AdverseReactionRiskAUCDI
type: StructureDefinition
node role: treeRoot
id:
  v: AdverseReactionRiskAUCDI
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition AdverseReactionRiskAUCDI Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> AdverseReactionRisk S 0..* AdverseReactionRisk Adverse Reaction Risk AUCDI Elements defined in Ancestors:Protocol, Data #xD; Data 0..1 BackboneElement Data #xD; Substance S 1..1 CodeableConcept Substance name #xD; Activeinactivestatus 0..1 Coding Active/inactive status #xD; Verificationstatus 0..1 Coding Verification status #xD; Category 0..1 CodeableConcept Category #xD; Criticality 0..1 CodeableConcept Criticality #xD; Onsetoflastreaction 0..1 Onset of last reaction #xD; <span title="Base StructureDefinition for dateTime Type: A date, date-time or partial date (e.g. just year or year + month). If hours and minutes are specified, a time zone SHALL be populated. The format is a union of the schema types gYear, gYearMonth, date and dateTime. Seconds must be provided due to schema type constraints but may be zero-filled and may be ignored. Dates SHALL be valid dates.">Onsetoflastreaction dateTime #xD; Onsetoflastreaction string #xD; Onsetoffirstreaction 0..1 Onset of first reaction #xD; <span title="Base StructureDefinition for dateTime Type: A date, date-time or partial date (e.g. just year or year + month). If hours and minutes are specified, a time zone SHALL be populated. The format is a union of the schema types gYear, gYearMonth, date and dateTime. Seconds must be provided due to schema type constraints but may be zero-filled and may be ignored. Dates SHALL be valid dates.">Onsetoffirstreaction dateTime #xD; Onsetoffirstreaction string #xD; Reactionmechanism 0..1 CodeableConcept Reaction mechanism #xD; Reactioneventsummary S 0..* Reference(Adverse Reaction Event AUCDI) Reaction event summary #xD; Comment S 0..1 string Comment #xD; Protocol 0..1 BackboneElement Protocol #xD; Lastupdated S 0..1 dateTime Last updated #xD; Extension 0..1 Reference() Extension #xD; <img src="[binary]" alt="…
url:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRiskAUCDI
  l: AdverseReactionRiskAUCDI
version:
  v: 0.0.1
name:
  v: AdverseReactionRiskAUCDI
title:
  v: Adverse Reaction Risk AUCDI
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 Risk AUCDI Logical Model Mindmap is shown below. <img src='[binary]'/> A summary or overview of a clinical assessment that identifies the potential for a harmful or undesirable physiological reaction unique to an individual and associated with exposure to a specific substance. **Context** This data group documents a clinician’s recommendation to avoid future exposure to a particular substance, emphasising the assessment of exposure risk and its substantiating evidence. In Release 1 the ‘Clinical evidence’ supporting the risk assessment is limited to the ‘Manifestation’ - symptoms or signs observed as part of an adverse reaction occurring on exposure to a substance. In future releases, it is anticipated that the details about the reaction event will be expanded and additional types of clinical evidence, such as immunogenetic test results can be included. While highlighting the clinical safety driver for accurately documenting adverse reactions, it is also important to recognise that such documentation within a clinical system will not always be limited to reactions categorised as true allergies, hypersensitivities, or intolerances. In practice, clinicians may encounter situations where the underlying pathophysiology of a reaction may not be known. Despite this, they still need to document that, in their judgment, the patient should avoid a specific substance. Such an entry is vital to prompt clinical safety alerts that prevent re-exposure, with previous manifestations offering insights into the risk of potential future harm, regardless of the unknown physiological mechanisms involved. Use cases include, but are not limited to: - 'Adverse Reaction List', or similar document, containing one or more ‘Adverse reaction summary’ data groups, - Triggering clinical decision alerts when prescribing, dispensing and administering a medication, and - To exchange safety-critical adverse reaction information with other healthcare providers. **Purpose** To reco…
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 036
    display:
      v: Australia (AUS)
keyword:
  system:
    v: https://aehrc.csiro.au/fhir/CodeSystem/cdi-category
    l: cdi-category
  code:
    v: core
fhir version:
  v: 4.0.1
kind:
  v: logical
abstract:
  v: false
type:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRiskAUCDI/AdverseReactionRisk
  l: AdverseReactionRisk
base definition:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRisk
  l: AdverseReactionRisk
derivation:
  v: specialization
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 0.0.1
  element:
    id:
      v: AdverseReactionRisk
    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 a clinical assessment of a propensity for an adverse reaction upon future exposure to a specified substance or class of substances including, but not limited to, incipients and excipients in medicinal preparations, biological products, metal salts, and organic chemical compounds. This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening: - immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or - non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities. In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient. Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT. Identification of the severity of the manifestation of the reaction, recorded in the CLUSTER.adverse_reaction_event archetype, can inform the 'Criticality' of the adverse reaction risk. For example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures. This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype. Use to record information about the positive presence of the risk of an adverse reaction: - to support the direct clinical care of an individual; - as part of…
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-misuse
        l: note-misuse
      value: String
        v: Not to be used for recording physiological reactions to physical agents, such as heat, cold, sunlight, vibration, exercise activity, by infectious agents or food contaminants. Use a specific archetype for EVALUATION.problem/diagnosis or CLUSTER.symptom/sign for this purpose. Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use, incorrect dosage or maladministration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for the purpose. Not to be used to record an adverse reaction where the substance is unknown. Use EVALUATION.problem_diagnosis or CLUSTER.symptom_sign to record as part of the health record until a possible substance is identified. Not to be used to record reactions to transfusions of blood products. Use a specific archetype for this purpose. Not to be used for recording 'alerts'. Use EVALUATION.precaution, EVALUATION.contraindication or related archetypes for this purpose. Not to be used for recording failed therapy. Not to be used for the explicit recording of an absence (or negative presence) of a reaction to 'any substances' or to identified substances, for example ‘No known allergies or adverse reactions’ or ‘No known allergies to Penicillin’. Use the EVALUATION.exclusion_global or EVALUATION.exclusion_specific archetypes to express a positive statement of adverse reaction exclusion. Not to be used for the explicit recording that no information was able to be obtained about the adverse reaction status of a patient. Use the EVALUATION.absence archetype to record that a positive statement that information was not able to be obtained, for example, if a non-cooperative patient refuses to answer questions.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-purpose
        l: note-purpose
      value: String
        v: To record the clinical assessment of the propensity for an individual to experience an adverse reaction if exposed, or re-exposed, to a specified substance or class of substances.
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
        l: structuredefinition-display-hint
      value: String
        v: orientation:right
    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: - Substances include but are not limited to: - A therapeutic substance administered correctly at an appropriate dosage for the individual, including medications or vaccinations, - Food, - Material derived from plants or animals, or - Venom from insect stings. - Manifestations include any symptom, sign, or diagnosis. - It is also possible to record the absence of a reaction on re-exposure to a substance where an existing adverse reaction summary exists. This may trigger further investigation to confirm whether the previously assumed causal relationship to the substance is correct or mistaken. - This data group is intended to provide a single place within the health record to document the propensity for the full range of adverse reactions, from trivial to life-threatening, irrespective of the underlying physical mechanism. This includes but is not limited to: - Immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or - Non-immune-mediated: such as pseudo-allergic reactions, side effects, intolerances, and drug toxicities in individuals with impaired excretion. - In Release 1, all adverse reactions are assumed active in the context of a summary for exchange. - In future updates, it is anticipated this data group will be extended to incorporate additional detail.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-misuse
        l: note-misuse
      value: String
        v: - Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose. - Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants. - Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-purpose
