archetype (adl_version=1.4) openEHR-EHR-EVALUATION.adverse_reaction_nehta-nz.v1 specialise openEHR-EHR-EVALUATION.adverse_reaction_nehta.v1 concept [at0000.1] -- Adverse Reaction for New Zealand language original_language = <[ISO_639-1::en]> description original_author = < ["name"] = <"Heather Leslie"> ["organisation"] = <"Ocean Informatics"> ["email"] = <"heather.leslie@oceaninformatics.com"> ["date"] = <"8-Nov-2010"> > details = < ["en"] = < language = <[ISO_639-1::en]> purpose = <"To record information about previous exposures to a substance, allowing a persisting and evolving summary of adverse reaction events to build up over time. To record additional information that will support and inform a clinical assessment of the propensity of an individual to experience an adverse reaction if exposed to a specific substance, class of substance or agent in the future. 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 (eg Gentamicin), 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. 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 archetypes, for example medication and problem/diagnosis etc. This archetype 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 archetype 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 archetypes 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 = <"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 archetypes to express a positive statement of exclusion. 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 archetypes 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. 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. Not to be used for recording alerts."> copyright = <"© openEHR Foundation"> > > lifecycle_state = <"OrganisationDraft"> other_contributors = <"John Bennett, NEHTA, Australia", "Sharmila Biswas, Dr Sharmila Biswas GP, 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 = < ["references"] = <"Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. PubMed PMID: 11072960. Horsfield P, Sibeko S. Representation in Electronic Patient Records of Allergic Reactions, Adverse Reactions, and Intolerance of Pharmaceutical Products [Internet]. London, UK: National Health Service; 2006 Sep 07 [cited 2011 Jun 21]; Available at https://svn.connectingforhealth.nhs.uk/svn/public/nhscontentmodels/TRUNK/ref/NPfIT/Allergy_ADR_Intolerance%20v%201.2Final.doc. Long R, Bentley S. SCG Guidance on the Representation of Allergies and Adverse Reaction Information Using NHS Message Templates [Internet]. London, UK: National Health Service; 2008 Apr 30 [cited 2011 Jun 21]; Available at http://www.connectingforhealth.nhs.uk/systemsandservices/data/scg/scg0001.pdf. Microsoft. Design Guidance: Displaying Adverse Drug Reaction Risks [Internet]. 2009 January 28 [cited 2011 Jun 21]; Available at www.mscui.net/DesignGuide/DisplayingAllergies.aspx. Microsoft. Design Guidance: Recording Adverse Drug Reaction Risks [Internet]. 2009 March 27 [cited 2011 Jun 21]; Available at www.mscui.net/DesignGuide/RecordingAllergies.aspx. Mosby. Mosby's Pocket Dictionary of Medicine, Nursing and Health Professions. 6th Edition. USA: Mosby Elsevier; 2010 National E-Health Transition Authority. Adverse Reactions (Data Specifications) Version 1.1 [Internet]. Sydney, Australia: NEHTA; 2008 Feb 29 [cited 2011 Jun 21]; Available at http://www.nehta.gov.au/component/docman/doc_download/453-adverse-reaction-data-specification-v11. Riedl MA, Casillas AM. Adverse drug reactions: types and treatment options. Am Fam Physician. 2003 Nov 1;68(9):1781-90. Review. PubMed PMID: 14620598. Royal Australian College of General Practitioners. Fact Sheet: Allergies & Adverse Reactions (Draft). 2010. Thien FC. Drug hypersensitivity. Med J Aust. 2006 Sep 18;185(6):333-8. Review. PubMed PMID: 16999678."> ["MD5-CAM-1.0.1"] = <"E8D536445577E41B84F5A15586861467"> > definition EVALUATION[at0000.1] matches { -- Adverse Reaction for New Zealand 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} } } } ELEMENT[at0006] occurrences matches {0..1} matches { -- Overall 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[at0.10] occurrences matches {0..1} matches { -- Reaction Severity value matches { DV_TEXT matches {*} } } ELEMENT[at0.3] occurrences matches {0..1} matches { -- Status value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0.4, -- Active at0.5] -- Resolved } } } } ELEMENT[at0.8] occurrences matches {0..1} matches { -- Episodicity value matches { DV_TEXT matches {*} } } ELEMENT[at0.7] occurrences matches {0..1} matches { -- Clinical Course value matches { DV_TEXT matches {*} } } ELEMENT[at0021] occurrences matches {0..1} matches { -- Certainty value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0022, -- Suspected at0023, -- Probable at0024] -- Confirmed } } } } 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 {*} } } ELEMENT[at0.2] occurrences matches {0..1} matches { -- Date of Resolution value matches { DV_DATE_TIME matches {*} } } ELEMENT[at0.9] occurrences matches {0..1} matches { -- Date of Last Reaction value matches { DV_DATE_TIME 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/} } 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\.medication_admin(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.timing(-[a-zA-Z0-9_]+)*\.v1/} } 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 { -- Reaction Comment value matches { DV_TEXT matches {*} } } } } } } } protocol matches { ITEM_TREE[at0042] matches { -- Tree items cardinality matches {0..*; unordered} matches { ELEMENT[at0044] occurrences matches {0..1} matches { -- Reaction Reported? value matches { DV_BOOLEAN matches { value matches {True, False} } } } ELEMENT[at0048] occurrences matches {0..1} matches { -- Report Comment value matches { DV_TEXT matches {*} } } 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 {*} } } ELEMENT[at0.11] occurrences matches {0..1} matches { -- Date Last Verified value matches { DV_DATE_TIME matches {*} } } } } } } ontology terminologies_available = <"SNOMED-CT", ...> term_definitions = < ["en"] = < items = < ["at0.10"] = < text = <"Reaction Severity"> description = <"Indication of severity."