Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: PackagedProductDefinition - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq Version: 1.0.0
Active as of 2024-05-08 Computable Name: PackagedProductDefinitionDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.34

This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance.

Usage:

Formal Views of Profile Content

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

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... type S 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example)
... packageFor S 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... description S 0..1 markdown Textual description. Note that this is not the name of the package or product
.... type S 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (preferred): A high level categorisation of a package.

.... material S 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.

.... shelfLifeStorage S 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer S 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property S 0..* BackboneElement General characteristics of this item
..... type S 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Package Property (example)
..... Slices for value[x] S 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
...... value[x]:valueCodeableConcept S 0..1 CodeableConcept A value for the characteristic
Binding: Grades (example)
Additional BindingsPurpose
Colors Extensible Binding
...... value[x]:valueQuantity S 0..1 Quantity A value for the characteristic
....... system 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
....... code 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

...... value[x]:valueBoolean S 0..1 boolean A value for the characteristic
.... containedItem S 0..* BackboneElement The item(s) within the packaging
..... amount S 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging S 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.packaging.typepreferredPackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialpreferredPackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleVsPackagePropertyPQ (a valid code from Package Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-packageProperty-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueCodeableConceptexampleVsGradePQ (a valid code from Package Grade Codes)
Additional Bindings Purpose
Colors Extensible Binding
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-grade-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive
NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... packageFor SΣ 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... description SΣ 0..1 markdown Textual description. Note that this is not the name of the package or product
... packaging SΣ 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (preferred): A high level categorisation of a package.

.... material SΣ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.


.... shelfLifeStorage SΣ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer SΣ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property SΣ 0..* BackboneElement General characteristics of this item
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Package Property (example)
..... Slices for value[x] SΣ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
...... value[x]:valueCodeableConcept SΣ 0..1 CodeableConcept A value for the characteristic
Binding: Grades (example)
Additional BindingsPurpose
Colors Extensible Binding
...... value[x]:valueQuantity SΣ 0..1 Quantity A value for the characteristic
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
....... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

...... value[x]:valueBoolean SΣ 0..1 boolean A value for the characteristic
.... containedItem SΣ 0..* BackboneElement The item(s) within the packaging
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
..... amount SΣ 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.packaging.typepreferredPackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialpreferredPackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleVsPackagePropertyPQ (a valid code from Package Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-packageProperty-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueCodeableConceptexampleVsGradePQ (a valid code from Package Grade Codes)
Additional Bindings Purpose
Colors Extensible Binding
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-grade-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier A unique identifier for this package as whole - not for the content of the package
... name Σ 0..1 string A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type SΣ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example)
... packageFor SΣ 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... containedItemQuantity Σ 0..* Quantity A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
... description SΣ 0..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

... marketingStatus Σ 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
... copackagedIndicator Σ 0..1 boolean Identifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer Σ 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers)
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product
... packaging SΣ 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type SΣ 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (preferred): A high level categorisation of a package.

.... componentPart Σ 0..1 boolean Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
.... quantity Σ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material SΣ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.


.... alternateMaterial Σ 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... shelfLifeStorage SΣ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer SΣ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property SΣ 0..* BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Package Property (example)
..... Slices for value[x] SΣ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
...... value[x]:valueCodeableConcept SΣ 0..1 CodeableConcept A value for the characteristic
Binding: Grades (example)
Additional BindingsPurpose
Colors Extensible Binding
...... value[x]:valueQuantity SΣ 0..1 Quantity A value for the characteristic
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value Σ 0..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit Σ 0..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
....... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

...... value[x]:valueBoolean SΣ 0..1 boolean A value for the characteristic
.... containedItem SΣ 0..* BackboneElement The item(s) within the packaging
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
..... amount SΣ 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ 0..* See property (PackagedProductDefinition) Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.packaging.typepreferredPackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialpreferredPackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleVsPackagePropertyPQ (a valid code from Package Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-packageProperty-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueCodeableConceptexampleVsGradePQ (a valid code from Package Grade Codes)
Additional Bindings Purpose
Colors Extensible Binding
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-grade-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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()

This structure is derived from PackagedProductDefinition

Summary

Must-Support: 17 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of PackagedProductDefinition.packaging.property.value[x]

Differential View

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... type S 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example)
... packageFor S 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... description S 0..1 markdown Textual description. Note that this is not the name of the package or product
.... type S 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (preferred): A high level categorisation of a package.

