ARCHETYPE Adverse reaction risk (openEHR-EHR-EVALUATION.adverse_reaction_risk_gr1.v0)

Name: Adverse reaction risk
License: http://creativecommons.org/licenses/by-sa/4.0/

ARCHETYPE ID	openEHR-EHR-EVALUATION.adverse_reaction_risk_gr1.v0
Concept	Adverse reaction risk
Description	Risk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance.
Use	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.
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 or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; 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.symptoms 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 the purpose. Not to be used as a proxy for an Adverse Event Report. See above for how it may be used as one component of an Adverse Event Report. 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-adverse_reaction archetype 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.
Purpose	To record a clinical assessment of a propensity for an adverse reaction upon future exposure to the specified substance, or class of substance. Where a propensity is identified, to record information or evidence about one or more reaction events that are characterised by any harmful or undesirable physiological response that is unique to the individual, and triggered by exposure of an individual to the identified substance or substance class.
References	Derived from: <Add reference to original resource here> Adverse Reaction, draft archetype, National eHealth Transition Authority [Internet]. NEHTA Clinical Knowledge Manager. Authored: 08 Nov 2010. Available at: http://dcm.nehta.org.au/ckm/OKM.html#showarchetype_1013.1.868_7 (accessed Jan 16, 2012). Allergy and Intolerance Domain Analysis Model, Release 1, HL7 [Internet]. Publication pending, expected August 2014; Available at http://wiki.hl7.org/images/1/1b/Allergy_and_Intolerance_INFORM_2013_MAY.pdf (accessed 06 July 2014). Allergy, clinical element model, GE/Intermountain Healthcare. Clinical Element Model Search. Available at: http://intermountainhealthcare.org/cem/Pages/Detail.aspx?NCID=520861661&k=allergy (accessed Jan 16, 2012). Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. PubMed PMID: 11072960. HL7 FHIR Resource - AllergyIntolerance R1.2.0 STU3 draft [Internet]. Health Level Seven International; [accessed 2020 Jan 17]. Available from: http://hl7.org/fhir/2016Jan/allergyintolerance.html. 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. - Uppsala Monitoring Centre (WHO): http://www.who-umc.org/ - European Medicines Agency: http://www.ema.europa.eu/ema/ - DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf
Copyright	© Australian Digital Health Agency, openEHR Foundation, HL7 International, Nasjonal IKT, HiGHmed
Authors	Author name: Heather Leslie Organisation: Ocean Informatics Email: heather.leslie@oceaninformatics.com Date originally authored: 2010-11-08
Other Details Language	Author name: Heather Leslie Organisation: Ocean Informatics Email: heather.leslie@oceaninformatics.com Date originally authored: 2010-11-08
OtherDetails Language Independent	{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=HiGHmed, references=Derived from: Adverse Reaction, draft archetype, National eHealth Transition Authority [Internet]. NEHTA Clinical Knowledge Manager. Authored: 08 Nov 2010. Available at: http://dcm.nehta.org.au/ckm/OKM.html#showarchetype_1013.1.868_7 (accessed Jan 16, 2012). Allergy and Intolerance Domain Analysis Model, Release 1, HL7 [Internet]. Publication pending, expected August 2014; Available at http://wiki.hl7.org/images/1/1b/Allergy_and_Intolerance_INFORM_2013_MAY.pdf (accessed 06 July 2014). Allergy, clinical element model, GE/Intermountain Healthcare. Clinical Element Model Search. Available at: http://intermountainhealthcare.org/cem/Pages/Detail.aspx?NCID=520861661&k=allergy (accessed Jan 16, 2012). Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. PubMed PMID: 11072960. HL7 FHIR Resource - AllergyIntolerance R1.2.0 STU3 draft [Internet]. Health Level Seven International; [accessed 2020 Jan 17]. Available from: http://hl7.org/fhir/2016Jan/allergyintolerance.html. 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. - Uppsala Monitoring Centre (WHO): http://www.who-umc.org/ - European Medicines Agency: http://www.ema.europa.eu/ema/ - DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf, current_contact=Heather Leslie, Atomica Informatics, Australia, original_namespace=org.highmed, original_publisher=HiGHmed, custodian_namespace=org.highmed, MD5-CAM-1.0.1=DE9C456914B8D0A7B4AF4C66FBC41143, build_uid=778b1273-b0e0-4d40-992d-cbb01ee5273e, revision=0.0.1-alpha}
