Medication Prescription and Dispense (MPD)
1.0.0-comment-2 - ballot

Medication Prescription and Dispense (MPD), published by Integrating the Healthcare Enterprise (IHE). This guide is not an authorized publication; it is the continuous build for version 1.0.0-comment-2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IHE/pharm-mpd/tree/jct-draft and changes regularly. See the Directory of published versions

## Extension: Off-label use

Official URL: https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel | Version: 1.0.0-comment-2
Active as of 2026-04-07 | Computable Name: OffLabel
Copyright/Legal: IHE http://www.ihe.net/Governance/#Intellectual_Property

Indicates that the prescriber has intentionally prescribed the medication in a manner not covered by the product authorization — such as for a different indication, age group, dosage, or route of administration.

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: IHE Medication Order

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 |  | 0..* | Extension | Off-label use
extension |  | 1..* | Extension | Extension
Slices for extension |  |  |  | Content/Rules for all slices
extension:isOffLabelUse |  | 1..1 | Extension | Indicates off-label use. Must be 'true' when .reason is provided.
extension |  | 0..0 |  | Extension
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 |  | Extension
url |  | 1..1 | uri | "reason"
value[x] |  | 0..1 | CodeableConcept | Value of extension
url |  | 1..1 | uri | "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"
value[x] |  | 0..0 |  | Value of extension
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Off-label use
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 | Indicates off-label use. Must be 'true' when .reason is provided.
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 | Reason or related clarification for off-label use.
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 | "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"
Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Indicates that the prescriber has intentionally prescribed the medication in a manner not covered by the product authorization — such as for a different indication, age group, dosage, or route of administration.

- 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 |  | 0..* | Extension | Off-label use
extension |  | 1..* | Extension | Extension
Slices for extension |  |  |  | Content/Rules for all slices
extension:isOffLabelUse |  | 1..1 | Extension | Indicates off-label use. Must be 'true' when .reason is provided.
extension |  | 0..0 |  | Extension
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 |  | Extension
url |  | 1..1 | uri | "reason"
value[x] |  | 0..1 | CodeableConcept | Value of extension
url |  | 1..1 | uri | "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"
value[x] |  | 0..0 |  | Value of extension
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Off-label use
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 | Indicates off-label use. Must be 'true' when .reason is provided.
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 | Reason or related clarification for off-label use.
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 | "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"
Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Indicates that the prescriber has intentionally prescribed the medication in a manner not covered by the product authorization — such as for a different indication, age group, dosage, or route of administration.

- 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()`