> > ["at0.11"] = < text = <"Date Last Verified"> description = <"The most recent date when the reaction has been observed or reported."> > ["at0.2"] = < text = <"Date of Resolution"> description = <"*"> > ["at0.3"] = < text = <"Status"> description = <"Whether the reaction is active or resolved."> > ["at0.4"] = < text = <"Active"> description = <"The reaction is still active"> > ["at0.5"] = < text = <"Resolved"> description = <"The reaction has been resolved"> > ["at0.7"] = < text = <"Clinical Course"> description = <"Description of the clinical course of the reaction"> > ["at0.8"] = < text = <"Episodicity"> description = <"Description of the episodicity of the reaction of any."> > ["at0.9"] = < text = <"Date of Last Reaction"> description = <"The date when last reaction occured."> > ["at0000"] = < text = <"Adverse Reaction (NEHTA)"> 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."> > ["at0000.1"] = < text = <"Adverse Reaction for New Zealand"> 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.!"> > ["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 = <"Coding of the Substance/Agent with a terminology is desirable, where possible."> > ["at0004"] = < text = <"Absolute Contraindication?"> description = <"Is administration of this Substance/Agent absolutely contraindicated in this individual?"> comment = <"A flag indicating that a clinician has identified a propensity for a serious reaction upon further exposure to the Substance/Agent. Record as True if the clinician recommends that deliberate or voluntary exposure to, or administration of, the Substance/Agent should be prevented in future."> > ["at0006"] = < text = <"Overall Comment"> description = <"Additional narrative about the Adverse Reaction not captured in other fields, including reason for flagging an absolute contraindication; and instructions related to future exposure or administration of the Substance/Agent."> > ["at0009"] = < text = <"Reaction Event"> description = <"Details about each Adverse Reaction Event."> > ["at0010"] = < text = <"Specific Substance/Agent"> description = <"Specific identification of the actual Substance/Agent considered to be responsible for the Adverse Reaction event."> comment = <"Coding of the specific Substance/Agent with a terminology is preferred, where possible. For example, a medication trade name or identification of a specific food."> > ["at0011"] = < text = <"Manifestation"> description = <"Clinical manifestation of the Adverse Reaction expressed as a single word, phrase or brief description, e.g. nausea or rash."> comment = <"Coding with a terminology is preferred, where possible. The values entered here may be used to display on an application screen as part a list of adverse reactions, as recommended in the NHS CUI guidelines."> > ["at0012"] = < text = <"Reaction Description"> description = <"Narrative description of the Adverse Reaction."> > ["at0016"] = < text = <"Reaction Type"> description = <"The type of Adverse Reaction as determined by the clinician."> comment = <"Coding of the reaction type is preferred, where possible. Examples: 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."> > ["at0018"] = < text = <"Exposure Description"> description = <"Description about exposure to the Substance/Agent."> > ["at0019"] = < text = <"Additional Exposure Detail"> description = <"Additional detail about exposure/s for this Adverse Reactionevent, including structured medication amount information."> > ["at0020"] = < text = <"Earliest Exposure"> description = <"Record of the date and/or time of the earliest or initial exposure to the Substance/Agent."> > ["at0021"] = < text = <"Certainty"> description = <"Degree of certainty, as assessed by a clinician, that the specific Substance/Agent was the cause of the Adverse Reaction."> > ["at0022"] = < text = <"Suspected"> description = <"Possibly the causative agent."> > ["at0023"] = < text = <"Probable"> description = <"Likely to be the causative agent, but not confirmed by testing or rechallenge."> > ["at0024"] = < text = <"Confirmed"> description = <"Confirmed as the causative agent, by testing or rechallenge."> > ["at0025"] = < text = <"Duration of Exposure"> description = <"The amount of time of exposure to the Substance/Agent."> > ["at0027"] = < text = <"Onset of Reaction"> description = <"Record of the date and/or time of the onset of the Adverse Reaction."> > ["at0028"] = < text = <"Duration of Reaction"> description = <"The amount of time that the Adverse Reaction was present."> > ["at0029"] = < text = <"Additional Reaction Detail"> description = <"Additional detail about the Adverse Reaction, including anatomical location."> > ["at0031"] = < text = <"Multimedia"> description = <"Inclusion of any multimedia file to support the recording of the Adverse Reaction event."> comment = <"For example, a photo of a rash or presentation with angioneurotic oedema."> > ["at0032"] = < text = <"Reaction Comment"> description = <"Additional narrative about the Adverse Reaction event not captured in other fields."> > ["at0040"] = < text = <"Clinical Management Description"> description = <"Description about the clinical management provided."> > ["at0041"] = < text = <"Reporting Details"> description = <"Further details required for reporting to regulatory bodies."> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0044"] = < text = <"Reaction Reported?"> description = <"Was the Adverse Reaction reported to a regulatory body?"> > ["at0045"] = < text = <"Adverse Reaction Report"> description = <"Link to an Adverse Reaction Report sent to a regulatory body."> > ["at0047"] = < text = <"Supporting Clinical Record Information"> description = <"Link to further information about the presentation and findings that exist elsewhere in the health record."> comment = <"For example, presenting symptoms, examination findings, diagnosis etc."> > ["at0048"] = < text = <"Report Comment"> description = <"Additional narrative about the Adverse Reaction Report, including the reason for non-reporting, if required."> > > > >