Keywords	reaction, allergy, allergic, adverse, event, effect, sensitivity, intolerance, hypersensitivity, side effect, toxicity, drug, food, agent, substance, immune, non-immune, chemical, anaphylaxis, allergen, medication, supplement, medicine, natural remedies, immunological, non-immunological, risk
Lifecycle	in_development
UID	aaa5d8f3-7583-4d6f-839c-840eaf76f6db
Language used	en
Citeable Identifier	1246.145.1887
Revision Number	0.0.1-alpha
All	Archetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Risk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance., archetypeConceptComment=Substances include, but are not limited to: a therapeutic substance administered correctly at an appropriate dosage for the individual; food; material derived from plants or animals; or venom from insect stings., otherContributors=Fatima Almeida, Critical SW, Portugal Grethe Almenning, Bergen kommune, Norway Magnus Alsaker, Helsedirektoratet, Norway Torunn Apelseth, Helse Bergen, Norway Vebjørn Arntzen, Oslo University Hospital, Norway Bent Asgeir Larsen, Helsedirektoratet, Norway Koray Atalag, University of Auckland, New Zealand Elaine Ayres, US National Institutes of Health, United States Russell B Leftwich MD, United States (openEHR Editor) Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor) John Bennett, NEHTA, Australia Steve Bentley, Allscripts, United Kingdom Sharmila Biswas, Dr Sharmila Biswas GP, Australia Lars Bitsch-Larsen, Haukeland University hospital, Norway Terje Bless, Helse Nord FIKS, Norway Laila Bruun, Oslo universitetssykehus HF, Norway Claire Chalopin, ICCAS, University of Leipzig, Germany Rong Chen, Cambio Healthcare Systems, Sweden Stephen Chu, Queensland Health, Australia Matthew Cordell, NEHTA, Australia Howard Edidin, Edidin Group, Inc, United States Brett Esler, Oridashi, Australia David Evans, Queensland Health, Australia Jerry Fahrni, Kaweah Delta Health Care District, United States Shahla Foozonkhah, Iran ministry of health and education, Iran Einar Fosse, National Centre for Integrated Care and Telemedicine, Norway Joanne Foster, School of Nursing & Midwifery, QLD University of Technology & Nursing Informatics Australia, Australia Sebastian Garde, Ocean Informatics, Germany 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, Health Intersections, Australia (Editor) Robert Hausam, Hausam Consulting LLC, United States Sam Heard, Ocean Informatics, Australia Kristian Heldal, Telemark Hospital Trust, Norway Anca Heyd, DIPS ASA, Norway Hilde Hollås, Norway Roar Holm, Helse Vest IKT A/S, Norway Andrew James, University of Toronto, Canada Julie James, Blue Wave Informatics LLP, United Kingdom Tom Jarl Jakobsen, Helse Bergen, Norway Ivor Jones, Queensalnd Helath, Australia Lars Jostein Silihagen, Sopra Steria / Sykehuspartner / Sykehuset Innlandet, Norway Silje Kaada, Helse-Bergen, Avdeling for immunologi og transfusjonsmedisin, Norway Konstantinos Kalliamvakos, Cambio Healthcare Systems, Sweden Lars Karlsen, DIPS ASA, Norway Lars Morgan Karlsen, DIPS ASA, Norway Goran Karlstrom, County Of Värmland, Sweden Mary Kelaher, NEHTA, Australia Diane Kirkham, NEHTA, Australia Shinji Kobayashi, Kyoto University, Japan Robert L'egan, NEHTA, Australia Jobst Landgrebe, ii4sm, Switzerland Russell Leftwich, Russell B Leftwich MD, United States Fest Legemiddelverket, Statens Legemiddelverk, Norway Heather Leslie, Atomica Informatics, Australia (openEHR Editor) Hugh Leslie, Ocean Informatics, Australia Rikard Lovstrom, Swedish Medical Association, Sweden Hallvard Lærum, Oslo Universitetssykehus HF, Norway Arne Løberg Sæter, DIPS ASA, Norway Sarah Mahoney, Australia Luis Marco Ruiz, Norwegian Center for Integrated Care and Telemedicine, Norway Siv Marie Lien, DIPS ASA, Norway Mike Martyn, The Hobart Anaesthetic Group, Australia Lloyd McKenzie, Gordon Point Informatics, Canada David McKillop, NEHTA, Australia Ian McNicoll, freshEHR Clinical Informatics, United Kingdom (openEHR Editor) Chris