Medication
1.1.0 - STU Belgium flag

Medication, published by HL7 Belgium. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-be/medication/tree/prescription and changes regularly. See the Directory of published versions

Extension: MedicationRequest - Off-label use

Official URL: https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel Version: 1.1.0
Draft as of 2025-04-09 Computable Name: OffLabel

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.

Context of Use

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension C 0..* Extension MedicationRequest - Off-label use
offLabel-reason-required: If isOffLabelUse is true, reason must be provided
... extension 1..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:isOffLabelUse 1..1 Extension Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.
..... extension 0..0
..... url 1..1 uri "isOffLabelUse"
..... value[x] 0..1 boolean Value of extension
.... extension:reason 0..* Extension Reason or related clarification for off-label use.
..... extension 0..0
..... url 1..1 uri "reason"
..... value[x] 0..1 CodeableConcept Value of extension
... url 1..1 uri "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension C 0..* Extension MedicationRequest - Off-label use
offLabel-reason-required: If isOffLabelUse is true, reason must be provided
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:isOffLabelUse 1..1 Extension Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "isOffLabelUse"
..... value[x] 0..1 boolean Value of extension
.... extension:reason 0..* Extension Reason or related clarification for off-label use.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "reason"
..... value[x] 0..1 CodeableConcept Value of extension
... url 1..1 uri "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: 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.

  • isOffLabelUse: boolean: An Extension
  • reason: CodeableConcept: An Extension

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension C 0..* Extension MedicationRequest - Off-label use
offLabel-reason-required: If isOffLabelUse is true, reason must be provided
... extension 1..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:isOffLabelUse 1..1 Extension Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.
..... extension 0..0
..... url 1..1 uri "isOffLabelUse"
..... value[x] 0..1 boolean Value of extension
.... extension:reason 0..* Extension Reason or related clarification for off-label use.
..... extension 0..0
..... url 1..1 uri "reason"
..... value[x] 0..1 CodeableConcept Value of extension
... url 1..1 uri "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension C 0..* Extension MedicationRequest - Off-label use
offLabel-reason-required: If isOffLabelUse is true, reason must be provided
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:isOffLabelUse 1..1 Extension Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "isOffLabelUse"
..... value[x] 0..1 boolean Value of extension
.... extension:reason 0..* Extension Reason or related clarification for off-label use.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "reason"
..... value[x] 0..1 CodeableConcept Value of extension
... url 1..1 uri "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/be-ext-OffLabel"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: 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.

  • isOffLabelUse: boolean: An Extension
  • reason: CodeableConcept: An Extension

 

Other representations of profile: CSV, Excel, Schematron

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
offLabel-reason-requirederrorExtensionIf isOffLabelUse is true, reason must be provided
: extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()