Release 4B

This page is part of the FHIR Specification (v4.3.0: R4B - STU). 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 Work GroupMaturity Level: 1 Trial UseSecurity 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.

15.5.2 References

This resource is referenced by Ingredient and PlanDefinition.

This resource does not implement any patterns.

15.5.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition TUDomainResourceA 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 Σ0..*IdentifierAn identifier for the administrable product
... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... formOf Σ0..*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 Σ0..1CodeableConceptThe presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
UnitOfPresentation (Example)
... producedFrom Σ0..*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 Σ0..*CodeableConceptThe 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 (Example)
... device Σ0..1Reference(DeviceDefinition)A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
... property Σ0..*BackboneElementCharacteristics e.g. a product's onset of action
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
SNOMEDCTCharacteristicCodes (Example)
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
.... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
PublicationStatus (Required)
... routeOfAdministration Σ1..*BackboneElementThe path by which the product is taken into or makes contact with the body
.... code Σ1..1CodeableConceptCoded expression for the route
SNOMED CT Route Codes (Example)
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered can be specified for the product
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered
.... maxDosePerDay Σ0..1QuantityThe maximum dose quantity to be administered in any one 24-h period
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which the product can be administered
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... code Σ1..1CodeableConceptCoded expression for the species
TargetSpecies (Example)
..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... tissue Σ1..1CodeableConceptThe type of tissue for which the withdrawal period applies, e.g. meat, milk
AnimalTissueType (Example)
...... value Σ1..1QuantityA value for the time
...... supportingInformation Σ0..1stringExtra information about the withdrawal period

doco Documentation for this format

UML Diagram (Legend)

AdministrableProductDefinition (DomainResource)An identifier for the administrable productidentifier : 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 wholeformOf : Reference [0..*] « MedicinalProductDefinition »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 creamproducedFrom : 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 usedingredient : 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-packageddevice : Reference [0..1] « DeviceDefinition »PropertyA code expressing the type of characteristictype : CodeableConcept [1..1] « null (Strength=Example)SNOMEDCTCharacteristicCodes?? »A value for the characteristicvalue[x] : Element [0..1] « CodeableConcept|Quantity|date|boolean| Attachment »The status of characteristic e.g. assigned or pendingstatus : CodeableConcept [0..1] « null (Strength=Required)PublicationStatus! »RouteOfAdministrationCoded expression for the routecode : 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 measurementfirstDose : Quantity [0..1]The maximum single dose that can be administered, specified using a numerical value and its unit of measurementmaxSingleDose : Quantity [0..1]The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administeredmaxDosePerDay : Quantity [0..1]The maximum dose per treatment period that can be administeredmaxDosePerTreatmentPeriod : Ratio [0..1]The maximum treatment period during which the product can be administeredmaxTreatmentPeriod : Duration [0..1]TargetSpeciesCoded expression for the speciescode : CodeableConcept [1..1] « null (Strength=Example)TargetSpecies?? »WithdrawalPeriodCoded expression for the type of tissue for which the withdrawal period applies, e.g. meat, milktissue : CodeableConcept [1..1] « null (Strength=Example)AnimalTissueType?? »A value for the timevalue : Quantity [1..1]Extra information about the withdrawal periodsupportingInformation : string [0..1]Characteristics e.g. a product's onset of actionproperty[0..*]A species specific time during which consumption of animal product is not appropriatewithdrawalPeriod[0..*]A species for which this route appliestargetSpecies[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><!-- 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><!-- 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>
 <property>  <!-- 0..* Characteristics e.g. a product's 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 -->
  <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) }], // 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
  "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 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
    "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: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..* 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:AdministrableProductDefinition.administrableDoseForm [ CodeableConcept ]; # 0..1 The dose form of the final product after necessary reconstitution or processing
  fhir:AdministrableProductDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
  fhir:AdministrableProductDefinition.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:AdministrableProductDefinition.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: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
  fhir:AdministrableProductDefinition.property [ # 0..* Characteristics e.g. a product's 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
    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
    fhir:AdministrableProductDefinition.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose quantity to be administered in any one 24-h period
    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 the 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 The type of tissue for which the withdrawal period applies, 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 R4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Conversions between R3 and R4

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition TUDomainResourceA 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 Σ0..*IdentifierAn identifier for the administrable product
... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... formOf Σ0..*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 Σ0..1CodeableConceptThe presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
UnitOfPresentation (Example)
... producedFrom Σ0..*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 Σ0..*CodeableConceptThe 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 (Example)
... device Σ0..1Reference(DeviceDefinition)A device that is integral to the medicinal product, in effect being considered as an "ingredient" of the medicinal product
... property Σ0..*BackboneElementCharacteristics e.g. a product's onset of action
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
SNOMEDCTCharacteristicCodes (Example)
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
.... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
PublicationStatus (Required)
... routeOfAdministration Σ1..*BackboneElementThe path by which the product is taken into or makes contact with the body
.... code Σ1..1CodeableConceptCoded expression for the route
SNOMED CT Route Codes (Example)
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered can be specified for the product
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered
.... maxDosePerDay Σ0..1QuantityThe maximum dose quantity to be administered in any one 24-h period
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which the product can be administered
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... code Σ1..1CodeableConceptCoded expression for the species
TargetSpecies (Example)
..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... tissue Σ1..1CodeableConceptThe type of tissue for which the withdrawal period applies, e.g. meat, milk
AnimalTissueType (Example)
...... value Σ1..1QuantityA value for the time
...... supportingInformation Σ0..1stringExtra information about the withdrawal period

doco Documentation for this format

UML Diagram (Legend)

