ARCHETYPE Adverse Reaction (/AllergyIntolerance) (openEHR-EHR-EVALUATION.adverse_reaction_gg.v1)

ARCHETYPE IDopenEHR-EHR-EVALUATION.adverse_reaction_gg.v1
ConceptAdverse Reaction (/AllergyIntolerance)
DescriptionA harmful or undesirable, unexpected 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.
UseUse to record all information about the presence of adverse reaction/s (including an allergic reaction/s) to a substance to support direct clinical care of an individual; as part of a managed Adverse Reaction list; to enable safe exchange of information about adverse reactions; and to assist 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. 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. Design of this archetype has been deliberatly focused on identifying a pragmatic, core data set that will be suitable for most common use clinical scenarios but permits extension of the model when additional detail is required through incorporation of additional archetypes in the 'Additional Reaction Detail', 'Additional Exposure Detail', and 'Reporting Details' slots. Examples of clinical situations where the extension will be required are for a detailed immunology assessment, for reporting to regulatory bodies or clinical trial use. A data element for Substance Category has not been modelled as this should be able to be derived from any coded entry for Substance/Agent and be used in decision support activities. A coded Category is not adequate to support decision support if Substance/Agent is only entered via free text. 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. A formal Adverse Reaction Report to regulatory bodies is a document that will contain a broad range of information in addition to the specific details of the adverse reaction. The report will be comprised of this Adverse Reaction archetype plus a variable number of others - for example, demographics, weight, medication and problem/diagnosis. FHIR: Most of the details of the sensitivity can be found in the set of reactions that are associated with the resource, though these may not be present when the patient has not provided enough information. Adverse Reactions do not have to be always associated with an AllergyIntolerance which may appropriate when an single reaction has not provided enough evidence for a meaningful Allergy/Intolerance, or in specific views of events rather than in a general clinical record.
MisuseNot 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 Adverse Reaction 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 that a positive statement that information was not 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. Not to be used for recording failed therapy.
PurposeTo record information about any harmful, desirable or unexpected reaction to a substance or agent, including: - immune mediated reactions Types I-IV (including true 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). 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. FHIR: Allergy/Intolerance resources are used to provide information about adverse sensitivities to substances that lead to physiologic changes that are clinically observable. An adverse sensitivity is defined as: A condition expected to result in undesirable physiologic reaction to an amount of a substance that would not produce a reaction in most individuals. The substance is the trigger of an immunologic response that produces the observed physiologic changes, or in some instances nonimmunologic mechanisms that produce clinically identical physiologic changes. The immunologic response might be considered the actual cause of the reaction, but it is exposure to the trigger substance that is clinically observable. This definition excludes clinically identical episodes that may be caused by physical agents, such as heat, cold, sunlight, or vibration, by exercise activity, or by infectious agents. Those conditions caused by physical agents or infectious would be captured on the problem list (List/Condition Resources). The allergy/intolerance list is a list of conditions that represent a propensity unique to this individual for a reaction upon future exposure to a specified substance. Note that this specification draws a distinction between the patients condition/problem list and an allergy/intolerance list, even though allergies and intolerances are also conditions. This is because the distinction is a long established clinical workflow, even to patients. Asking an individual "if they have any problems" is not going to invoke an account of their past reactions to medications or foods. Instead, they are asked if they "have any allergies". An allergy/intolerance is also different in that a potential harm from exposure to an external substance that may be ordered by a provider in the course of their care but is not inherent to exposure to that substance for the general population.
ReferencesAdverse 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, 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.

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.
