Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: ClinicalUseDefinition Indication (ePI)

Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/ClinicalUseDefinition-indication-uv-epi Version: 0.1.0
Active as of 2022-09-02 Computable Name: ClinicalUseDefinitionIndicationUvEpi

ClinicalUseDefinition Indication (ePI)

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from ClinicalUseDefinition

Summary

Mandatory: 2 elements (1 nested mandatory element)

Structures

This structure refers to these other structures:

This structure is derived from ClinicalUseDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition 0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
... identifier 0..*IdentifierBusiness identifier for this issue.
... type 1..1codeindication | contraindication | interaction | undesirable-effect | warning
Required Pattern: indication
... subject 1..*Reference(MedicinalProductDefinition (ePI))The medication or procedure for which this is an indication
... indication 1..1BackboneElementSpecifics for when this is an indication
.... diseaseSymptomProcedure
..... concept 1..1CodeableConceptReference to a concept (by class)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition I0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness identifier for this issue.
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | warning
Binding: ClinicalUseIssueType (required): Overall defining type of this clinical use issue.


Required Pattern: indication
... category Σ0..*CodeableConceptA categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines"
... subject Σ1..*Reference(MedicinalProductDefinition (ePI))The medication or procedure for which this is an indication
... status Σ0..1CodeableConceptWhether this is a current issue or one that has been retired
... contraindication Σ0..1BackboneElementSpecifics for when this is a contraindication
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as contraindicating against this item
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the contraindication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection
.... indication Σ0..*Reference(ClinicalUseDefinition)The indication which this is a contraidication for
.... otherTherapy Σ0..*BackboneElementInformation about the use of the medicinal product in relation to other therapies described as part of the contraindication
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... relationshipType Σ1..1CodeableConceptThe type of relationship between the medicinal product indication or contraindication and another therapy
Binding: TherapyRelationshipType (preferred): Classification of relationship between a therapy and a contraindication or an indication.

..... therapy Σ1..1CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition)Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
... indication Σ1..1BackboneElementSpecifics for when this is an indication
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as an indicaton for this item
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ1..1CodeableConceptReference to a concept (by class)
..... reference Σ0..1Reference()Reference to a resource (by instance)
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the indication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection as part of the indication
.... intendedEffect Σ0..1CodeableReference(ObservationDefinition)The intended effect, aim or strategy to be achieved
.... duration Σ0..1QuantityTiming or duration information
.... undesirableEffect Σ0..*Reference(ClinicalUseDefinition)The specific undesirable effects of the medicinal product
.... otherTherapy Σ0..*See otherTherapy (ClinicalUseDefinition)Information about the use of the medicinal product in relation to other therapies described as part of the indication
... interaction Σ0..1BackboneElementSpecifics for when this is an interaction
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... interactant Σ0..*BackboneElementThe specific medication, food, substance or laboratory test that interacts
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... item[x] Σ1..1The specific medication, food or laboratory test that interacts
...... itemReferenceReference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)
...... itemCodeableConceptCodeableConcept
.... type Σ0..1CodeableConceptThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
.... effect Σ0..1CodeableReference(ObservationDefinition)The effect of the interaction, for example "reduced gastric absorption of primary medication"
.... incidence Σ0..1CodeableConceptThe incidence of the interaction, e.g. theoretical, observed
.... management Σ0..*CodeableConceptActions for managing the interaction
... population Σ0..*Reference(Group)The population group to which this applies
... undesirableEffect Σ0..1BackboneElementA possible negative outcome from the use of this treatment
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... symptomConditionEffect Σ0..1CodeableReference(ObservationDefinition)The situation in which the undesirable effect may manifest
.... classification Σ0..1CodeableConceptHigh level classification of the effect
.... frequencyOfOccurrence Σ0..1CodeableConceptHow often the effect is seen
... warning Σ0..1BackboneElementA critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness' or 'Get medical advice/attention if you feel unwell'
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... description Σ0..1markdownA textual definition of this warning, with formatting
.... code Σ0..1CodeableConceptA coded or unformatted textual definition of this warning
Binding: WarningType (example): Classification of warning type.


doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition I0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure

doco Documentation for this format

This structure is derived from ClinicalUseDefinition

Summary

Mandatory: 2 elements (1 nested mandatory element)

Structures

This structure refers to these other structures:

Differential View

This structure is derived from ClinicalUseDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition 0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
... identifier 0..*IdentifierBusiness identifier for this issue.
... type 1..1codeindication | contraindication | interaction | undesirable-effect | warning
Required Pattern: indication
... subject 1..*Reference(MedicinalProductDefinition (ePI))The medication or procedure for which this is an indication
... indication 1..1BackboneElementSpecifics for when this is an indication
.... diseaseSymptomProcedure
..... concept 1..1CodeableConceptReference to a concept (by class)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition I0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness identifier for this issue.
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | warning
Binding: ClinicalUseIssueType (required): Overall defining type of this clinical use issue.


Required Pattern: indication
... category Σ0..*CodeableConceptA categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines"
... subject Σ1..*Reference(MedicinalProductDefinition (ePI))The medication or procedure for which this is an indication
... status Σ0..1CodeableConceptWhether this is a current issue or one that has been retired
... contraindication Σ0..1BackboneElementSpecifics for when this is a contraindication
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as contraindicating against this item
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the contraindication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection
.... indication Σ0..*Reference(ClinicalUseDefinition)The indication which this is a contraidication for
.... otherTherapy Σ0..*BackboneElementInformation about the use of the medicinal product in relation to other therapies described as part of the contraindication
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... relationshipType Σ1..1CodeableConceptThe type of relationship between the medicinal product indication or contraindication and another therapy
Binding: TherapyRelationshipType (preferred): Classification of relationship between a therapy and a contraindication or an indication.

..... therapy Σ1..1CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition)Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
... indication Σ1..1BackboneElementSpecifics for when this is an indication
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as an indicaton for this item
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ1..1CodeableConceptReference to a concept (by class)
..... reference Σ0..1Reference()Reference to a resource (by instance)
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the indication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection as part of the indication
.... intendedEffect Σ0..1CodeableReference(ObservationDefinition)The intended effect, aim or strategy to be achieved
.... duration Σ0..1QuantityTiming or duration information
.... undesirableEffect Σ0..*Reference(ClinicalUseDefinition)The specific undesirable effects of the medicinal product
.... otherTherapy Σ0..*See otherTherapy (ClinicalUseDefinition)Information about the use of the medicinal product in relation to other therapies described as part of the indication
... interaction Σ0..1BackboneElementSpecifics for when this is an interaction
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... interactant Σ0..*BackboneElementThe specific medication, food, substance or laboratory test that interacts
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... item[x] Σ1..1The specific medication, food or laboratory test that interacts
...... itemReferenceReference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)
...... itemCodeableConceptCodeableConcept
.... type Σ0..1CodeableConceptThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
.... effect Σ0..1CodeableReference(ObservationDefinition)The effect of the interaction, for example "reduced gastric absorption of primary medication"
.... incidence Σ0..1CodeableConceptThe incidence of the interaction, e.g. theoretical, observed
.... management Σ0..*CodeableConceptActions for managing the interaction
... population Σ0..*Reference(Group)The population group to which this applies
... undesirableEffect Σ0..1BackboneElementA possible negative outcome from the use of this treatment
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... symptomConditionEffect Σ0..1CodeableReference(ObservationDefinition)The situation in which the undesirable effect may manifest
.... classification Σ0..1CodeableConceptHigh level classification of the effect
.... frequencyOfOccurrence Σ0..1CodeableConceptHow often the effect is seen
... warning Σ0..1BackboneElementA critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness' or 'Get medical advice/attention if you feel unwell'
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... description Σ0..1markdownA textual definition of this warning, with formatting
.... code Σ0..1CodeableConceptA coded or unformatted textual definition of this warning
Binding: WarningType (example): Classification of warning type.


doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet / Code
ClinicalUseDefinition.languagepreferredCommonLanguages
Max Binding: AllLanguages
ClinicalUseDefinition.typerequiredPattern: indication
ClinicalUseDefinition.contraindication.otherTherapy.relationshipTypepreferredTherapyRelationshipType
ClinicalUseDefinition.warning.codeexampleWarningType