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15.5 Resource AdministrableProductDefinition - Content

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

A medicinal product in the final form which is suitable for administering to a patient (after any mixing of multiple components, dissolution etc. has been performed).

15.5.1 Scope and Usage

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

A medicinal product may consist of several items, which need to be combined or processed before administration to the patient. This resource covers the ready-for-use administrable product - the components of which are ManufacturedItemDefinition resources. Note that in some cases the administrable product needs no processing or transformation from the manufactured item.

This resource represents the final form of the product; hence it details properties such as the route, that only apply to the final product. It is a definitional resource, representing the properties of a product, but not the actual instance given to someone. When necessary to record that, a Medication resource is used.

This resource corresponds to the Pharmaceutical Product as defined by the ISO IDMP set of standards, see ISO 11615 icon and ISO 11616 icon. To better align with the HL7 guidelines for supporting different product concepts and to avoid possible confusion with the resources defined in the Medications module of HL7 FHIR, the concept "Administrable Product" has been adopted for the name of this resource, whereas the terms and definitions of other core resources in the Medication Definition module do correspond directly to the ISO IDMP terms. See also the mapping table for a detailed mapping of this resource to the IDMP Pharmaceutical Product definition.

15.5.2 References to this Resource

15.5.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition TU DomainResource A medicinal product in the final form, suitable for administration - after any mixing of multiple components
+ Rule: RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ 0..* Identifier An identifier for the administrable product

... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... formOf ΣC 0..* Reference(MedicinalProductDefinition) References a product from which one or more of the constituent parts of that product can be prepared and used as described by this administrable product

... unitOfPresentation Σ 0..1 CodeableConcept The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
Binding: Unit Of Presentation (Example)
... producedFrom Σ 0..* Reference(ManufacturedItemDefinition) Indicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form

... ingredient Σ 0..* CodeableConcept The ingredients of this administrable medicinal product. This is only needed if the ingredients are not specified either using ManufacturedItemDefiniton, or using by incoming references from the Ingredient resource
Binding: SNOMED CT Substance Codes (Example)

... device Σ 0..1 Reference(DeviceDefinition) A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
... description 0..1 markdown A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed
... property Σ 0..* BackboneElement Characteristics e.g. a product's onset of action

.... 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
..... valueMarkdown markdown
..... valueAttachment Attachment
..... valueReference Reference(Binary)
.... status Σ 0..1 CodeableConcept The status of characteristic e.g. assigned or pending
Binding: PublicationStatus (Required)
... routeOfAdministration Σ 1..* BackboneElement The path by which the product is taken into or makes contact with the body

.... code Σ 1..1 CodeableConcept Coded expression for the route
Binding: SNOMED CT Route Codes (Example)
.... firstDose Σ 0..1 Quantity The first dose (dose quantity) administered can be specified for the product
.... maxSingleDose Σ 0..1 Quantity The maximum single dose that can be administered
.... maxDosePerDay Σ 0..1 Quantity The maximum dose quantity to be administered in any one 24-h period
.... maxDosePerTreatmentPeriod Σ 0..1 Ratio The maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ 0..1 Duration The maximum treatment period during which the product can be administered
.... targetSpecies Σ 0..* BackboneElement A species for which this route applies

..... code Σ 1..1 CodeableConcept Coded expression for the species
Binding: Target Species (Example)
..... withdrawalPeriod Σ 0..* BackboneElement A species specific time during which consumption of animal product is not appropriate

...... tissue Σ 1..1 CodeableConcept The type of tissue for which the withdrawal period applies, e.g. meat, milk
Binding: Animal Tissue Type (Example)
...... value Σ 1..1 Quantity A value for the time
...... supportingInformation Σ 0..1 string Extra information about the withdrawal period

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

15.5.3.1 Terminology Bindings

Path ValueSet Type Documentation
AdministrableProductDefinition.status PublicationStatus Required

The lifecycle status of an artifact.
AdministrableProductDefinition.administrableDoseForm AdministrableDoseForm Example

Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
AdministrableProductDefinition.unitOfPresentation UnitOfPresentation Example

The presentation type in which an administrable medicinal product is given to a patient.
AdministrableProductDefinition.ingredient SNOMEDCTSubstanceCodes Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
AdministrableProductDefinition.property.type ProductCharacteristic Example

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
AdministrableProductDefinition.property.status PublicationStatus Required

The lifecycle status of an artifact.
AdministrableProductDefinition.routeOfAdministration.code SNOMEDCTRouteCodes Example

This value set includes all Route codes from SNOMED CT - provided as an exemplar.
AdministrableProductDefinition.routeOfAdministration.targetSpecies.code TargetSpecies Example

A species for which a medicinal product is intended.
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue AnimalTissueType Example

A tissue type of an animal.

15.5.3.2 Constraints

UniqueKeyLevelLocationDescriptionExpression
img apd-1Rule (base)RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)AdministrableProductDefinition.formOf.resolve().route.empty()



15.5.4 Search Parameters

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
device reference A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product. This is not intended for devices that are just co-packaged AdministrableProductDefinition.device
(DeviceDefinition)
dose-form token The administrable dose form, i.e. the dose form of the final product after necessary reconstitution or processing AdministrableProductDefinition.administrableDoseForm
form-of reference The medicinal product that this is an administrable form of. This is not a reference to the item(s) that make up this administrable form - it is the whole product AdministrableProductDefinition.formOf
(MedicinalProductDefinition)
identifier token An identifier for the administrable product AdministrableProductDefinition.identifier
ingredient token The ingredients of this administrable medicinal product AdministrableProductDefinition.ingredient
manufactured-item reference The manufactured item(s) that this administrable product is produced from. Either a single item, or several that are mixed before administration (e.g. a power item and a solution item). Note that these are not raw ingredients AdministrableProductDefinition.producedFrom
(ManufacturedItemDefinition)
route token Coded expression for the route AdministrableProductDefinition.routeOfAdministration.code
status token The status of this administrable product. Enables tracking the life-cycle of the content. AdministrableProductDefinition.status
target-species token Coded expression for the species AdministrableProductDefinition.routeOfAdministration.targetSpecies.code