Copyright© openEHR Foundation
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{references=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, 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. 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=67BF5339209F5F0B2426E22715898C4F}
Keywordsreaction, allergy, allergic, adverse, event, effect, sensitivity, intolerance, hypersensitivity, side effect, toxicity, interaction, drug, food, medication, agent, substance, immune, non-immune, chemical
LifecycleCommitteeDraft
Language useden
Citeable Identifier1013.1.1610
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=A harmful or undesirable, unexpected 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., archetypeConceptComment=Substance/Agent should be coded with a terminology, where possible. FHIR: Indicates the patient has a susceptibility to an adverse reaction upon exposure to a specified substance., otherContributors=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, originalLanguage=en, translators=, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={identities=[], activities=[], credentials=[], state=[], capabilities=[], items=[], events=[], provider=[], content=[], target=[], contacts=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0069], code=at0069, itemType=ELEMENT, level=2, text=recorder, description=Indicates who has responsibility for the record., comment=openEHR: implicit in the reference model ENTRY/provider., uncommonOntologyItems={source=FHIR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0050], code=at0050, itemType=ELEMENT, level=2, text=identifier, description=External Ids for this item. Note: in openEHR, this is implicit in the reference model, comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0068], code=at0068, itemType=ELEMENT, level=2, text=subject, description=The patient who has the allergy or intolerance., comment=openEHR: implicit in the reference model ENTRY/subject., uncommonOntologyItems={source=FHIR}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=Reaction Reported?, description=Was the Adverse Reaction 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[at0048], code=at0048, itemType=ELEMENT, level=2, text=Report Comment, description=Additional narrative about the Adverse Reaction Report, including the reason for non-reporting, if required., 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=/protocol[at0042]/items[at0045], code=at0045, itemType=ELEMENT, level=2, 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], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0062], code=at0062, itemType=ELEMENT, level=2, text=recordedDate, description=Date when the sensitivity was recorded.. Note: in openEHR, this is implicit in the reference model, 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[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., uncommonOntologyItems={source=FHIR, openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null]], other_participations=[], relationships=[], ism_transition=[], description=[], source=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, 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=openEHR: Substance/Agent should be coded with a terminology, where possible. In openEHR, this is text or code. FHIR: this is a reference to a substance, which is text / code + composition information (more text + code...), uncommonOntologyItems={source=openEHR,FHIR}, 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[at0094], code=at0094, itemType=ELEMENT, level=2, text=Substance/Agent type, description=*, comment=null, uncommonOntologyItems=null, 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[at0053], code=at0053, itemType=ELEMENT, level=2, text=Criticality, description=Criticality of the sensitivity, 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=
  • fatal [Likely to result in death if re-exposed.]
  • high [Likely to result in reactions that will need to be treated if re-exposed.]
  • medium [Likely to result in reactions that will inconvenience the subject]
  • low [Not likely to result in any inconveniences for the subject]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, 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., uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Allowed values: {true}, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0049], code=at0049, itemType=ELEMENT, level=2, text=Future Use, description=Narrative description of clinician instructions or advice related to future exposure to, or administration of, the Substance/Agent., 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[at0058], code=at0058, itemType=ELEMENT, level=2, text=SensitivityType, description=Type of the sensitivity. Control 1..1, comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • allergy [Allergic Reaction]
  • intolerance [Non-Allergic Reaction]
  • unknown [Unknown type]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0063], code=at0063, itemType=ELEMENT, level=2, text=Status, description=Status of the sensitivity., comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • suspected [A suspected sensitivity to a substance]
  • confirmed [The sensitivity has been confirmed and is active]
  • refuted [The sensitivity has been shown to never have existed]