.... material S 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.

.... shelfLifeStorage S 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer S 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property S 0..* BackboneElement General characteristics of this item
..... type S 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Package Property (example)
..... Slices for value[x] S 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
...... value[x]:valueCodeableConcept S 0..1 CodeableConcept A value for the characteristic
Binding: Grades (example)
Additional BindingsPurpose
Colors Extensible Binding
...... value[x]:valueQuantity S 0..1 Quantity A value for the characteristic
....... system 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
....... code 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

...... value[x]:valueBoolean S 0..1 boolean A value for the characteristic
.... containedItem S 0..* BackboneElement The item(s) within the packaging
..... amount S 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging S 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.packaging.typepreferredPackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialpreferredPackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleVsPackagePropertyPQ (a valid code from Package Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-packageProperty-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueCodeableConceptexampleVsGradePQ (a valid code from Package Grade Codes)
Additional Bindings Purpose
Colors Extensible Binding
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-grade-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... packageFor SΣ 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... description SΣ 0..1 markdown Textual description. Note that this is not the name of the package or product
... packaging SΣ 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (preferred): A high level categorisation of a package.

.... material SΣ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.


.... shelfLifeStorage SΣ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer SΣ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property SΣ 0..* BackboneElement General characteristics of this item
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Package Property (example)
..... Slices for value[x] SΣ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
...... value[x]:valueCodeableConcept SΣ 0..1 CodeableConcept A value for the characteristic
Binding: Grades (example)
Additional BindingsPurpose
Colors Extensible Binding
...... value[x]:valueQuantity SΣ 0..1 Quantity A value for the characteristic
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
....... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

...... value[x]:valueBoolean SΣ 0..1 boolean A value for the characteristic
.... containedItem SΣ 0..* BackboneElement The item(s) within the packaging
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
..... amount SΣ 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.packaging.typepreferredPackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialpreferredPackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleVsPackagePropertyPQ (a valid code from Package Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-packageProperty-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueCodeableConceptexampleVsGradePQ (a valid code from Package Grade Codes)
Additional Bindings Purpose
Colors Extensible Binding
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-grade-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier A unique identifier for this package as whole - not for the content of the package
... name Σ 0..1 string A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type SΣ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example)
... packageFor SΣ 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... containedItemQuantity Σ 0..* Quantity A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
... description SΣ 0..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

... marketingStatus Σ 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
... copackagedIndicator Σ 0..1 boolean Identifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer Σ 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers)
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product
... packaging SΣ 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type SΣ 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (preferred): A high level categorisation of a package.

.... componentPart Σ 0..1 boolean Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
.... quantity Σ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material SΣ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (preferred): A material used in the construction of packages and their components.


.... alternateMaterial Σ 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... shelfLifeStorage SΣ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer SΣ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property SΣ 0..* BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type SΣ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Package Property (example)
..... Slices for value[x] SΣ 0..1 A value for the characteristic
Slice: Unordered, Open by type:$this
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
...... value[x]:valueCodeableConcept SΣ 0..1 CodeableConcept A value for the characteristic
Binding: Grades (example)
Additional BindingsPurpose
Colors Extensible Binding
...... value[x]:valueQuantity SΣ 0..1 Quantity A value for the characteristic
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... value Σ 0..1 decimal Numerical value (with implicit precision)
....... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

....... unit Σ 0..1 string Unit representation
....... system ΣC 0..1 uri System that defines coded unit form
Required Pattern: http://unitsofmeasure.org
....... code ΣC 0..1 code Coded form of the unit
Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit

...... value[x]:valueBoolean SΣ 0..1 boolean A value for the characteristic
.... containedItem SΣ 0..* BackboneElement The item(s) within the packaging
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
..... amount SΣ 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ 0..* See property (PackagedProductDefinition) Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.packaging.typepreferredPackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialpreferredPackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleVsPackagePropertyPQ (a valid code from Package Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-packageProperty-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueCodeableConceptexampleVsGradePQ (a valid code from Package Grade Codes)
Additional Bindings Purpose
Colors Extensible Binding
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-grade-pq
from this IG
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]:valueQuantity.coderequiredUnitsOfMeasureCaseSensitive (a valid code from UCUM)
http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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()

This structure is derived from PackagedProductDefinition

Summary

Must-Support: 17 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of PackagedProductDefinition.packaging.property.value[x]

 

Other representations of profile: CSV, Excel, Schematron