AdverseReactionEvent
type: StructureDefinition
node role: treeRoot
id:
  v: AdverseReactionEvent
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition AdverseReactionEvent Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> AdverseReactionEvent S 0..* Base Adverse Reaction Event #xD; Items S 0..1 BackboneElement Items #xD; Specificsubstance S 0..1 CodeableConcept Specific substance #xD; Certainty S 0..1 CodeableConcept Certainty #xD; Manifestation S 0..* CodeableConcept Manifestation #xD; Reactiondescription S 0..1 string Reaction description #xD; Onsetofreaction S 0..1 dateTime Onset of reaction #xD; Severityofreaction S 0..1 CodeableConcept Severity of reaction #xD; Reactiondetails S 0..1 Reference() Reaction details #xD; Initialexposure S 0..1 dateTime Initial exposure #xD; Routeofexposure S 0..1 string Route of exposure #xD; Exposuredescription S 0..1 string Exposure description #xD; Exposuredetails S 0..1 Reference() Exposure details #xD; Clinicalmanagementdescription S 0..1 string Clinical management description #xD; Clinicalmanagementdetails S 0..1 Reference() Clinical management details #xD; Reportingdetails S 0..1 Reference() Reporting details #xD; Informationsource S 0..1 Reference() Information source #xD; Comment S 0..1 string Comment #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionEvent
  l: AdverseReactionEvent
identifier:
  system:
    v: https://aehrc.csiro.au/id/archetype_id
    l: archetype id
  value:
    v: openEHR-EHR-CLUSTER.adverse_reaction_event.v1
version:
  v: 0.0.1
name:
  v: AdverseReactionEvent
title:
  v: Adverse Reaction Event
status:
  v: draft
experimental:
  v: false
date:
  v: 2023-09-11T00:54:09+10:00
publisher:
  v: CSIRO
contact:
  name:
    v: CSIRO
  telecom:
    system:
      v: url
    value:
      v: https://aehrc.csiro.au/
contact:
  name:
    v: AU logical models
  telecom:
    system:
      v: url
    value:
      v: https://aehrc.csiro.au/
description:
  v: The Adverse Reaction Event Logical Model Mindmap is shown below. <img src='[binary]'/> Information about a specific adverse reaction event caused by exposure to a specific substance. **Purpose** To record information about a specific adverse reaction event caused by exposure to a specific substance. **Misuse** Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose. **Considerations** Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested. This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 036
    display:
      v: Australia (AUS)
fhir version:
  v: 4.0.1
kind:
  v: logical
abstract:
  v: false
type:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionEvent
  l: AdverseReactionEvent
base definition:
  v: http://hl7.org/fhir/StructureDefinition/Base
  l: Base
derivation:
  v: specialization
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 4.0.1
  element:
    id:
      v: AdverseReactionEvent
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
        l: elementdefinition-identifier
      value: Identifier
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
        l: note-considerations
      value: String
        v: Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested. This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-misuse
        l: note-misuse
      value: String
        v: Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-purpose
        l: note-purpose
      value: String
        v: To record information about a specific adverse reaction event caused by exposure to a specific substance.
    path:
      v: AdverseReactionEvent
    short:
      v: Adverse Reaction Event
    definition:
      v: Information about a specific adverse reaction event caused by exposure to a specific substance.
    comment:
      v: **Purpose** To record information about a specific adverse reaction event caused by exposure to a specific substance. **Misuse** Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose. **Considerations** Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested. This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
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  element:
    id:
      v: AdverseReactionEvent.Items
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
        l: elementdefinition-identifier
      value: Identifier
    path:
      v: AdverseReactionEvent.Items
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      v: Items
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        l: BackboneElement
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      source:
        v: http://hl7.org/fhir/StructureDefinition/Element
        l: Element
    must support:
      v: true
  element:
    id:
      v: AdverseReactionEvent.Items.id
    path:
      v: AdverseReactionEvent.Items.id
    representation:
      v: xmlAttr
    short:
      v: Unique id for inter-element referencing
    definition:
      v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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      code:
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        l: System.String
    is modifier:
      v: false

