Release 5 Preview #1

This page is part of the FHIR Specification (v4.2.0: R5 Preview #1). 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

11.15 Resource AdministrableProductDefinition - Content

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

A pharmaceutical product described in terms of its composition and dose form.

Qualitative and quantitative composition of a Medicinal Product in the dose form approved for administration in line with the regulated product information

Note that in many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

This resource is referenced by MedicinalProductDefinition.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition ΣTUDomainResourceA pharmaceutical product described in terms of its composition and dose form
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierAn identifier for the pharmaceutical medicinal product
... subject Σ0..*Reference(MedicinalProductDefinition)The product that this is a pharmaceutical product of
... administrableDoseForm Σ1..1CodeableConceptThe administrable dose form, after necessary reconstitution
... producedFrom Σ0..*Reference(ManufacturedItemDefinition)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
... ingredient Σ0..*Reference(Ingredient)The ingredients of this administrable pharmaceutical product
... device Σ0..*Reference(DeviceDefinition)Accompanying device
... characteristic Σ0..*BackboneElementCharacteristics e.g. a products onset of action
.... code Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodingCoding
..... valueQuantityQuantity
..... valueStringstring
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
.... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
... routeOfAdministration Σ1..*BackboneElementThe path by which the pharmaceutical product is taken into or makes contact with the body
.... code Σ1..1CodeableConceptCoded expression for the route
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
.... maxDosePerDay Σ0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... code Σ1..1CodeableConceptCoded expression for the species
..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... tissue Σ1..1CodeableConceptCoded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
...... 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 pharmaceutical medicinal productidentifier : Identifier [0..*]The product that this is a pharmaceutical product ofsubject : Reference [0..*] « MedicinalProductDefinition »The administrable dose form, after necessary reconstitutionadministrableDoseForm : CodeableConcept [1..1]TodounitOfPresentation : CodeableConcept [0..1]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 ingredientsproducedFrom : Reference [0..*] « ManufacturedItemDefinition »The ingredients of this administrable pharmaceutical productingredient : Reference [0..*] « Ingredient »Accompanying devicedevice : Reference [0..*] « DeviceDefinition »CharacteristicA code expressing the type of characteristiccode : CodeableConcept [1..1]A value for the characteristicvalue[x] : DataType [0..1] « Coding|Quantity|string|date|boolean| Attachment »The status of characteristic e.g. assigned or pendingstatus : CodeableConcept [0..1]RouteOfAdministrationCoded expression for the routecode : CodeableConcept [1..1]The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurementfirstDose : Quantity [0..1]The maximum single dose that can be administered as per the protocol of a clinical trial can be 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 administered as per the protocol referenced in the clinical trial authorisationmaxDosePerDay : Quantity [0..1]The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisationmaxDosePerTreatmentPeriod : Ratio [0..1]The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisationmaxTreatmentPeriod : Duration [0..1]TargetSpeciesCoded expression for the speciescode : CodeableConcept [1..1]WithdrawalPeriodCoded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milktissue : CodeableConcept [1..1]A value for the timevalue : Quantity [1..1]Extra information about the withdrawal periodsupportingInformation : string [0..1]Characteristics e.g. a products onset of actioncharacteristic[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 pharmaceutical product is taken into or makes contact with the bodyrouteOfAdministration[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 pharmaceutical medicinal product --></identifier>
 <subject><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pharmaceutical product of --></subject>
 <administrableDoseForm><!-- 1..1 CodeableConcept The administrable dose form, after necessary reconstitution --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept Todo --></unitOfPresentation>
 <producedFrom><!-- 0..* Reference(ManufacturedItemDefinition) 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 --></producedFrom>
 <ingredient><!-- 0..* Reference(Ingredient) The ingredients of this administrable pharmaceutical product --></ingredient>
 <device><!-- 0..* Reference(DeviceDefinition) Accompanying device --></device>
 <characteristic>  <!-- 0..* Characteristics e.g. a products onset of action -->
  <code><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></code>
  <value[x]><!-- 0..1 Coding|Quantity|string|date|boolean|Attachment A value for the characteristic --></value[x]>
  <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status>
 </characteristic>
 <routeOfAdministration>  <!-- 1..* The path by which the pharmaceutical 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 in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerDay>
  <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerTreatmentPeriod>
  <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation --></maxTreatmentPeriod>
  <targetSpecies>  <!-- 0..* A species for which this route applies -->
   <code><!-- 1..1 CodeableConcept Coded expression for the species --></code>
   <withdrawalPeriod>  <!-- 0..* A species specific time during which consumption of animal product is not appropriate -->
    <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue>
    <value><!-- 1..1 Quantity A value for the time --></value>
    <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period -->
   </withdrawalPeriod>
  </targetSpecies>
 </routeOfAdministration>
</AdministrableProductDefinition>