        l: note-purpose
      value: String
        v: To record: - An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance. - Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-context
        l: note-context
      value: String
        v: This data group documents a clinician’s recommendation to avoid future exposure to a particular substance, emphasising the assessment of exposure risk and its substantiating evidence. In Release 1 the ‘Clinical evidence’ supporting the risk assessment is limited to the ‘Manifestation’ - symptoms or signs observed as part of an adverse reaction occurring on exposure to a substance. In future releases, it is anticipated that the details about the reaction event will be expanded and additional types of clinical evidence, such as immunogenetic test results can be included. While highlighting the clinical safety driver for accurately documenting adverse reactions, it is also important to recognise that such documentation within a clinical system will not always be limited to reactions categorised as true allergies, hypersensitivities, or intolerances. In practice, clinicians may encounter situations where the underlying pathophysiology of a reaction may not be known. Despite this, they still need to document that, in their judgment, the patient should avoid a specific substance. Such an entry is vital to prompt clinical safety alerts that prevent re-exposure, with previous manifestations offering insights into the risk of potential future harm, regardless of the unknown physiological mechanisms involved. Use cases include, but are not limited to: - 'Adverse Reaction List', or similar document, containing one or more ‘Adverse reaction summary’ data groups, - Triggering clinical decision alerts when prescribing, dispensing and administering a medication, and - To exchange safety-critical adverse reaction information with other healthcare providers.
    extension:
      url:
        v: https://aehrc.csiro.au/fhir/StructureDefinition/note-mapping
        l: note-mapping
      value: String
        v: - Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.7022](https://ckm.openehr.org/ckm/archetypes/1013.1.7022) - Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.5795](https://ckm.openehr.org/ckm/archetypes/1013.1.5795) - AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: [https://hl7.org/fhir/R5/allergyintolerance.html](https://hl7.org/fhir/R5/allergyintolerance.html). - AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: [https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html](https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html).
    path:
      v: AdverseReactionRisk
    short:
      v: Adverse Reaction Risk AUCDI
    definition:
      v: A summary or overview of a clinical assessment that identifies the potential for a harmful or undesirable physiological reaction unique to an individual and associated with exposure to a specific substance.
    comment:
      v: **Purpose** To record: - An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance. - Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results. **Misuse** - Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose. - Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants. - Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning. **Supporting Model(s)** - Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.7022](https://ckm.openehr.org/ckm/archetypes/1013.1.7022) - Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.5795](https://ckm.openehr.org/ckm/archetypes/1013.1.5795) - AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: [https://hl7.org/fhir/R5/allergyintolerance.html](https://hl7.org/fhir/R5/allergyintolerance.html). - AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: [https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html](https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html).…
    alias:
      v: reaction
    alias:
      v: Adverse reaction
    alias:
      v: Allergy
    alias:
      v: Intolerance
    alias:
      v: Hypersensitivity
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: Base
      min:
        v: 0
      max:
        v: *
    must support:
      v: true
    is modifier:
      v: false
  element:
    id:
      v: AdverseReactionRisk.Protocol
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
        l: elementdefinition-identifier
      value: Identifier
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
        l: structuredefinition-display-hint
      value: String
        v: orientation:right
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/elementdefinition-identifier
        l: elementdefinition-identifier
      value: Identifier
    path:
      v: AdverseReactionRisk.Protocol
    short:
      v: Protocol

