Profile Comparison between http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi vs http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition
copyright
date	2023-07-26T13:32:34+00:00	2025-07-21T10:31:44+00:00	Values Differ
description	ClinicalUseDefinition Undesirable Effect (ePI)
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	ClinicalUseDefinitionUndesirableEffectUvEpi
publisher	HL7 International - Biomedical Research & Regulation Work Group
purpose
status	active
title	ClinicalUseDefinition Undesirable Effect (ePI)
type	ClinicalUseDefinition
url	http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi
version	1.0.0	1.1.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
ClinicalUseDefinition	C	0..*	ClinicalUseDefinition	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure	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	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for this clinical use.	Σ	0..*	Identifier	Business identifier for this clinical use.
type	Σ	1..1	code	indication | contraindication | interaction | undesirable-effect | warning Binding: ?? (required): Overall defining type of this clinical use definition. Required Pattern: undesirable-effect	Σ	1..1	code	indication | contraindication | interaction | undesirable-effect | warning Binding: ?? (required): Overall defining type of this clinical use definition. Required Pattern: undesirable-effect
category	Σ	0..*	CodeableConcept	A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ?? (preferred): A categorisation for a clinical use information item.	Σ	0..*	CodeableConcept	A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: ?? (preferred): A categorisation for a clinical use information item.
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The medication, product, substance, device, procedure etc. for which this is an indication
status	Σ	0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired Binding: ?? (preferred): The lifecycle status of an artifact.	Σ	0..1	CodeableConcept	Defines whether this clinical use is draft, active or retired Binding: ?? (preferred): The lifecycle status of an artifact.
contraindication	ΣC	0..0			ΣC	0..0
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
diseaseSymptomProcedure	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as contraindicating against this item Binding: ?? (example): A symptom, disease or procedure.	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as contraindicating against this item Binding: ?? (example): A symptom, disease or procedure.
diseaseStatus	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the contraindication Binding: ?? (example): The status of a disease or symptom.	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the contraindication Binding: ?? (example): The status of a disease or symptom.
comorbidity	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity (concurrent condition) or coinfection Binding: ?? (example): A symptom, disease or procedure.	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity (concurrent condition) or coinfection Binding: ?? (example): A symptom, disease or procedure.
indication	Σ	0..*	Reference(ClinicalUseDefinition)	The indication which this is a contraidication for	Σ	0..*	Reference(ClinicalUseDefinition)	The indication which this is a contraidication for
applicability		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
otherTherapy	Σ	0..*	BackboneElement	Information about use of the product in relation to other therapies described as part of the contraindication	Σ	0..*	BackboneElement	Information about use of the product in relation to other therapies described as part of the contraindication
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relationshipType	Σ	1..1	CodeableConcept	The type of relationship between the product indication/contraindication and another therapy Binding: ?? (preferred): Classification of relationship between a therapy and a contraindication or an indication.	Σ	1..1	CodeableConcept	The type of relationship between the product indication/contraindication and another therapy Binding: ?? (preferred): Classification of relationship between a therapy and a contraindication or an indication.
treatment	Σ	1..1	CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition)	Reference to a specific medication, substance etc. as part of an indication or contraindication Binding: ?? (example): A therapy.	Σ	1..1	CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition)	Reference to a specific medication, substance etc. as part of an indication or contraindication Binding: ?? (example): A therapy.
indication	ΣC	0..0			ΣC	0..0
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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: ?? (example): A symptom, disease or procedure.	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as an indicaton for this item Binding: ?? (example): A symptom, disease or procedure.
diseaseStatus	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the indication Binding: ?? (example): The status of a disease or symptom.	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the indication Binding: ?? (example): The status of a disease or symptom.
comorbidity	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity or coinfection as part of the indication Binding: ?? (example): A symptom, disease or procedure.	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity or coinfection as part of the indication Binding: ?? (example): A symptom, disease or procedure.
intendedEffect	Σ	0..1	CodeableReference(ObservationDefinition)	The intended effect, aim or strategy to be achieved Binding: ?? (preferred): The overall intended use of a product.	Σ	0..1	CodeableReference(ObservationDefinition)	The intended effect, aim or strategy to be achieved Binding: ?? (preferred): The overall intended use of a product.
