Release 4B R5 Final QA

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-draft-final: Final QA Preview for R5 - STU see ballot notes ). The current version which supercedes this version is 5.0.0 . 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 icon Work Group Maturity Level : 1 2   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 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

This resource is referenced by

15.5.3 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 Σ C 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: UnitOfPresentation 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
SNOMEDCTSubstanceCodes 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
SNOMEDCTCharacteristicCodes Binding: Product Characteristic ( Example )
. . . . value[x] Σ 0..1 A value for the characteristic
. . . . . valueCodeableConcept CodeableConcept
. . . . . valueQuantity Quantity
. . . . . valueDate date
. . . . . valueDate valueBoolean date boolean
. . . . . valueBoolean valueMarkdown boolean 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: TargetSpecies 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: AnimalTissueType 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

UML Diagram ( Legend )

AdministrableProductDefinition ( DomainResource ) An identifier for the administrable product identifier : Identifier [0..*] The status of this administrable product. Enables tracking the life-cycle of the content (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) PublicationStatus ! » 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 formOf : Reference [0..*] « MedicinalProductDefinition » « This element has or is affected by some invariants C » 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 : CodeableConcept [0..1] « null (Strength=Example) AdministrableDoseForm ?? » 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 : CodeableConcept [0..1] « null (Strength=Example) UnitOfPresentation ?? » 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 producedFrom : Reference [0..*] « ManufacturedItemDefinition » 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 : CodeableConcept [0..*] « null (Strength=Example) SNOMEDCTSubstanceCodes ?? » 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 : Reference [0..1] « DeviceDefinition » 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 description : markdown [0..1] Property A code expressing the type of characteristic type : CodeableConcept [1..1] « null (Strength=Example) SNOMEDCTCharacteristicCodes ProductCharacteristic ?? » A value for the characteristic value[x] : Element DataType [0..1] « CodeableConcept | Quantity | date | boolean | markdown | Attachment | Reference ( Binary ) » The status of characteristic e.g. assigned or pending status : CodeableConcept [0..1] « null (Strength=Required) PublicationStatus ! » RouteOfAdministration Coded expression for the route code : CodeableConcept [1..1] « null (Strength=Example) SNOMEDCTRouteCodes ?? » The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement firstDose : Quantity [0..1] The maximum single dose that can be administered, specified using a numerical value and its unit of measurement maxSingleDose : Quantity [0..1] The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered maxDosePerDay : Quantity [0..1] The maximum dose per treatment period that can be administered maxDosePerTreatmentPeriod : Ratio [0..1] The maximum treatment period during which the product can be administered maxTreatmentPeriod : Duration [0..1] TargetSpecies Coded expression for the species code : CodeableConcept [1..1] « null (Strength=Example) TargetSpecies ?? » WithdrawalPeriod Coded expression for the type of tissue for which the withdrawal period applies, e.g. meat, milk tissue : CodeableConcept [1..1] « null (Strength=Example) AnimalTissueType ?? » A value for the time value : Quantity [1..1] Extra information about the withdrawal period supportingInformation : string [0..1] Characteristics e.g. a product's onset of action property [0..*] A species specific time during which consumption of animal product is not appropriate withdrawalPeriod [0..*] A species for which this route applies targetSpecies [0..*] 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) routeOfAdministration [1..*]

XML Template 

<AdministrableProductDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- 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>

 <formOf><!-- I 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 --></formOf>

 <administrableDoseForm><!-- 0..1 CodeableConcept The dose form of the final product after necessary reconstitution or processing --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The presentation type in which this item is given to a patient. e.g. for a spray - 'puff' --></unitOfPresentation>
 <producedFrom><!-- 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 --></producedFrom>
 <</ingredient>

 <ingredient><!-- 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 --></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 --></device>
 <description value="[markdown]"/><!-- 0..1 A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed -->

 <property>  <!-- 0..* Characteristics e.g. a product's onset of action -->
  <</type>
  <</value[x]>

  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|markdown|Attachment|
    Reference(Binary) 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 -->
  <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 --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose quantity to be administered in any one 24-h period --></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 the 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 The type of tissue for which the withdrawal period applies, 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 

{doco
  "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) }], // I 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

  "administrableDoseForm" : { CodeableConcept }, // The dose form of the final product after necessary reconstitution or processing
  "unitOfPresentation" : { CodeableConcept }, // The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
  "producedFrom" : [{ 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" : [{ 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

  "device" : { Reference(DeviceDefinition) }, // A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
  "description" : "<markdown>", // A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed

  "property" : [{ // Characteristics e.g. a product's onset of action
    "
    

    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 7:
    "valueCodeableConcept" : { CodeableConcept },
    "valueQuantity" : { Quantity },
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueMarkdown" : "<markdown>",

    "valueAttachment" : { Attachment },
    "valueReference" : { Reference(Binary) },

    "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
    "code" : { CodeableConcept }, // R!  Coded expression for the route
    "firstDose" : { Quantity }, // The first dose (dose quantity) administered can be specified for the product
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered
    "maxDosePerDay" : { Quantity }, // The maximum dose quantity to be administered in any one 24-h period
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which the 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!  The type of tissue for which the withdrawal period applies, 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/> .doco


[ 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    # . One of these 5
      fhir: ]
      fhir: ]
      fhir: ]
      fhir: ]
      fhir: ]
    fhir:
  ], ...;
  fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:
        fhir:
        fhir:
        fhir:
      ], ...;
    ], ...;
  ], ...;

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* An identifier for the administrable product
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:formOf  ( [ Reference(MedicinalProductDefinition) ] ... ) ; # 0..* I 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
  fhir:administrableDoseForm [ CodeableConcept ] ; # 0..1 The dose form of the final product after necessary reconstitution or processing
  fhir:unitOfPresentation [ CodeableConcept ] ; # 0..1 The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
  fhir:producedFrom  ( [ Reference(ManufacturedItemDefinition) ] ... ) ; # 0..* Indicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form
  fhir:ingredient  ( [ CodeableConcept ] ... ) ; # 0..* 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
  fhir: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
  fhir:description [ markdown ] ; # 0..1 A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed
  fhir:property ( [ # 0..* Characteristics e.g. a product's onset of action
    fhir:type [ CodeableConcept ] ; # 1..1 A code expressing the type of characteristic
    # value[x] : 0..1 A value for the characteristic. One of these 7
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:date ; date ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:markdown ; markdown ]
      fhir:value [  a fhir:Attachment ; Attachment ]
      fhir:value [  a fhir:Reference ; Reference(Binary) ]
    fhir:status [ CodeableConcept ] ; # 0..1 The status of characteristic e.g. assigned or pending
  ] ... ) ;
  fhir:routeOfAdministration ( [ # 1..* The path by which the product is taken into or makes contact with the body
    fhir:code [ CodeableConcept ] ; # 1..1 Coded expression for the route
    fhir:firstDose [ Quantity ] ; # 0..1 The first dose (dose quantity) administered can be specified for the product
    fhir:maxSingleDose [ Quantity ] ; # 0..1 The maximum single dose that can be administered
    fhir:maxDosePerDay [ Quantity ] ; # 0..1 The maximum dose quantity to be administered in any one 24-h period
    fhir:maxDosePerTreatmentPeriod [ Ratio ] ; # 0..1 The maximum dose per treatment period that can be administered
    fhir:maxTreatmentPeriod [ Duration ] ; # 0..1 The maximum treatment period during which the product can be administered
    fhir:targetSpecies ( [ # 0..* A species for which this route applies
      fhir:code [ CodeableConcept ] ; # 1..1 Coded expression for the species
      fhir:withdrawalPeriod ( [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:tissue [ CodeableConcept ] ; # 1..1 The type of tissue for which the withdrawal period applies, e.g. meat, milk
        fhir:value [ Quantity ] ; # 1..1 A value for the time
        fhir:supportingInformation [ string ] ; # 0..1 Extra information about the withdrawal period
      ] ... ) ;
    ] ... ) ;
  ] ... ) ;

]

Changes since R4

This resource did not exist in Release 3

This analysis is available as XML or JSON .

Conversions between R3 and R4

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 Σ C 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: UnitOfPresentation 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
SNOMEDCTSubstanceCodes 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
SNOMEDCTCharacteristicCodes Binding: Product Characteristic ( Example )
. . . . value[x] Σ 0..1 A value for the characteristic
. . . . . valueCodeableConcept CodeableConcept
. . . . . valueQuantity Quantity
. . . . . valueDate date
. . . . . valueDate valueBoolean date boolean
. . . . . valueBoolean valueMarkdown boolean 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: TargetSpecies 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: AnimalTissueType 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

UML Diagram ( Legend )

