R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

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

Detailed Descriptions for the elements in the AdministrableProductDefinition resource.

AdministrableProductDefinition
Element IdAdministrableProductDefinition
Definition

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).

Short DisplayA medicinal product in the final form, suitable for administration - after any mixing of multiple components
Cardinality0..*
TypeDomainResource
Alternate NamesPharmaceutical Product
Summaryfalse
Invariants
Defined on this element
apd-1Rule RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)AdministrableProductDefinition.formOf.resolve().route.empty()
AdministrableProductDefinition.identifier
Element IdAdministrableProductDefinition.identifier
Definition

An identifier for the administrable product.

Short DisplayAn identifier for the administrable product
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
AdministrableProductDefinition.status
Element IdAdministrableProductDefinition.status
Definition

The status of this administrable product. Enables tracking the life-cycle of the content.

Short Displaydraft | active | retired | unknown
Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summarytrue
Comments

Allows filtering of administrable products that are appropriate for use versus not.

AdministrableProductDefinition.formOf
Element IdAdministrableProductDefinition.formOf
Definition

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. If this administrable product describes the administration of a crushed tablet, the 'formOf' would be the product representing a distribution containing tablets and possibly also a cream. This is distinct from the 'producedFrom' which refers to the specific components of the product that are used in this preparation, rather than the product as a whole.

Short DisplayReferences 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
Cardinality0..*
TypeReference(MedicinalProductDefinition)
Summarytrue
Invariants
Affect this element
apd-1Rule RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa)AdministrableProductDefinition.formOf.resolve().route.empty()
AdministrableProductDefinition.administrableDoseForm
Element IdAdministrableProductDefinition.administrableDoseForm
Definition

The dose form of the final product after necessary reconstitution or processing. Contrasts to the manufactured dose form (see ManufacturedItemDefinition). If the manufactured form was 'powder for solution for injection', the administrable dose form could be 'solution for injection' (once mixed with another item having manufactured form 'solvent for solution for injection').

Short DisplayThe dose form of the final product after necessary reconstitution or processing
Cardinality0..1
Terminology BindingAdministrable Dose Form (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.unitOfPresentation
Element IdAdministrableProductDefinition.unitOfPresentation
Definition

The presentation type in which this item is given to a patient. e.g. for a spray - 'puff' (as in 'contains 100 mcg per puff'), or for a liquid - 'vial' (as in 'contains 5 ml per vial').

Short DisplayThe presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
Cardinality0..1
Terminology BindingUnit Of Presentation (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.producedFrom
Element IdAdministrableProductDefinition.producedFrom
Definition

Indicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form. In some cases, an administrable form might use all of the items from the overall product (or there might only be one item), while in other cases, an administrable form might use only a subset of the items available in the overall product. For example, an administrable form might involve combining a liquid and a powder available as part of an overall product, but not involve applying the also supplied cream.

Short DisplayIndicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form
Cardinality0..*
TypeReference(ManufacturedItemDefinition)
Summarytrue
AdministrableProductDefinition.ingredient
Element IdAdministrableProductDefinition.ingredient
Definition

The ingredients of this administrable medicinal product. This is only needed if the ingredients are not specified either using ManufacturedItemDefiniton (via AdministrableProductDefinition.producedFrom) to state which component items are used to make this, or using by incoming references from the Ingredient resource, to state in detail which substances exist within this. This element allows a basic coded ingredient to be used.

Short DisplayThe 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
Cardinality0..*
Terminology BindingSNOMED CT Substance Codes (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.device
Element IdAdministrableProductDefinition.device
Definition

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.

Short DisplayA device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
Cardinality0..1
TypeReference(DeviceDefinition)
Summarytrue
AdministrableProductDefinition.description
Element IdAdministrableProductDefinition.description
Definition

A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed. Intended to be used when the other structured properties of this resource are insufficient or cannot be supported. It is not intended to duplicate information already carried elswehere.

Short DisplayA general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed
Cardinality0..1
Typemarkdown
Summaryfalse
AdministrableProductDefinition.property
Element IdAdministrableProductDefinition.property
Definition

Characteristics e.g. a product's onset of action.

Short DisplayCharacteristics e.g. a product's onset of action
Cardinality0..*
Summarytrue
AdministrableProductDefinition.property.type
Element IdAdministrableProductDefinition.property.type
Definition

A code expressing the type of characteristic.

Short DisplayA code expressing the type of characteristic
Cardinality1..1
Terminology BindingProduct Characteristic (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.property.value[x]
Element IdAdministrableProductDefinition.property.value[x]
Definition

A value for the characteristic.

Short DisplayA value for the characteristic
Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|markdown|Attachment|Reference(Binary)
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
AdministrableProductDefinition.property.status
Element IdAdministrableProductDefinition.property.status
Definition

The status of characteristic e.g. assigned or pending.

Short DisplayThe status of characteristic e.g. assigned or pending
Cardinality0..1
Terminology BindingPublicationStatus (Required)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration
Element IdAdministrableProductDefinition.routeOfAdministration
Definition

The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa).

Short DisplayThe path by which the product is taken into or makes contact with the body
Cardinality1..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.code
Element IdAdministrableProductDefinition.routeOfAdministration.code
Definition

Coded expression for the route.

Short DisplayCoded expression for the route
Cardinality1..1
Terminology BindingSNOMED CT Route Codes (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.firstDose
Element IdAdministrableProductDefinition.routeOfAdministration.firstDose
Definition

The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement.

Short DisplayThe first dose (dose quantity) administered can be specified for the product
Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxSingleDose
Element IdAdministrableProductDefinition.routeOfAdministration.maxSingleDose
Definition

The maximum single dose that can be administered, specified using a numerical value and its unit of measurement.

Short DisplayThe maximum single dose that can be administered
Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxDosePerDay
Element IdAdministrableProductDefinition.routeOfAdministration.maxDosePerDay
Definition

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered.

Short DisplayThe maximum dose quantity to be administered in any one 24-h period
Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod
Definition

The maximum dose per treatment period that can be administered.

Short DisplayThe maximum dose per treatment period that can be administered
Cardinality0..1
TypeRatio
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod
Definition

The maximum treatment period during which the product can be administered.

Short DisplayThe maximum treatment period during which the product can be administered
Cardinality0..1
TypeDuration
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies
Definition

A species for which this route applies.

Short DisplayA species for which this route applies
Cardinality0..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.code
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.code
Definition

Coded expression for the species.

Short DisplayCoded expression for the species
Cardinality1..1
Terminology BindingTarget Species (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod
Definition

A species specific time during which consumption of animal product is not appropriate.

Short DisplayA species specific time during which consumption of animal product is not appropriate
Cardinality0..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue
Definition

Coded expression for the type of tissue for which the withdrawal period applies, e.g. meat, milk.

Short DisplayThe type of tissue for which the withdrawal period applies, e.g. meat, milk
Cardinality1..1
Terminology BindingAnimal Tissue Type (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Definition

A value for the time.

Short DisplayA value for the time
Cardinality1..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation
Definition

Extra information about the withdrawal period.

Short DisplayExtra information about the withdrawal period
Cardinality0..1
Typestring
Summarytrue