Release
4B
5
Medication
Definition
This
page
is
part
of
the
FHIR
Specification
(v4.3.0:
R4B
(v5.0.0:
R5
-
STU
).
The
This
is
the
current
published
version
which
supercedes
in
it's
permanent
home
(it
will
always
be
available
at
this
version
is
5.0.0
.
URL).
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R5
R4B
|
Biomedical
Research
and
Regulation
Work
Group
|
Maturity
Level
:
|
Trial Use | Security Category : Anonymous |
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
supply,
shipping
or
similar
use.
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.
themselves
and
may
contain
other
packages
(parent/child
relationships).
In
some
cases
a
"product"
exists
at
a
exists
at
logically
higher
level,
which
different
levels,
and
therefore
has
a
variety
of
available
packages
associated
with
it,
typically
of
it.
Typically
the
packages
are
associated
with
different
sizes.
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.)
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
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: |
packageFor
|
Σ | 0..* | Reference ( MedicinalProductDefinition ) |
The
product
that
this
is
a
pack
for
|
|
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
|
|
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: |
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 |
|
|
|
|
manufacturer
|
Σ |
|
|
|
|
|
Σ | 0..* |
Reference
(
|
|
|
|
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: |
|
|
Σ | 0..1 |
|
|
|
quantity
|
Σ |
|
|
|
|
|
Σ | 0..* | CodeableConcept |
Binding: |
|
alternateMaterial
|
Σ | 0..* |
|
Binding: Package Material |
|
|
Σ | 0..* |
|
|
|
manufacturer
|
Σ | 0..* | Reference ( Organization ) |
Manufacturer
of
this
|
|
property
|
Σ | 0..* | BackboneElement |
General
characteristics
of
this
item
|
|
type
|
Σ | 1..1 | CodeableConcept |
A
code
expressing
the
type
of
characteristic
|
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)
|
|
Σ | 0..* |
see
|
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"
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
UML Diagram ( Legend )
XML Template
<PackagedProductDefinition xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension -->
<</identifier><identifier><!-- 0..* Identifier A unique identifier for this package as whole - not for the content of the package --></identifier> <name value="[string]"/><!-- 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc --> <type><!-- 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc --></type><</packageFor><packageFor><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></packageFor> <status><!-- 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 --></status> <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable --><</containedItemQuantity><containedItemQuantity><!-- 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) --></containedItemQuantity> <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the package or product --> <legalStatusOfSupply> <!-- 0..* The legal status of supply of the packaged item as classified by the regulator --> <code><!-- 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use --></code> <jurisdiction><!-- 0..1 CodeableConcept The place where the legal status of supply applies --></jurisdiction> </legalStatusOfSupply> <marketingStatus><!-- 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 --></marketingStatus><</characteristic> <<copackagedIndicator value="[boolean]"/><!-- 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant --> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers) --></manufacturer>< <</identifier> <</type> < <</material> <</alternateMaterial> < <</type> <</period[x]> <</specialPrecautionsForStorage> </shelfLifeStorage> <</manufacturer> < <</type> <</value[x]><attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product --></attachedDocument> <packaging> <!-- 0..1 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><!-- 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier --></identifier> <type><!-- 0..1 CodeableConcept The physical type of the container of the items --></type> <componentPart value="[boolean]"/><!-- 0..1 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 value="[integer]"/><!-- 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) --> <material><!-- 0..* CodeableConcept Material type of the package item --></material> <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material --></alternateMaterial> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers) --></manufacturer> <property> <!-- 0..* General characteristics of this item --> <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type> <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]> </property>< <|<containedItem> <!-- 0..* The item(s) within the packaging --> <item><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|DeviceDefinition| ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) 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 --></item><</amount><amount><!-- 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) --></amount> </containedItem><</package> </package><packaging><!-- 0..* Content as for PackagedProductDefinition.packaging Allows containers (and parts of containers) within containers, still as a part of single packaged product --></packaging> </packaging> <characteristic><!-- 0..* Content as for PackagedProductDefinition.packaging.property Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" --></characteristic> </PackagedProductDefinition>