v: at0000

v: at0000

v: protocol

v: protocol

v: @ internal @

v: 0

v: 1

path:
  v: AdverseReactionRisk.Protocol
min:
  v: 0
max:
  v: 1

code:
  v: BackboneElement
  l: BackboneElement

key:
  v: ele-1
severity:
  v: error
human:
  v: All FHIR elements must have a @value or children
expression:
  v: hasValue() or (children().count() > id.count())
xpath:
  v: @value|f:*|h:div
source:
  v: http://hl7.org/fhir/StructureDefinition/Element
  l: Element

v: false

id:
  v: AdverseReactionRisk.Protocol.id
path:
  v: AdverseReactionRisk.Protocol.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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionRisk.Protocol.extension
path:
  v: AdverseReactionRisk.Protocol.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:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    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
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionRisk.Protocol.modifierExtension
path:
  v: AdverseReactionRisk.Protocol.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:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    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
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    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: AdverseReactionRisk.Protocol.Lastupdated
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0062
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0062
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00
path:
  v: AdverseReactionRisk.Protocol.Lastupdated
short:
  v: Last updated
definition:
  v: The date when this 'Adverse reaction risk summary' data group was last updated.
comment:
  v: **Considerations** For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Protocol.Lastupdated
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
must support:
  v: true

id:
  v: AdverseReactionRisk.Protocol.Extension
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0128
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: local information requirements or additional metadata to align with FHIR equivalents.
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0128
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: local information requirements or additional metadata to align with FHIR equivalents.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Protocol.Extension
short:
  v: Extension
definition:
  v: Additional information required to capture local content or to align with other reference models/formalisms.
comment:
  v: **Considerations** For example: local information requirements or additional metadata to align with FHIR equivalents.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Protocol.Extension
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: false

id:
  v: AdverseReactionRisk.Data
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: data
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data
short:
  v: Data
definition:
  v: @ internal @
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: true

id:
  v: AdverseReactionRisk.Data.id
path:
  v: AdverseReactionRisk.Data.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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionRisk.Data.extension
path:
  v: AdverseReactionRisk.Data.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:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    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
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionRisk.Data.modifierExtension
path:
  v: AdverseReactionRisk.Data.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:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    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
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    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: AdverseReactionRisk.Data.Substance
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0002
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Both an individual substance and a substance class are valid entries in 'Substance'. A substance may be a compound of simpler substances, for example a medicinal product. It is strongly recommended that the 'Substance' is coded with a terminology capable of triggering decision support, where possible. For example: Snomed CT, DM+D, RxNorm, NDFRT, ATC, New Zealand Universal List of Medicines and Australian Medicines Terminology. Free text entry should only be used if there is no appropriate terminology available.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0002
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: In this context, appropriate values for ‘Substance name’ include, but are not limited to: - A therapeutic substance administered correctly at an appropriate dosage for the individual, - Food, - Material derived from plants or animals, - Venom from insect stings, and - Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape. It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available.
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-terminology
    l: note-terminology
  value: String
    v: The [Adverse Reaction Agent value set](https://healthterminologies.gov.au/fhir/ValueSet/adverse-reaction-agent-1) published by the NCTS currently includes all Substances (and classes) within SNOMED CT-AU and all AMT Product (notable) concepts.
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-example
    l: note-example
  value: String
    v: AMT provides concepts at various granularities from brand to specific substance: - TP: 3738011000036101|Amoxil| - TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid| - MP: 27658006| Product containing amoxicillin| - MP: 831021000168104 |measles + mumps + rubella live vaccine| Note: The above examples reflect the future state of AMT, v4. Specific substances and non-medicinal substances from SCT-AU: - 372687004| Amoxicillin| - 764147003 |Cephalosporin| - 111088007 | Latex | - 256259004 | Pollen | - 762952008| Peanut | - 1222501000168103 | Vegemite | - 348608005 | Surgical adhesive tape | - ‘Band-Aid’
path:
  v: AdverseReactionRisk.Data.Substance
short:
  v: Substance name
definition:
  v: Identification of a specific substance, compounded product, combination therapy product, or class of substances that is considered to have a causal link to the adverse reaction.
comment:
  v: **Considerations** In this context, appropriate values for ‘Substance name’ include, but are not limited to: - A therapeutic substance administered correctly at an appropriate dosage for the individual, - Food, - Material derived from plants or animals, - Venom from insect stings, and - Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape. It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available. **Example** AMT provides concepts at various granularities from brand to specific substance: - TP: 3738011000036101|Amoxil| - TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid| - MP: 27658006| Product containing amoxicillin| - MP: 831021000168104 |measles + mumps + rubella live vaccine| Note: The above examples reflect the future state of AMT, v4. Specific substances and non-medicinal substances from SCT-AU: - 372687004| Amoxicillin| - 764147003 |Cephalosporin| - 111088007 | Latex | - 256259004 | Pollen | - 762952008| Peanut | - 1222501000168103 | Vegemite | - 348608005 | Surgical adhesive tape | - ‘Band-Aid’
alias:
  v: Agent
alias:
  v: Class
alias:
  v: Product
alias:
  v: Drug
alias:
  v: Allergen
alias:
  v: Medicine
min:
  v: 1
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Substance
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

