Sparked Logical Models, published by CSIRO. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/aehrc/logical-model-web/ and changes regularly. See the Directory of published versions

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Logical Model: Adverse Reaction Event

Official URL: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionEvent				Version: 0.0.1
Draft as of 2023-09-11				Computable Name: AdverseReactionEvent
Other Identifiers: https://aehrc.csiro.au/id/archetype_id#openEHR-EHR-CLUSTER.adverse_reaction_event.v1

The Adverse Reaction Event 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 archetype for this purpose.

Considerations

Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested.

This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate.

The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.

Usage:

• Derived from this Logical Model Profile: Adverse Reaction Event AUCDI
• Refer to this Logical Model Profile: Adverse Reaction Risk

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

 

​Other representations of profile: CSV, Excel