| Package | hl7.fhir.be.medication |
| Resource Type | StructureDefinition |
| Id | BeExtOffLabel |
| FHIR Version | R4 |
| Source | https://www.ehealth.fgov.be/standards/fhir/medication/https://build.fhir.org/ig/hl7-be/medication/StructureDefinition-BeExtOffLabel.html |
| URL | https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel |
| Version | 1.1.0 |
| Status | draft |
| Date | 2025-07-25T19:42:33+00:00 |
| Name | BeExtOffLabel |
| Title | MedicationRequest - Off-label use |
| Realm | be |
| Authority | hl7 |
| Description | 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. |
| Type | Extension |
| Kind | complex-type |
| StructureDefinition | |
| BeMedicationDispense | BeMedicationDispense |
| BeMedicationLine | BeMedicationLine |
| BeMedicationPrescription | BeMedicationPrescription |
No resources found
No extension usage examples found
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition BeExtOffLabel
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Extension | C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required |
  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/BeExtOffLabel" | |
 value[x] | 0..0 | |||
| Documentation for this format | ||||
FHIR{
"resourceType": "StructureDefinition",
"id": "BeExtOffLabel",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"url": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel",
"version": "1.1.0",
"name": "BeExtOffLabel",
"title": "MedicationRequest - Off-label use",
"status": "draft",
"date": "2025-07-25T19:42:33+00:00",
"publisher": "HL7 Belgium",
"contact": [
{
"name": "HL7 Belgium",
"telecom": [
{
"system": "url",
"value": "https://www.hl7belgium.org"
},
{
"system": "email",
"value": "hl7belgium@hl7belgium.org"
}
]
},
{
"name": "Message Structure eHealth",
"telecom": [
{
"system": "email",
"value": "message-structure@ehealth.fgov.be",
"use": "work"
}
]
}
],
"description": "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": "urn:iso:std:iso:3166",
"code": "BE",
"display": "Belgium"
}
]
}
],
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "complex-type",
"abstract": false,
"context": [
{
"type": "element",
"expression": "MedicationRequest"
},
{
"type": "element",
"expression": "MedicationStatement"
}
],
"type": "Extension",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.0.1"
}
],
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "MedicationRequest - Off-label use",
"definition": "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": 0,
"max": "*",
"base": {
"path": "Extension",
"min": 0,
"max": "*"
},
"condition": [
"ele-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
},
{
"key": "offLabel-reason-required",
"severity": "error",
"human": "If isOffLabelUse is true, reason must be provided",
"expression": "extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()",
"source": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel"
}
],
"isModifier": false
},
{
"id": "Extension.id",
"path": "Extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension",
"path": "Extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 1,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:isOffLabelUse",
"path": "Extension.extension",
"sliceName": "isOffLabelUse",
"short": "Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.",
"definition": "An Extension",
"min": 1,
"max": "1",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:isOffLabelUse.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:isOffLabelUse.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:isOffLabelUse.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "isOffLabelUse",
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:isOffLabelUse.value[x]",
"path": "Extension.extension.value[x]",
"short": "Value of extension",
"definition": "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": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "boolean"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:reason",
"path": "Extension.extension",
"sliceName": "reason",
"short": "Reason or related clarification for off-label use.",
"definition": "An Extension",
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:reason.id",
"path": "Extension.extension.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "Extension.extension:reason.extension",
"path": "Extension.extension.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "0",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "Extension.extension:reason.url",
"path": "Extension.extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "reason",
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.extension:reason.value[x]",
"path": "Extension.extension.value[x]",
"short": "Value of extension",
"definition": "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": 0,
"max": "1",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"representation": [
"xmlAttr"
],
"short": "identifies the meaning of the extension",
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"comment": "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": 1,
"max": "1",
"base": {
"path": "Extension.url",
"min": 1,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"fixedUri": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel",
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"short": "Value of extension",
"definition": "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": 0,
"max": "0",
"base": {
"path": "Extension.value[x]",
"min": 0,
"max": "1"
},
"type": [
{
"code": "base64Binary"
},
{
"code": "boolean"
},
{
"code": "canonical"
},
{
"code": "code"
},
{
"code": "date"
},
{
"code": "dateTime"
},
{
"code": "decimal"
},
{
"code": "id"
},
{
"code": "instant"
},
{
"code": "integer"
},
{
"code": "markdown"
},
{
"code": "oid"
},
{
"code": "positiveInt"
},
{
"code": "string"
},
{
"code": "time"
},
{
"code": "unsignedInt"
},
{
"code": "uri"
},
{
"code": "url"
},
{
"code": "uuid"
},
{
"code": "Address"
},
{
"code": "Age"
},
{
"code": "Annotation"
},
{
"code": "Attachment"
},
{
"code": "CodeableConcept"
},
{
"code": "Coding"
},
{
"code": "ContactPoint"
},
{
"code": "Count"
},
{
"code": "Distance"
},
{
"code": "Duration"
},
{
"code": "HumanName"
},
{
"code": "Identifier"
},
{
"code": "Money"
},
{
"code": "Period"
},
{
"code": "Quantity"
},
{
"code": "Range"
},
{
"code": "Ratio"
},
{
"code": "Reference"
},
{
"code": "SampledData"
},
{
"code": "Signature"
},
{
"code": "Timing"
},
{
"code": "ContactDetail"
},
{
"code": "Contributor"
},
{
"code": "DataRequirement"
},
{
"code": "Expression"
},
{
"code": "ParameterDefinition"
},
{
"code": "RelatedArtifact"
},
{
"code": "TriggerDefinition"
},
{
"code": "UsageContext"
},
{
"code": "Dosage"
},
{
"code": "Meta"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
}
]
},
"differential": {
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "MedicationRequest - Off-label use",
"definition": "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": "offLabel-reason-required",
"severity": "error",
"human": "If isOffLabelUse is true, reason must be provided",
"expression": "extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()",
"source": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel"
}
]
},
{
"id": "Extension.extension",
"path": "Extension.extension",
"min": 1
},
{
"id": "Extension.extension:isOffLabelUse",
"path": "Extension.extension",
"sliceName": "isOffLabelUse",
"short": "Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.",
"min": 1,
"max": "1"
},
{
"id": "Extension.extension:isOffLabelUse.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:isOffLabelUse.url",
"path": "Extension.extension.url",
"fixedUri": "isOffLabelUse"
},
{
"id": "Extension.extension:isOffLabelUse.value[x]",
"path": "Extension.extension.value[x]",
"type": [
{
"code": "boolean"
}
]
},
{
"id": "Extension.extension:reason",
"path": "Extension.extension",
"sliceName": "reason",
"short": "Reason or related clarification for off-label use.",
"min": 0,
"max": "*"
},
{
"id": "Extension.extension:reason.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:reason.url",
"path": "Extension.extension.url",
"fixedUri": "reason"
},
{
"id": "Extension.extension:reason.value[x]",
"path": "Extension.extension.value[x]",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel"
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"max": "0"
}
]
}
}