id:
  v: AdverseReactionRisk.Data.Activeinactivestatus
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0130
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0130
path:
  v: AdverseReactionRisk.Data.Activeinactivestatus
short:
  v: Active/inactive status
definition:
  v: Status about whether the adverse reaction risk statement is active or inactive.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Activeinactivestatus
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Coding
    l: Coding
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Verificationstatus
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0063
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0063
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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.
path:
  v: AdverseReactionRisk.Data.Verificationstatus
short:
  v: Verification status
definition:
  v: Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction.
comment:
  v: **Considerations** Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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
base:
  path:
    v: AdverseReactionRisk.Data.Verificationstatus
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Coding
    l: Coding
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Criticality
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0101
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0101
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.
path:
  v: AdverseReactionRisk.Data.Criticality
short:
  v: Criticality
definition:
  v: An indication of the potential for critical system organ damage or life threatening consequence.
comment:
  v: **Considerations** This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Criticality
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Category
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0120
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0120
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.
path:
  v: AdverseReactionRisk.Data.Category
short:
  v: Category
definition:
  v: Category of the identified 'Substance'.
comment:
  v: **Considerations** This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Category
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Onsetoflastreaction
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0117
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0117
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Onsetoflastreaction
short:
  v: Onset of last reaction
definition:
  v: The date and/or time of the onset of the last known occurrence of a reaction event.
comment:
  v: **Considerations** For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Onsetoflastreaction
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
type:
  code:
    v: string
    l: string
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Onsetoffirstreaction
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0133
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0133
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Onsetoffirstreaction
short:
  v: Onset of first reaction
definition:
  v: The onset of the first known occurrence of a reaction event.
comment:
  v: **Considerations** For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Onsetoffirstreaction
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
    l: dateTime
type:
  code:
    v: string
    l: string
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Reactionmechanism
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0058
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0058
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.
path:
  v: AdverseReactionRisk.Data.Reactionmechanism
short:
  v: Reaction mechanism
definition:
  v: Identification of the underlying physiological mechanism for the adverse reaction.
comment:
  v: **Considerations** Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Reactionmechanism
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Reactioneventsummary
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0129
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0129
path:
  v: AdverseReactionRisk.Data.Reactioneventsummary
short:
  v: Reaction event summary
definition:
  v: Summary details about each adverse reaction event linked to exposure to the identified 'Substance'.
min:
  v: 0
max:
  v: *
base:
  path:
    v: AdverseReactionRisk.Data.Reactioneventsummary
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionEventAUCDI
    l: AdverseReactionEventAUCDI
must support:
  v: true

id:
  v: AdverseReactionRisk.Data.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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0006
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: including reason for flagging a 'Criticality' of 'High risk'; and instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0006
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Comment
short:
  v: Comment
definition:
  v: Additional narrative about the adverse reaction risk not captured in other fields.
comment:
  v: **Considerations** For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.
alias:
  v: Note
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data.Comment
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionRisk.Data
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: data
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data
short:
  v: Data
definition:
  v: @ internal @
min:
  v: 0
max:
  v: 1
base:
  path:
    v: AdverseReactionRisk.Data
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: BackboneElement
    l: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    v: @value|f:*|h:div
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.id
path:
  v: AdverseReactionRisk.Data.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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: string
      l: string
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionRisk.Data.extension
path:
  v: AdverseReactionRisk.Data.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:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    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
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    l: Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: AdverseReactionRisk.Data.modifierExtension
path:
  v: AdverseReactionRisk.Data.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:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  xpath:
    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
  expression:
    v: extension.exists() != value.exists()
  xpath:
    v: exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
  source:
    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