JSON Template
{
"resourceType" : "PackagedProductDefinition",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"
"identifier" : [{ Identifier }], // A unique identifier for this package as whole - not for the content of the package
"name" : "<string>", // A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
"type" : { CodeableConcept }, // A high level category e.g. medicinal product, raw material, shipping container etc
"
"packageFor" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for
"status" : { 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
"statusDate" : "<dateTime>", // The date at which the given status became applicable
"
"containedItemQuantity" : [{ 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" : "<markdown>", // Textual description. Note that this is not the name of the package or product
"legalStatusOfSupply" : [{ // The legal status of supply of the packaged item as classified by the regulator
"code" : { CodeableConcept }, // The actual status of supply. In what situation this package type may be supplied for use
"jurisdiction" : { CodeableConcept } // The place where the legal status of supply applies
}],
"marketingStatus" : [{ 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" : <boolean>, // Identifies if the drug product is supplied with another item such as a diluent or adjuvant
"manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package type (multiple means these are all possible manufacturers)
"
"
"
"
"
"
"
"
The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
" },
">",
"
}],
"
"
"
"attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the packaged product
"packaging" : { // 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" : [{ Identifier }], // An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
"type" : { CodeableConcept }, // The physical type of the container of the items
"componentPart" : <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" : <integer>, // The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
"material" : [{ CodeableConcept }], // Material type of the package item
"alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
"shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
"manufacturer" : [{ Reference(Organization) }], // Manufacturer of this packaging item (multiple means these are all potential manufacturers)
"property" : [{ // General characteristics of this item
"type" : { CodeableConcept }, // R! A code expressing the type of characteristic
// value[x]: A value for the characteristic. One of these 5:
" }
" }
">"
">
" }
"valueCodeableConcept" : { CodeableConcept },
"valueQuantity" : { Quantity },
"valueDate" : "<date>",
"valueBoolean" : <boolean>,
"valueAttachment" : { Attachment }
}],
"
"|
"containedItem" : [{ // The item(s) within the packaging
"item" : { CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|
ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) }, // R! 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" : { 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" : [{ Content as for PackagedProductDefinition.packaging }] // Allows containers (and parts of containers) within containers, still as a part of single packaged product
},
"characteristic" : [{ Content as for PackagedProductDefinition.packaging.property }] // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: # . One of these 2 fhir: ] fhir: ] fhir: ], ...; fhir: fhir: fhir: # . One of these 5 fhir: ] fhir: ] fhir: ] fhir: ] fhir: ] ], ...; fhir: fhir:| fhir: ], ...; fhir: ];fhir:identifier ( [ Identifier ] ... ) ; # 0..* A unique identifier for this package as whole - not for the content of the package fhir:name [ string ] ; # 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc fhir:type [ CodeableConcept ] ; # 0..1 A high level category e.g. medicinal product, raw material, shipping container etc fhir:packageFor ( [ Reference(MedicinalProductDefinition) ] ... ) ; # 0..* The product that this is a pack for fhir:status [ CodeableConcept ] ; # 0..1 The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status fhir:statusDate [ dateTime ] ; # 0..1 The date at which the given status became applicable fhir:containedItemQuantity ( [ Quantity ] ... ) ; # 0..* 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) fhir:description [ markdown ] ; # 0..1 Textual description. Note that this is not the name of the package or product fhir:legalStatusOfSupply ( [ # 0..* The legal status of supply of the packaged item as classified by the regulator fhir:code [ CodeableConcept ] ; # 0..1 The actual status of supply. In what situation this package type may be supplied for use fhir:jurisdiction [ CodeableConcept ] ; # 0..1 The place where the legal status of supply applies ] ... ) ; fhir:marketingStatus ( [ MarketingStatus ] ... ) ; # 0..* Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated fhir:copackagedIndicator [ boolean ] ; # 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this package type (multiple means these are all possible manufacturers) fhir:attachedDocument ( [ Reference(DocumentReference) ] ... ) ; # 0..* Additional information or supporting documentation about the packaged product fhir:packaging [ # 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap fhir:identifier ( [ Identifier ] ... ) ; # 0..* An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier fhir:type [ CodeableConcept ] ; # 0..1 The physical type of the container of the items fhir:componentPart [ boolean ] ; # 0..1 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) fhir:quantity [ integer ] ; # 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) fhir:material ( [ CodeableConcept ] ... ) ; # 0..* Material type of the package item fhir:alternateMaterial ( [ CodeableConcept ] ... ) ; # 0..* A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material fhir:shelfLifeStorage ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this packaging item (multiple means these are all potential manufacturers) fhir:property ( [ # 0..* General characteristics of this item fhir:type [ CodeableConcept ] ; # 1..1 A code expressing the type of characteristic # value[x] : 0..1 A value for the characteristic. One of these 5 fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:date ; date ] fhir:value [ a fhir:boolean ; boolean ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:containedItem ( [ # 0..* The item(s) within the packaging fhir:item [ CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|ManufacturedItemDefinition| NutritionProduct|PackagedProductDefinition) ] ; # 1..1 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 fhir:amount [ Quantity ] ; # 0..1 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) ] ... ) ; fhir:packaging ( [ See PackagedProductDefinition.packaging ] ... ) ; # 0..* Allows containers (and parts of containers) within containers, still as a part of single packaged product ] ; fhir:characteristic ( [ See PackagedProductDefinition.packaging.property ] ... ) ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" ]
Changes
since
from
both
R4
and
R4B
This
resource
did
not
exist
in
Release
3
R4
See the Full Difference for further information
This
analysis
is
available
for
R4
as
XML
or
JSON
.
Conversions
between
R3
and
R4
for
R4B
as
XML
or
JSON
.
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
|
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: |
|
packageFor
|
Σ | 0..* | Reference ( MedicinalProductDefinition ) |
The
product
that
this
is
a
pack
for
|
|
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
|
|
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: |
|
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 |
|
|
|
|
manufacturer
|
Σ |
|
|
|
|
|
Σ | 0..* |
Reference
(
|
|
|
|
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: |
|
|
Σ | 0..1 |
|
|
|
quantity
|
Σ |
|
|
|
|
|
Σ | 0..* | CodeableConcept |
Binding: |
|
alternateMaterial
|
Σ | 0..* |
|
Binding: Package Material |
|
|
Σ | 0..* |
|
|
|
manufacturer
|
Σ | 0..* | Reference ( Organization ) |
Manufacturer
of
this
|
|
property
|
Σ | 0..* | BackboneElement |
General
characteristics
of
this
item
|
|
type
|
Σ | 1..1 | CodeableConcept |
A
code
expressing
the
type
of
characteristic
|
|
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)
|
|
|
Σ | 0..* |
see
|
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"
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
XML Template
<PackagedProductDefinition xmlns="http://hl7.org/fhir"><</identifier><identifier><!-- 0..* Identifier A unique identifier for this package as whole - not for the content of the package --></identifier> <name value="[string]"/><!-- 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc --> <type><!-- 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc --></type><</packageFor><packageFor><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></packageFor> <status><!-- 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 --></status> <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable --><</containedItemQuantity><containedItemQuantity><!-- 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) --></containedItemQuantity> <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the package or product --> <legalStatusOfSupply> <!-- 0..* The legal status of supply of the packaged item as classified by the regulator --> <code><!-- 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use --></code> <jurisdiction><!-- 0..1 CodeableConcept The place where the legal status of supply applies --></jurisdiction> </legalStatusOfSupply> <marketingStatus><!-- 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 --></marketingStatus><</characteristic> <<copackagedIndicator value="[boolean]"/><!-- 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant --> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers) --></manufacturer>< <</identifier> <</type> < <</material> <</alternateMaterial> < <</type> <</period[x]> <</specialPrecautionsForStorage> </shelfLifeStorage> <</manufacturer> < <</type> <</value[x]><attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product --></attachedDocument> <packaging> <!