openEHR-EHR-EVALUATION.adverse_reaction_risk.v1.xml
Risk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance.
text
@ internal @
Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event.
Additional narrative about the propensity for the adverse reaction, not captured in other fields.
Details about each adverse reaction event linked to exposure to the identified 'Substance'.
Identification of the substance considered to be responsible for the specific adverse reaction event.
Clinical symptoms and/or signs that are observed or associated with the adverse reaction.
Narrative description about the adverse reaction as a whole, including details of the manifestation if required.
Narrative description about exposure to the identified 'Specific substance'.
Record of the date and/or time of the first exposure to the Substance for this Reaction Event.
datetime
Statement about the degree of clinical certainty that the identified 'Specific substance' was the cause of the 'Manifestation' in this reaction event.
The total amount of time the individual was exposed to the identified 'Specific substance'.
Record of the date and/or time of the onset of the reaction.
The total amount of time that the manifestation of the adverse reaction persisted.
Additional details about the adverse reaction, including anatomical location and Common Toxicity Criteria, can be provided by inclusion of specific archetypes in this SLOT.
Additional narrative about the adverse reaction event not captured in other fields.
Narrative description about the clinical management provided.
Additional structured details required for reporting to regulatory bodies can be provided by inclusion of specific archetypes in this SLOT.
Has the adverse reaction ever been reported to a regulatory body?
boolean
Link to an adverse reaction Report sent to a regulatory body.
Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports.
Narrative about the adverse reaction report or reporting process.
Identification of the underlying physiological mechanism for the adverse reaction.
Date when the propensity or the reaction event was updated.
Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction.
Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
Additional details about exposure to the 'Specific substance', especially in situations where there may have been multiple or cumulative exposures can be provided by inclusion of specific archetypes in this SLOT.
Structured details about reports that have been forwarded to regulatory bodies.
An indication of the potential for critical system organ damage or life threatening consequence.
Identification of the route by which the subject was exposed to the identified 'Specific substance'.
Details about the provenance of the information can be provided by inclusion of specific archetypes in this SLOT.
The date and/or time of the onset of the last known occurrence of a reaction event.
Additional structured details about clinical management for this reaction event can be provided by inclusion of specific archetypes in this SLOT.
Category of the identified 'Substance'.
Date that the report was sent to the regulatory authority.
Additional information required to capture local content or to align with other reference models/formalisms.