v: at0000

v: items

Url
v: string
l: string

v: false

identity:
  v: rim
map:
  v: n/a

id:
  v: AdverseReactionEvent.Items.extension
path:
  v: AdverseReactionEvent.Items.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
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    l: Extension
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  key:
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  expression:
    v: hasValue() or (children().count() > id.count())
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    l: Element
constraint:
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    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionEvent.Items.modifierExtension
path:
  v: AdverseReactionEvent.Items.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
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alias:
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type:
  code:
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    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
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    v: extension.exists() != value.exists()
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    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
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    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: AdverseReactionEvent.Items.Specificsubstance
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0001
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionEvent.Items.Specificsubstance
short:
  v: Specific substance
definition:
  v: The substance considered to be responsible for the specific adverse reaction event.
comment:
  v: **Considerations** For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
min:
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type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Certainty
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0002
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionEvent.Items.Certainty
short:
  v: Certainty
definition:
  v: The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.
comment:
  v: **Considerations** The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.
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type:
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    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Manifestation
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0006
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionEvent.Items.Manifestation
short:
  v: Manifestation
definition:
  v: Clinical symptoms and/or signs that are observed or associated with the adverse reaction.
comment:
  v: **Considerations** Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.
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type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Reactiondescription
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
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      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
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path:
  v: AdverseReactionEvent.Items.Reactiondescription
short:
  v: Reaction description
definition:
  v: Narrative description about the adverse reaction as a whole, including details of the manifestation if required.
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type:
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    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Onsetofreaction
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0008
path:
  v: AdverseReactionEvent.Items.Onsetofreaction
short:
  v: Onset of reaction
definition:
  v: The date and/or time of the onset of the reaction.
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type:
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    v: dateTime
    l: dateTime
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Severityofreaction
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
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    value:
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extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionEvent.Items.Severityofreaction
short:
  v: Severity of reaction
definition:
  v: Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
comment:
  v: **Considerations** It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
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type:
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    l: CodeableConcept
must support:
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id:
  v: AdverseReactionEvent.Items.Reactiondetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
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extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
path:
  v: AdverseReactionEvent.Items.Reactiondetails
short:
  v: Reaction details
definition:
  v: Additional details about the adverse reaction.
comment:
  v: **Considerations** May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
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type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Initialexposure
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
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extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
path:
  v: AdverseReactionEvent.Items.Initialexposure
short:
  v: Initial exposure
definition:
  v: The date and/or time of the first exposure to the Substance for this Reaction Event.
comment:
  v: **Considerations** Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Initialexposure
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Routeofexposure
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0017
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Coding of the Route of Exposure with a terminology should be used wherever possible.
path:
  v: AdverseReactionEvent.Items.Routeofexposure
short:
  v: Route of exposure
definition:
  v: The route by which the subject was exposed to the identified 'Specific substance'.
comment:
  v: **Considerations** Coding of the Route of Exposure with a terminology should be used wherever possible.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Routeofexposure
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Exposuredescription
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0018
path:
  v: AdverseReactionEvent.Items.Exposuredescription
short:
  v: Exposure description
definition:
  v: Narrative description about the exposure to the identified 'Specific substance'.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Exposuredescription
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Exposuredetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0019
path:
  v: AdverseReactionEvent.Items.Exposuredetails
short:
  v: Exposure details
definition:
  v: Additional details about exposure to the 'Specific substance'.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Exposuredetails
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Clinicalmanagementdescription
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0020
path:
  v: AdverseReactionEvent.Items.Clinicalmanagementdescription
short:
  v: Clinical management description
definition:
  v: Narrative description about the clinical management provided.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Clinicalmanagementdescription
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Clinicalmanagementdetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0021
path:
  v: AdverseReactionEvent.Items.Clinicalmanagementdetails
short:
  v: Clinical management details
definition:
  v: Additional structured details about clinical management for this reaction event.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Clinicalmanagementdetails
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Reportingdetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0022
path:
  v: AdverseReactionEvent.Items.Reportingdetails
short:
  v: Reporting details
definition:
  v: Additional structured details required for reporting to regulatory bodies.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Reportingdetails
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Informationsource
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0023
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
path:
  v: AdverseReactionEvent.Items.Informationsource
short:
  v: Information source
definition:
  v: Details about the provenance of the information.
comment:
  v: **Considerations** This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Informationsource
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Comment
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0024
path:
  v: AdverseReactionEvent.Items.Comment
short:
  v: Comment
definition:
  v: Additional narrative about the adverse reaction event not captured in other fields.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionEvent.Items.Comment
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

