This page is part of the FHIR Specification v4.3.0-snapshot1: R4B Snapshot to support the Jan 2022 Connectathon. About the R4B version of FHIR. The current officially released version is 4.3.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.5 Resource AdministrableProductDefinition - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security Category: Anonymous

Compartments: Not linked to any 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 processinng 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.

15.5.2 References

This resource is referenced by Ingredient and PlanDefinition.

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
AdministrableProductDefinition	TU		DomainResource	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) 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 PublicationStatus (Required)
formOf	Σ	0..*	Reference(MedicinalProductDefinition)	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)
administrableDoseForm	Σ	0..1	CodeableConcept	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')
unitOfPresentation	Σ	0..1	CodeableConcept	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')
producedFrom	Σ	0..*	Reference(ManufacturedItemDefinition)	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)
ingredient	Σ	0..*	CodeableConcept	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
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. This is not intended for devices that are just co-packaged
property	Σ	0..*	BackboneElement	Characteristics e.g. a products onset of action
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
status	Σ	0..1	CodeableConcept	The status of characteristic e.g. assigned or pending
routeOfAdministration	Σ	1..*	BackboneElement	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
code	Σ	1..1	CodeableConcept	Coded expression for the route
firstDose	Σ	0..1	Quantity	The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
maxSingleDose	Σ	0..1	Quantity	The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
maxDosePerDay	Σ	0..1	Quantity	The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
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 an Investigational Medicinal 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
withdrawalPeriod	Σ	0..*	BackboneElement	A species specific time during which consumption of animal product is not appropriate
tissue	Σ	1..1	CodeableConcept	Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
value	Σ	1..1	Quantity	A value for the time
supportingInformation	Σ	0..1	string	Extra information about the withdrawal period
Documentation for this format

UML Diagram (Legend)

XML Template

<AdministrableProductDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier An identifier for the administrable product --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <formOf><!-- 0..* Reference(MedicinalProductDefinition) 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) --></formOf>
 <administrableDoseForm><!-- 0..1 CodeableConcept 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') --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept 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') --></unitOfPresentation>
 <producedFrom><!-- 0..* Reference(ManufacturedItemDefinition) 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) --></producedFrom>
 <ingredient><!-- 0..* CodeableConcept 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 --></ingredient>
 <device><!-- 0..1 Reference(DeviceDefinition) 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 --></device>
 <property>  <!-- 0..* Characteristics e.g. a products onset of action -->
  <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]>
  <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status>
 </property>
 <routeOfAdministration>  <!-- 1..* 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 -->
  <code><!-- 1..1 CodeableConcept Coded expression for the route --></code>
  <firstDose><!-- 0..1 Quantity The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered --></maxDosePerDay>
  <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered --></maxDosePerTreatmentPeriod>
  <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered --></maxTreatmentPeriod>
  <targetSpecies>  <!-- 0..* A species for which this route applies -->
   <code><!-- 1..1 CodeableConcept Coded expression for the species --></code>
   <withdrawalPeriod>  <!-- 0..* A species specific time during which consumption of animal product is not appropriate -->
    <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue>
    <value><!-- 1..1 Quantity A value for the time --></value>
    <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period -->
   </withdrawalPeriod>
  </targetSpecies>
 </routeOfAdministration>
</AdministrableProductDefinition>

