Order Catalog Implementation Guide
current - CI Build

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

Defining URL:http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DrugPackage
Version:current
Name:DrugPackage
Title:definition of a packaging of a medication
Status:Draft as of 2022-06-10 11:57:00+0100
Definition:

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

Publisher:HL7 International - Orders and Observations Work Group
Source Resource:XML / JSON / Turtle

The official URL for this profile is:

http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DrugPackage

Formal Views of Profile Content

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

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 1 element
Must-Support: 1 element

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
... 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
... 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: Jurisdiction ValueSet (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
... characteristic Σ0..*CodeableConceptAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Binding: PackageCharacteristic (example): A characteristic of a package.


... 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.

.... 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
.... packaging Σ0..*See packaging (PackagedProductDefinition)Allows containers (and parts of containers) within containers, still a single packaged product

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..*PackagedProductDefinitionA medically related item or items, in a container or package
... name Σ0..1stringA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc

doco Documentation for this format

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

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
... 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: Jurisdiction ValueSet (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
... characteristic Σ0..*CodeableConceptAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Binding: PackageCharacteristic (example): A characteristic of a package.


... 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.

.... 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
.... packaging Σ0..*See packaging (PackagedProductDefinition)Allows containers (and parts of containers) within containers, still a single packaged product

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
PackagedProductDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
PackagedProductDefinition.typeexamplePackageType
PackagedProductDefinition.statuspreferredPublicationStatus
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdiction ValueSet
PackagedProductDefinition.characteristicexamplePackageCharacteristic
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()