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

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Resource Profile: ClinicalUseDefinition Interaction (ePI)

ClinicalUseDefinition Interaction (ePI)

Usage:

• Examples for this Resource Profile: ClinicalUseDefinition/e60575aa-e7b3-4461-a456-d310514f4041, ClinicalUseDefinition/f7d8f2a0-27eb-4e37-8036-58f3d5aa6537

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

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: interaction
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		0..0
interaction
interactant
itemCodeableConcept		0..1	CodeableConcept	The specific medication, food or laboratory test that interacts Binding: WHO ATC (preferred): The specific substance that interacts. Additional Bindings Purpose Substances Validation Binding
type		0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab.
undesirableEffect		0..0
warning		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ClinicalUseDefinition.interaction.interactant.itemCodeableConcept	preferred	VsAtcClassification Additional Bindings Purpose Documentation Substances Validation Binding The specific substance that interacts.

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: interaction
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.type	required	Pattern: interaction
ClinicalUseDefinition.status	preferred	PublicationStatus

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 Additional Bindings Purpose AllLanguages Max Binding
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: interaction
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.
interaction	Σ	0..1	BackboneElement	Specifics for when this is an interaction
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
interactant	Σ	0..*	BackboneElement	The specific medication, food, substance or laboratory test that interacts
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
Slices for item[x]	Σ	1..1		The specific medication, food or laboratory test that interacts Slice: Unordered, Open by type:$this Binding: Interactant (example): An interactant - a substance that may have an clinically significant effect on another.
itemReference			Reference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)
itemCodeableConcept			CodeableConcept
item[x]:itemCodeableConcept	Σ	0..1	CodeableConcept	The specific medication, food or laboratory test that interacts Binding: WHO ATC (preferred): The specific substance that interacts. Additional Bindings Purpose Substances Validation Binding
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab. Binding: InteractionType (example): A categorisation for an interaction between two substances.
effect	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: InteractionEffect (example): A interaction effect of clinical use of a medication or other substance.
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: InteractionIncidence (example): A categorisation for incidence of occurence of an interaction.
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: InteractionManagement (example): A type of management for an interaction of a medication or other substance.
population	Σ	0..*	Reference(Group)	The population group to which this applies
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ClinicalUseDefinition.type	required	Pattern: interaction
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	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.diseaseStatus	example	DiseaseStatus
ClinicalUseDefinition.indication.comorbidity	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.intendedEffect	preferred	ProductIntendedUse
ClinicalUseDefinition.interaction.interactant.item[x]	example	Interactant
ClinicalUseDefinition.interaction.interactant.item[x]:itemCodeableConcept	preferred	VsAtcClassification Additional Bindings Purpose Documentation Substances Validation Binding The specific substance that interacts.
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

Summary

Mandatory: 1 element
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)

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: interaction
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		0..0
interaction
interactant
itemCodeableConcept		0..1	CodeableConcept	The specific medication, food or laboratory test that interacts Binding: WHO ATC (preferred): The specific substance that interacts. Additional Bindings Purpose Substances Validation Binding
type		0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab.
undesirableEffect		0..0
warning		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ClinicalUseDefinition.interaction.interactant.itemCodeableConcept	preferred	VsAtcClassification Additional Bindings Purpose Documentation Substances Validation Binding The specific substance that interacts.

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: interaction
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.type	required	Pattern: interaction
ClinicalUseDefinition.status	preferred	PublicationStatus

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 Additional Bindings Purpose AllLanguages Max Binding
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: interaction
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.
interaction	Σ	0..1	BackboneElement	Specifics for when this is an interaction
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
interactant	Σ	0..*	BackboneElement	The specific medication, food, substance or laboratory test that interacts
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
Slices for item[x]	Σ	1..1		The specific medication, food or laboratory test that interacts Slice: Unordered, Open by type:$this Binding: Interactant (example): An interactant - a substance that may have an clinically significant effect on another.
itemReference			Reference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)
itemCodeableConcept			CodeableConcept
item[x]:itemCodeableConcept	Σ	0..1	CodeableConcept	The specific medication, food or laboratory test that interacts Binding: WHO ATC (preferred): The specific substance that interacts. Additional Bindings Purpose Substances Validation Binding
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug, drug-food, drug-lab. Binding: InteractionType (example): A categorisation for an interaction between two substances.
effect	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: InteractionEffect (example): A interaction effect of clinical use of a medication or other substance.
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: InteractionIncidence (example): A categorisation for incidence of occurence of an interaction.
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: InteractionManagement (example): A type of management for an interaction of a medication or other substance.
population	Σ	0..*	Reference(Group)	The population group to which this applies
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
ClinicalUseDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ClinicalUseDefinition.type	required	Pattern: interaction
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	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.diseaseStatus	example	DiseaseStatus
ClinicalUseDefinition.indication.comorbidity	example	DiseaseSymptomProcedure
ClinicalUseDefinition.indication.intendedEffect	preferred	ProductIntendedUse
ClinicalUseDefinition.interaction.interactant.item[x]	example	Interactant
ClinicalUseDefinition.interaction.interactant.item[x]:itemCodeableConcept	preferred	VsAtcClassification Additional Bindings Purpose Documentation Substances Validation Binding The specific substance that interacts.
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

Summary

Mandatory: 1 element
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)

Other representations of profile: CSV, Excel, Schematron