archetype (adl_version=1.4; uid=0ddef6b1-79de-4b08-8d2d-2ff3e3901624) openEHR-EHR-EVALUATION.adverse_reaction.v5 concept [at0000] -- Adverse Reaction language original_language = <[ISO_639-1::en]> description original_author = < ["name"] = <"Stephen Chu"> ["organisation"] = <"National E-Health Transition Authority"> ["email"] = <"clinicalinfo@nehta.gov.au"> ["date"] = <"2010-11-08"> > details = < ["en"] = < language = <[ISO_639-1::en]> purpose = <" To record health information that will inform a clinical assessment of the propensity of an individual for a future reaction to a substance, class of substance or agent. To record information about exposure events to a substance, building up a persisting and evolving summary over time. To record information about any adverse reaction, including: - immune mediated reactions Types I-IV (including allergic reactions and hypersensitivities), and - non-immune mediated reactions (including pseudoallergic reactions, side effects, intolerances, drug toxicities (e. g. Gentamycin), drug-drug interactions, food-drug interactions, drug-disease interactions and idiosyncratic reactions). "> use = <" Use to record all information about adverse reactions (including allergic reactions) that are required to support direct clinical care of an individual, safe exchange of information about adverse reactions and to enable computerised knowledge-based activities such as clinical decision support and alerts. Use to provide a single place within the health record to record a range of clinical statements about adverse reactions, including: - record cumulative information about each exposure to a known substance, class of substance or agent; and - record a clinician's opinion that administration of, or exposure to, a substance or agent is absolutely contraindicated. Can also be used to record an individual's reflections on their adverse reactions. Use to record the information about an adverse reaction that might be exchanged with other systems, including as part of an adverse reaction report sent to statutory authorities. It is likely that a formal Adverse Reaction report will require additional information that will be captured in the health record using other data groups, for example medication and problem/diagnosis etc. This data group has been designed to allow recording of information about a more generic substance, class of substance or agent, and then allow more specific details to be recorded including identification of the specific substance on a per exposure basis, including links to other parts of the health record where further details may be located. Note: it is possible on second or subsequent exposures to a previously identified substance for a reaction not to occur and this data group allows for these events to be closely linked in a way that will assist in determining if the adverse reaction has been incorrectly identified. In addition, it is anticipated that in some very specific clinical situations, such as immunologist assessment or for use in clinical trials, more information about the adverse reaction may be required. Additional details can be added as cluster data groups using the ‘Further Exposure Details’ and ‘Further Reaction Details’ slots. Similarly, additional details that are required only for reporting can be added using the ‘Reporting Details’ slot. The act of recording an adverse reaction in the health record implies there is a potential hazard for the individual if they are exposed to the same substance/agent in the future - a relative contraindication. 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 anaphylaxis, the 'Absolute contraindication' data flag should be recorded as ‘True’. Note: Conversely, a statement about ‘Severity’ of propensity (with possible values such as Mild, Moderate and Severe) has deliberately not been modelled explicitly. Predicting or estimating the grade of possible severity of a future reaction is not safe to record and persist in data, except where it is absolutely clear that the risk of deliberate re-exposure is unacceptable and highly likely to cause significant harm, such as a previous manifestation of anaphylaxis, and in this case the ‘Absolute contraindication’ data flag should be used. 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 - a flag for absolute contra-indication. 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. "> keywords = <"reaction", "allergy", "allergic", "adverse", "event", "effect", "sensitivity", "intolerance", "hypersensitivity", "side effect", "toxicity", "interaction", "drug", "food", "medication", "agent", "substance", "immune", "non-immune", "chemical"> misuse = <" 1. Not to be used for recording the absence (or negative presence) of a reaction to 'any substances' or to identified substances – use the EVALUATION.exclusion family of data groups to express a positive statement of exclusion. 