AdministrableProductDefinition (DomainResource)An identifier for the administrable productidentifier : 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 wholeformOf : Reference [0..*] « MedicinalProductDefinition »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 creamproducedFrom : 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 usedingredient : 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-packageddevice : Reference [0..1] « DeviceDefinition »PropertyA code expressing the type of characteristictype : CodeableConcept [1..1] « null (Strength=Example)SNOMEDCTCharacteristicCodes?? »A value for the characteristicvalue[x] : Element [0..1] « CodeableConcept|Quantity|date|boolean| Attachment »The status of characteristic e.g. assigned or pendingstatus : CodeableConcept [0..1] « null (Strength=Required)PublicationStatus! »RouteOfAdministrationCoded expression for the routecode : 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 measurementfirstDose : Quantity [0..1]The maximum single dose that can be administered, specified using a numerical value and its unit of measurementmaxSingleDose : Quantity [0..1]The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administeredmaxDosePerDay : Quantity [0..1]The maximum dose per treatment period that can be administeredmaxDosePerTreatmentPeriod : Ratio [0..1]The maximum treatment period during which the product can be administeredmaxTreatmentPeriod : Duration [0..1]TargetSpeciesCoded expression for the speciescode : CodeableConcept [1..1] « null (Strength=Example)TargetSpecies?? »WithdrawalPeriodCoded expression for the type of tissue for which the withdrawal period applies, e.g. meat, milktissue : CodeableConcept [1..1] « null (Strength=Example)AnimalTissueType?? »A value for the timevalue : Quantity [1..1]Extra information about the withdrawal periodsupportingInformation : string [0..1]Characteristics e.g. a product's onset of actionproperty[0..*]A species specific time during which consumption of animal product is not appropriatewithdrawalPeriod[0..*]A species for which this route appliestargetSpecies[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><!-- 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><!-- 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>
 <property>  <!-- 0..* Characteristics e.g. a product's 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 -->
  <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) }], // 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
  "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 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
    "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: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..* 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:AdministrableProductDefinition.administrableDoseForm [ CodeableConcept ]; # 0..1 The dose form of the final product after necessary reconstitution or processing
  fhir:AdministrableProductDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The presentation type in which this item is given to a patient. e.g. for a spray - 'puff'
  fhir:AdministrableProductDefinition.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:AdministrableProductDefinition.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: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
  fhir:AdministrableProductDefinition.property [ # 0..* Characteristics e.g. a product's 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
    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
    fhir:AdministrableProductDefinition.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose quantity to be administered in any one 24-h period
    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 the 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 The type of tissue for which the withdrawal period applies, 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 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 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

PathDefinitionTypeReference
AdministrableProductDefinition.status RequiredPublicationStatus
AdministrableProductDefinition.administrableDoseForm ExampleAdministrableDoseForm
AdministrableProductDefinition.unitOfPresentation ExampleUnitOfPresentation
AdministrableProductDefinition.ingredient Examplehttp://hl7.org/fhir/ValueSet/substance-codes
AdministrableProductDefinition.property.type Examplehttp://hl7.org/fhir/ValueSet/product-characteristic-codes
AdministrableProductDefinition.property.status RequiredPublicationStatus
AdministrableProductDefinition.routeOfAdministration.code ExampleSNOMEDCTRouteCodes
AdministrableProductDefinition.routeOfAdministration.targetSpecies.code ExampleTargetSpecies
AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue ExampleAnimalTissueType

15.5.3.2 Constraints

idLevelLocationDescriptionExpression
apd-1Rule (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

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.

NameTypeDescriptionExpressionIn Common
devicereferenceA 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-packagedAdministrableProductDefinition.device
(DeviceDefinition)
dose-formtokenThe administrable dose form, i.e. the dose form of the final product after necessary reconstitution or processingAdministrableProductDefinition.administrableDoseForm
form-ofreferenceThe 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 productAdministrableProductDefinition.formOf
(MedicinalProductDefinition)
identifiertokenAn identifier for the administrable productAdministrableProductDefinition.identifier
ingredienttokenThe ingredients of this administrable medicinal productAdministrableProductDefinition.ingredient
manufactured-itemreferenceThe 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 ingredientsAdministrableProductDefinition.producedFrom
(ManufacturedItemDefinition)
routetokenCoded expression for the routeAdministrableProductDefinition.routeOfAdministration.code
target-speciestokenCoded expression for the speciesAdministrableProductDefinition.routeOfAdministration.targetSpecies.code