JSON Template

{doco
  "resourceType" : "AdministrableProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // An identifier for the pharmaceutical medicinal product
  "subject" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pharmaceutical product of
  "administrableDoseForm" : { CodeableConcept }, // R!  The administrable dose form, after necessary reconstitution
  "unitOfPresentation" : { CodeableConcept }, // Todo
  "producedFrom" : [{ Reference(ManufacturedItemDefinition) }], // 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
  "ingredient" : [{ Reference(Ingredient) }], // The ingredients of this administrable pharmaceutical product
  "device" : [{ Reference(DeviceDefinition) }], // Accompanying device
  "characteristic" : [{ // Characteristics e.g. a products onset of action
    "code" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 6:
    "valueCoding" : { Coding },
    "valueQuantity" : { Quantity },
    "valueString" : "<string>",
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueAttachment" : { Attachment },
    "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending
  }],
  "routeOfAdministration" : [{ // R!  The path by which the pharmaceutical 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 in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
    "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
    "targetSpecies" : [{ // A species for which this route applies
      "code" : { CodeableConcept }, // R!  Coded expression for the species
      "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate
        "tissue" : { CodeableConcept }, // R!  Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        "value" : { Quantity }, // R!  A value for the time
        "supportingInformation" : "<string>" // Extra information about the withdrawal period
      }]
    }]
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .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 pharmaceutical medicinal product
  fhir:AdministrableProductDefinition.subject [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pharmaceutical product of
  fhir:AdministrableProductDefinition.administrableDoseForm [ CodeableConcept ]; # 1..1 The administrable dose form, after necessary reconstitution
  fhir:AdministrableProductDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 Todo
  fhir:AdministrableProductDefinition.producedFrom [ Reference(ManufacturedItemDefinition) ], ... ; # 0..* 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
  fhir:AdministrableProductDefinition.ingredient [ Reference(Ingredient) ], ... ; # 0..* The ingredients of this administrable pharmaceutical product
  fhir:AdministrableProductDefinition.device [ Reference(DeviceDefinition) ], ... ; # 0..* Accompanying device
  fhir:AdministrableProductDefinition.characteristic [ # 0..* Characteristics e.g. a products onset of action
    fhir:AdministrableProductDefinition.characteristic.code [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # AdministrableProductDefinition.characteristic.value[x] : 0..1 A value for the characteristic. One of these 6
      fhir:AdministrableProductDefinition.characteristic.valueCoding [ Coding ]
      fhir:AdministrableProductDefinition.characteristic.valueQuantity [ Quantity ]
      fhir:AdministrableProductDefinition.characteristic.valueString [ string ]
      fhir:AdministrableProductDefinition.characteristic.valueDate [ date ]
      fhir:AdministrableProductDefinition.characteristic.valueBoolean [ boolean ]
      fhir:AdministrableProductDefinition.characteristic.valueAttachment [ Attachment ]
    fhir:AdministrableProductDefinition.characteristic.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending
  ], ...;
  fhir:AdministrableProductDefinition.routeOfAdministration [ # 1..* The path by which the pharmaceutical 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 in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period
      ], ...;
    ], ...;
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdministrableProductDefinition ΣTUDomainResourceA pharmaceutical product described in terms of its composition and dose form
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierAn identifier for the pharmaceutical medicinal product
... subject Σ0..*Reference(MedicinalProductDefinition)The product that this is a pharmaceutical product of
... administrableDoseForm Σ1..1CodeableConceptThe administrable dose form, after necessary reconstitution
... producedFrom Σ0..*Reference(ManufacturedItemDefinition)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
... ingredient Σ0..*Reference(Ingredient)The ingredients of this administrable pharmaceutical product
... device Σ0..*Reference(DeviceDefinition)Accompanying device
... characteristic Σ0..*BackboneElementCharacteristics e.g. a products onset of action
.... code Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodingCoding
..... valueQuantityQuantity
..... valueStringstring
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment
.... status Σ0..1CodeableConceptThe status of characteristic e.g. assigned or pending
