IHE Pharmacy Medication Overview
0.1.0 - ci-build
IHE Pharmacy Medication Overview
0.1.0 - ci-build
IHE Pharmacy Medication Overview, published by Integrating the Healthcare Enterprise (IHE). This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IHE/pharm-meow/tree/jct-draft and changes regularly. See the Directory of published versions
Built from commit 62c0f394. Branch: jct-draft.
| Official URL: http://profiles.ihe.net/PHARM/MEOW/StructureDefinition/ihe-ext-medicationstatement-offlabel | Version: 0.1.0 | |||
| Active as of 2026-04-07 | Computable Name: OffLabel | |||
Copyright/Legal: IHE http://www.ihe.net/Governance/#Intellectual_Property |
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Indication that the medication is being used off-label (outside of approved indication, age group, dosage, or route) and the reason for such use. When isOffLabelUse is true, a reason SHALL be provided.
Context of Use
This extension may be used on the following element(s)
MedicationStatement
MedicationRequest
Usage info
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Extension |
C | 0..* | Extension | MedicationStatement - Off-Label Use Constraints: offlabel-reason-required |
  extension |
1..* | Extension | Extension | |
  Slices for extension |
Content/Rules for all slices | |||
   extension:isOffLabelUse |
1..1 | Extension | Whether the medication is being used off-label | |
  extension |
0..0 | Extension | ||
| url |
1..1 | uri | "isOffLabelUse" | |
  value[x] |
0..1 | boolean | Value of extension | |
 extension:reason |
0..* | Extension | The reason for off-label use or dosage override | |
 extension |
0..0 | Extension | ||
| url |
1..1 | uri | "reason" | |
 value[x] |
0..1 | CodeableConcept | Value of extension | |
| url |
1..1 | uri | "http://profiles.ihe.net/PHARM/MEOW/StructureDefinition/ihe-ext-medicationstatement-offlabel" | |
 value[x] |
0..0 | Value of extension | ||
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
C | 0..* | Extension | MedicationStatement - Off-Label Use Constraints: offlabel-reason-required |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:isOffLabelUse |
1..1 | Extension | Whether the medication is being used off-label | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | "isOffLabelUse" | |
| value[x] |
0..1 | boolean | Value of extension | |
| extension:reason |
0..* | Extension | The reason for off-label use or dosage override | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | "reason" | |
| value[x] |
0..1 | CodeableConcept | Value of extension | |
| url |
1..1 | uri | "http://profiles.ihe.net/PHARM/MEOW/StructureDefinition/ihe-ext-medicationstatement-offlabel" | |
| Documentation for this format | ||||
This structure is derived from Extension
Summary
Complex Extension: Indication that the medication is being used off-label (outside of approved indication, age group, dosage, or route) and the reason for such use. When isOffLabelUse is true, a reason SHALL be provided.
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
C | 0..* | Extension | MedicationStatement - Off-Label Use Constraints: offlabel-reason-required |
| extension |
1..* | Extension | Extension | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:isOffLabelUse |
1..1 | Extension | Whether the medication is being used off-label | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "isOffLabelUse" | |
| value[x] |
0..1 | boolean | Value of extension | |
| extension:reason |
0..* | Extension | The reason for off-label use or dosage override | |
| extension |
0..0 | Extension | ||
| url |
1..1 | uri | "reason" | |
| value[x] |
0..1 | CodeableConcept | Value of extension | |
| url |
1..1 | uri | "http://profiles.ihe.net/PHARM/MEOW/StructureDefinition/ihe-ext-medicationstatement-offlabel" | |
| value[x] |
0..0 | Value of extension | ||
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
C | 0..* | Extension | MedicationStatement - Off-Label Use Constraints: offlabel-reason-required |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:isOffLabelUse |
1..1 | Extension | Whether the medication is being used off-label | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | "isOffLabelUse" | |
| value[x] |
0..1 | boolean | Value of extension | |
| extension:reason |
0..* | Extension | The reason for off-label use or dosage override | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | "reason" | |
| value[x] |
0..1 | CodeableConcept | Value of extension | |
| url |
1..1 | uri | "http://profiles.ihe.net/PHARM/MEOW/StructureDefinition/ihe-ext-medicationstatement-offlabel" | |
| Documentation for this format | ||||
This structure is derived from Extension
Summary
Complex Extension: Indication that the medication is being used off-label (outside of approved indication, age group, dosage, or route) and the reason for such use. When isOffLabelUse is true, a reason SHALL be provided.
Other representations of profile: CSV, Excel, Schematron
| 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, at least one reason must be provided |
extension.where(url='isOffLabelUse').value.ofType(boolean).where(true).exists() implies extension.where(url='reason').exists()
|
IG © 2022+ Integrating the Healthcare Enterprise (IHE). Package ihe.pharm.meow#0.1.0 based on FHIR 5.0.0. Generated 2026-04-07
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