3. Not to be used for recording that no information was able to be obtained about the Adverse Reaction status of a patient. Use the EVALUATION.absent_information family of data group to record a positive statement of absent information about Adverse Reactions was able to be obtained, for example, if a non-cooperative patient refuses to answer questions. 5. 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 administration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose, etc. 7. Not to be used for recording alerts. "> copyright = <"© openEHR Foundation"> > > lifecycle_state = <"in_development"> other_contributors = <"Heather Leslie, NEHTA", "John Bennett, NEHTA, Australia", "Rong Chen, Cambio Healthcare System, Sweden", "Stephen Chu, NEHTA, Australia (Editor)", "Matthew Cordell, NEHTA, Australia", "David Evans, Queensland Health, Australia", "Shahla Foozonkhah, Ocean Informatics, Australia", "Joanne Foster, School of Nursing & Midwifery, QLD University of Technology & Nursing Informatics Australia, Australia", "Jacquie Garton-Smith, Royal Perth Hospital and DoHWA, Australia", "Sarah Gaunt, NEHTA, Australia", "Andrew Goodchild, NEHTA, Australia", "Heather Grain, Llewelyn Grain Informatics, Australia", "Trina Gregory, cpc, Australia", "Grahame Grieve, Australia", "Sam Heard, Ocean Informatics, Australia", "Andrew James, University of Toronto, Canada", "Julie James, Blue Wave Informatics LLP, United Kingdom", "Ivor Jones, Queensalnd Helath, Australia", "Mary Kelaher, NEHTA, Australia", "Diane Kirkham, NEHTA, Australia", "Robert L'egan, NEHTA, Australia", "Jobst Landgrebe, ii4sm, Switzerland", "Heather Leslie, Ocean Informatics, Australia (Editor)", "Hugh Leslie, Ocean Informatics, Australia", "Rikard Lovstrom, Swedish Medical Association, Sweden", "Sarah Mahoney, Australia", "Mike Martyn, The Hobart Anaesthetic Group, Australia", "David McKillop, NEHTA, Australia", "Ian McNicoll, Ocean Informatics, United Kingdom", "Chris Mitchell, RACGP, Australia", "Stewart Morrison, NEHTA, Australia", "Jörg Niggemann, Compugroup, Germany", "Chris Pearce, Melbourne East GP Network, Australia", "General Practice Computing Group, Australia", "Camilla Preeston, Royal Australian College of General Practitioners, Australia", "Margaret Prichard, NEHTA, Australia", "Jodie Pycroft, Adelaide Northern Division of General Practice Ltd, Australia", "Cathy Richardson, NEHTA, Australia", "Robyn Richards, NEHTA - Clinical Terminology, Australia", "Thilo Schuler, Australia", "Peter Scott, Medical Objects, Australia", "Elena Shabanova, UMMSSOft, Russian Federation", "Elizabeth Stanick, Hobart Anaesthetic Group, Australia", "Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore", "John Taylor, NEHTA, Australia", "Gordon Tomes, Australian Institute of Health and Welfare, Australia", "Richard Townley-O'Neill, NEHTA, Australia", "Kylie Young, The Royal Australian College of General Practitioners, Australia"> other_details = < ["revision"] = <"5.0.0-alpha"> ["references"] = <"Derived from: "> ["build_uid"] = <"ffb60c8e-4d77-42a8-abf8-5717360af3f0"> ["original_namespace"] = <"com.oceaninformatics"> ["original_publisher"] = <"Ocean Informatics"> ["MD5-CAM-1.0.1"] = <"936BD1AD298989E23B73FAD069A36F53"> ["custodian_namespace"] = <"com.oceaninformatics"> ["custodian_organisation"] = <"Ocean Informatics"> > definition EVALUATION[at0000] matches { -- Adverse Reaction data matches { ITEM_TREE[at0001] matches { -- Tree items cardinality matches {1..*; unordered} matches { ELEMENT[at0002] matches { -- Substance/Agent value matches { DV_TEXT matches {*} } } ELEMENT[at0004] occurrences matches {0..1} matches { -- Absolute Contraindication value matches { DV_BOOLEAN matches { value matches {True, False} } } } ELEMENT[at0006] occurrences matches {0..1} matches { -- Comment value matches { DV_TEXT matches {*} } } CLUSTER[at0009] occurrences matches {0..*} matches { -- Reaction Event items cardinality matches {1..*; unordered} matches { ELEMENT[at0010] occurrences matches {0..1} matches { -- Specific Substance/Agent value matches { DV_TEXT matches {*} } } ELEMENT[at0011] occurrences matches {0..