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

ARCHETYPE IDopenEHR-EHR-EVALUATION.adverse_reaction_risk.v0
ConceptAdverse reaction risk
DescriptionRisk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance.
UseUse 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.
MisuseNot 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.
PurposeTo 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.
ReferencesDerived 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.

FHIR Resource AllergyIntolerance, HL7 [Internet]. Available at: http://www.hl7.org/implement/standards/fhir/allergyintolerance.html (accessed 06 Jul 2014).

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
AuthorsAuthor name: Heather Leslie
Organisation: Ocean Informatics
Email: heather.leslie@oceaninformatics.com
Date originally authored: 2010-11-08
Other Details LanguageAuthor 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 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/., 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. FHIR Resource AllergyIntolerance, HL7 [Internet]. Available at: http://www.hl7.org/implement/standards/fhir/allergyintolerance.html (accessed 06 Jul 2014). 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, Ocean Informatics, Australia, original_namespace=org.highmed, original_publisher=HiGHmed, custodian_namespace=org.highmed, MD5-CAM-1.0.1=80C7A80F4057AFF73DCEF1FB0392B12B, build_uid=3d449dd2-8124-4133-a917-e68b3dea4e9b, revision=0.0.1-alpha}
Keywordsreaction, 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
Lifecyclein_development
UID0124697d-8752-42e8-8ca0-ae6e5ee76fd9
Language useden
Citeable Identifier1246.145.20
Revision Number0.0.1-alpha
AllArchetype [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, Nasjonal IKT HF, 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, UNB, 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, BIPH, China, originalLanguage=en, translators=German: Birger Haarbrandt, Medizinische Hochschule Hannover, haarbrandt@googlemail.com
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=[], identities=[], provider=[], content=[], events=[], 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
    • Suspected [A low level of clinical certainty about the propensity of a reaction to the identified 'Substance'.]
    • Likely [A reasonable level of certainty about the propensity for a reaction to the identified 'Substance'.]
    • 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.]
    • Resolved [The previously known reaction to the identified 'Substance' has been clinically reassessed and considered no longer to be an active risk.]
    • 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=
  • 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.]
  • 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.]
  • 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
    • Food [Any substance consumed to provide nutritional support for the body, such as peanut or egg.]
    • Medication [Any substance administered to achieve a physiological effect.]
    • Other [Any other substance encountered including venom, latex and other environmental substances.]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0117], code=at0117, itemType=ELEMENT, level=2, text=Onset of last reaction, description=The date and/or time of the onset of the last known occurrence of a reaction event., comment=This date may be be a duplicate of the most recent 'Onset of reaction' date. Where a textual representation of the date of last occurrence is required e.g 'In Childhood, '10 years ago' the Comment element should be used., uncommonOntologyItems={source=IMH}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0058], code=at0058, itemType=ELEMENT, level=2, text=Reaction mechanism, description=Identification of the underlying physiological mechanism for the adverse reaction., comment=Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute., 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
    • Immune mediated [Immune mediated reaction, including allergic reactions and hypersensitivities.]
    • Non-immune mediated [A non-immune mediated reaction, which can include pseudo-allergic reactions, side effects, intolerances, drug toxicities (for example, to Gentamicin).]
    • Indeterminate [The physiological mechanism could not be determined.]
  •  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], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009], code=at0009, itemType=CLUSTER, level=2, text=Reaction event, description=Details about each adverse reaction event linked to exposure to the identified 'Substance'., comment=null, uncommonOntologyItems={source=openEHR,FHIR,DAM}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0010], code=at0010, itemType=ELEMENT, level=3, text=Specific substance, description=Identification of the substance considered to be responsible for the specific adverse reaction event., comment=For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the value in 'Substance' is an individual substance and not a substance class, then it may be duplicated in this data element. It is strongly recommended that 'Specific substance' be coded with a terminology capable of triggering decision support, where possible. For example: RxNorm, Snomed CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC and CPT. Free text entry should only be used if there is no appropriate terminology available., uncommonOntologyItems={source=FHIR, openEHR,DAM}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0021], code=at0021, itemType=ELEMENT, level=3, text=Certainty, description=Statement about the degree of clinical certainty that the identified 'Specific substance' was the cause of the 'Manifestation' in this reaction event., comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Suspected [A low level of clinical certainty that the reaction was caused by the identified 'Specific substance'.]
  • Likely [A reasonable level of clinical certainty that the reaction was caused by the identified 'Specific substance'.]
  • Confirmed [A high level of clinical certainty that the reaction was due to the identified 'Substance', which may include clinical evidence by testing or re-challenge.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0011], code=at0011, itemType=ELEMENT, level=3, text=Manifestation, description=Clinical symptoms and/or signs that are observed or associated with the adverse reaction., comment=Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction'may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions, as recommended in the UK NHS CUI guidelines. Terminologies commonly used include, but are not limited to, SNOMED-CT or ICD10., uncommonOntologyItems={source=FHIR, openEHR,DAM}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0012], code=at0012, itemType=ELEMENT, level=3, text=Reaction description, description=Narrative description about the adverse reaction as a whole, including details of the manifestation if required., comment=null, uncommonOntologyItems={source=FHIR, openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0027], code=at0027, itemType=ELEMENT, level=3, text=Onset of reaction, description=Record of the date and/or time of the onset of the reaction., comment=null, 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=/data[at0001]/items[at0009]/items[at0028], code=at0028, itemType=ELEMENT, level=3, text=Duration of reaction, description=The total amount of time that the manifestation of the adverse reaction persisted., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0089], code=at0089, itemType=ELEMENT, level=3, text=Severity of reaction, description=Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations., comment=It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster., uncommonOntologyItems={source=DAM}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
