Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
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 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi | Version: 1.0.0-ballot | |||
| Active as of 2022-12-04 | 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 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 | 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 |
 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 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. |
 undesirableEffect | Σ | 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 |
| 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
| |||||
| 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 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. | ||||
| population | Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
| undesirableEffect | Σ | 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 | preferred | CommonLanguages
| ||||
| 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 |
This structure is derived from ClinicalUseDefinition
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 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 | 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 |
| 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 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. |
| undesirableEffect | Σ | 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 |
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
| |||||
| 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 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. | ||||
| population | Σ | 0..* | Reference(Group) | The population group to which this applies | ||||
| undesirableEffect | Σ | 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 | preferred | CommonLanguages
| ||||
| 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 |
This structure is derived from ClinicalUseDefinition
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
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