BeExtOffLabel
type: StructureDefinition
node role: treeRoot
id:
  v: BeExtOffLabel
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition BeExtOffLabel Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R4/conformance-rules.html#constraints" title="This element has or is affected by constraints ( offLabel-reason-required )">C 0..* Extension MedicationRequest - Off-label use Constraints: offLabel-reason-required #xD; extension 1..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:isOffLabelUse 1..1 Extension Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided. #xD; extension 0..0 Extension #xD; url 1..1 uri "isOffLabelUse" #xD; value[x] 0..1 boolean Value of extension #xD; extension:reason 0..* Extension Reason or related clarification for off-label use. #xD; extension 0..0 Extension #xD; url 1..1 uri "reason" #xD; value[x] 0..1 CodeableConcept Value of extension #xD; url 1..1 uri "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel" #xD; value[x] 0..0 Value of extension #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel
  l: BeExtOffLabel
version:
  v: 1.1.0
name:
  v: BeExtOffLabel
title:
  v: MedicationRequest - Off-label use
status:
  v: active
date:
  v: 2026-01-09T09:08:32+00:00
publisher:
  v: eHealth Platform
contact:
  name:
    v: eHealth Platform
  telecom:
    system:
      v: url
    value:
      v: https://www.ehealth.fgov.be/standards/fhir
  telecom:
    system:
      v: email
contact:
  name:
    v: Message Structure eHealth
  telecom:
    system:
      v: email
    use:
      v: work
description:
  v: Indicates that the order placer has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the product.
jurisdiction:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: BE
    display:
      v: Belgium
fhir version:
  v: 4.0.1
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
    l: v3
  name:
    v: RIM Mapping
kind:
  v: complex-type
abstract:
  v: false
context:
  type:
    v: element
  expression:
    v: MedicationRequest
context:
  type:
    v: element
  expression:
    v: MedicationStatement
type:
  v: Extension
  l: Extension
base definition:
  v: http://hl7.org/fhir/StructureDefinition/Extension
  l: Extension
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 4.0.1
  element:
    id:
      v: Extension
    path:
      v: Extension
    short:
      v: MedicationRequest - Off-label use
    definition:
      v: Indicates that the order placer has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the product.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: Extension
      min:
        v: 0
      max:
        v: *
    condition:
      v: ele-1
    constraint:
      key:
        v: ele-1
      severity:
        v: error
      human:
        v: All FHIR elements must have a @value or children
      expression:
        v: hasValue() or (children().count() > id.count())
      xpath:
        v: @value|f:*|h:div
      source:
        v: http://hl7.org/fhir/StructureDefinition/Element
        l: Element
    constraint:
      key:
        v: ext-1
      severity:
        v: error
      human:
        v: Must have either extensions or value[x], not both
      expression:
        v: extension.exists() != value.exists()
      xpath:
        v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
      source:
        v: http://hl7.org/fhir/StructureDefinition/Extension
        l: Extension
    constraint:
      key:
        v: offLabel-reason-required
      severity:
        v: error
      human:
        v: If isOffLabelUse is true, reason must be provided
      expression:
        v: extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()
      source:
        v: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel
        l: BeExtOffLabel
    is modifier:
      v: false
  element:
    id:
      v: Extension.id
    path:
      v: Extension.id
    representation:
      v: xmlAttr
    short:
      v: Unique id for inter-element referencing
    definition:
      v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
    min:
      v: 0
    max:
      v: 1
    base:
      path:
        v: Element.id
      min:
        v: 0
      max:
        v: 1
    type:
      extension:
        value: Url
      code:
        v: http://hl7.org/fhirpath/System.String
        l: System.String
    is modifier:
      v: false
    is summary:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: n/a
  element:
    id:
      v: Extension.extension
    path:
      v: Extension.extension
    slicing:
      description:
        v: Extensions are always sliced by (at least) url
      rules:
        v: open

Url
v: string
l: string

v: value

v: url

v: Extension

v: An Extension

v: 1

v: *

path:
  v: Element.extension
min:
  v: 0
max:
  v: *

code:
  v: Extension
  l: Extension

key:
  v: ele-1
severity:
  v: error
human:
  v: All FHIR elements must have a @value or children
expression:
  v: hasValue() or (children().count() > id.count())
xpath:
  v: @value|f:*|h:div
source:
  v: http://hl7.org/fhir/StructureDefinition/Element
  l: Element

key:
  v: ext-1
severity:
  v: error
human:
  v: Must have either extensions or value[x], not both
expression:
  v: extension.exists() != value.exists()
xpath:
  v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
source:
  v: http://hl7.org/fhir/StructureDefinition/Extension
  l: Extension