element:
  id:
    v: AdverseReactionRisk
  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-EVALUATION.adverse_reaction_risk.v2
        l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
      value:
        v: at0000
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
      l: note-considerations
    value: String
      v: - Substances include but are not limited to: - A therapeutic substance administered correctly at an appropriate dosage for the individual, including medications or vaccinations, - Food, - Material derived from plants or animals, or - Venom from insect stings. - Manifestations include any symptom, sign, or diagnosis. - It is also possible to record the absence of a reaction on re-exposure to a substance where an existing adverse reaction summary exists. This may trigger further investigation to confirm whether the previously assumed causal relationship to the substance is correct or mistaken. - This data group is intended to provide a single place within the health record to document the propensity for the full range of adverse reactions, from trivial to life-threatening, irrespective of the underlying physical mechanism. This includes but is not limited to: - Immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or - Non-immune-mediated: such as pseudo-allergic reactions, side effects, intolerances, and drug toxicities in individuals with impaired excretion. - In Release 1, all adverse reactions are assumed active in the context of a summary for exchange. - In future updates, it is anticipated this data group will be extended to incorporate additional detail.
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-misuse
      l: note-misuse
    value: String
      v: - Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose. - Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants. - Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning.
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-purpose
      l: note-purpose
    value: String
      v: To record: - An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance. - Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results.
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-context
      l: note-context
    value: String
      v: This data group documents a clinician’s recommendation to avoid future exposure to a particular substance, emphasising the assessment of exposure risk and its substantiating evidence. In Release 1 the ‘Clinical evidence’ supporting the risk assessment is limited to the ‘Manifestation’ - symptoms or signs observed as part of an adverse reaction occurring on exposure to a substance. In future releases, it is anticipated that the details about the reaction event will be expanded and additional types of clinical evidence, such as immunogenetic test results can be included. While highlighting the clinical safety driver for accurately documenting adverse reactions, it is also important to recognise that such documentation within a clinical system will not always be limited to reactions categorised as true allergies, hypersensitivities, or intolerances. In practice, clinicians may encounter situations where the underlying pathophysiology of a reaction may not be known. Despite this, they still need to document that, in their judgment, the patient should avoid a specific substance. Such an entry is vital to prompt clinical safety alerts that prevent re-exposure, with previous manifestations offering insights into the risk of potential future harm, regardless of the unknown physiological mechanisms involved. Use cases include, but are not limited to: - 'Adverse Reaction List', or similar document, containing one or more ‘Adverse reaction summary’ data groups, - Triggering clinical decision alerts when prescribing, dispensing and administering a medication, and - To exchange safety-critical adverse reaction information with other healthcare providers.
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-mapping
      l: note-mapping
    value: String
      v: - Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.7022](https://ckm.openehr.org/ckm/archetypes/1013.1.7022) - Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.5795](https://ckm.openehr.org/ckm/archetypes/1013.1.5795) - AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: [https://hl7.org/fhir/R5/allergyintolerance.html](https://hl7.org/fhir/R5/allergyintolerance.html). - AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: [https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html](https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html).
  path:
    v: AdverseReactionRisk
  short:
    v: Adverse Reaction Risk AUCDI
  definition:
    v: A summary or overview of a clinical assessment that identifies the potential for a harmful or undesirable physiological reaction unique to an individual and associated with exposure to a specific substance.
  comment:
