AdverseReactionRisk
type: StructureDefinition
node role: treeRoot
id:
  v: AdverseReactionRisk
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition AdverseReactionRisk Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> AdverseReactionRisk S 0..* Base Adverse Reaction Risk #xD; Protocol S 0..1 BackboneElement Protocol #xD; Lastupdated S 0..1 dateTime Last updated #xD; Extension S 0..1 Reference() Extension #xD; Data S 0..1 BackboneElement Data #xD; Substance S 1..1 CodeableConcept Substance #xD; Activeinactivestatus S 0..1 Coding Activeinactivestatus #xD; Verificationstatus S 0..1 Coding Verification status #xD; Criticality S 0..1 CodeableConcept Criticality #xD; Category S 0..1 CodeableConcept Category #xD; Onsetoflastreaction S 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 S 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 S 0..1 CodeableConcept Reaction mechanism #xD; Reactioneventsummary S 0..* Reference(Adverse Reaction Event) Reaction event summary #xD; Comment S 0..1 string Comment #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this…
url:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRisk
  l: AdverseReactionRisk
identifier:
  system:
    v: https://aehrc.csiro.au/id/archetype_id
    l: archetype id
  value:
    v: openEHR-EHR-EVALUATION.adverse_reaction_risk.v2
version:
  v: 0.0.1
name:
  v: AdverseReactionRisk
title:
  v: Adverse Reaction Risk
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 Logical Model Mindmap is shown below. <img src='[binary]'/> Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, to a substance. **Purpose** 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. **Misuse** 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 infor…
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 036
    display:
      v: Australia (AUS)
fhir version:
  v: 4.0.1
kind:
  v: logical
abstract:
  v: false
type:
  v: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRisk
  l: AdverseReactionRisk
base definition:
  v: http://hl7.org/fhir/StructureDefinition/Base
  l: Base
derivation:
  v: specialization
snapshot:
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    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
      l: snapshot-base-version
    value: String
      v: 4.0.1
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    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…
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      url:
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        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.
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      v: AdverseReactionRisk
    short:
      v: Adverse Reaction Risk
    definition:
      v: Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, to a substance.
    comment:
      v: **Purpose** 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. **Misuse** 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…
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comment:
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id:
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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).
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    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
path:
  v: AdverseReactionRisk.Data.Substance
short:
  v: Substance
definition:
  v: Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event.
comment:
  v: **Considerations** 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.
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
path:
  v: AdverseReactionRisk.Data.Activeinactivestatus
short:
  v: Activeinactivestatus
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: true

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
base:
  path:
    v: AdverseReactionRisk.Data.Verificationstatus
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Coding
    l: Coding
must support:
  v: true

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
base:
  path:
    v: AdverseReactionRisk.Data.Criticality
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

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
base:
  path:
    v: AdverseReactionRisk.Data.Category
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

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.
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: true

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.
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: true

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
base:
  path:
    v: AdverseReactionRisk.Data.Reactionmechanism
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
must support:
  v: true

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: *
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/AdverseReactionEvent
    l: AdverseReactionEvent
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.
path:
  v: AdverseReactionRisk.Data.Comment
short:
  v: Comment
definition:
  v: Additional narrative about the propensity for the adverse reaction, not captured in other fields.
comment:
  v: **Considerations** 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.
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

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: 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
  path:
    v: AdverseReactionRisk
  short:
    v: Adverse Reaction Risk
  definition:
    v: Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, to a substance.
  comment:
    v: **Purpose** 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. **Misuse** 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…
  alias:
    v: reaction
  min:
    v: 0
  max:
    v: *
  must support:
    v: true
element:
  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: true
element:
  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
  path:
    v: AdverseReactionRisk.Protocol.Lastupdated
  short:
    v: Last updated
  definition:
    v: Date when the propensity or the reaction event was updated.
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: dateTime
      l: dateTime
  must support:
    v: true
element:
  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.
  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: 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: true
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

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.

url:
  v: http://hl7.org/fhir/StructureDefinition/structuredefinition-display-hint
  l: structuredefinition-display-hint
value: String
  v: orientation:right

v: AdverseReactionRisk.Data.Substance

v: Substance

v: Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event.

v: **Considerations** 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.

v: 1

v: 1

code:
  v: CodeableConcept
  l: CodeableConcept

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
path:
  v: AdverseReactionRisk.Data.Activeinactivestatus
short:
  v: Activeinactivestatus
definition:
  v: Status about whether the adverse reaction risk statement is active or inactive.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Coding
    l: Coding
must support:
  v: true

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: true

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: true

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: true

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.
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: true

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.
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: true

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: true

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/AdverseReactionEvent
    l: AdverseReactionEvent
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.
path:
  v: AdverseReactionRisk.Data.Comment
short:
  v: Comment
definition:
  v: Additional narrative about the propensity for the adverse reaction, not captured in other fields.
comment:
  v: **Considerations** 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.
min:
  v: 0
max:
  v: 1
type:
  code:
    v: string
    l: string
must support:
  v: true