-- 0..1 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><!-- 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier --></identifier> <type><!-- 0..1 CodeableConcept The physical type of the container of the items --></type> <componentPart value="[boolean]"/><!-- 0..1 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 value="[integer]"/><!-- 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) --> <material><!-- 0..* CodeableConcept Material type of the package item --></material> <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material --></alternateMaterial> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers) --></manufacturer> <property> <!-- 0..* General characteristics of this item --> <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type> <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]> </property>< <|<containedItem> <!-- 0..* The item(s) within the packaging --> <item><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|DeviceDefinition| ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) 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 --></item><</amount><amount><!-- 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) --></amount> </containedItem><</package> </package><packaging><!-- 0..* Content as for PackagedProductDefinition.packaging Allows containers (and parts of containers) within containers, still as a part of single packaged product --></packaging> </packaging> <characteristic><!-- 0..* Content as for PackagedProductDefinition.packaging.property Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" --></characteristic> </PackagedProductDefinition>
JSON Template
{
"resourceType" : "PackagedProductDefinition",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"
"identifier" : [{ Identifier }], // A unique identifier for this package as whole - not for the content of the package
"name" : "<string>", // A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
"type" : { CodeableConcept }, // A high level category e.g. medicinal product, raw material, shipping container etc
"
"packageFor" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for
"status" : { 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
"statusDate" : "<dateTime>", // The date at which the given status became applicable
"
"containedItemQuantity" : [{ 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" : "<markdown>", // Textual description. Note that this is not the name of the package or product
"legalStatusOfSupply" : [{ // The legal status of supply of the packaged item as classified by the regulator
"code" : { CodeableConcept }, // The actual status of supply. In what situation this package type may be supplied for use
"jurisdiction" : { CodeableConcept } // The place where the legal status of supply applies
}],
"marketingStatus" : [{ 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" : <boolean>, // Identifies if the drug product is supplied with another item such as a diluent or adjuvant
"manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package type (multiple means these are all possible manufacturers)
"
"
"
"
"
"
"
"
The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
" },
">",
"
}],
"
"
"
"attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the packaged product
"packaging" : { // 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" : [{ Identifier }], // An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
"type" : { CodeableConcept }, // The physical type of the container of the items
"componentPart" : <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" : <integer>, // The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
"material" : [{ CodeableConcept }], // Material type of the package item
"alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
"shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
"manufacturer" : [{ Reference(Organization) }], // Manufacturer of this packaging item (multiple means these are all potential manufacturers)
"property" : [{ // General characteristics of this item
"type" : { CodeableConcept }, // R! A code expressing the type of characteristic
// value[x]: A value for the characteristic. One of these 5:
" }
" }
">"
">
" }
"valueCodeableConcept" : { CodeableConcept },
"valueQuantity" : { Quantity },
"valueDate" : "<date>",
"valueBoolean" : <boolean>,
"valueAttachment" : { Attachment }
}],
"
"|
"containedItem" : [{ // The item(s) within the packaging
"item" : { CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|
ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) }, // R! 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" : { 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" : [{ Content as for PackagedProductDefinition.packaging }] // Allows containers (and parts of containers) within containers, still as a part of single packaged product
},
