Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the PackagedProductDefinition resource.

PackagedProductDefinition
Element IdPackagedProductDefinition
Definition

A medically related item or items, in a container or package.

Cardinality0..*
TypeDomainResource
Summaryfalse
PackagedProductDefinition.identifier
Element IdPackagedProductDefinition.identifier
Definition

Unique identifier.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
PackagedProductDefinition.name
Element IdPackagedProductDefinition.name
Definition

A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.

Cardinality0..1
Typestring
Summarytrue
PackagedProductDefinition.type
Element IdPackagedProductDefinition.type
Definition

A high level category e.g. medicinal product, raw material, shipping/transport container, etc.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.packageFor
Element IdPackagedProductDefinition.packageFor
Definition

The product that this is a pack for.

Cardinality0..*
TypeReference(MedicinalProductDefinition)
Summarytrue
PackagedProductDefinition.status
Element IdPackagedProductDefinition.status
Definition

The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.

Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Is Modifiertrue (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)
Summarytrue
PackagedProductDefinition.statusDate
Element IdPackagedProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Cardinality0..1
TypedateTime
Summarytrue
PackagedProductDefinition.containedItemQuantity
Element IdPackagedProductDefinition.containedItemQuantity
Definition

A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.

Cardinality0..*
TypeQuantity
Summarytrue
PackagedProductDefinition.description
Element IdPackagedProductDefinition.description
Definition

Textual description. Note that this is not the name of the package or product.

Cardinality0..1
Typemarkdown
Summarytrue
PackagedProductDefinition.legalStatusOfSupply
Element IdPackagedProductDefinition.legalStatusOfSupply
Definition

The legal status of supply of the packaged item as classified by the regulator.

Cardinality0..*
Summarytrue
PackagedProductDefinition.legalStatusOfSupply.code
Element IdPackagedProductDefinition.legalStatusOfSupply.code
Definition

The actual status of supply. In what situation this package type may be supplied for use.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.legalStatusOfSupply.jurisdiction
Element IdPackagedProductDefinition.legalStatusOfSupply.jurisdiction
Definition

The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.marketingStatus
Element IdPackagedProductDefinition.marketingStatus
Definition

Marketing information.

Cardinality0..*
TypeMarketingStatus
Summarytrue
PackagedProductDefinition.characteristic
Element IdPackagedProductDefinition.characteristic
Definition

Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".

Cardinality0..*
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.copackagedIndicator
Element IdPackagedProductDefinition.copackagedIndicator
Definition

States whether a drug product is supplied with another item such as a diluent or adjuvant.

Cardinality0..1
Typeboolean
Summarytrue
PackagedProductDefinition.manufacturer
Element IdPackagedProductDefinition.manufacturer
Definition

Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.

Cardinality0..*
TypeReference(Organization)
Summarytrue
PackagedProductDefinition.attachedDocument
Element IdPackagedProductDefinition.attachedDocument
Definition

Additional information or supporting documentation about the packaged product.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
PackagedProductDefinition.package
Element IdPackagedProductDefinition.package
Definition

A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).

Cardinality0..1
Summarytrue
PackagedProductDefinition.package.identifier
Element IdPackagedProductDefinition.package.identifier
Definition

Including possibly Data Carrier Identifier.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
PackagedProductDefinition.package.type
Element IdPackagedProductDefinition.package.type
Definition

The physical type of the container of the items.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.quantity
Element IdPackagedProductDefinition.package.quantity
Definition

The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.

Cardinality0..1
Typeinteger
Summarytrue
PackagedProductDefinition.package.material
Element IdPackagedProductDefinition.package.material
Definition

Material type of the package item.

Cardinality0..*
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.alternateMaterial
Element IdPackagedProductDefinition.package.alternateMaterial
Definition

A possible alternate material for the packaging.

Cardinality0..*
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.shelfLifeStorage
Element IdPackagedProductDefinition.package.shelfLifeStorage
Definition

Shelf Life and storage information.

Cardinality0..*
TypeProductShelfLife
Summarytrue
PackagedProductDefinition.package.manufacturer
Element IdPackagedProductDefinition.package.manufacturer
Definition

Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers.

Cardinality0..*
TypeReference(Organization)
Summarytrue
PackagedProductDefinition.package.property
Element IdPackagedProductDefinition.package.property
Definition

General characteristics of this item.

Cardinality0..*
Summarytrue
PackagedProductDefinition.package.property.type
Element IdPackagedProductDefinition.package.property.type
Definition

A code expressing the type of characteristic.

Cardinality1..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.property.value[x]
Element IdPackagedProductDefinition.package.property.value[x]
Definition

A value for the characteristic.

Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
PackagedProductDefinition.package.containedItem
Element IdPackagedProductDefinition.package.containedItem
Definition

The item(s) within the packaging.

Cardinality0..*
Summarytrue
PackagedProductDefinition.package.containedItem.item
Element IdPackagedProductDefinition.package.containedItem.item
Definition

The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package).

Cardinality1..1
TypeCodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)
PatternsCodeableReference(ManufacturedItemDefinition,DeviceDefinition,PackagedProductDefinition,BiologicallyDerivedProduct,NutritionProduct): No common pattern
Summarytrue
PackagedProductDefinition.package.containedItem.amount
Element IdPackagedProductDefinition.package.containedItem.amount
Definition

The number of this type of item within this packaging.

Cardinality0..1
TypeQuantity
Summarytrue
PackagedProductDefinition.package.package
Element IdPackagedProductDefinition.package.package
Definition

Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition).

Cardinality0..*
TypeSee PackagedProductDefinition.package
Summarytrue