*} matches { -- Manifestation value matches { DV_TEXT matches {*} } } ELEMENT[at0016] occurrences matches {0..1} matches { -- Reaction Type value matches { DV_TEXT matches {*} } } ELEMENT[at0021] occurrences matches {0..1} matches { -- Certainty value matches { DV_CODED_TEXT matches { defining_code matches {[ac0064]} -- Adverse Reaction Certainty Values } } } ELEMENT[at0012] occurrences matches {0..1} matches { -- Reaction Description value matches { DV_TEXT matches {*} } } ELEMENT[at0027] occurrences matches {0..1} matches { -- Onset of Reaction value matches { DV_DATE_TIME matches {*} } } ELEMENT[at0028] occurrences matches {0..1} matches { -- Duration of Reaction value matches { DV_DURATION matches {*} } } allow_archetype CLUSTER[at0029] occurrences matches {0..*} matches { -- Additional Reaction Detail include archetype_id/value matches {/openEHR-EHR-CLUSTER\.anatomical_location(-[a-zA-Z0-9_]+)*\.v1/} exclude archetype_id/value matches {/.*/} } ELEMENT[at0018] occurrences matches {0..1} matches { -- Exposure Description value matches { DV_TEXT matches {*} } } ELEMENT[at0020] occurrences matches {0..1} matches { -- Earliest Exposure value matches { DV_DATE_TIME matches {*} } } ELEMENT[at0025] occurrences matches {0..1} matches { -- Duration of Exposure value matches { DV_DURATION matches {*} } } allow_archetype CLUSTER[at0019] occurrences matches {0..*} matches { -- Additional Exposure Detail include archetype_id/value matches {/openEHR-EHR-CLUSTER\.amount(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.timing(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.medication_admin(-[a-zA-Z0-9_]+)*\.v1/} exclude archetype_id/value matches {/.*/} } ELEMENT[at0040] occurrences matches {0..1} matches { -- Clinical Management Description value matches { DV_TEXT matches {*} } } ELEMENT[at0031] occurrences matches {0..*} matches { -- Multimedia value matches { DV_MULTIMEDIA matches { media_type matches {[openEHR::]} } } } allow_archetype CLUSTER[at0041] occurrences matches {0..*} matches { -- Reporting Details include archetype_id/value matches {/.*/} } ELEMENT[at0032] occurrences matches {0..1} matches { -- Comment value matches { DV_TEXT matches {*} } } } } } } } protocol matches { ITEM_TREE[at0042] matches { -- Tree items cardinality matches {1..*; unordered} matches { ELEMENT[at0044] occurrences matches {0..1} matches { -- Reaction Reported value matches { DV_BOOLEAN matches { value matches {True, False} } } } ELEMENT[at0045] occurrences matches {0..*} matches { -- Adverse Reaction Report value matches { DV_URI matches {*} } } ELEMENT[at0047] occurrences matches {0..1} matches { -- Supporting Clinical Record Information value matches { DV_URI matches {*} } } } } } } ontology terminologies_available = <"NCTIS-OID", ...> term_definitions = < ["en"] = < items = < ["at0000"] = < text = <"Adverse Reaction"> description = <"A harmful or undesirable effect associated with exposure to any substance or agent, including food, plants, animals, venom from animal stings or a medication at therapeutic or sub-therapeutic doses."> spec_id = <"9"> detail_docref = <"data_groups/NEHTA-15517-Adverse_Reaction-Data_Group.xml"> > ["at0001"] = < text = <"Tree"> description = <"@ internal @"> > ["at0002"] = < text = <"Substance/Agent"> description = <"Identification of a substance, agent, or a class of substance, that is considered to be responsible for the adverse reaction."> comment = <"It is preferred that this item be coded from the Substance/Agent Values Value Domain. An agent can be a substance such as food, drug or an environmental allergen. Examples: 1. Peanut 2. Penicillin 3. Bee venom 4. Animal protein 5. Latex"> value_domain_dc_id = <"15521"> value_domain_name = <"Substance/Agent Values"> coding_preferred = <"true"> detail_docref = <"data_elements/NEHTA-15521-Substance_Agent-Data_Element.xml"> > ["at0004"] = < text = <"Absolute Contraindication"> description = <"A flag indicating that a clinician has identified a propensity for a serious reaction upon further exposure to the substance/agent."> detail_docref = <"data_elements/NEHTA-16073-Absolute_Contraindication-Data_Element.xml"> > ["at0006"] = < text = <"Comment"> description = <"Additional narrative about the adverse reaction not captured in other fields, including reason for flagging an absolute contraindication, instructions related to future exposure or administration of the substance/agent."> comment = <"Used to provide additional narrative information in relation to the adverse reaction such as finding site or route of administration."> fsn = <"Adverse Reaction Comment"> detail_docref = <"data_elements/NEHTA-15590-Adverse_Reaction_Comment-Data_Element.xml"> > ["at0009"] = < text = <"Reaction Event"> description = <"Details about each adverse reaction event."> detail_docref = <"data_groups/NEHTA-16474-Reaction_Event-Data_Group.xml"> > ["at0010"] = < text = <"Specific Substance/Agent"> description = <"Specific identification of the substance/agent considered to be responsible for the adverse reaction event."