Order Catalog Implementation Guide
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Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Resource Profile: UndesirableEffectDefinition Profile

Official URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/UndesirableEffectDefinition Version: current
Draft as of 2023-07-08 Computable Name: UndesirableEffectDefinition

This profile constrains the base resource ClinicalUseDefinition to represent an undesirable effect associated with a healthcare item (medication, device, test, service …) described in a catalog

Usage:

  • This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

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
... type 1..1codeindication | contraindication | interaction | undesirable-effect | warning
Fixed Value: undesirable-effect
... contraindication 0..0
... indication 0..0
... undesirableEffect 1..1BackboneElementA possible negative outcome from the use of this treatment
... warning 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition C0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... undesirableEffect ΣC1..1BackboneElementA possible negative outcome from the use of this treatment
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
ClinicalUseDefinition.typerequiredFixed Value: undesirable-effect

Constraints

IdGradePath(s)DetailsRequirements
cud-1errorClinicalUseDefinitionIndication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance
: (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2
dom-2errorClinicalUseDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorClinicalUseDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorClinicalUseDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorClinicalUseDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceClinicalUseDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition C0..*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 ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness identifier for this issue
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | warning
Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition.


Fixed Value: undesirable-effect
... category Σ0..*CodeableConceptA 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 Σ0..*Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct)The medication, product, substance, device, procedure etc. for which this is an indication
... status Σ0..1CodeableConceptWhether this is a current issue or one that has been retired etc
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... population Σ0..*Reference(Group)The population group to which this applies
... library Σ0..*canonical(Library)Logic used by the clinical use definition
... undesirableEffect ΣC1..1BackboneElementA possible negative outcome from the use of this treatment
.... id 0..1stringUnique 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
Binding: UndesirableEffectSymptom (example): An undesirable effect of clinical use.

.... classification Σ0..1CodeableConceptHigh level classification of the effect
Binding: UndesirableEffectClassification (example): A categorisation for an undesirable effect.

.... frequencyOfOccurrence Σ0..1CodeableConceptHow often the effect is seen
Binding: UndesirablEffectFrequency (example): A categorisation for a frequency of occurence of an undesirable effect.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
ClinicalUseDefinition.languagerequiredAllLanguages
ClinicalUseDefinition.typerequiredFixed Value: undesirable-effect
ClinicalUseDefinition.categorypreferredClinicalUseDefinitionCategory
ClinicalUseDefinition.statuspreferredPublicationStatus
ClinicalUseDefinition.contraindication.diseaseSymptomProcedureexampleDiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.diseaseStatusexampleDiseaseStatus
ClinicalUseDefinition.contraindication.comorbidityexampleDiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.otherTherapy.relationshipTypepreferredTherapyRelationshipType
ClinicalUseDefinition.contraindication.otherTherapy.treatmentexampleTherapy
ClinicalUseDefinition.indication.diseaseSymptomProcedureexampleDiseaseSymptomProcedure
ClinicalUseDefinition.indication.diseaseStatusexampleDiseaseStatus
ClinicalUseDefinition.indication.comorbidityexampleDiseaseSymptomProcedure
ClinicalUseDefinition.indication.intendedEffectpreferredProductIntendedUse
ClinicalUseDefinition.interaction.interactant.item[x]exampleInteractant
ClinicalUseDefinition.interaction.typeexampleInteractionType
ClinicalUseDefinition.interaction.effectexampleInteractionEffect
ClinicalUseDefinition.interaction.incidenceexampleInteractionIncidence
ClinicalUseDefinition.interaction.managementexampleInteractionManagement
ClinicalUseDefinition.undesirableEffect.symptomConditionEffectexampleUndesirableEffectSymptom
ClinicalUseDefinition.undesirableEffect.classificationexampleUndesirableEffectClassification
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrenceexampleUndesirablEffectFrequency
ClinicalUseDefinition.warning.codeexampleWarningType

