Medication
1.1.0 - STU

Medication, published by eHealth Platform. 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/ 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/BeExtOffLabel | Version: 1.1.0
Active as of 2025-10-10 | Computable Name: BeExtOffLabel

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

This extension may be used on the following element(s)

- Element ID: `MedicationRequest`
- Element ID: `MedicationStatement`

Usage info

Usages:

- Use this Extension: BeMedicationDispense, BeMedicationLine and BeMedicationPrescription

You can also check for usages in the FHIR IG Statistics

### Formal Views of Extension Content

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

- Differential Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension | C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required
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/BeExtOffLabel"
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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension | C | 0..* | Extension | MedicationRequest - Off-label use Constraints: offLabel-reason-required
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/BeExtOffLabel"
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

Id | Grade | Path(s) | Description | Expression
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`
offLabel-reason-required | error | Extension | If isOffLabelUse is true, reason must be provided | `extension.where(url = 'isOffLabelUse').value.ofType(boolean).where($this = true).exists() implies extension.where(url = 'reason').exists()`