"characteristic" : [{ Content as for PackagedProductDefinition.packaging.property }] // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: # . One of these 2 fhir: ] fhir: ] fhir: ], ...; fhir: fhir: fhir: # . One of these 5 fhir: ] fhir: ] fhir: ] fhir: ] fhir: ] ], ...; fhir: fhir:| fhir: ], ...; fhir: ];fhir:identifier ( [ Identifier ] ... ) ; # 0..* A unique identifier for this package as whole - not for the content of the package fhir:name [ string ] ; # 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc fhir:type [ CodeableConcept ] ; # 0..1 A high level category e.g. medicinal product, raw material, shipping container etc fhir:packageFor ( [ Reference(MedicinalProductDefinition) ] ... ) ; # 0..* The product that this is a pack for fhir:status [ CodeableConcept ] ; # 0..1 The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status fhir:statusDate [ dateTime ] ; # 0..1 The date at which the given status became applicable fhir:containedItemQuantity ( [ Quantity ] ... ) ; # 0..* 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) fhir:description [ markdown ] ; # 0..1 Textual description. Note that this is not the name of the package or product fhir:legalStatusOfSupply ( [ # 0..* The legal status of supply of the packaged item as classified by the regulator fhir:code [ CodeableConcept ] ; # 0..1 The actual status of supply. In what situation this package type may be supplied for use fhir:jurisdiction [ CodeableConcept ] ; # 0..1 The place where the legal status of supply applies ] ... ) ; fhir:marketingStatus ( [ MarketingStatus ] ... ) ; # 0..* Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated fhir:copackagedIndicator [ boolean ] ; # 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this package type (multiple means these are all possible manufacturers) fhir:attachedDocument ( [ Reference(DocumentReference) ] ... ) ; # 0..* Additional information or supporting documentation about the packaged product fhir:packaging [ # 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap fhir:identifier ( [ Identifier ] ... ) ; # 0..* An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier fhir:type [ CodeableConcept ] ; # 0..1 The physical type of the container of the items fhir:componentPart [ boolean ] ; # 0..1 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) fhir:quantity [ integer ] ; # 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) fhir:material ( [ CodeableConcept ] ... ) ; # 0..* Material type of the package item fhir:alternateMaterial ( [ CodeableConcept ] ... ) ; # 0..* A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material fhir:shelfLifeStorage ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this packaging item (multiple means these are all potential manufacturers) fhir:property ( [ # 0..* General characteristics of this item fhir:type [ CodeableConcept ] ; # 1..1 A code expressing the type of characteristic # value[x] : 0..1 A value for the characteristic. One of these 5 fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:date ; date ] fhir:value [ a fhir:boolean ; boolean ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:containedItem ( [ # 0..* The item(s) within the packaging fhir:item [ CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|ManufacturedItemDefinition| NutritionProduct|PackagedProductDefinition) ] ; # 1..1 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 fhir:amount [ Quantity ] ; # 0..1 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) ] ... ) ; fhir:packaging ( [ See PackagedProductDefinition.packaging ] ... ) ; # 0..* Allows containers (and parts of containers) within containers, still as a part of single packaged product ] ; fhir:characteristic ( [ See PackagedProductDefinition.packaging.property ] ... ) ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" ]
Changes
since
Release
4
from
both
R4
and
R4B
This
resource
did
not
exist
in
Release
3
R4
See the Full Difference for further information
This
analysis
is
available
for
R4
as
XML
or
JSON
.
Conversions
between
R3
and
R4
for
R4B
as
XML
or
JSON
.
See
the
Profiles
&
Extensions
and
the
alternate
Additional
definitions:
Master
Definition
XML
+
JSON
,
XML
Schema
/
Schematron
+
JSON
Schema
,
ShEx
(for
Turtle
)
+
see
the
extensions
,
the
spreadsheet
version
&
the
dependency
analysis
| Path |
|
Type |
|
|---|---|---|---|
| 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 |
|
|
|
contained-item
|
reference | Any of the contained items within this packaged product |
|
|
|
device
|
reference | A device within this packaged product |
|
|
| identifier | token | Unique identifier | PackagedProductDefinition.identifier | |
|
manufactured-item
|
reference | A manufactured item of medication within this packaged product |
|
|
|
medication
|
reference | A manufactured item of medication within this packaged product |
|
|
|
name
|
token |
A
name
for
this
package.
Typically
what
it
would
be
listed
as
in
a
drug
formulary
or
catalogue,
inventory
|
PackagedProductDefinition.name | |
|
nutrition
|
reference | A nutrition product within this packaged product |
|
|
|
package
|
reference | A complete packaged product within this packaged product |
|
|
| 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 |
FHIR
®©
HL7.org
2011+.
FHIR
Release
4B
(v4.3.0)
hl7.fhir.r4b.core#4.3.0
R5
hl7.fhir.core#5.0.0
generated
on
Sat,
May
28,
2022
12:56+1000.
Sun,
Mar
26,
2023
15:25+1100.
Links:
Search
|
Version
History
|
Table
of
Contents
|
Glossary
|
QA
Page
|
Compare
to
R4
|
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to
R4B
|
|
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a
change