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ClinicalUseDefinition

Summary

Mandatory: 1 element
Fixed Value: 1 element
Prohibited: 4 elements

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
... type 1..1codeindication | contraindication | interaction | undesirable-effect | warning
Fixed Value: undesirable-effect
... contraindication 0..0
... indication 0..0
... undesirableEffect 1..1BackboneElementA possible negative outcome from the use of this treatment
... warning 0..0

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition C0..*ClinicalUseDefinitionA single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... contained 0..*ResourceContained, inline Resources
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... undesirableEffect ΣC1..1BackboneElementA possible negative outcome from the use of this treatment
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
ClinicalUseDefinition.typerequiredFixed Value: undesirable-effect

Constraints

IdGradePath(s)DetailsRequirements
cud-1errorClinicalUseDefinitionIndication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance
: (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2
dom-2errorClinicalUseDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorClinicalUseDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorClinicalUseDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorClinicalUseDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceClinicalUseDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition C0..*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 ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness identifier for this issue
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | warning
Binding: ClinicalUseDefinitionType (required): Overall defining type of this clinical use definition.


Fixed Value: undesirable-effect
... category Σ0..*CodeableConceptA 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 Σ0..*Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct)The medication, product, substance, device, procedure etc. for which this is an indication
... status Σ0..1CodeableConceptWhether this is a current issue or one that has been retired etc
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... population Σ0..*Reference(Group)The population group to which this applies
... library Σ0..*canonical(Library)Logic used by the clinical use definition
... undesirableEffect ΣC1..1BackboneElementA possible negative outcome from the use of this treatment
.... id 0..1stringUnique 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
Binding: UndesirableEffectSymptom (example): An undesirable effect of clinical use.

.... classification Σ0..1CodeableConceptHigh level classification of the effect
Binding: UndesirableEffectClassification (example): A categorisation for an undesirable effect.

.... frequencyOfOccurrence Σ0..1CodeableConceptHow often the effect is seen
Binding: UndesirablEffectFrequency (example): A categorisation for a frequency of occurence of an undesirable effect.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
ClinicalUseDefinition.languagerequiredAllLanguages
ClinicalUseDefinition.typerequiredFixed Value: undesirable-effect
ClinicalUseDefinition.categorypreferredClinicalUseDefinitionCategory
ClinicalUseDefinition.statuspreferredPublicationStatus
ClinicalUseDefinition.contraindication.diseaseSymptomProcedureexampleDiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.diseaseStatusexampleDiseaseStatus
ClinicalUseDefinition.contraindication.comorbidityexampleDiseaseSymptomProcedure
ClinicalUseDefinition.contraindication.otherTherapy.relationshipTypepreferredTherapyRelationshipType
ClinicalUseDefinition.contraindication.otherTherapy.treatmentexampleTherapy
ClinicalUseDefinition.indication.diseaseSymptomProcedureexampleDiseaseSymptomProcedure
ClinicalUseDefinition.indication.diseaseStatusexampleDiseaseStatus
ClinicalUseDefinition.indication.comorbidityexampleDiseaseSymptomProcedure
ClinicalUseDefinition.indication.intendedEffectpreferredProductIntendedUse
ClinicalUseDefinition.interaction.interactant.item[x]exampleInteractant
ClinicalUseDefinition.interaction.typeexampleInteractionType
ClinicalUseDefinition.interaction.effectexampleInteractionEffect
ClinicalUseDefinition.interaction.incidenceexampleInteractionIncidence
ClinicalUseDefinition.interaction.managementexampleInteractionManagement
ClinicalUseDefinition.undesirableEffect.symptomConditionEffectexampleUndesirableEffectSymptom
ClinicalUseDefinition.undesirableEffect.classificationexampleUndesirableEffectClassification
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrenceexampleUndesirablEffectFrequency
ClinicalUseDefinition.warning.codeexampleWarningType

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ClinicalUseDefinition

Summary

Mandatory: 1 element
Fixed Value: 1 element
Prohibited: 4 elements

 

Other representations of profile: CSV, Excel, Schematron