> comment = <"It is preferred that this item be coded from the Substance/Agent Values Value Domain. This may include a medication trade name."> value_domain_dc_id = <"15521"> value_domain_name = <"Substance/Agent Values"> coding_preferred = <"true"> detail_docref = <"data_elements/NEHTA-16349-Specific_Substance_Agent-Data_Element.xml"> > ["at0011"] = < text = <"Manifestation"> description = <"Clinical manifestation of the adverse reaction expressed as a single word, phrase or brief description."> comment = <"It is preferred that this item be coded from the Clinical Manifestation Values Value Domain. The signs, symptoms, severity and/or certainty of the adverse reaction are relevant as it contributes towards the decision as to the immediacy and extent of treatment to be provided, as determined by a healthcare provider. Given that an adverse reaction has occurred, it is important to determine the manifestations of that reaction. Examples: 1. Itchy eyes. 2. Dysphagia. 3. Tinnitus. 4. Nausea. 5. Rash."> value_domain_dc_id = <"15564"> value_domain_name = <"Clinical Manifestation Values"> coding_preferred = <"true"> detail_docref = <"data_elements/NEHTA-15564-Manifestation-Data_Element.xml"> > ["at0012"] = < text = <"Reaction Description"> description = <"Narrative description of the reaction."> comment = <"Examples: 1. Itchy eyes. 2. Dysphagia. 3. Tinnitus."> detail_docref = <"data_elements/NEHTA-15563-Reaction_Description-Data_Element.xml"> > ["at0016"] = < text = <"Reaction Type"> description = <"The type of reaction, as determined by the clinician."> comment = <"It is preferred that this item be coded from the Adverse Substance Reaction Type Values Value Domain. This field is used to identify the type of adverse reaction as determined by: the signs and/or symptoms experienced by the subject of care; information provided by a relevant individual; previously documented history; and/or a clinical assessment by a healthcare provider. Examples include Immune mediated - Types I-IV (including allergy and hypersensitivity); Non-immune mediated - including pseudoallergic reaction, side effect, intolerance, drug toxicity, drug-drug interaction, food-drug interaction, drug-disease interaction and idiosyncratic reaction. Examples: 1. Allergy. 2. Idiosyncracy. 3. Interactions. 4. Intolerance / sensitivity. 5. Pseudoallergy / anaphylactoid reaction. 6. Side effects."> value_domain_dc_id = <"15554"> value_domain_name = <"Adverse Substance Reaction Type Values"> coding_preferred = <"true"> detail_docref = <"data_elements/NEHTA-15554-Reaction_Type-Data_Element.xml"> > ["at0018"] = < text = <"Exposure Description"> description = <"Description about exposure to the substance/agent."> detail_docref = <"data_elements/NEHTA-16477-Exposure_Description-Data_Element.xml"> > ["at0019"] = < text = <"Additional Exposure Detail"> description = <"Additional detail about exposure/s for this reaction event, including structured medication amount information."> detail_docref = <"choices/NEHTA-16478-Additional_Exposure_Detail-Choice.xml"> > ["at0020"] = < text = <"Earliest Exposure"> description = <"Record of the date and/or time of the earliest or initial exposure to the substance/agent."> detail_docref = <"data_elements/NEHTA-16372-Earliest_Exposure-Data_Element.xml"> > ["at0021"] = < text = <"Certainty"> description = <"Degree of certainty, as assessed by clinician, that the specific substance/agent was the cause of the reaction."> comment = <"It is important to know the degree of certainty of an adverse reaction to an agent/substance as there may be instances where it is not clear whether it is the active agent or a secondary component causing the problem. For example, it may be the filler in a tablet that may be the allergen rather than the active drug. Another example is where there is suspicion of a reaction which warrants recording but it has not been confirmed objectively, or where a reaction has been recorded but is subsequently discounted following further observation and/or investigation. Examples: 1. Certain. 2. Probable. 3. Unlikely."> fsn = <"Adverse Reaction Certainty"> detail_docref = <"data_elements/NEHTA-15568-Adverse_Reaction_Certainty-Data_Element.xml"> > ["at0025"] = < text = <"Duration of Exposure"> description = <"Length of duration of exposure."> comment = <"Used to describe the length of exposure to substance/agent triggering a specific reaction event."> detail_docref = <"data_elements/NEHTA-16373-Duration_of_Exposure-Data_Element.xml"> > ["at0027"] = < text = <"Onset of Reaction"> description = <"Record of the date and/or time of the onset of the reaction."