element:
  id:
    v: AdverseReactionEvent
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
      l: elementdefinition-identifier
    value: Identifier
      system:
        v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
        l: openEHR-EHR-CLUSTER.adverse reaction event.v1
      value:
        v: at0000
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
      l: note-considerations
    value: String
      v: Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested. This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-misuse
      l: note-misuse
    value: String
      v: Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-purpose
      l: note-purpose
    value: String
      v: To record information about a specific adverse reaction event caused by exposure to a specific substance.
  path:
    v: AdverseReactionEvent
  short:
    v: Adverse Reaction Event
  definition:
    v: Information about a specific adverse reaction event caused by exposure to a specific substance.
  comment:
    v: **Purpose** To record information about a specific adverse reaction event caused by exposure to a specific substance. **Misuse** Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose. **Considerations** Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested. This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
  min:
    v: 0
  max:
    v: *
  must support:
    v: true
element:
  id:
    v: AdverseReactionEvent.Items
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
      l: elementdefinition-identifier
    value: Identifier
      system:
        v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
        l: openEHR-EHR-CLUSTER.adverse reaction event.v1
      value:
        v: items
  path:
    v: AdverseReactionEvent.Items
  short:
    v: Items
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: BackboneElement
      l: BackboneElement
  must support:
    v: true
element:
  id:
    v: AdverseReactionEvent.Items.Specificsubstance
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
      l: elementdefinition-identifier
    value: Identifier
      system:
        v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
        l: openEHR-EHR-CLUSTER.adverse reaction event.v1
      value:
        v: at0001
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
      l: note-considerations
    value: String
      v: For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  path:
    v: AdverseReactionEvent.Items.Specificsubstance
  short:
    v: Specific substance
  definition:
    v: The substance considered to be responsible for the specific adverse reaction event.
  comment:
    v: **Considerations** For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
  must support:
    v: true
element:
  id:
    v: AdverseReactionEvent.Items.Certainty
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
      l: elementdefinition-identifier
    value: Identifier
      system:
        v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
        l: openEHR-EHR-CLUSTER.adverse reaction event.v1
      value:
        v: at0002
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
      l: note-considerations
    value: String
      v: The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  path:
    v: AdverseReactionEvent.Items.Certainty
  short:
    v: Certainty
  definition:
    v: The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.
  comment:
    v: **Considerations** The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
  must support:
    v: true
element:
  id:
    v: AdverseReactionEvent.Items.Manifestation
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
      l: elementdefinition-identifier
    value: Identifier
      system:
        v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
        l: openEHR-EHR-CLUSTER.adverse reaction event.v1
      value:
        v: at0006
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
      l: note-considerations
    value: String
      v: Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  path:
    v: AdverseReactionEvent.Items.Manifestation
  short:
    v: Manifestation
  definition:
    v: Clinical symptoms and/or signs that are observed or associated with the adverse reaction.
  comment:
    v: **Considerations** Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.
  min:
    v: 0
  max:
    v: *
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
  must support:
    v: true

id:
  v: AdverseReactionEvent.Items.Reactiondescription
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0007
path:
  v: AdverseReactionEvent.Items.Reactiondescription
short:
  v: Reaction description
definition:
  v: Narrative description about the adverse reaction as a whole, including details of the manifestation if required.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Onsetofreaction
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0008
path:
  v: AdverseReactionEvent.Items.Onsetofreaction
short:
  v: Onset of reaction
definition:
  v: The date and/or time of the onset of the reaction.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: dateTime
    l: dateTime
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Severityofreaction
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0010
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionEvent.Items.Severityofreaction
short:
  v: Severity of reaction
definition:
  v: Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
comment:
  v: **Considerations** It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Reactiondetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0014
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
path:
  v: AdverseReactionEvent.Items.Reactiondetails
short:
  v: Reaction details
definition:
  v: Additional details about the adverse reaction.
comment:
  v: **Considerations** May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Initialexposure
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0015
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
path:
  v: AdverseReactionEvent.Items.Initialexposure
short:
  v: Initial exposure
definition:
  v: The date and/or time of the first exposure to the Substance for this Reaction Event.
comment:
  v: **Considerations** Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: dateTime
    l: dateTime
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Routeofexposure
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0017
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Coding of the Route of Exposure with a terminology should be used wherever possible.
path:
  v: AdverseReactionEvent.Items.Routeofexposure
short:
  v: Route of exposure
definition:
  v: The route by which the subject was exposed to the identified 'Specific substance'.
comment:
  v: **Considerations** Coding of the Route of Exposure with a terminology should be used wherever possible.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Exposuredescription
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0018
path:
  v: AdverseReactionEvent.Items.Exposuredescription
short:
  v: Exposure description
definition:
  v: Narrative description about the exposure to the identified 'Specific substance'.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Exposuredetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0019
path:
  v: AdverseReactionEvent.Items.Exposuredetails
short:
  v: Exposure details
definition:
  v: Additional details about exposure to the 'Specific substance'.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Clinicalmanagementdescription
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0020
path:
  v: AdverseReactionEvent.Items.Clinicalmanagementdescription
short:
  v: Clinical management description
definition:
  v: Narrative description about the clinical management provided.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Clinicalmanagementdetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0021
path:
  v: AdverseReactionEvent.Items.Clinicalmanagementdetails
short:
  v: Clinical management details
definition:
  v: Additional structured details about clinical management for this reaction event.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Reportingdetails
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0022
path:
  v: AdverseReactionEvent.Items.Reportingdetails
short:
  v: Reporting details
definition:
  v: Additional structured details required for reporting to regulatory bodies.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Informationsource
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0023
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
path:
  v: AdverseReactionEvent.Items.Informationsource
short:
  v: Information source
definition:
  v: Details about the provenance of the information.
comment:
  v: **Considerations** This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: true

id:
  v: AdverseReactionEvent.Items.Comment
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
    l: elementdefinition-identifier
  value: Identifier
    system:
      v: https://aehrc.csiro.au/id/archetype_id/openEHR-EHR-CLUSTER.adverse_reaction_event.v1
      l: openEHR-EHR-CLUSTER.adverse reaction event.v1
    value:
      v: at0024
path:
  v: AdverseReactionEvent.Items.Comment
short:
  v: Comment
definition:
  v: Additional narrative about the adverse reaction event not captured in other fields.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true