Medication Prescription and Dispense (MPD)
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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-3 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/113/merge and changes regularly. See the Directory of published versions
Built from commit 90f3bc69.   Branch: 100-pc-pharm-7-copy-paste-error-in-text.

Extension: Off-label use

Official URL: https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel Version: 1.0.0-comment-3
Active as of 2026-04-22 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

Usage info

Usages:

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.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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"

doco 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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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"

doco 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()