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
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

The medicinal product that this is a prepared administrable form of. This element is not a reference to the item(s) that make up this administrable form (for which see AdministrableProductDefinition.producedFrom). It is medicinal product as a whole, which may have several components (as well as packaging, devices etc.), that are given to the patient in this final administrable form. A single medicinal product may have several different administrable products (e.g. a tablet and a cream), and these could have different administrable forms (e.g. tablet as oral solid, or tablet crushed).

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
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
TypeCodeableConcept
Summarytrue
AdministrableProductDefinition.producedFrom
Element IdAdministrableProductDefinition.producedFrom
Definition

The constituent 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 solvent item, to make a consumable solution). Note the items this is produced from are not raw ingredients (see AdministrableProductDefinition.ingredient), but manufactured medication items (ManufacturedItemDefinitions), which may be combined or prepared and transformed for patient use. The constituent items that this administrable form is produced from are all part of the product (for which see AdministrableProductDefinition.formOf).

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..*
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 products onset of action.

Cardinality0..*
Summarytrue
AdministrableProductDefinition.property.type
Element IdAdministrableProductDefinition.property.type
Definition

A code expressing the type of characteristic.

Cardinality1..1
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
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.

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

Coded expression for the route.

Cardinality1..1
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, can be 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 an Investigational Medicinal 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
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 applues, e.g. meat, milk.

Cardinality1..1
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