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 Risk AUCDI

Official URL: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRiskAUCDI				Version: 0.0.1
Draft as of 2023-09-11				Computable Name: AdverseReactionRiskAUCDI
Keywords: core

The Adverse Reaction Risk AUCDI Logical Model Mindmap is shown below.

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 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.

Supported Models

• 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

• 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

• AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: 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.

Considerations

• 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.

Roadmap

Usage:

• This Logical Model Profile is not used by any profiles in this Implementation Guide

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