... routeOfAdministration Σ1..*BackboneElementThe path by which the pharmaceutical product is taken into or makes contact with the body
.... code Σ1..1CodeableConceptCoded expression for the route
.... firstDose Σ0..1QuantityThe first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
.... maxSingleDose Σ0..1QuantityThe maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
.... maxDosePerDay Σ0..1QuantityThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
.... maxDosePerTreatmentPeriod Σ0..1RatioThe maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
.... maxTreatmentPeriod Σ0..1DurationThe maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
.... targetSpecies Σ0..*BackboneElementA species for which this route applies
..... code Σ1..1CodeableConceptCoded expression for the species
..... withdrawalPeriod Σ0..*BackboneElementA species specific time during which consumption of animal product is not appropriate
...... tissue Σ1..1CodeableConceptCoded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
...... 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 pharmaceutical medicinal productidentifier : Identifier [0..*]The product that this is a pharmaceutical product ofsubject : Reference [0..*] « MedicinalProductDefinition »The administrable dose form, after necessary reconstitutionadministrableDoseForm : CodeableConcept [1..1]TodounitOfPresentation : CodeableConcept [0..1]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 ingredientsproducedFrom : Reference [0..*] « ManufacturedItemDefinition »The ingredients of this administrable pharmaceutical productingredient : Reference [0..*] « Ingredient »Accompanying devicedevice : Reference [0..*] « DeviceDefinition »CharacteristicA code expressing the type of characteristiccode : CodeableConcept [1..1]A value for the characteristicvalue[x] : DataType [0..1] « Coding|Quantity|string|date|boolean| Attachment »The status of characteristic e.g. assigned or pendingstatus : CodeableConcept [0..1]RouteOfAdministrationCoded expression for the routecode : CodeableConcept [1..1]The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurementfirstDose : Quantity [0..1]The maximum single dose that can be administered as per the protocol of a clinical trial can be 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 administered as per the protocol referenced in the clinical trial authorisationmaxDosePerDay : Quantity [0..1]The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisationmaxDosePerTreatmentPeriod : Ratio [0..1]The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisationmaxTreatmentPeriod : Duration [0..1]TargetSpeciesCoded expression for the speciescode : CodeableConcept [1..1]WithdrawalPeriodCoded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milktissue : CodeableConcept [1..1]A value for the timevalue : Quantity [1..1]Extra information about the withdrawal periodsupportingInformation : string [0..1]Characteristics e.g. a products onset of actioncharacteristic[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 pharmaceutical product is taken into or makes contact with the bodyrouteOfAdministration[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 pharmaceutical medicinal product --></identifier>
 <subject><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pharmaceutical product of --></subject>
 <administrableDoseForm><!-- 1..1 CodeableConcept The administrable dose form, after necessary reconstitution --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept Todo --></unitOfPresentation>
 <producedFrom><!-- 0..* Reference(ManufacturedItemDefinition) 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 --></producedFrom>
 <ingredient><!-- 0..* Reference(Ingredient) The ingredients of this administrable pharmaceutical product --></ingredient>
 <device><!-- 0..* Reference(DeviceDefinition) Accompanying device --></device>
 <characteristic>  <!-- 0..* Characteristics e.g. a products onset of action -->
  <code><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></code>
  <value[x]><!-- 0..1 Coding|Quantity|string|date|boolean|Attachment A value for the characteristic --></value[x]>
  <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status>
 </characteristic>
 <routeOfAdministration>  <!-- 1..* The path by which the pharmaceutical 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 in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerDay>
  <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerTreatmentPeriod>
  <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation --></maxTreatmentPeriod>
  <targetSpecies>  <!-- 0..* A species for which this route applies -->
   <code><!-- 1..1 CodeableConcept Coded expression for the species --></code>
   <withdrawalPeriod>  <!-- 0..* A species specific time during which consumption of animal product is not appropriate -->
    <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue>
    <value><!-- 1..1 Quantity A value for the time --></value>
    <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period -->
   </withdrawalPeriod>
  </targetSpecies>
 </routeOfAdministration>
</AdministrableProductDefinition>

