Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any 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).

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.routeOfAdministration.code.count() + AdministrableProductDefinition.formOf.resolve().route.count()) < 2
AdministrableProductDefinition.identifier
Element IdAdministrableProductDefinition.identifier
Definition

An 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.

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.

Cardinality0..*
TypeReference(MedicinalProductDefinition)
Summarytrue
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').

Cardinality0..1
Terminology BindingAdministrableDoseForm (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').

Cardinality0..1
Terminology BindingUnitOfPresentation (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.

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.

Cardinality0..*
Terminology BindingSNOMEDCTSubstanceCodes :
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.

Cardinality0..1
TypeReference(DeviceDefinition)
Summarytrue
AdministrableProductDefinition.property
Element IdAdministrableProductDefinition.property
Definition

Characteristics 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.

Cardinality1..1
Terminology BindingSNOMEDCTCharacteristicCodes :
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.property.value[x]
Element IdAdministrableProductDefinition.property.value[x]
Definition

A value for the characteristic.

Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Data Types 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.

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).

Cardinality1..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.code
Element IdAdministrableProductDefinition.routeOfAdministration.code
Definition

Coded 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.

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.

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.

Cardinality0..1
TypeQuantity
Summarytrue
AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod
Element IdAdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod
Definition

The 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.

Cardinality0..1
TypeDuration
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies
Definition

A species for which this route applies.

Cardinality0..*
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.code
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.code
Definition

Coded expression for the species.

Cardinality1..1
Terminology BindingTargetSpecies (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.

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.

Cardinality1..1
Terminology BindingAnimalTissueType (Example)
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Element IdAdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value
Definition

A 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.

Cardinality0..1
Typestring
Summarytrue