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

Official URL: https://aehrc.csiro.au/fhir/logical-models/AdverseReactionRisk				Version: 0.0.1
Draft as of 2023-09-11				Computable Name: AdverseReactionRisk
Other Identifiers: https://aehrc.csiro.au/id/archetype_id#openEHR-EHR-EVALUATION.adverse_reaction_risk.v2

The Adverse Reaction Risk Logical Model Mindmap is shown below.

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 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.

Considerations

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 a managed adverse reaction or allergy/intolerance list;
• to support the exchange of information about the propensity and events related to adverse reactions;
• to inform adverse reaction reporting; and
• to assist with computerised knowledge-based activities such as clinical decision support and alerts.

The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing.

Usage:

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

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