JSON Template

{doco
  "resourceType" : "AdministrableProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // An identifier for the pharmaceutical medicinal product
  "subject" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pharmaceutical product of
  "administrableDoseForm" : { CodeableConcept }, // R!  The administrable dose form, after necessary reconstitution
  "unitOfPresentation" : { CodeableConcept }, // Todo
  "producedFrom" : [{ Reference(ManufacturedItemDefinition) }], // 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
  "ingredient" : [{ Reference(Ingredient) }], // The ingredients of this administrable pharmaceutical product
  "device" : [{ Reference(DeviceDefinition) }], // Accompanying device
  "characteristic" : [{ // Characteristics e.g. a products onset of action
    "code" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 6:
    "valueCoding" : { Coding },
    "valueQuantity" : { Quantity },
    "valueString" : "<string>",
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueAttachment" : { Attachment },
    "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending
  }],
  "routeOfAdministration" : [{ // R!  The path by which the pharmaceutical 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 in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
    "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
    "targetSpecies" : [{ // A species for which this route applies
      "code" : { CodeableConcept }, // R!  Coded expression for the species
      "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate
        "tissue" : { CodeableConcept }, // R!  Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        "value" : { Quantity }, // R!  A value for the time
        "supportingInformation" : "<string>" // Extra information about the withdrawal period
      }]
    }]
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .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 pharmaceutical medicinal product
  fhir:AdministrableProductDefinition.subject [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pharmaceutical product of
  fhir:AdministrableProductDefinition.administrableDoseForm [ CodeableConcept ]; # 1..1 The administrable dose form, after necessary reconstitution
  fhir:AdministrableProductDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 Todo
  fhir:AdministrableProductDefinition.producedFrom [ Reference(ManufacturedItemDefinition) ], ... ; # 0..* 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
  fhir:AdministrableProductDefinition.ingredient [ Reference(Ingredient) ], ... ; # 0..* The ingredients of this administrable pharmaceutical product
  fhir:AdministrableProductDefinition.device [ Reference(DeviceDefinition) ], ... ; # 0..* Accompanying device
  fhir:AdministrableProductDefinition.characteristic [ # 0..* Characteristics e.g. a products onset of action
    fhir:AdministrableProductDefinition.characteristic.code [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # AdministrableProductDefinition.characteristic.value[x] : 0..1 A value for the characteristic. One of these 6
      fhir:AdministrableProductDefinition.characteristic.valueCoding [ Coding ]
      fhir:AdministrableProductDefinition.characteristic.valueQuantity [ Quantity ]
      fhir:AdministrableProductDefinition.characteristic.valueString [ string ]
      fhir:AdministrableProductDefinition.characteristic.valueDate [ date ]
      fhir:AdministrableProductDefinition.characteristic.valueBoolean [ boolean ]
      fhir:AdministrableProductDefinition.characteristic.valueAttachment [ Attachment ]
    fhir:AdministrableProductDefinition.characteristic.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending
  ], ...;
  fhir:AdministrableProductDefinition.routeOfAdministration [ # 1..* The path by which the pharmaceutical 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 in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:AdministrableProductDefinition.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:AdministrableProductDefinition.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species
      fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time
        fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period
      ], ...;
    ], ...;
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

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

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
dose-formtokenThe administrable dose form, after necessary reconstitutionAdministrableProductDefinition.administrableDoseForm
identifiertokenAn identifier for the pharmaceutical medicinal productAdministrableProductDefinition.identifier
routetokenCoded expression for the routeAdministrableProductDefinition.routeOfAdministration.code
subjectreferenceThe product that this is a pharmaceutical product ofAdministrableProductDefinition.subject
(MedicinalProductDefinition)
target-speciestokenCoded expression for the speciesAdministrableProductDefinition.routeOfAdministration.targetSpecies.code