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 Undesirable Effect (ePI)

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

ClinicalUseDefinition Undesirable Effect (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
Prohibited: 4 elements

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: undesirableEffect
... subject 1..*Reference(MedicinalProductDefinition (ePI))The medication or procedure for which this is an indication
... contraindication 0..0
... indication 0..0
... interaction 0..0
... undesirableEffect 1..1BackboneElementA possible negative outcome from the use of this treatment
.... symptomConditionEffect 0..1CodeableReference(ObservationDefinition)The situation in which the undesirable effect may manifest.
.... classification 0..1CodeableConceptHigh level classification of the effect.
.... frequencyOfOccurrence 0..1CodeableConceptHow often the effect is seen.
... warning 0..0

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: undesirableEffect
... 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
... population Σ0..*Reference(Group)The population group to which this applies
... undesirableEffect Σ1..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.

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
Prohibited: 4 elements

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: undesirableEffect
... subject 1..*Reference(MedicinalProductDefinition (ePI))The medication or procedure for which this is an indication
... contraindication 0..0
... indication 0..0
... interaction 0..0
... undesirableEffect 1..1BackboneElementA possible negative outcome from the use of this treatment
.... symptomConditionEffect 0..1CodeableReference(ObservationDefinition)The situation in which the undesirable effect may manifest.
.... classification 0..1CodeableConceptHigh level classification of the effect.
.... frequencyOfOccurrence 0..1CodeableConceptHow often the effect is seen.
... warning 0..0

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: undesirableEffect
... 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
... population Σ0..*Reference(Group)The population group to which this applies
... undesirableEffect Σ1..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.

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

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