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FHIR IG Statistics: StructureDefinition/ihe-ext-offLabel

Packageihe.pharm.mpd
TypeStructureDefinition
Idihe-ext-offLabel
FHIR VersionR5
Sourcehttps://profiles.ihe.net/PHARM/MPD/https://build.fhir.org/ig/IHE/pharm-mpd/StructureDefinition-ihe-ext-offLabel.html
URLhttps://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel
Version1.0.0-comment-2
Statusactive
Date2025-06-09T07:25:27+00:00
NameOffLabel
TitleOff-label use
Realmuv
Authorityihe
DescriptionIndicates 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.
CopyrightIHE http://www.ihe.net/Governance/#Intellectual_Property
TypeExtension
Kindcomplex-type

Resources that use this resource

StructureDefinition
MedicationRequest-eu-mpdMedicationRequest: MPD
IHEMedicationOrderIHE Medication Order

Resources that this resource uses

No resources found


Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: StructureDefinition ihe-ext-offLabel

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..*ExtensionOff-label use
... extension 1..*ExtensionExtension
... Slices for extension Content/Rules for all slices
.... extension:isOffLabelUse 1..1ExtensionIndicates off-label use. Must be 'true' when .reason is provided.
..... extension 0..0
..... url 1..1uri"isOffLabelUse"
..... value[x] 0..1booleanValue of extension
.... extension:reason 0..*ExtensionReason or related clarification for off-label use.
..... extension 0..0
..... url 1..1uri"reason"
..... value[x] 0..1CodeableConceptValue of extension
... url 1..1uri"https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"
... value[x] 0..0