Mitchell, RACGP, Australia Stewart Morrison, NEHTA, Australia Jörg Niggemann, Compugroup, Germany Bjørn Næss, DIPS ASA, Norway Tom Oniki, Intermountain Healthcare, United States Chris Pearce, Melbourne East GP Network, Australia Rune Pedersen, Universitetssykehuset i Nord Norge, Norway 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 Tanja Riise, Nasjonal IKT HF, Norway Jussara Rotzsch, Hospital Alemão Oswaldo Cruz, Brazil Stefan Sauermann, University of Applied Sciences Technikum Wien, Austria Thomas Schopf, University Hospital of North-Norway, Norway Thilo Schuler, Australia Jason Scott, Plymouth Hospitals NHS Trust, United Kingdom Peter Scott, Medical Objects, Australia Elena Shabanova, UMMSSOft, Russian Federation Anoop Shah, University College London, United Kingdom Elizabeth Stanick, Hobart Anaesthetic Group, Australia Laila Storesund, Haraldsplass diakonale sykehus, Norway Norwegian Review Summary, Nasjonal IKT HF, Norway Line Sæle, Nasjonal IKT HF, Norway Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore John Taylor, NEHTA, Australia Micaela Thierley, Helse Bergen, Norway Gordon Tomes, Australian Institute of Health and Welfare, Australia John Tore Valand, Haukeland Universitetssjukehus, Norway (Nasjonal IKT redaktør) Richard Townley-O'Neill, Australian Digital Health Agency, Australia Ines Vaz, UFN, Portugal Nils Widnes, Helse-Bergen, Norway Andrew Yap, Australia Kylie Young, The Royal Australian College of General Practitioners, Australia Lin Zhang, Taikang Insurance Group, China, originalLanguage=en, translators= German: Natalia Strauch, Medizinische Hochschule Hannover, Strauch.Natalia@mh-hannover.de Swedish: Emma Malm, Karolinska Universitetssjukhuset, emma.malm@cambio.se Norwegian Bokmål: Lars Bitsch-Larsen, Haukeland University Hospital, Bergen Norway, MD DEAA MBA spec in anesthesia and intensive care, spec in tropical med., Lbla@Helse-Bergen.No: lbla@helse-bergen.no Portuguese (Brazil): Osmeire Chamelette Sanzovo, Hospital Sírio Libanês, osmeire.acsanzovo@hsl.org.br , subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={relationships=[], source=[], capabilities=[], activities=[], details=[], context=[], ism_transition=[], other_participations=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Substance, description=Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event., comment=Both an individual substance and a substance class are valid entries in 'Substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the value in 'Substance' is an individual substance, it may be duplicated in 'Specific substance'. It is strongly recommended that both 'Substance' and 'Specific substance' be coded with a terminology capable of triggering decision support, where possible. For example: Snomed CT, DM+D, RxNorm, NDFRT, ATC, New Zealand Universal List of Medicines and Australian Medicines Terminology. Free text entry should only be used if there is no appropriate terminology available., uncommonOntologyItems={source=openEHR,FHIR,DAM}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0063], code=at0063, itemType=ELEMENT, level=2, text=Status, description=Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction., comment=Decision support would typically raise alerts for 'Suspected', 'Likely', 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems . Some implementations may choose to make this field mandatory. 'Resolved' may be used variably across systems, depending on clinical use and context - there appears to be differing opinion whether this should still be used to raise potential alerts or to display in an Adverse Reaction List. The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology., uncommonOntologyItems={source=FHIR, DAM}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of: Coded Text at0127::Suspected [A low level of clinical certainty about the propensity of a reaction to the identified 'Substance'.] at0064::Likely [A reasonable level of certainty about the propensity for a reaction to the identified 'Substance'.] at0065::Confirmed [A high level of certainty about the propensity for a reaction to the identified 'Substance', which may include clinical evidence by testing or re-challenge.] at0067::Resolved [The previously known reaction to the identified 'Substance' has been clinically reassessed