Medication Prescription and Dispense (MPD)
1.0.0-comment-2 - ballot
Medication Prescription and Dispense (MPD)
1.0.0-comment-2 - ballot
This page is part of the Medication Prescription and Dispense (MPD) (v1.0.0-comment-2: Publication) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
| Official URL: https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel | Version: 1.0.0-comment-2 | |||
| Active as of 2025-05-27 | Computable Name: OffLabel | |||
Copyright/Legal: IHE http://www.ihe.net/Governance/#Intellectual_Property |
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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):
MedicationRequest
MedicationStatement
Usage info
Usage:
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 |
|---|---|---|---|---|
  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 | |||
| 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://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel" | |
 value[x] |
0..0 | |||
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 | |||
| 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 | |||
| 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.
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 | |||
| 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://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel" | |
| value[x] |
0..0 | |||
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 | |||
| 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 | |||
| 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.
Other representations of profile: CSV, Excel, Schematron
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
IG © 2021+ Integrating the Healthcare Enterprise (IHE). Package ihe.pharm.mpd#1.0.0-comment-2 based on FHIR 5.0.0. Generated 2025-05-27
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