Order Catalog Implementation Guide
current - CI Build International flag

Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Resource Profile: DrugPackage Profile

Official URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DrugPackage Version: current
Draft as of 2022-06-10 Computable Name: DrugPackage

This profile constrains the base resource PackagedProductDefinition to represent a definition of a packaging in a catalog of medications.

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..*PackagedProductDefinitionA medically related item or items, in a container or package
... name S0..1stringA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type 1..1CodeableConceptA high level category e.g. medicinal product, raw material, shipping container etc

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..*PackagedProductDefinitionA medically related item or items, in a container or package
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... type Σ1..1CodeableConceptA high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

... status ?!Σ0..1CodeableConceptThe 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
PackagedProductDefinition.typeexamplePackageType
PackagedProductDefinition.statuspreferredPublicationStatus

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..*PackagedProductDefinitionA medically related item or items, in a container or package
... 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 ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierA unique identifier for this package as whole - not for the content of the package
... name SΣ0..1stringA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type Σ1..1CodeableConceptA high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

... packageFor Σ0..*Reference(MedicinalProductDefinition)The product that this is a pack for
... status ?!Σ0..1CodeableConceptThe 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 Σ0..1dateTimeThe date at which the given status became applicable
... containedItemQuantity Σ0..*QuantityA 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 Σ0..1markdownTextual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ0..*BackboneElementThe legal status of supply of the packaged item as classified by the regulator
.... 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 Σ0..1CodeableConceptThe 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 Σ0..1CodeableConceptThe place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

... marketingStatus Σ0..*MarketingStatusAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
... copackagedIndicator Σ0..1booleanIdentifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer Σ0..*Reference(Organization)Manufacturer of this package type (multiple means these are all possible manufacturers)
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the packaged product
... packaging Σ0..1BackboneElementA 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..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier Σ0..*IdentifierAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type Σ0..1CodeableConceptThe physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

.... componentPart Σ0..1booleanIs 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 Σ0..1integerThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material Σ0..*CodeableConceptMaterial type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... alternateMaterial Σ0..*CodeableConceptA 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 Σ0..*ProductShelfLifeShelf Life and storage information
.... manufacturer Σ0..*Reference(Organization)Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property Σ0..*BackboneElementGeneral characteristics of this item
..... 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
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueAttachmentAttachment
.... containedItem Σ0..*BackboneElementThe item(s) within the packaging
..... 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
..... item Σ1..1CodeableReference(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 Σ0..1QuantityThe 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 Σ0..*See packaging (PackagedProductDefinition)Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ0..*See property (PackagedProductDefinition)Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
PackagedProductDefinition.languagerequiredAllLanguages
PackagedProductDefinition.typeexamplePackageType
PackagedProductDefinition.statuspreferredPublicationStatus
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
PackagedProductDefinition.packaging.typeexamplePackagingType
PackagedProductDefinition.packaging.materialexamplePackageMaterial
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic

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 PackagedProductDefinition

Summary

Mandatory: 1 element
Must-Support: 1 element

Differential View

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..*PackagedProductDefinitionA medically related item or items, in a container or package
... name S0..1stringA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type 1..1CodeableConceptA high level category e.g. medicinal product, raw material, shipping container etc

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..*PackagedProductDefinitionA medically related item or items, in a container or package
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... type Σ1..1CodeableConceptA high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

... status ?!Σ0..1CodeableConceptThe 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
PackagedProductDefinition.typeexamplePackageType
PackagedProductDefinition.statuspreferredPublicationStatus

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..*PackagedProductDefinitionA medically related item or items, in a container or package
... 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 ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierA unique identifier for this package as whole - not for the content of the package
... name SΣ0..1stringA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type Σ1..1CodeableConceptA high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

... packageFor Σ0..*Reference(MedicinalProductDefinition)The product that this is a pack for
... status ?!Σ0..1CodeableConceptThe 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 Σ0..1dateTimeThe date at which the given status became applicable
... containedItemQuantity Σ0..*QuantityA 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 Σ0..1markdownTextual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ0..*BackboneElementThe legal status of supply of the packaged item as classified by the regulator
.... 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 Σ0..1CodeableConceptThe 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 Σ0..1CodeableConceptThe place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

... marketingStatus Σ0..*MarketingStatusAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
... copackagedIndicator Σ0..1booleanIdentifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer Σ0..*Reference(Organization)Manufacturer of this package type (multiple means these are all possible manufacturers)
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the packaged product
... packaging Σ0..1BackboneElementA 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..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier Σ0..*IdentifierAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type Σ0..1CodeableConceptThe physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

.... componentPart Σ0..1booleanIs 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 Σ0..1integerThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material Σ0..*CodeableConceptMaterial type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... alternateMaterial Σ0..*CodeableConceptA 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 Σ0..*ProductShelfLifeShelf Life and storage information
.... manufacturer Σ0..*Reference(Organization)Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property Σ0..*BackboneElementGeneral characteristics of this item
..... 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
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueAttachmentAttachment
.... containedItem Σ0..*BackboneElementThe item(s) within the packaging
..... 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
..... item Σ1..1CodeableReference(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 Σ0..1QuantityThe 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 Σ0..*See packaging (PackagedProductDefinition)Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ0..*See property (PackagedProductDefinition)Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
PackagedProductDefinition.languagerequiredAllLanguages
PackagedProductDefinition.typeexamplePackageType
PackagedProductDefinition.statuspreferredPublicationStatus
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
PackagedProductDefinition.packaging.typeexamplePackagingType
PackagedProductDefinition.packaging.materialexamplePackageMaterial
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic

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 PackagedProductDefinition

Summary

Mandatory: 1 element
Must-Support: 1 element

 

Other representations of profile: CSV, Excel, Schematron