{
"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.",
"_filename": "StructureDefinition-BeExtOffLabel.json",
"package_name": "hl7.fhir.be.medication",
"date": "2025-10-10T13:23:29+02:00",
"derivation": "constraint",
"publisher": "eHealth Platform",
"fhirVersion": "4.0.1",
"jurisdiction": [ {
"coding": [ {
"code": "BE",
"system": "urn:iso:std:iso:3166",
"display": "Belgium"
} ]
} ],
"name": "BeExtOffLabel",
"mapping": [ {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
} ],
"abstract": false,
"type": "Extension",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "MedicationRequest - Off-label use",
"package_version": "1.1.0",
"snapshot": {
"element": [ {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
}, {
"key": "offLabel-reason-required",
"human": "If isOffLabelUse is true, reason must be provided",
"source": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel",
"severity": "error",
"expression": "extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()"
} ],
"path": "Extension",
"min": 0,
"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.",
"isModifier": false,
"short": "MedicationRequest - Off-label use",
"max": "*",
"id": "Extension",
"condition": [ "ele-1" ],
"base": {
"max": "*",
"min": 0,
"path": "Extension"
}
}, {
"path": "Extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension",
"min": 1,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "*",
"id": "Extension.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension",
"min": 1,
"definition": "An Extension",
"isModifier": false,
"short": "Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.",
"type": [ {
"code": "Extension"
} ],
"sliceName": "isOffLabelUse",
"max": "1",
"id": "Extension.extension:isOffLabelUse",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:isOffLabelUse.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:isOffLabelUse.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "isOffLabelUse",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:isOffLabelUse.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "Extension.extension:isOffLabelUse.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Reason or related clarification for off-label use.",
"type": [ {
"code": "Extension"
} ],
"sliceName": "reason",
"max": "*",
"id": "Extension.extension:reason",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:reason.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:reason.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "reason",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:reason.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"max": "1",
"id": "Extension.extension:reason.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
}, {
"path": "Extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.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.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.value[x]",
"min": 0,
"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).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"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"
} ],
"max": "0",
"id": "Extension.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.0.1"
} ]
},
"status": "active",
"id": "fe437b1b-3311-4d8e-9909-7db2a139fcc3",
"kind": "complex-type",
"url": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel",
"context": [ {
"type": "element",
"expression": "MedicationRequest"
}, {
"type": "element",
"expression": "MedicationStatement"
} ],
"version": "1.1.0",
"differential": {
"element": [ {
"id": "Extension",
"path": "Extension",
"short": "MedicationRequest - Off-label use",
"constraint": [ {
"key": "offLabel-reason-required",
"human": "If isOffLabelUse is true, reason must be provided",
"source": "https://www.ehealth.fgov.be/standards/fhir/medication/StructureDefinition/BeExtOffLabel",
"severity": "error",
"expression": "extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()"
} ],
"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."
}, {
"id": "Extension.extension",
"min": 1,
"path": "Extension.extension"
}, {
"id": "Extension.extension:isOffLabelUse",
"max": "1",
"min": 1,
"path": "Extension.extension",
"short": "Indicates that the recommended dosage was overridden. Must be 'true' when .reason is provided.",
"sliceName": "isOffLabelUse"
}, {
"id": "Extension.extension:isOffLabelUse.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"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",
"max": "*",
"min": 0,
"path": "Extension.extension",
"short": "Reason or related clarification for off-label use.",
"sliceName": "reason"
}, {
"id": "Extension.extension:reason.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"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]",
"max": "0",
"path": "Extension.value[x]"
} ]
},
"contact": [ {
"name": "eHealth Platform",
"telecom": [ {
"value": "https://www.ehealth.fgov.be/standards/fhir",
"system": "url"
}, {
"value": "support@be-ehealth-standards.atlassian.net",
"system": "email"
} ]
}, {
"name": "Message Structure eHealth",
"telecom": [ {
"use": "work",
"value": "support@be-ehealth-standards.atlassian.net",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}