AdministrableProductDefinition ( DomainResource ) An identifier for the administrable product identifier : Identifier [0..*] The status of this administrable product. Enables tracking the life-cycle of the content (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) PublicationStatus ! » 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 formOf : Reference [0..*] « MedicinalProductDefinition » « This element has or is affected by some invariants C » 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 : CodeableConcept [0..1] « null (Strength=Example) AdministrableDoseForm ?? » 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 : CodeableConcept [0..1] « null (Strength=Example) UnitOfPresentation ?? » 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 producedFrom : Reference [0..*] « ManufacturedItemDefinition » 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 : CodeableConcept [0..*] « null (Strength=Example) SNOMEDCTSubstanceCodes ?? » 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 : Reference [0..1] « DeviceDefinition » 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 description : markdown [0..1] Property A code expressing the type of characteristic type : CodeableConcept [1..1] « null (Strength=Example) SNOMEDCTCharacteristicCodes ProductCharacteristic ?? » A value for the characteristic value[x] : Element DataType [0..1] « CodeableConcept | Quantity | date | boolean | markdown | Attachment | Reference ( Binary ) » The status of characteristic e.g. assigned or pending status : CodeableConcept [0..1] « null (Strength=Required) PublicationStatus ! » RouteOfAdministration Coded expression for the route code : CodeableConcept [1..1] « null (Strength=Example) SNOMEDCTRouteCodes ?? » The first dose (dose quantity) administered can be specified for the product, using a numerical value and its unit of measurement firstDose : Quantity [0..1] The maximum single dose that can be administered, specified using a numerical value and its unit of measurement maxSingleDose : Quantity [0..1] The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered maxDosePerDay : Quantity [0..1] The maximum dose per treatment period that can be administered maxDosePerTreatmentPeriod : Ratio [0..1] The maximum treatment period during which the product can be administered maxTreatmentPeriod : Duration [0..1] TargetSpecies Coded expression for the species code : CodeableConcept [1..1] « null (Strength=Example) TargetSpecies ?? » WithdrawalPeriod Coded expression for the type of tissue for which the withdrawal period applies, e.g. meat, milk tissue : CodeableConcept [1..1] « null (Strength=Example) AnimalTissueType ?? » A value for the time value : Quantity [1..1] Extra information about the withdrawal period supportingInformation : string [0..1] Characteristics e.g. a product's onset of action property [0..*] A species specific time during which consumption of animal product is not appropriate withdrawalPeriod [0..*] A species for which this route applies targetSpecies [0..*] 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) routeOfAdministration [1..*]

XML Template 

<AdministrableProductDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- 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>

 <formOf><!-- I 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 --></formOf>

 <administrableDoseForm><!-- 0..1 CodeableConcept The dose form of the final product after necessary reconstitution or processing --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The presentation type in which this item is given to a patient. e.g. for a spray - 'puff' --></unitOfPresentation>
 <producedFrom><!-- 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 --></producedFrom>
 <</ingredient>

 <ingredient><!-- 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 --></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 --></device>
 <description value="[markdown]"/><!-- 0..1 A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed -->

 <property>  <!-- 0..* Characteristics e.g. a product's onset of action -->
  <</type>
  <</value[x]>

  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|markdown|Attachment|
    Reference(Binary) 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 -->
  <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 --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose quantity to be administered in any one 24-h period --></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 the 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 The type of tissue for which the withdrawal period applies, 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 

{doco
  "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) }], // I 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

  "administrableDoseForm" : { CodeableConcept }, // The dose form of the final product after necessary reconstitution or processing
  "unitOfPresentation" : { CodeableConcept }, // The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
  "producedFrom" : [{ 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" : [{ 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

  "device" : { Reference(DeviceDefinition) }, // A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
  "description" : "<markdown>", // A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed

  "property" : [{ // Characteristics e.g. a product's onset of action
    "
    

    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 7:
    "valueCodeableConcept" : { CodeableConcept },
    "valueQuantity" : { Quantity },
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueMarkdown" : "<markdown>",

    "valueAttachment" : { Attachment },
    "valueReference" : { Reference(Binary) },

    "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
    "code" : { CodeableConcept }, // R!  Coded expression for the route
    "firstDose" : { Quantity }, // The first dose (dose quantity) administered can be specified for the product
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered
    "maxDosePerDay" : { Quantity }, // The maximum dose quantity to be administered in any one 24-h period
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which the 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!  The type of tissue for which the withdrawal period applies, 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/> .doco


[ 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:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    # . One of these 5
      fhir: ]
      fhir: ]
      fhir: ]
      fhir: ]
      fhir: ]
    fhir:
  ], ...;
  fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:
        fhir:
        fhir:
        fhir:
      ], ...;
    ], ...;
  ], ...;