  •  Coded Text
    • Mild [Causes mild physiological effects.]
    • Moderate [Causes moderate physiological effects.]
    • Severe [Causes severe physiological effects.]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0029], code=at0029, itemType=SLOT, level=3, text=Reaction details, description=Additional details about the adverse reaction, including anatomical location and Common Toxicity Criteria, can be provided by inclusion of specific archetypes in this SLOT., comment=May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or the Multimedia CLUSTER archetype. [Note: FHIR - These would be extensions as specified in a profile.], uncommonOntologyItems={source=FHIR, openEHR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.anatomical_location.v1 and specialisations Or
openEHR-EHR-CLUSTER.multimedia.v1 and specialisations Or
openEHR-EHR-CLUSTER.anatomical_location_relative.v1 and specialisations Or
openEHR-EHR-CLUSTER.symptom_sign.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0020], code=at0020, itemType=ELEMENT, level=3, text=Initial exposure, description=Record of the date and/or time of the first exposure to the Substance for this Reaction Event., comment=Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'., uncommonOntologyItems={source=FHIR, openEHR,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=/data[at0001]/items[at0009]/items[at0025], code=at0025, itemType=ELEMENT, level=3, text=Duration of exposure, description=The total amount of time the individual was exposed to the identified 'Specific substance'., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0106], code=at0106, itemType=ELEMENT, level=3, text=Route of exposure, description=Identification of the route by which the subject was exposed to the identified 'Specific substance'., comment=Coding of the Route of Exposure with a terminology should be used wherever possible., uncommonOntologyItems={source=FHIR, DAM}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0018], code=at0018, itemType=ELEMENT, level=3, text=Exposure description, description=Narrative description about exposure to the identified 'Specific substance'., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0096], code=at0096, itemType=SLOT, level=3, text=Exposure details, description=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., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.citation.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0040], code=at0040, itemType=ELEMENT, level=3, text=Clinical management description, description=Narrative description about the clinical management provided., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0119], code=at0119, itemType=SLOT, level=3, text=Clinical management details, description=Additional structured details about clinical management for this reaction event can be provided by inclusion of specific archetypes in this SLOT., comment=null, 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=/data[at0001]/items[at0009]/items[at0041], code=at0041, itemType=SLOT, level=3, text=Reporting details, description=Additional structured details required for reporting to regulatory bodies can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems={source=FHIR, openEHR}, 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=/data[at0001]/items[at0009]/items[at0116], code=at0116, itemType=SLOT, level=3, text=Information source, description=Details about the provenance of the information can be provided by inclusion of specific archetypes in this SLOT., comment=This SLOT is intended to provide details about the source of information for this particular 'Reaction event'. Details about the source of information for the entire 'Adverse reaction risk' should be recorded using the 'Information Provider' reference model attribute., 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=/data[at0001]/items[at0009]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=Reaction comment, description=Additional narrative about the adverse reaction event not captured in other fields., comment=null, 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=[], capabilities=[], target=[], items=[], 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..1, occurencesText=Optional, 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=, 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], code=at0048, itemType=ELEMENT, level=3, text=Report comment, description=Narrative about the adverse reaction report or reporting process., comment=For example, the reason for non-reporting., uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0099]/items[at0045], code=at0045, itemType=ELEMENT, level=3, text=Adverse reaction report, description=Link to an adverse reaction Report sent to a regulatory body., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null]], ism_transition=[], contacts=[], activities=[], context=[], other_participations=[], state=[], details=[], description=[], source=[]}, topLevelItems={data=ResourceSimplifiedHierarchyItem [path=ROOT_/data[at0001], code=at0001, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=1..*, subCardinalityText=, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null], protocol=ResourceSimplifiedHierarchyItem [path=ROOT_/protocol[at0042], code=at0042, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=1..*, subCardinalityText=, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=protocol, currentHierarchyItemsForAdding=[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 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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..1, occurencesText=Optional, 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=, 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], code=at0048, itemType=ELEMENT, level=3, text=Report comment, description=Narrative about the adverse reaction report or reporting process., comment=For example, the reason for non-reporting., uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0099]/items[at0045], code=at0045, itemType=ELEMENT, level=3, text=Adverse reaction report, description=Link to an adverse reaction Report sent to a regulatory body., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]