCoded expression for the route
Binding: Routes and Methods of Administration (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
AdministrableProductDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition C0..*AdministrableProductDefinitionA medicinal product in the final form, suitable for administration - after any mixing of multiple components
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierPhPID or other relevant identifier
... formOf Σ1..*Reference(PPL Medicinal Product profile)Reference to the Medicinal Product
... administrableDoseForm Σ1..1CodeableConceptDose form of the administrable product (after preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation Σ0..1CodeableConceptUnit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging.
Binding: Unit of Presentation EMA (required)
... producedFrom Σ0..*Reference(PPL Manufactured Item profile)References to manufactured items that are used in the preparation of this administrable product
... routeOfAdministration Σ1..*BackboneElementThe path by which the product is taken into or makes contact with the body
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptCoded expression for the route
Binding: Routes and Methods of Administration (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdministrableProductDefinition.statusrequiredPublicationStatus
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
AdministrableProductDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)

Constraints

IdGradePath(s)DetailsRequirements
apd-1errorAdministrableProductDefinitionRouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)
: (AdministrableProductDefinition.routeOfAdministration.code.count() + AdministrableProductDefinition.formOf.resolve().route.count()) < 2
dom-2errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdministrableProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorAdministrableProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdministrableProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
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
.. AdministrableProductDefinition C0..*AdministrableProductDefinitionA medicinal product in the final form, suitable for administration - after any mixing of multiple components
... 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 Σ0..*IdentifierPhPID or other relevant identifier
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... formOf Σ1..*Reference(PPL Medicinal Product profile)Reference to the Medicinal Product
... administrableDoseForm Σ1..1CodeableConceptDose form of the administrable product (after preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation Σ0..1CodeableConceptUnit of presentation of the administrable product (after preparing for administration). Not applicable for certain products/packaging.
Binding: Unit of Presentation EMA (required)
... producedFrom Σ0..*Reference(PPL Manufactured Item profile)References to manufactured items that are used in the preparation of this administrable product
... device Σ0..1Reference(DeviceDefinition)A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
... routeOfAdministration Σ1..*BackboneElementThe path by which the product is taken into or makes contact with the body
.... id 0..1stringUnique 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
Binding: Routes and Methods of Administration (required)
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered can be specified for the product
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered
.... maxDosePerDay Σ0..1QuantityThe maximum dose quantity to be administered in any one 24-h period
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which the product can be administered
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... id 0..1stringUnique 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
Binding: TargetSpecies (example): A tissue type of an animal.

..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
...... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
...... tissue Σ1..1CodeableConceptThe type of tissue for which the withdrawal period applies, e.g. meat, milk
Binding: AnimalTissueType (example): A tissue type of an animal.

...... value Σ1..1QuantityA value for the time
...... supportingInformation Σ0..1stringExtra information about the withdrawal period

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
AdministrableProductDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdministrableProductDefinition.statusrequiredPublicationStatus
AdministrableProductDefinition.administrableDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
AdministrableProductDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
AdministrableProductDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
AdministrableProductDefinition.property.statusrequiredPublicationStatus
AdministrableProductDefinition.routeOfAdministration.coderequiredRoutesAndMethodsOfAdministration (a valid code from Routes and Methods of Administration EMA)
AdministrableProductDefinition.routeOfAdministration.targetSpecies.codeexampleTargetSpecies
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissueexampleAnimalTissueType

Constraints

IdGradePath(s)DetailsRequirements
dom-r4bwarningAdministrableProductDefinition.containedContaining new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
: ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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()

 

Other representations of profile: CSV, Excel, Schematron