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 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-mpd/tree/master and changes regularly. See the Directory of published versions

Extension: Off-label use

Official URL: http://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel Version: 0.1.0
Active as of 2025-03-30 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

Usage:

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 & Constraintsdoco
.. 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 "http://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 "http://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 & Constraintsdoco
.. 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 "http://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 "http://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

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()