    v: **Purpose** To record: - An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance. - Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results. **Misuse** - Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose. - Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants. - Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning. **Supporting Model(s)** - Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.7022](https://ckm.openehr.org/ckm/archetypes/1013.1.7022) - Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: [https://ckm.openehr.org/ckm/archetypes/1013.1.5795](https://ckm.openehr.org/ckm/archetypes/1013.1.5795) - AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: [https://hl7.org/fhir/R5/allergyintolerance.html](https://hl7.org/fhir/R5/allergyintolerance.html). - AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: [https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html](https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html).…
  alias:
    v: Adverse reaction
  alias:
    v: Allergy
  alias:
    v: Intolerance
  alias:
    v: Hypersensitivity
  min:
    v: 0
  max:
    v: *
  must support:
    v: true
element:
  id:
    v: AdverseReactionRisk.Data
  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-EVALUATION.adverse_reaction_risk.v2
        l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
      value:
        v: data
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  path:
    v: AdverseReactionRisk.Data
  short:
    v: Data
  definition:
    v: @ internal @
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: BackboneElement
      l: BackboneElement
  must support:
    v: false
element:
  id:
    v: AdverseReactionRisk.Data.Substance
  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-EVALUATION.adverse_reaction_risk.v2
        l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
      value:
        v: at0002
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
      l: note-considerations
    value: String
      v: In this context, appropriate values for ‘Substance name’ include, but are not limited to: - A therapeutic substance administered correctly at an appropriate dosage for the individual, - Food, - Material derived from plants or animals, - Venom from insect stings, and - Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape. It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available.
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-terminology
      l: note-terminology
    value: String
      v: The [Adverse Reaction Agent value set](https://healthterminologies.gov.au/fhir/ValueSet/adverse-reaction-agent-1) published by the NCTS currently includes all Substances (and classes) within SNOMED CT-AU and all AMT Product (notable) concepts.
  extension:
    url:
      v: https://aehrc.csiro.au/fhir/StructureDefinition/note-example
      l: note-example
    value: String
      v: AMT provides concepts at various granularities from brand to specific substance: - TP: 3738011000036101|Amoxil| - TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid| - MP: 27658006| Product containing amoxicillin| - MP: 831021000168104 |measles + mumps + rubella live vaccine| Note: The above examples reflect the future state of AMT, v4. Specific substances and non-medicinal substances from SCT-AU: - 372687004| Amoxicillin| - 764147003 |Cephalosporin| - 111088007 | Latex | - 256259004 | Pollen | - 762952008| Peanut | - 1222501000168103 | Vegemite | - 348608005 | Surgical adhesive tape | - ‘Band-Aid’
  path:
    v: AdverseReactionRisk.Data.Substance
  short:
    v: Substance name
  definition:
    v: Identification of a specific substance, compounded product, combination therapy product, or class of substances that is considered to have a causal link to the adverse reaction.
  comment:
    v: **Considerations** In this context, appropriate values for ‘Substance name’ include, but are not limited to: - A therapeutic substance administered correctly at an appropriate dosage for the individual, - Food, - Material derived from plants or animals, - Venom from insect stings, and - Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape. It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available. **Example** AMT provides concepts at various granularities from brand to specific substance: - TP: 3738011000036101|Amoxil| - TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid| - MP: 27658006| Product containing amoxicillin| - MP: 831021000168104 |measles + mumps + rubella live vaccine| Note: The above examples reflect the future state of AMT, v4. Specific substances and non-medicinal substances from SCT-AU: - 372687004| Amoxicillin| - 764147003 |Cephalosporin| - 111088007 | Latex | - 256259004 | Pollen | - 762952008| Peanut | - 1222501000168103 | Vegemite | - 348608005 | Surgical adhesive tape | - ‘Band-Aid’
  alias:
    v: Agent
  alias:
    v: Class
  alias:
    v: Product
  alias:
    v: Drug
  alias:
    v: Allergen
  alias:
    v: Medicine
  min:
    v: 1
  max:
    v: 1
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
  must support:
    v: true
element:
  id:
    v: AdverseReactionRisk.Data.Activeinactivestatus
  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-EVALUATION.adverse_reaction_risk.v2
        l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
      value:
        v: at0130
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
      l: structuredefinition-display-hint
    value: String
      v: orientation:right
  path:
    v: AdverseReactionRisk.Data.Activeinactivestatus
  short:
    v: Active/inactive status
  definition:
    v: Status about whether the adverse reaction risk statement is active or inactive.
  min:
    v: 0
  max:
    v: 1