> comment = <"The date or date and time that the specific Reaction commenced. Sometimes, the date or age at which a person reacts to an agent is a relevant to understanding a condition, or to determining appropriate treatment. Often, this will be an approximate, self-reported age, date or datetime. Examples: (Please see)"> fsn = <"Reaction Onset Date"> detail_docref = <"data_elements/NEHTA-15507-Reaction_Onset_Date-Data_Element.xml"> > ["at0028"] = < text = <"Duration of Reaction"> description = <"Length of duration of the reaction."> detail_docref = <"data_elements/NEHTA-16352-Duration_of_Reaction-Data_Element.xml"> > ["at0029"] = < text = <"Additional Reaction Detail"> description = <"Additional detail about the reaction, including anatomical location."> spec_id = <"108"> detail_docref = <"data_groups/NEHTA-16150-Additional_Reaction_Detail-Data_Group.xml"> > ["at0031"] = < text = <"Multimedia"> description = <"Inclusion of any multimedia file to support the recording of the reaction event."> comment = <"An example is a photo of a rash or presentation with angioneurotic oedema."> detail_docref = <"data_elements/NEHTA-16376-Multimedia-Data_Element.xml"> > ["at0032"] = < text = <"Comment"> description = <"Further comment about the reaction event."> fsn = <"Adverse Reaction Event Comment"> detail_docref = <"data_elements/NEHTA-16483-Adverse_Reaction_Event_Comment-Data_Element.xml"> > ["at0040"] = < text = <"Clinical Management Description"> description = <"Description about the clinical management provided."> detail_docref = <"data_elements/NEHTA-16482-Clinical_Management_Description-Data_Element.xml"> > ["at0041"] = < text = <"Reporting Details"> description = <"Further details required for reporting to regulatory bodies."> detail_docref = <"choices/NEHTA-16631-Reporting_Details-Choice.xml"> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0044"] = < text = <"Reaction Reported"> description = <"Was the adverse reaction reported to a regulatory body?"> detail_docref = <"data_elements/NEHTA-16379-Reaction_Reported-Data_Element.xml"> > ["at0045"] = < text = <"Adverse Reaction Report"> description = <"Link to an Adverse Reaction Report sent to a regulatory body."> detail_docref = <"data_elements/NEHTA-16484-Adverse_Reaction_Report-Data_Element.xml"> > ["at0047"] = < text = <"Supporting Clinical Record Information"> description = <"Link to further information about about the presentation and findings that exist elsewhere in the health record."> comment = <"Examples are presenting symptoms, examination findings, diagnosis."> detail_docref = <"data_elements/NEHTA-16485-Supporting_Clinical_Record_Information-Data_Element.xml"> > > > > constraint_definitions = < ["en"] = < items = < ["ac0064"] = < text = <"Adverse Reaction Certainty Values"> description = <"The set of values for the degree of confidence that the agent/substance has caused the adverse reaction."> > > > > term_bindings = < ["NCTIS-OID"] = < items = < ["at0000"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.102.15517]> ["at0002"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15521]> ["at0004"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16073]> ["at0006"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15590]> ["at0009"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.102.16474]> ["at0010"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16349]> ["at0011"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15564]> ["at0012"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15563]> ["at0016"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15554]> ["at0018"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16477]> ["at0019"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.105.16478]> ["at0020"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16372]> ["at0021"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15568]> ["at0025"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16373]> ["at0027"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.15507]> ["at0028"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16352]> ["at0029"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.102.16150.9.1]> ["at0031"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16376]> ["at0032"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16483]> ["at0040"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16482]> ["at0041"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.105.16631]> ["at0044"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16379]> ["at0045"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16484]> ["at0047"] = <[NCTIS-OID::1.2.36.1.2001.1001.101.103.16485]> > > >