description: 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.
package_name: rs/ihe.pharm.mpd
derivation: constraint
name: OffLabel
type: Extension
elements:
  extension:
    index: 0
    slicing:
      slices:
        isOffLabelUse:
          match: {}
          schema:
            short: Indicates off-label use. Must be 'true' when .reason is provided.
            _required: true
            index: 1
            extensions: {}
            elements:
              extension: {index: 2}
              url:
                pattern: {type: uri, value: isOffLabelUse}
                type: uri
                index: 3
              value:
                choices: [valueBoolean]
                index: 5
              valueBoolean: {type: boolean, choiceOf: value, index: 6}
        reason:
          match: {}
          schema:
            short: Reason or related clarification for off-label use.
            array: true
            index: 7
            extensions: {}
            elements:
              extension: {index: 8}
              url:
                pattern: {type: uri, value: reason}
                type: uri
                index: 9
              value:
                choices: [valueCodeableConcept]
                index: 11
              valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 12}
  url:
    pattern: {type: uri, value: 'https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel'}
    type: uri
    index: 13
  value:
    choices: []
    index: 15
package_version: 1.0.0-comment-2
extensions:
  isOffLabelUse:
    url: null
    short: Indicates off-label use. Must be 'true' when .reason is provided.
    _required: true
    index: 1
    extensions: {}
    elements:
      extension: {index: 2}
      url:
        pattern: {type: uri, value: isOffLabelUse}
        type: uri
        index: 3
      value:
        choices: [valueBoolean]
        index: 5
      valueBoolean: {type: boolean, choiceOf: value, index: 6}
  reason:
    url: null
    short: Reason or related clarification for off-label use.
    array: true
    index: 7
    extensions: {}
    elements:
      extension: {index: 8}
      url:
        pattern: {type: uri, value: reason}
        type: uri
        index: 9
      value:
        choices: [valueCodeableConcept]
        index: 11
      valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 12}
class: extension
kind: complex-type
url: https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel
base: http://hl7.org/fhir/StructureDefinition/Extension
version: 1.0.0-comment-2
required: [extension]