doco Documentation for this format

Source

{
  "resourceType": "StructureDefinition",
  "id": "ihe-ext-offLabel",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
      "valueCode": "can-bind"
    }
  ],
  "url": "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel",
  "version": "1.0.0-comment-2",
  "name": "OffLabel",
  "title": "Off-label use",
  "status": "active",
  "date": "2025-06-09T07:25:27+00:00",
  "publisher": "Integrating the Healthcare Enterprise (IHE)",
  "contact": [
    {
      "name": "Integrating the Healthcare Enterprise (IHE)",
      "telecom": [
        {
          "system": "url",
          "value": "http://ihe.net"
        },
        {
          "system": "email",
          "value": "secretary@ihe.net"
        }
      ]
    },
    {
      "name": "José Costa Teixeira",
      "telecom": [
        {
          "system": "email",
          "value": "jose.a.teixeira@gmail.com",
          "use": "work"
        }
      ]
    }
  ],
  "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.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001"
        }
      ]
    }
  ],
  "copyright": "IHE http://www.ihe.net/Governance/#Intellectual_Property",
  "fhirVersion": "5.0.0",
  "mapping": [
    {
      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
    }
  ],
  "kind": "complex-type",
  "abstract": false,
  "context": [
    {
      "type": "element",
      "expression": "MedicationRequest"
    },
    {
      "type": "element",
      "expression": "MedicationStatement"
    }
  ],
  "type": "Extension",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
  "derivation": "constraint",
  "snapshot": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
        "valueString": "5.0.0"
      }
    ],
    "element": [
      {
        "id": "Extension",
        "path": "Extension",
        "short": "Off-label use",
        "definition": "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.",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Extension",
          "min": 0,
          "max": "*"
        },
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false
      },
      {
        "id": "Extension.id",
        "path": "Extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension",
        "path": "Extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 1,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:isOffLabelUse",
        "path": "Extension.extension",
        "sliceName": "isOffLabelUse",
        "short": "Indicates off-label use. Must be 'true' when .reason is provided.",
        "definition": "An Extension",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:isOffLabelUse.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:isOffLabelUse.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:isOffLabelUse.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "isOffLabelUse",
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:isOffLabelUse.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "boolean"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:reason",
        "path": "Extension.extension",
        "sliceName": "reason",
        "short": "Reason or related clarification for off-label use.",
        "definition": "An Extension",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:reason.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:reason.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:reason.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "reason",
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:reason.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.url",
        "path": "Extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel",
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.value[x]",
        "path": "Extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "base64Binary"
          },
          {
            "code": "boolean"
          },
          {
            "code": "canonical"
          },
          {
            "code": "code"
          },
          {
            "code": "date"
          },
          {
            "code": "dateTime"
          },
          {
            "code": "decimal"
          },
          {
            "code": "id"
          },
          {
            "code": "instant"
          },
          {
            "code": "integer"
          },
          {
            "code": "integer64"
          },
          {
            "code": "markdown"
          },
          {
            "code": "oid"
          },
          {
            "code": "positiveInt"
          },
          {
            "code": "string"
          },
          {
            "code": "time"
          },
          {
            "code": "unsignedInt"
          },
          {
            "code": "uri"
          },
          {
            "code": "url"
          },
          {
            "code": "uuid"
          },
          {
            "code": "Address"
          },
          {
            "code": "Age"
          },
          {
            "code": "Annotation"
          },
          {
            "code": "Attachment"
          },
          {
            "code": "CodeableConcept"
          },
          {
            "code": "CodeableReference"
          },
          {
            "code": "Coding"
          },
          {
            "code": "ContactPoint"
          },
          {
            "code": "Count"
          },
          {
            "code": "Distance"
          },
          {
            "code": "Duration"
          },
          {
            "code": "HumanName"
          },
          {
            "code": "Identifier"
          },
          {
            "code": "Money"
          },
          {
            "code": "Period"
          },
          {
            "code": "Quantity"
          },
          {
            "code": "Range"
          },
          {
            "code": "Ratio"
          },
          {
            "code": "RatioRange"
          },
          {
            "code": "Reference"
          },
          {
            "code": "SampledData"
          },
          {
            "code": "Signature"
          },
          {
            "code": "Timing"
          },
          {
            "code": "ContactDetail"
          },
          {
            "code": "DataRequirement"
          },
          {
            "code": "Expression"
          },
          {
            "code": "ParameterDefinition"
          },
          {
            "code": "RelatedArtifact"
          },
          {
            "code": "TriggerDefinition"
          },
          {
            "code": "UsageContext"
          },
          {
            "code": "Availability"
          },
          {
            "code": "ExtendedContactDetail"
          },
          {
            "code": "Dosage"
          },
          {
            "code": "Meta"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      }
    ]
  },
  "differential": {
    "element": [
      {
        "id": "Extension",
        "path": "Extension",
        "short": "Off-label use",
        "definition": "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."
      },
      {
        "id": "Extension.extension",
        "path": "Extension.extension",
        "min": 1
      },
      {
        "id": "Extension.extension:isOffLabelUse",
        "path": "Extension.extension",
        "sliceName": "isOffLabelUse",
        "short": "Indicates off-label use. Must be 'true' when .reason is provided.",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Extension.extension:isOffLabelUse.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:isOffLabelUse.url",
        "path": "Extension.extension.url",
        "fixedUri": "isOffLabelUse"
      },
      {
        "id": "Extension.extension:isOffLabelUse.value[x]",
        "path": "Extension.extension.value[x]",
        "type": [
          {
            "code": "boolean"
          }
        ]
      },
      {
        "id": "Extension.extension:reason",
        "path": "Extension.extension",
        "sliceName": "reason",
        "short": "Reason or related clarification for off-label use.",
        "min": 0,
        "max": "*"
      },
      {
        "id": "Extension.extension:reason.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:reason.url",
        "path": "Extension.extension.url",
        "fixedUri": "reason"
      },
      {
        "id": "Extension.extension:reason.value[x]",
        "path": "Extension.extension.value[x]",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ]
      },
      {
        "id": "Extension.url",
        "path": "Extension.url",
        "fixedUri": "https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-offLabel"
      },
      {
        "id": "Extension.value[x]",
        "path": "Extension.value[x]",
        "max": "0"
      }
    ]
  }
}