ID

23534

Description

Derived from www.openehr.org . Use to provide a single place within the health record to document a range of clinical statements about adverse reactions, including: - record a clinical assessment of the individual’s propensity for a potential future reaction upon re-exposure; and - record cumulative information about the reaction to each exposure. Use to record information about the positive presence of the risk of an adverse reaction: - to support direct clinical care of an individual; - as part of a managed adverse reaction or allergy/intolerance list; - to support exchange of information about the propensity and events related to adverse reactions; - to inform adverse reaction reporting; and - to assist computerised knowledge-based activities such as clinical decision support and alerts. Use to record information about the risk of adverse reactions to a broad range of substances, including: incipients and excipients in medicinal preparations; biological products; metal salts; and organic chemical compounds. Adverse reaction may be: - an immune mediated reaction - Types I-IV (including allergic reactions and hypersensitivities); or - a non-immune mediated reaction - including pseudo-allergic reactions, side effects, intolerances, drug toxicities (eg to Gentamicin). In clinical practice distinguishing between immune-mediated and non-immune mediated reactions is difficult and often not practical. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient, which is better expressed by the manifestation in clinical practice. The risk of an adverse reaction event or manifestation should not be recorded without identifying a proposed causative substance or class of substance. If there is uncertainty that a specific substance is the cause, this uncertainty can be recorded using the ‘Status’ data element. If there are multiple possible substances that may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction archetype with the ‘Status’ set to an initial state of ‘Suspected’ so that adverse reaction checking can be activated in clinical systems. Once the substance, agent or class is later proven not to be the cause for a given reaction then the ‘Status’ can be modified to ‘Refuted’. This archetype has been designed to allow recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (eg Penicillins). If a class of substance is recorded then identification of the exact substance can be recorded on a per exposure basis. 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, for example 'Reaction details', 'Exposure details', and 'Reporting details' slots. Examples of clinical situations where the extension may be required include: a detailed allergist/immunologist assessment, for reporting to regulatory bodies or use in a clinical trial. The act of recording any adverse reaction risk in a health record involves the clinical assessment that a potential hazard exists for an individual if they are exposed to the same substance/agent/class in the future – that is, a relative contraindication - and the default ‘Criticality’ value should be set to ‘Low risk’. If a clinician considers that it is not safe for the individual to be deliberately re-exposed to the substance/agent again, for example, following a manifestation of a life-threatening anaphylaxis, then the 'Criticality' data element should be amended to ‘High’. A formal Adverse Event Report to regulatory bodies is a document that will contain a broad range of information in addition to the specific details about the adverse reaction. The report could utilise parts of this Risk of adverse reaction archetype plus include additional data as required per jurisdiction. An adverse reaction or allergy/intolerance list is a record of all identified propensities for an adverse reaction for the individual upon future exposure to the substance or class, plus provides potential access to the evidence provided by details about each reaction event, such as manifestation. Valuable first-level information that could be presented to the clinician when they need to assess propensity for future reactions are: - statements about previous clinical manifestations following exposure; - source of the information/reporter; and - the ‘Criticality’ flag. Second-level information can be drawn from each exposure event and links to additional detailed information such as history, examination and diagnoses stored elsewhere in the record, if it is available. This archetype is designed as one component of the therapeutic precautions family of archetypes that need to be considered when a clinician is about to commence a new treatment, test or procedure for an individual. Links to other parts of the health record where further details may be located, such as consultation notes, is allowed by the openEHR reference model, but not modelled explicitly in this archetype. The content of this archetype is a result of a collaboration between the openEHR and HL7 FHIR communities. FHIR specific content that was included as part of the peer review process has been removed from this openEHR archetype.

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www.openehr.org

Keywords

Versions (2)

1. 7/8/17 7/8/17 - Martin Dugas
2. 7/8/17 7/8/17 - Martin Dugas

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July 8, 2017

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