duration[x]	Σ	0..1	Range, string	Timing or duration information	Σ	0..1	Range, string	Timing or duration information
undesirableEffect	Σ	0..*	Reference(ClinicalUseDefinition)	An unwanted side effect or negative outcome of the subject of this resource when being used for this indication	Σ	0..*	Reference(ClinicalUseDefinition)	An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
applicability		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
otherTherapy	Σ	0..*	See otherTherapy (ClinicalUseDefinition)	The use of the medicinal product in relation to other therapies described as part of the indication	Σ	0..*	See otherTherapy (ClinicalUseDefinition)	The use of the medicinal product in relation to other therapies described as part of the indication
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relationshipType	Σ	1..1	CodeableConcept	The type of relationship between the product indication/contraindication and another therapy Binding: ?? (preferred): Classification of relationship between a therapy and a contraindication or an indication.	Σ	1..1	CodeableConcept	The type of relationship between the product indication/contraindication and another therapy Binding: ?? (preferred): Classification of relationship between a therapy and a contraindication or an indication.
treatment	Σ	1..1	CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition)	Reference to a specific medication, substance etc. as part of an indication or contraindication Binding: ?? (example): A therapy.	Σ	1..1	CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition)	Reference to a specific medication, substance etc. as part of an indication or contraindication Binding: ?? (example): A therapy.
interaction	ΣC	0..0			ΣC	0..0
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
interactant	Σ	0..*	BackboneElement	The specific medication, product, food etc. or laboratory test that interacts	Σ	0..*	BackboneElement	The specific medication, product, food etc. or laboratory test that interacts
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item[x]	Σ	1..1	Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition), CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Binding: ?? (example): An interactant - a substance that may have a clinically significant effect on another.	Σ	1..1	Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition), CodeableConcept	The specific medication, product, food etc. or laboratory test that interacts Binding: ?? (example): An interactant - a substance that may have a clinically significant effect on another.
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug interaction, drug-lab test interaction Binding: ?? (example): A categorisation for an interaction between two substances.	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug interaction, drug-lab test interaction Binding: ?? (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: ?? (example): A interaction effect of clinical use of a medication or other substance.	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: ?? (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: ?? (example): A categorisation for incidence of occurence of an interaction.	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: ?? (example): A categorisation for incidence of occurence of an interaction.
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: ?? (example): A type of management for an interaction of a medication or other substance.	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: ?? (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	Σ	0..*	Reference(Group)	The population group to which this applies
library	Σ	0..*	canonical(Library)	Logic used by the clinical use definition	Σ	0..*	canonical(Library)	Logic used by the clinical use definition
undesirableEffect	ΣC	1..1	BackboneElement	A possible negative outcome from the use of this treatment	ΣC	1..1	BackboneElement	A possible negative outcome from the use of this treatment
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
symptomConditionEffect	Σ	0..1	CodeableReference(ObservationDefinition)	The situation in which the undesirable effect may manifest. Binding: ?? (example): An undesirable effect of clinical use.	Σ	0..1	CodeableReference(ObservationDefinition)	The situation in which the undesirable effect may manifest. Binding: ?? (example): An undesirable effect of clinical use.
classification	Σ	0..1	CodeableConcept	High level classification of the effect. Binding: ?? (example): A categorisation for an undesirable effect.	Σ	0..1	CodeableConcept	High level classification of the effect. Binding: ?? (example): A categorisation for an undesirable effect.
frequencyOfOccurrence	Σ	0..1	CodeableConcept	How often the effect is seen. Binding: ?? (example): A categorisation for a frequency of occurence of an undesirable effect.	Σ	0..1	CodeableConcept	How often the effect is seen. Binding: ?? (example): A categorisation for a frequency of occurence of an undesirable effect.
warning	ΣC	0..0			ΣC	0..0
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
description	Σ	0..1	markdown	A textual definition of this warning, with formatting	Σ	0..1	markdown	A textual definition of this warning, with formatting
code	Σ	0..1	CodeableConcept	A coded or unformatted textual definition of this warning Binding: ?? (example): Classification of warning type.	Σ	0..1	CodeableConcept	A coded or unformatted textual definition of this warning Binding: ?? (example): Classification of warning type.
Documentation for this format