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Biomedical Research and Regulation ![]() | Maturity Level: 2 | Trial Use | Security 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.
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.)
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 |
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 |