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15.2 Resource PackagedProductDefinition - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

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



For an overview of this resource and others in the Medication Definition domain, also see the module page

A medically related item or items of any type, in a container or package, representing the unit that has been prepared for sale, supply, shipping or storage. These can include packaged medications, devices and other items such as food, biologicals, raw materials, cosmetics, medical fluids, gases etc. This resource represents the whole package of items, and all the packaging within, rather than the individual items themselves and may contain other packages (parent/child relationships). In some cases a "product" exists at exists at logically different levels, and therefore has a variety of available packages associated with it. Typically the packages are associated with different sizes/quantities.

This resource is usually used with MedicinalProductDefinition, via the productFor relationship. For cases where only a subset of PackagedProductDefinition is need in a product, use as a contained resource to MPD may be appropriate. See MedicinalProductDefinition for an example.

The PackagedProductDefinition resource covers two main areas - package types that exist for a product (linked via productFor), and the packaging within those packages.

These can be thought of as the "package type" and the "packaging" respectively. The package type is covered by the PackagedProductDefinition class and the packaging by the Package backbone element (broadly the left and right of the UML model). It is possible to leave either part un-populated.

A package type can be documented without needing to say in detail what physical packaging or items are within it. This is common in many drug dictionaries, which list package types, but not their internals.

Conversely it is possible to only populate the Package backbone, and child classes, to cover packaging of an item but not say anything about the product outer packaging or the overall package that will eventually be on sale. This would be appropriate when focusing on the physical product and the inner packaging, perhaps at a manufacturing stage, without needing to populate package details not relevant (or not existing) at that phase.

Other implementations will use both "halves". A single application could start by using the Package class for packaging and then populate the package type data later on.

It is very important that a consistent representation is used. Packaging always uses the Package backbone, whether or not there are any package type properties documented. A diagram of this is shown on the Medication Definition module page.

This resource has two recursive relationships. One is primarily intended to be "internal" to the package - for package layers and contents, and the other for aggregated packages (e.g. for wholesaling) that are made up of other packages.

  • PackagedProductDefinition.package.package
    This recursive relationship is used for the inner parts and containers within a package - the package being indivisible and marketed or prescribed as a whole entity. However see also the "referenceable" packaging case in the next bullet.
  • PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
    This recursive route is primarily for cases where the whole (indivisible) package is then aggregated into another, divisible, package - for example a warehousing or transport pack. This represents a package of packages. It is not generally used for the internal parts of a single package (see previous bullet). However for cases where there is a need to represent the distinct regulation of specific inner parts of a package, and so a need for these to be directly referenceable as packaging layers by other resources, this relationship SHOULD also be used for packaging within the package.

Feedback
In order to properly meet all packaging uses cases, consistent representation of different package information and recursive relationships are aspects of this resource that BR&R workgroup are particularly seeking implementation feedback on. (Comments links are found at the bottom of each page.)

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition TU DomainResource A medically related item or items, in a container or package

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... 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 Σ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: Package Type (Example)
... 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)
... 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 Σ 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

.... code Σ 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: Legal Status Of Supply (Example)
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: Jurisdiction ValueSet (Example)
... 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 Σ 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
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier

.... type Σ 0..1 CodeableConcept The physical type of the container of the items
Binding: Packaging Type (Example)
.... 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 Σ 0..* CodeableConcept Material type of the package item
Binding: Package Material (Example)

.... 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: Package Material (Example)

.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information

.... manufacturer Σ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)

.... property Σ 0..* BackboneElement General characteristics of this item

..... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Product Characteristic (Example)
..... value[x] Σ 0..1 A value for the characteristic
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging

..... 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 Σ 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 Σ 0..* see packaging Allows containers (and parts of containers) within containers, still as a part of single packaged product

... characteristic Σ 0..* see property Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"


doco Documentation for this format icon

See the Extensions for this resource

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

Path ValueSet Type Documentation
PackagedProductDefinition.type PackageType Example

A high level categorisation of a package.

PackagedProductDefinition.status PublicationStatus Preferred

The lifecycle status of an artifact.

PackagedProductDefinition.legalStatusOfSupply.code LegalStatusOfSupply Example

The prescription supply types appropriate to a medicinal product

PackagedProductDefinition.legalStatusOfSupply.jurisdiction JurisdictionValueSet Example

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.

PackagedProductDefinition.packaging.type PackagingType Example

A type of packaging.

PackagedProductDefinition.packaging.material PackageMaterial Example

A material used in the construction of packages and their components.

PackagedProductDefinition.packaging.alternateMaterial PackageMaterial Example

A material used in the construction of packages and their components.

PackagedProductDefinition.packaging.property.type ProductCharacteristic Example

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.



Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
biological reference A biologically derived product within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
contained-item reference Any of the contained items within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
device reference A device within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
identifier token Unique identifier PackagedProductDefinition.identifier
manufactured-item reference A manufactured item of medication within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
medication reference A manufactured item of medication within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
name token A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. PackagedProductDefinition.name
nutrition reference A nutrition product within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
package reference A complete packaged product within this packaged product PackagedProductDefinition.packaging.containedItem.item.reference
package-for reference The product that this is a pack for PackagedProductDefinition.packageFor
(MedicinalProductDefinition)
status token 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 PackagedProductDefinition.status