code:
  v: Coding
  l: Coding

v: false

id:
  v: AdverseReactionRisk.Data.Verificationstatus
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0063
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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: AdverseReactionRisk.Data.Verificationstatus
short:
  v: Verification status
definition:
  v: Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction.
comment:
  v: **Considerations** Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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: Coding
    l: Coding
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Category
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0120
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Category
short:
  v: Category
definition:
  v: Category of the identified 'Substance'.
comment:
  v: **Considerations** This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Criticality
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0101
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Criticality
short:
  v: Criticality
definition:
  v: An indication of the potential for critical system organ damage or life threatening consequence.
comment:
  v: **Considerations** This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Onsetoflastreaction
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0117
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Onsetoflastreaction
short:
  v: Onset of last reaction
definition:
  v: The date and/or time of the onset of the last known occurrence of a reaction event.
comment:
  v: **Considerations** For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: dateTime
    l: dateTime
type:
  code:
    v: string
    l: string
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Onsetoffirstreaction
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0133
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Onsetoffirstreaction
short:
  v: Onset of first reaction
definition:
  v: The onset of the first known occurrence of a reaction event.
comment:
  v: **Considerations** For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: dateTime
    l: dateTime
type:
  code:
    v: string
    l: string
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Reactionmechanism
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0058
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Reactionmechanism
short:
  v: Reaction mechanism
definition:
  v: Identification of the underlying physiological mechanism for the adverse reaction.
comment:
  v: **Considerations** Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: false

id:
  v: AdverseReactionRisk.Data.Reactioneventsummary
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0129
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Reactioneventsummary
short:
  v: Reaction event summary
definition:
  v: Summary details about each adverse reaction event linked to exposure to the identified 'Substance'.
min:
  v: 0
max:
  v: *
type:
  code:
    v: Reference
    l: Reference
  target profile:
    v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionEventAUCDI
    l: AdverseReactionEventAUCDI
must support:
  v: true

id:
  v: AdverseReactionRisk.Data.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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0006
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Data.Comment
short:
  v: Comment
definition:
  v: Additional narrative about the adverse reaction risk not captured in other fields.
comment:
  v: **Considerations** For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.
alias:
  v: Note
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true

id:
  v: AdverseReactionRisk.Protocol
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: protocol
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Protocol
short:
  v: Protocol
definition:
  v: @ internal @
min:
  v: 0
max:
  v: 1
type:
  code:
    v: BackboneElement
    l: BackboneElement
must support:
  v: false

id:
  v: AdverseReactionRisk.Protocol.Lastupdated
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0062
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00
path:
  v: AdverseReactionRisk.Protocol.Lastupdated
short:
  v: Last updated
definition:
  v: The date when this 'Adverse reaction risk summary' data group was last updated.
comment:
  v: **Considerations** For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00
min:
  v: 0
max:
  v: 1
type:
  code:
    v: dateTime
    l: dateTime
must support:
  v: true

id:
  v: AdverseReactionRisk.Protocol.Extension
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-EVALUATION.adverse_reaction_risk.v2
      l: openEHR-EHR-EVALUATION.adverse reaction risk.v2
    value:
      v: at0128
extension:
  url:
    v: https://aehrc.csiro.au/fhir/StructureDefinition/note-considerations
    l: note-considerations
  value: String
    v: For example: local information requirements or additional metadata to align with FHIR equivalents.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
    l: structuredefinition-display-hint
  value: String
    v: orientation:right
path:
  v: AdverseReactionRisk.Protocol.Extension
short:
  v: Extension
definition:
  v: Additional information required to capture local content or to align with other reference models/formalisms.
comment:
  v: **Considerations** For example: local information requirements or additional metadata to align with FHIR equivalents.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Reference
    l: Reference
must support:
  v: false