v: false

v: false

id:
  v: Extension.extension:isOffLabelUse
path:
  v: Extension.extension
slice name:
  v: isOffLabelUse
short:
  v: Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.
definition:
  v: An Extension
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:isOffLabelUse.id
path:
  v: Extension.extension.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Extension.extension:isOffLabelUse.extension
path:
  v: Extension.extension.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:isOffLabelUse.url
path:
  v: Extension.extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: uri
      l: uri
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
fixed: Uri
  v: isOffLabelUse
  l: isOffLabelUse
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:isOffLabelUse.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Value of extension
definition:
  v: Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: boolean
    l: boolean
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:reason
path:
  v: Extension.extension
slice name:
  v: reason
short:
  v: Reason or related clarification for off-label use.
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:reason.id
path:
  v: Extension.extension.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: Extension.extension:reason.extension
path:
  v: Extension.extension.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:reason.url
path:
  v: Extension.extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: uri
      l: uri
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
fixed: Uri
  v: reason
  l: reason
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:reason.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Value of extension
definition:
  v: Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.url
path:
  v: Extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: uri
      l: uri
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
fixed: Uri
  v: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel
  l: BeExtOffLabel
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.value[x]
path:
  v: Extension.value[x]
short:
  v: Value of extension
definition:
  v: Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: base64Binary
    l: base64Binary
type:
  code:
    v: boolean
    l: boolean
type:
  code:
    v: canonical
    l: canonical
type:
  code:
    v: code
    l: code
type:
  code:
    v: date
    l: date
type:
  code:
    v: dateTime
    l: dateTime
type:
  code:
    v: decimal
    l: decimal
type:
  code:
    v: id
    l: id
type:
  code:
    v: instant
    l: instant
type:
  code:
    v: integer
    l: integer
type:
  code:
    v: markdown
    l: markdown
type:
  code:
    v: oid
    l: oid
type:
  code:
    v: positiveInt
    l: positiveInt
type:
  code:
    v: string
    l: string
type:
  code:
    v: time
    l: time
type:
  code:
    v: unsignedInt
    l: unsignedInt
type:
  code:
    v: uri
    l: uri
type:
  code:
    v: url
    l: url
type:
  code:
    v: uuid
    l: uuid
type:
  code:
    v: Address
    l: Address
type:
  code:
    v: Age
    l: Age
type:
  code:
    v: Annotation
    l: Annotation
type:
  code:
    v: Attachment
    l: Attachment
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
type:
  code:
    v: Coding
    l: Coding
type:
  code:
    v: ContactPoint
    l: ContactPoint
type:
  code:
    v: Count
    l: Count
type:
  code:
    v: Distance
    l: Distance
type:
  code:
    v: Duration
    l: Duration
type:
  code:
    v: HumanName
    l: HumanName
type:
  code:
    v: Identifier
    l: Identifier
type:
  code:
    v: Money
    l: Money
type:
  code:
    v: Period
    l: Period
type:
  code:
    v: Quantity
    l: Quantity
type:
  code:
    v: Range
    l: Range
type:
  code:
    v: Ratio
    l: Ratio
type:
  code:
    v: Reference
    l: Reference
type:
  code:
    v: SampledData
    l: SampledData
type:
  code:
    v: Signature
    l: Signature
type:
  code:
    v: Timing
    l: Timing
type:
  code:
    v: ContactDetail
    l: ContactDetail
type:
  code:
    v: Contributor
    l: Contributor
type:
  code:
    v: DataRequirement
    l: DataRequirement
type:
  code:
    v: Expression
    l: Expression
type:
  code:
    v: ParameterDefinition
    l: ParameterDefinition
type:
  code:
    v: RelatedArtifact
    l: RelatedArtifact

code:
  v: TriggerDefinition
  l: TriggerDefinition

code:
  v: UsageContext
  l: UsageContext

code:
  v: Dosage
  l: Dosage

code:
  v: Meta
  l: Meta

key:
  v: ele-1
severity:
  v: error
human:
  v: All FHIR elements must have a @value or children
expression:
  v: hasValue() or (children().count() > id.count())
xpath:
  v: @value|f:*|h:div
source:
  v: http://hl7.org/fhir/StructureDefinition/Element
  l: Element

v: false

v: false

identity:
  v: rim
map:
  v: N/A

element:
  id:
    v: Extension
  path:
    v: Extension
  short:
    v: MedicationRequest - Off-label use
  definition:
    v: Indicates that the order placer has knowingly prescribed the medication for an indication, age group, dosage, or route of administration that is not approved by the regulatory agencies and is not mentioned in the prescribing information for the product.
  constraint:
    key:
      v: offLabel-reason-required
    severity:
      v: error
    human:
      v: If isOffLabelUse is true, reason must be provided
    expression:
      v: extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()
    source:
      v: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel
      l: BeExtOffLabel
element:
  id:
    v: Extension.extension
  path:
    v: Extension.extension
  min:
    v: 1
element:
  id:
    v: Extension.extension:isOffLabelUse
  path:
    v: Extension.extension
  slice name:
    v: isOffLabelUse
  short:
    v: Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.
  min:
    v: 1
  max:
    v: 1
element:
  id:
    v: Extension.extension:isOffLabelUse.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:isOffLabelUse.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: isOffLabelUse
    l: isOffLabelUse
element:
  id:
    v: Extension.extension:isOffLabelUse.value[x]
  path:
    v: Extension.extension.value[x]
  type:
    code:
      v: boolean
      l: boolean
element:
  id:
    v: Extension.extension:reason
  path:
    v: Extension.extension
  slice name:
    v: reason
  short:
    v: Reason or related clarification for off-label use.
  min:
    v: 0
  max:
    v: *
element:
  id:
    v: Extension.extension:reason.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:reason.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: reason
    l: reason
element:
  id:
    v: Extension.extension:reason.value[x]
  path:
    v: Extension.extension.value[x]
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
element:
  id:
    v: Extension.url
  path:
    v: Extension.url
  fixed: Uri
    v: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel
    l: BeExtOffLabel
element:
  id:
    v: Extension.value[x]
  path:
    v: Extension.value[x]
  max:
    v: 0