Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi | Version: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: ClinicalUseDefinitionUndesirableEffectUvEpi | ||
ClinicalUseDefinition Undesirable Effect (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
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: undesirable-effect | |
 subject | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. 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 | 0..0 | |||
 undesirableEffect | 1..1 | BackboneElement | A possible negative outcome from the use of this treatment | |
 symptomConditionEffect | 0..1 | CodeableReference(ObservationDefinition) | The situation in which the undesirable effect may manifest. | |
| classification | 0..1 | CodeableConcept | High level classification of the effect. | |
 frequencyOfOccurrence | 0..1 | CodeableConcept | How often the effect is seen. | |
| warning | 0..0 | |||
| Documentation for this format | ||||
| 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 |
| contained | 0..* | Resource | Contained, inline Resources | |
 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: undesirable-effect |
| subject | 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: PublicationStatus (preferred): The lifecycle status of an artifact. |
 undesirableEffect | ΣC | 1..1 | BackboneElement | A possible negative outcome from the use of this treatment |
 modifierExtension | ?!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: UndesirableEffectSymptom (example): An undesirable effect of clinical use. |
| classification | Σ | 0..1 | CodeableConcept | High level classification of the effect. Binding: UndesirableEffectClassification (example): A categorisation for an undesirable effect. |
| frequencyOfOccurrence | Σ | 0..1 | CodeableConcept | How often the effect is seen. Binding: UndesirablEffectFrequency (example): A categorisation for a frequency of occurence of an undesirable effect. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ClinicalUseDefinition.type | required | Pattern: undesirable-effect |
| ClinicalUseDefinition.status | preferred | PublicationStatus |
| ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptom |
| ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassification |
| ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequency |
| Id | Grade | Path(s) | Details | Requirements |
| cud-1 | error | ClinicalUseDefinition | Indication, 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-2 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ClinicalUseDefinition | If 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-4 | error | ClinicalUseDefinition | If 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-5 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ClinicalUseDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| 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: AllLanguages (required): IETF language tag for a human language | |
| 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: undesirable-effect |
| 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, 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: PublicationStatus (preferred): The lifecycle status of an artifact. |
| population | Σ | 0..* | Reference(Group) | The population group to which this applies |
| library | 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 |
| 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 |
| symptomConditionEffect | Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation in which the undesirable effect may manifest. Binding: UndesirableEffectSymptom (example): An undesirable effect of clinical use. |
| classification | Σ | 0..1 | CodeableConcept | High level classification of the effect. Binding: UndesirableEffectClassification (example): A categorisation for an undesirable effect. |
| frequencyOfOccurrence | Σ | 0..1 | CodeableConcept | How often the effect is seen. Binding: UndesirablEffectFrequency (example): A categorisation for a frequency of occurence of an undesirable effect. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ClinicalUseDefinition.language | required | AllLanguages |
| ClinicalUseDefinition.type | required | Pattern: undesirable-effect |
| 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.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 |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ClinicalUseDefinition
Summary
Mandatory: 2 elements
Prohibited: 4 elements
Structures
This structure refers to these other structures:
Maturity: 2
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: undesirable-effect | |
| subject | 1..* | Reference(MedicinalProductDefinition (ePI)) | The medication, product, substance, device, procedure etc. 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 | 0..0 | |||
| undesirableEffect | 1..1 | BackboneElement | A possible negative outcome from the use of this treatment | |
| symptomConditionEffect | 0..1 | CodeableReference(ObservationDefinition) | The situation in which the undesirable effect may manifest. | |
| classification | 0..1 | CodeableConcept | High level classification of the effect. | |
| frequencyOfOccurrence | 0..1 | CodeableConcept | How often the effect is seen. | |
| warning | 0..0 | |||
| Documentation for this format | ||||
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 |
| contained | 0..* | Resource | Contained, inline Resources | |
| 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: undesirable-effect |
| subject | 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: PublicationStatus (preferred): The lifecycle status of an artifact. |
| undesirableEffect | ΣC | 1..1 | BackboneElement | A possible negative outcome from the use of this treatment |
| modifierExtension | ?!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: UndesirableEffectSymptom (example): An undesirable effect of clinical use. |
| classification | Σ | 0..1 | CodeableConcept | High level classification of the effect. Binding: UndesirableEffectClassification (example): A categorisation for an undesirable effect. |
| frequencyOfOccurrence | Σ | 0..1 | CodeableConcept | How often the effect is seen. Binding: UndesirablEffectFrequency (example): A categorisation for a frequency of occurence of an undesirable effect. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ClinicalUseDefinition.type | required | Pattern: undesirable-effect |
| ClinicalUseDefinition.status | preferred | PublicationStatus |
| ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | example | UndesirableEffectSymptom |
| ClinicalUseDefinition.undesirableEffect.classification | example | UndesirableEffectClassification |
| ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | example | UndesirablEffectFrequency |
| Id | Grade | Path(s) | Details | Requirements |
| cud-1 | error | ClinicalUseDefinition | Indication, 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-2 | error | ClinicalUseDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ClinicalUseDefinition | If 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-4 | error | ClinicalUseDefinition | If 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-5 | error | ClinicalUseDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ClinicalUseDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
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: AllLanguages (required): IETF language tag for a human language | |
| 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: undesirable-effect |
| 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, 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: PublicationStatus (preferred): The lifecycle status of an artifact. |
| population | Σ | 0..* | Reference(Group) | The population group to which this applies |
| library | 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 |
| 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 |
| symptomConditionEffect | Σ | 0..1 | CodeableReference(ObservationDefinition) | The situation in which the undesirable effect may manifest. Binding: UndesirableEffectSymptom (example): An undesirable effect of clinical use. |
| classification | Σ | 0..1 | CodeableConcept | High level classification of the effect. Binding: UndesirableEffectClassification (example): A categorisation for an undesirable effect. |
| frequencyOfOccurrence | Σ | 0..1 | CodeableConcept | How often the effect is seen. Binding: UndesirablEffectFrequency (example): A categorisation for a frequency of occurence of an undesirable effect. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ClinicalUseDefinition.language | required | AllLanguages |
| ClinicalUseDefinition.type | required | Pattern: undesirable-effect |
| 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.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 |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ClinicalUseDefinition
Summary
Mandatory: 2 elements
Prohibited: 4 elements
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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