and considered no longer to be an active risk.] at0066::Refuted [The propensity for a reaction to the identified 'Substance' has been clinically reassessed or has been disproved with a high level of clinical certainty by re-exposure or deliberate challenge.] Text , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0101], code=at0101, itemType=ELEMENT, level=2, text=Criticality, description=An indication of the potential for critical system organ damage or life threatening consequence., comment=This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value., uncommonOntologyItems={source=DAM, openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values= at0102::Low [Exposure to substance unlikely to result in critical system organ damage or life threatening consequence. Future exposure to the identified 'Substance' should be considered a relative contra-indication in normal clinical circumstances.] at0103::High [Exposure to substance may result in critical organ system damage or life threatening consequence. Future exposure to the identified 'Substance' should be considered an absolute contra-indication in normal clinical circumstances.] at0124::Indeterminate [Unable to assess with information available.] , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0120], code=at0120, itemType=ELEMENT, level=2, text=Category, description=Category of the identified 'Substance'., comment=This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of: Coded Text at0121::Food [Any substance consumed to provide nutritional support for the body, such as peanut or egg.] at0122::Medication [Any substance administered to achieve a physiological effect.] at0123::Other [Any other substance encountered including venom, latex and other environmental substances.] Text , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0006], code=at0006, itemType=ELEMENT, level=2, text=Comment, description=Additional narrative about the propensity for the adverse reaction, not captured in other fields., comment=For example: including reason for flagging a 'Criticality' of 'High risk'; and instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover., uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], credentials=[], target=[], items=[], content=[], description=[], contacts=[], state=[], events=[], provider=[], identities=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0062], code=at0062, itemType=ELEMENT, level=2, text=Last updated, description=Date when the propensity or the reaction event was updated., comment=Note: maps to recordedDate in FHIR., uncommonOntologyItems={source=openEHR, FHIR, DAM}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0128], code=at0128, itemType=SLOT, level=2, text=Extension, description=Additional information required to capture local content or to align with other reference models/formalisms., comment=For example: local information requirements or additional metadata to align with FHIR or CIMI equivalents., uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:* All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0047], code=at0047, itemType=ELEMENT, level=2, text=Supporting clinical record information, description=Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports., comment=For example, presenting symptoms, examination findings, diagnosis etc. [Note: FHIR,DAM: Maps to Sensitivity Test.], uncommonOntologyItems={source=FHIR, openEHR, DAM}, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=Reaction reported?, description=Has the adverse reaction ever been reported to a regulatory body?, comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0099], code=at0099, itemType=CLUSTER, level=2, text=Report summary, description=Structured details about reports that have been forwarded to regulatory bodies., comment=null, uncommonOntologyItems=null, occurencesFormal=0.., occurencesText=Optional, repeating, cardinalityFormal=1.., cardinalityText= (Cardinality: 1.., unordered), subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0099]/items[at0125], code=at0125, itemType=ELEMENT, level=3, text=Date of report, description=Date that the report was sent to the regulatory authority., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0099]/items[at0048], 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