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* An identifier for the administrable product
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:formOf  ( [ Reference(MedicinalProductDefinition) ] ... ) ; # 0..* I 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
  fhir:administrableDoseForm [ CodeableConcept ] ; # 0..1 The dose form of the final product after necessary reconstitution or processing
  fhir:unitOfPresentation [ CodeableConcept ] ; # 0..1 The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
  fhir:producedFrom  ( [ Reference(ManufacturedItemDefinition) ] ... ) ; # 0..* Indicates the specific manufactured items that are part of the 'formOf' product that are used in the preparation of this specific administrable form
  fhir:ingredient  ( [ CodeableConcept ] ... ) ; # 0..* 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
  fhir: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
  fhir:description [ markdown ] ; # 0..1 A general description of the product, when in its final form, suitable for administration e.g. effervescent blue liquid, to be swallowed
  fhir:property ( [ # 0..* Characteristics e.g. a product's onset of action
    fhir:type [ CodeableConcept ] ; # 1..1 A code expressing the type of characteristic
    # value[x] : 0..1 A value for the characteristic. One of these 7
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:date ; date ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:markdown ; markdown ]
      fhir:value [  a fhir:Attachment ; Attachment ]
      fhir:value [  a fhir:Reference ; Reference(Binary) ]
    fhir:status [ CodeableConcept ] ; # 0..1 The status of characteristic e.g. assigned or pending
  ] ... ) ;
  fhir:routeOfAdministration ( [ # 1..* The path by which the product is taken into or makes contact with the body
    fhir:code [ CodeableConcept ] ; # 1..1 Coded expression for the route
    fhir:firstDose [ Quantity ] ; # 0..1 The first dose (dose quantity) administered can be specified for the product
    fhir:maxSingleDose [ Quantity ] ; # 0..1 The maximum single dose that can be administered
    fhir:maxDosePerDay [ Quantity ] ; # 0..1 The maximum dose quantity to be administered in any one 24-h period
    fhir:maxDosePerTreatmentPeriod [ Ratio ] ; # 0..1 The maximum dose per treatment period that can be administered
    fhir:maxTreatmentPeriod [ Duration ] ; # 0..1 The maximum treatment period during which the product can be administered
    fhir:targetSpecies ( [ # 0..* A species for which this route applies
      fhir:code [ CodeableConcept ] ; # 1..1 Coded expression for the species
      fhir:withdrawalPeriod ( [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:tissue [ CodeableConcept ] ; # 1..1 The type of tissue for which the withdrawal period applies, e.g. meat, milk
        fhir:value [ Quantity ] ; # 1..1 A value for the time
        fhir:supportingInformation [ string ] ; # 0..1 Extra information about the withdrawal period
      ] ... ) ;
    ] ... ) ;
  ] ... ) ;

]

Changes since Release 4

This resource did not exist in Release 3

This analysis is available as XML or JSON .

Conversions between R3 and R4

 

See the Profiles & Extensions and the alternate 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 Definition ValueSet Type Reference Documentation
AdministrableProductDefinition.status PublicationStatus Required PublicationStatus

The lifecycle status of an artifact.

AdministrableProductDefinition.administrableDoseForm AdministrableDoseForm Example AdministrableDoseForm

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

AdministrableProductDefinition.unitOfPresentation UnitOfPresentation Example UnitOfPresentation

The presentation type in which an administrable medicinal product is given to a patient.

AdministrableProductDefinition.ingredient SNOMEDCTSubstanceCodes Example http://hl7.org/fhir/ValueSet/substance-codes

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

AdministrableProductDefinition.property.type ProductCharacteristic Example http://hl7.org/fhir/ValueSet/product-characteristic-codes

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

AdministrableProductDefinition.property.status PublicationStatus Required PublicationStatus

The lifecycle status of an artifact.

AdministrableProductDefinition.routeOfAdministration.code SNOMEDCTRouteCodes Example SNOMEDCTRouteCodes

This value set includes all Route codes from SNOMED CT - provided as an exemplar.

AdministrableProductDefinition.routeOfAdministration.targetSpecies.code TargetSpecies Example TargetSpecies

A species for which a medicinal product is intended.

AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue AnimalTissueType Example AnimalTissueType

A tissue type of an animal.

15.5.3.2 Constraints

id UniqueKey Level Location Description Expression
apd-1 img  apd-1 Rule (base) 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.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