JSON Template

{
  "resourceType" : "AdministrableProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // An identifier for the administrable product
  "status" : "<code>", // R!  draft | active | retired | unknown
  "formOf" : [{ Reference(MedicinalProductDefinition) }], // 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)
  "administrableDoseForm" : { CodeableConcept }, // 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')
  "unitOfPresentation" : { CodeableConcept }, // 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')
  "producedFrom" : [{ Reference(ManufacturedItemDefinition) }], // 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)
  "ingredient" : [{ CodeableConcept }], // 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
  "device" : { Reference(DeviceDefinition) }, // 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
  "property" : [{ // Characteristics e.g. a products onset of action
    "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 },
    "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending
  }],
  "routeOfAdministration" : [{ // R!  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
    "code" : { CodeableConcept }, // R!  Coded expression for the route
    "firstDose" : { Quantity }, // The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
    "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered
    "targetSpecies" : [{ // A species for which this route applies
      "code" : { CodeableConcept }, // R!  Coded expression for the species
      "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate
        "tissue" : { CodeableConcept }, // R!  Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        "value" : { Quantity }, // R!  A value for the time
        "supportingInformation" : "<string>" // Extra information about the withdrawal period
      }]
    }]
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:AdministrableProductDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:AdministrableProductDefinition.identifier [ Identifier ], ... ; # 0..* An identifier for the administrable product
  fhir:AdministrableProductDefinition.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:AdministrableProductDefinition.formOf [ Reference(MedicinalProductDefinition) ], ... ; # 0..* 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)
  fhir:AdministrableProductDefinition.administrableDoseForm [ CodeableConcept ]; # 0..1 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')
  fhir:AdministrableProductDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 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')
  fhir:AdministrableProductDefinition.producedFrom [ Reference(ManufacturedItemDefinition) ], ... ; # 0..* 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)
  fhir:AdministrableProductDefinition.ingredient [ CodeableConcept ], ... ; # 0..* 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
  fhir:AdministrableProductDefinition.device [ Reference(DeviceDefinition) ]; # 0..1 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
  fhir:AdministrableProductDefinition.property [ # 0..* Characteristics e.g. a products onset of action
    fhir:AdministrableProductDefinition.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # AdministrableProductDefinition.property.value[x] : 0..1 A value for the characteristic. One of these 5
      fhir:AdministrableProductDefinition.property.valueCodeableConcept [ CodeableConcept ]
      fhir:AdministrableProductDefinition.property.valueQuantity [ Quantity ]
      fhir:AdministrableProductDefinition.property.valueDate [ date ]
      fhir:AdministrableProductDefinition.property.valueBoolean [ boolean ]
      fhir:AdministrableProductDefinition.property.valueAttachment [ Attachment ]
    fhir:AdministrableProductDefinition.property.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending
  ], ...;
  fhir:AdministrableProductDefinition.routeOfAdministration [ # 1..* 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
    fhir:AdministrableProductDefinition.routeOfAdministration.code [ CodeableConcept ]; # 1..1 Coded expression for the route
    fhir:AdministrableProductDefinition.routeOfAdministration.firstDose [ Quantity ]; # 0..1 The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period
      ], ...;
    ], ...;
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
AdministrableProductDefinition	TU		DomainResource	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) 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 PublicationStatus (Required)
formOf	Σ	0..*	Reference(MedicinalProductDefinition)	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)
administrableDoseForm	Σ	0..1	CodeableConcept	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')
unitOfPresentation	Σ	0..1	CodeableConcept	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')
producedFrom	Σ	0..*	Reference(ManufacturedItemDefinition)	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)
ingredient	Σ	0..*	CodeableConcept	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
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. This is not intended for devices that are just co-packaged
property	Σ	0..*	BackboneElement	Characteristics e.g. a products onset of action
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
status	Σ	0..1	CodeableConcept	The status of characteristic e.g. assigned or pending
routeOfAdministration	Σ	1..*	BackboneElement	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
code	Σ	1..1	CodeableConcept	Coded expression for the route
firstDose	Σ	0..1	Quantity	The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
maxSingleDose	Σ	0..1	Quantity	The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
maxDosePerDay	Σ	0..1	Quantity	The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
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 an Investigational Medicinal 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
withdrawalPeriod	Σ	0..*	BackboneElement	A species specific time during which consumption of animal product is not appropriate
tissue	Σ	1..1	CodeableConcept	Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
value	Σ	1..1	Quantity	A value for the time
supportingInformation	Σ	0..1	string	Extra information about the withdrawal period
Documentation for this format

UML Diagram (Legend)

XML Template

<AdministrableProductDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier An identifier for the administrable product --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <formOf><!-- 0..* Reference(MedicinalProductDefinition) 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) --></formOf>
 <administrableDoseForm><!-- 0..1 CodeableConcept 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') --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept 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') --></unitOfPresentation>
 <producedFrom><!-- 0..* Reference(ManufacturedItemDefinition) 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) --></producedFrom>
 <ingredient><!-- 0..* CodeableConcept 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 --></ingredient>
 <device><!-- 0..1 Reference(DeviceDefinition) 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 --></device>
 <property>  <!-- 0..* Characteristics e.g. a products onset of action -->
  <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]>
  <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status>
 </property>
 <routeOfAdministration>  <!-- 1..* 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 -->
  <code><!-- 1..1 CodeableConcept Coded expression for the route --></code>
  <firstDose><!-- 0..1 Quantity The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered --></maxDosePerDay>
  <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered --></maxDosePerTreatmentPeriod>
  <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered --></maxTreatmentPeriod>
  <targetSpecies>  <!-- 0..* A species for which this route applies -->
   <code><!-- 1..1 CodeableConcept Coded expression for the species --></code>
   <withdrawalPeriod>  <!-- 0..* A species specific time during which consumption of animal product is not appropriate -->
    <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue>
    <value><!-- 1..1 Quantity A value for the time --></value>
    <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period -->
   </withdrawalPeriod>
  </targetSpecies>
 </routeOfAdministration>
</AdministrableProductDefinition>

