Generated Narrative: StructureDefinition AdverseReactionEventAUCDI Name Flags Card. Type Description & Constraints AdverseReactionEvent S 0..* AdverseReactionEvent Adverse Reaction Event AUCDI Elements defined in Ancestors:Items #xD; Items 0..1 BackboneElement Items #xD; Specificsubstance 0..1 CodeableConcept Specific substance #xD; Certainty 0..1 CodeableConcept Certainty #xD; Manifestation S 0..* CodeableConcept Manifestation #xD; Reactiondescription 0..1 string Reaction description #xD; Onsetofreaction 0..1 dateTime Onset of reaction #xD; Severityofreaction 0..1 CodeableConcept Severity of reaction #xD; Reactiondetails 0..1 Reference() Reaction details #xD; Initialexposure 0..1 dateTime Initial exposure #xD; Routeofexposure 0..1 string Route of exposure #xD; Exposuredescription 0..1 string Exposure description #xD; Exposuredetails 0..1 Reference() Exposure details #xD; Clinicalmanagementdescription 0..1 string Clinical management description #xD; Clinicalmanagementdetails 0..1 Reference() Clinical management details #xD; Reportingdetails 0..1 Reference() Reporting details #xD; Informationsource 0..1 Reference() Information source #xD; Comment 0..1 string Comment #xD; Documentation for this format
The Adverse Reaction Event AUCDI Logical Model Mindmap is shown below. Information about a specific adverse reaction event caused by exposure to a specific substance. **Purpose** To record information about a specific adverse reaction event caused by exposure to a specific substance. **Misuse** Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific model for this purpose. **Considerations** Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent in which this is nested. **Roadmap**
Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested. This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.
To record information about a specific adverse reaction event caused by exposure to a specific substance.
Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent in which this is nested.
Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific model for this purpose.
Information about a specific adverse reaction event caused by exposure to a specific substance.
**Purpose** To record information about a specific adverse reaction event caused by exposure to a specific substance. **Misuse** Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific model for this purpose. **Considerations** Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent in which this is nested.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Extensions that cannot be ignored even if unrecognized
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).
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
The substance considered to be responsible for the specific adverse reaction event.
**Considerations** For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
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.
The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.
**Considerations** The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.
Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.
It is strongly recommended that ‘Manifestation’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate coded value is available. This data element has multiple occurrences to allow the recording of more than one manifestation per substance.
The [Clinical Finding value set](https://healthterminologies.gov.au/fhir/ValueSet/clinical-finding-1) published by the NCTS currently includes all Clinical findings within SNOMED CT-AU that could manifest as the result of an adverse reaction. Additionally, the [Clinical manifestation reference set](https://healthterminologies.gov.au/fhir/ValueSet/sctau-reference-set-142341000036103) is a subset of Clinical Findings that is published as part of SNOMED CT-AU that was developed collaboratively with a number of different health jurisdictions to identify the most commonly encountered reactions.
Symptom or sign observed or associated with the reaction.
**Considerations** It is strongly recommended that ‘Manifestation’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate coded value is available. This data element has multiple occurrences to allow the recording of more than one manifestation per substance. **Example** SNOMED CT-AU: * 247472004|Hives| * 267038008|Oedema| * 62315008|Diarrhoea| * 422587007|Nausea| * 39579001|Anaphylaxis|
Narrative description about the adverse reaction as a whole, including details of the manifestation if required.
The date and/or time of the onset of the reaction.
It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
**Considerations** It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
Additional details about the adverse reaction.
**Considerations** May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
The date and/or time of the first exposure to the Substance for this Reaction Event.
**Considerations** Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
Coding of the Route of Exposure with a terminology should be used wherever possible.
The route by which the subject was exposed to the identified 'Specific substance'.
**Considerations** Coding of the Route of Exposure with a terminology should be used wherever possible.
Narrative description about the exposure to the identified 'Specific substance'.
Additional details about exposure to the 'Specific substance'.
Narrative description about the clinical management provided.
Additional structured details about clinical management for this reaction event.
Additional structured details required for reporting to regulatory bodies.
This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
Details about the provenance of the information.
**Considerations** This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
Additional narrative about the adverse reaction event not captured in other fields.