Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi | Version: 1.0.0-ballot | |||
| Active as of 2022-12-04 | Computable Name: ClinicalUseDefinitionIndicationUvEpi | |||
ClinicalUseDefinition Indication (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ClinicalUseDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ClinicalUseDefinition | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure | |
  identifier | 0..* | Identifier | Business identifier for this clinical use. | |
| type | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Required Pattern: indication | |
 subject | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication or procedure for which this is an indication | |
| status | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired | |
| contraindication | 0..0 | |||
 indication | 1..1 | BackboneElement | Specifics for when this is an indication | |
  diseaseSymptomProcedure | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | |
| interaction | 0..0 | |||
| undesirableEffect | 0..0 | |||
| warning | 0..0 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ClinicalUseDefinition | C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier | Σ | 0..* | Identifier | Business identifier for this clinical use. |
| type | Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication |
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication or procedure for which this is an indication |
| status | Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
 indication | Σ | 1..1 | BackboneElement | Specifics for when this is an indication |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| diseaseSymptomProcedure | Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ClinicalUseDefinition.type | required | Pattern: indication |
| ClinicalUseDefinition.status | preferred | PublicationStatus |
| ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ClinicalUseDefinition | C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Business identifier for this clinical use. | ||||
| type | Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication | ||||
| category | Σ | 0..* | CodeableConcept | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ClinicalUseDefinitionCategory (preferred): A categorisation for a clinical use information item. | ||||
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication or procedure for which this is an indication | ||||
| status | Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| indication | Σ | 1..1 | BackboneElement | Specifics for when this is an indication | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| diseaseSymptomProcedure | Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | ||||
| diseaseStatus | Σ | 0..1 | CodeableReference(ObservationDefinition) | The status of the disease or symptom for the indication Binding: DiseaseStatus (example): The status of a disease or symptom. | ||||
| comorbidity | Σ | 0..* | CodeableReference(ObservationDefinition) | A comorbidity or coinfection as part of the indication Binding: DiseaseSymptomProcedure (example): A symptom, disease or procedure. | ||||
| intendedEffect | Σ | 0..1 | CodeableReference(ObservationDefinition) | The intended effect, aim or strategy to be achieved Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
 duration[x] | Σ | 0..1 | Timing or duration information | |||||
| durationRange | Range | |||||||
| durationString | string | |||||||
| undesirableEffect | Σ | 0..* | Reference(ClinicalUseDefinition) | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||
| otherTherapy | Σ | 0..* | See otherTherapy (ClinicalUseDefinition) | The use of the medicinal product in relation to other therapies described as part of the indication | ||||
| population | Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| ClinicalUseDefinition.language | preferred | CommonLanguages
| ||||
| ClinicalUseDefinition.type | required | Pattern: indication | ||||
| ClinicalUseDefinition.category | preferred | ClinicalUseDefinitionCategory | ||||
| ClinicalUseDefinition.status | preferred | PublicationStatus | ||||
| ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | example | DiseaseSymptomProcedure | ||||
| ClinicalUseDefinition.contraindication.diseaseStatus | example | DiseaseStatus | ||||
| ClinicalUseDefinition.contraindication.comorbidity | example | DiseaseSymptomProcedure | ||||
| ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | preferred | TherapyRelationshipType | ||||
| ClinicalUseDefinition.contraindication.otherTherapy.treatment | example | Therapy | ||||
| ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra | ||||
| ClinicalUseDefinition.indication.diseaseStatus | example | DiseaseStatus | ||||
| ClinicalUseDefinition.indication.comorbidity | example | DiseaseSymptomProcedure | ||||
| ClinicalUseDefinition.indication.intendedEffect | preferred | ProductIntendedUse | ||||
| ClinicalUseDefinition.interaction.interactant.item[x] | example | Interactant | ||||
| ClinicalUseDefinition.interaction.type | example | InteractionType | ||||
| ClinicalUseDefinition.interaction.effect | example | InteractionEffect | ||||
| ClinicalUseDefinition.interaction.incidence | example | InteractionIncidence | ||||
| ClinicalUseDefinition.interaction.management | example | InteractionManagement | ||||
| ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptom | ||||
| ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassification | ||||
| ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequency | ||||
| ClinicalUseDefinition.warning.code | example | WarningType |
This structure is derived from ClinicalUseDefinition
Differential View
This structure is derived from ClinicalUseDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ClinicalUseDefinition | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure | |
| identifier | 0..* | Identifier | Business identifier for this clinical use. | |
| type | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Required Pattern: indication | |
| subject | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication or procedure for which this is an indication | |
| status | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired | |
| contraindication | 0..0 | |||
| indication | 1..1 | BackboneElement | Specifics for when this is an indication | |
| diseaseSymptomProcedure | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | |
| interaction | 0..0 | |||
| undesirableEffect | 0..0 | |||
| warning | 0..0 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ClinicalUseDefinition | C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..* | Identifier | Business identifier for this clinical use. |
| type | Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication |
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication or procedure for which this is an indication |
| status | Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| indication | Σ | 1..1 | BackboneElement | Specifics for when this is an indication |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| diseaseSymptomProcedure | Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ClinicalUseDefinition.type | required | Pattern: indication |
| ClinicalUseDefinition.status | preferred | PublicationStatus |
| ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| ClinicalUseDefinition | C | 0..* | ClinicalUseDefinition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | Business identifier for this clinical use. | ||||
| type | Σ | 1..1 | code | indication | contraindication | interaction | undesirable-effect | warning Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition. Required Pattern: indication | ||||
| category | Σ | 0..* | CodeableConcept | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ClinicalUseDefinitionCategory (preferred): A categorisation for a clinical use information item. | ||||
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication or procedure for which this is an indication | ||||
| status | Σ | 0..1 | CodeableConcept | Defines whether this clinical use is draft, active or retired Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| indication | Σ | 1..1 | BackboneElement | Specifics for when this is an indication | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| diseaseSymptomProcedure | Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation that is being documented as an indicaton for this item Binding: MedDRA Terms for clinical diseases and symptoms (preferred) | ||||
| diseaseStatus | Σ | 0..1 | CodeableReference(ObservationDefinition) | The status of the disease or symptom for the indication Binding: DiseaseStatus (example): The status of a disease or symptom. | ||||
| comorbidity | Σ | 0..* | CodeableReference(ObservationDefinition) | A comorbidity or coinfection as part of the indication Binding: DiseaseSymptomProcedure (example): A symptom, disease or procedure. | ||||
| intendedEffect | Σ | 0..1 | CodeableReference(ObservationDefinition) | The intended effect, aim or strategy to be achieved Binding: ProductIntendedUse (preferred): The overall intended use of a product. | ||||
| duration[x] | Σ | 0..1 | Timing or duration information | |||||
| durationRange | Range | |||||||
| durationString | string | |||||||
| undesirableEffect | Σ | 0..* | Reference(ClinicalUseDefinition) | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication | ||||
| otherTherapy | Σ | 0..* | See otherTherapy (ClinicalUseDefinition) | The use of the medicinal product in relation to other therapies described as part of the indication | ||||
| population | Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| ClinicalUseDefinition.language | preferred | CommonLanguages
| ||||
| ClinicalUseDefinition.type | required | Pattern: indication | ||||
| ClinicalUseDefinition.category | preferred | ClinicalUseDefinitionCategory | ||||
| ClinicalUseDefinition.status | preferred | PublicationStatus | ||||
| ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | example | DiseaseSymptomProcedure | ||||
| ClinicalUseDefinition.contraindication.diseaseStatus | example | DiseaseStatus | ||||
| ClinicalUseDefinition.contraindication.comorbidity | example | DiseaseSymptomProcedure | ||||
| ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | preferred | TherapyRelationshipType | ||||
| ClinicalUseDefinition.contraindication.otherTherapy.treatment | example | Therapy | ||||
| ClinicalUseDefinition.indication.diseaseSymptomProcedure | preferred | VsMeddra | ||||
| ClinicalUseDefinition.indication.diseaseStatus | example | DiseaseStatus | ||||
| ClinicalUseDefinition.indication.comorbidity | example | DiseaseSymptomProcedure | ||||
| ClinicalUseDefinition.indication.intendedEffect | preferred | ProductIntendedUse | ||||
| ClinicalUseDefinition.interaction.interactant.item[x] | example | Interactant | ||||
| ClinicalUseDefinition.interaction.type | example | InteractionType | ||||
| ClinicalUseDefinition.interaction.effect | example | InteractionEffect | ||||
| ClinicalUseDefinition.interaction.incidence | example | InteractionIncidence | ||||
| ClinicalUseDefinition.interaction.management | example | InteractionManagement | ||||
| ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptom | ||||
| ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassification | ||||
| ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequency | ||||
| ClinicalUseDefinition.warning.code | example | WarningType |
This structure is derived from ClinicalUseDefinition
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change