JSON Template

{
  "resourceType" : "AdministrableProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // An identifier for the administrable product
  "status" : "<code>", // R!  draft | active | retired | unknown
  "formOf" : [{ Reference(MedicinalProductDefinition) }], // 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)
  "administrableDoseForm" : { CodeableConcept }, // 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')
  "unitOfPresentation" : { CodeableConcept }, // 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')
  "producedFrom" : [{ Reference(ManufacturedItemDefinition) }], // 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)
  "ingredient" : [{ CodeableConcept }], // 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
  "device" : { Reference(DeviceDefinition) }, // 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
  "property" : [{ // Characteristics e.g. a products onset of action
    "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 },
    "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending
  }],
  "routeOfAdministration" : [{ // R!  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
    "code" : { CodeableConcept }, // R!  Coded expression for the route
    "firstDose" : { Quantity }, // The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
    "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered
    "targetSpecies" : [{ // A species for which this route applies
      "code" : { CodeableConcept }, // R!  Coded expression for the species
      "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate
        "tissue" : { CodeableConcept }, // R!  Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        "value" : { Quantity }, // R!  A value for the time
        "supportingInformation" : "<string>" // Extra information about the withdrawal period
      }]
    }]
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:AdministrableProductDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:AdministrableProductDefinition.identifier [ Identifier ], ... ; # 0..* An identifier for the administrable product
  fhir:AdministrableProductDefinition.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:AdministrableProductDefinition.formOf [ Reference(MedicinalProductDefinition) ], ... ; # 0..* 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)
  fhir:AdministrableProductDefinition.administrableDoseForm [ CodeableConcept ]; # 0..1 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')
  fhir:AdministrableProductDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 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')
  fhir:AdministrableProductDefinition.producedFrom [ Reference(ManufacturedItemDefinition) ], ... ; # 0..* 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)
  fhir:AdministrableProductDefinition.ingredient [ CodeableConcept ], ... ; # 0..* 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
  fhir:AdministrableProductDefinition.device [ Reference(DeviceDefinition) ]; # 0..1 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
  fhir:AdministrableProductDefinition.property [ # 0..* Characteristics e.g. a products onset of action
    fhir:AdministrableProductDefinition.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # AdministrableProductDefinition.property.value[x] : 0..1 A value for the characteristic. One of these 5
      fhir:AdministrableProductDefinition.property.valueCodeableConcept [ CodeableConcept ]
      fhir:AdministrableProductDefinition.property.valueQuantity [ Quantity ]
      fhir:AdministrableProductDefinition.property.valueDate [ date ]
      fhir:AdministrableProductDefinition.property.valueBoolean [ boolean ]
      fhir:AdministrableProductDefinition.property.valueAttachment [ Attachment ]
    fhir:AdministrableProductDefinition.property.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending
  ], ...;
  fhir:AdministrableProductDefinition.routeOfAdministration [ # 1..* 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
    fhir:AdministrableProductDefinition.routeOfAdministration.code [ CodeableConcept ]; # 1..1 Coded expression for the route
    fhir:AdministrableProductDefinition.routeOfAdministration.firstDose [ Quantity ]; # 0..1 The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered, can be specified using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period
      ], ...;
    ], ...;
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

15.5.3.1 Terminology Bindings

Path	Definition	Type	Reference
AdministrableProductDefinition.status		Required	PublicationStatus

Path

Definition

Type

Reference

AdministrableProductDefinition.status

Required

PublicationStatus

15.5.4 Search Parameters

Search parameters for 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
target-species	token	Coded expression for the species	AdministrableProductDefinition.routeOfAdministration.targetSpecies.code