  • resolved [The sensitivity used to exist but no longer does]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0006], code=at0006, itemType=ELEMENT, level=2, text=Overall Comment, description=Additional narrative about the Adverse Reaction as a whole, 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], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009], code=at0009, itemType=CLUSTER, level=2, text=Adverse Reaction Event, description=Details about each Adverse Reaction Event., comment=FHIR: Adverse Reaction resources are used to provide information about specific reactions to a substance. These are normally associated with an AllergyIntolerance resource, but can be reported on their own when no assumption of further reactions is being made, or when specific events are being described. 4.1.2 Background and Context An Adverse Reaction normally has a set of signs or symptoms that are reported in the Symptom class. However, it is possible to convey that an adverse reaction occurred without knowing the specific signs or symptoms that occurred, e.g. Some unknown reaction occurred. Similarly, it is possible to convey that an adverse reaction with a set of symptoms occurred but not indicate the substance if it is not known. e.g. A rash occurred for some unknown reason. The Exposure class is used to indicate a set of exposures that preceded the reaction. There is no assertion of causality, purely a statement of timing. Each exposure can indicate a substance that might be different from the reaction if needed., uncommonOntologyItems={source=openEHR,FHIR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=3..*, cardinalityText=Minimum of 3 items, 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/Agent, description=Specific identification of the actual Substance/Agent considered to be responsible for the Adverse Reaction event. In openEHR, this is text or code. In FHIR, this is a reference to a substance, which is text / code + composition information (more text + code...), 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., uncommonOntologyItems={source=FHIR, openEHR}, 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[at0072], code=at0072, itemType=ELEMENT, level=3, text=identifier, description=External Ids for this Adverse Reaction., comment=openEHR: implicit in the reference model, uncommonOntologyItems={source=FHIR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0085], code=at0085, itemType=ELEMENT, level=3, text=subject, description=The subject of the adverse reaction. In openEHR, this is not relevant because the reaction event never stands alone, but since it can in FHIR, this is present, comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0086], code=at0086, itemType=ELEMENT, level=3, text=recorder, description=Identifies the individual responsible for the information in the reaction record. In openEHR, this must be the same as the evaluation; the event cannot be recorded separately, comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0011], code=at0011, itemType=ELEMENT, level=3, text=Manifestation, description=Clinical manifestation of the Adverse Reaction expressed as a single word, phrase or brief description, e.g. nausea or rash., comment=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 NHS CUI guidelines., uncommonOntologyItems={source=FHIR, openEHR}, 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[at0009]/items[at0016], code=at0016, itemType=ELEMENT, level=3, 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. FHIR: Maps to manifestation-type in AllergyIntolerance resource, 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[at0012], code=at0012, itemType=ELEMENT, level=3, text=Reaction Description, description=Narrative description of the Adverse Reaction., 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[at0020], code=at0020, itemType=ELEMENT, level=3, text=Earliest Exposure, description=Record of the date and/or time of the earliest or initial exposure to the Substance/Agent. , comment=FHIR: Maps to , uncommonOntologyItems={source=FHIR, openEHR}, 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[at0096], code=at0096, itemType=SLOT, level=3, text=Further Exposure Details, description=*, 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[at0027], code=at0027, itemType=ELEMENT, level=3, text=Onset of Reaction, description=Record of the date and/or time of the onset of the Adverse Reaction., comment=FHIR: Maps to adversereaction/date, uncommonOntologyItems={source=openEHR,FHIR}, 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 amount of time that the Adverse Reaction was present., 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=The severity of the sign or symptom, 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=
  • severe [Severe complications arose due to the reaction]
  • serious [Serious inconvenience to the subject]
  • moderate [Moderate inconvenience to the subject]
  • minor [Minor inconvenience to the subject]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0025], code=at0025, itemType=ELEMENT, level=3, text=Duration of Exposure, description=The amount of time of exposure to the Substance/Agent., 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[at0018], code=at0018, itemType=ELEMENT, level=3, text=Exposure Description, description=Description about exposure to the Substance/Agent., 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[at0021], code=at0021, itemType=ELEMENT, level=3, text=Certainty of Causality, description=Degree of certainty, as assessed by a clinician, that the specific Substance/Agent was the cause of the Adverse Reaction., comment=null, uncommonOntologyItems={source=openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Unlikely [*]
  • Suspected [Possibly the causative agent.]
  • Probable [Likely to be the causative agent, but not confirmed by testing or rechallenge.]
  • Confirmed [Confirmed as the causative agent, by testing or rechallenge.]


Possible reasons why null:
  • unknown
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0087], code=at0087, itemType=ELEMENT, level=3, text=didNotOccurFlag, description=If true, indicates that no reaction occurred. Generally only useful in conjunction with other positive reaction records. I.e. "Patient reacted to A and B, but did not react when exposed to C, therefore . . ."., comment=null, uncommonOntologyItems={source=FHIR, openEHR}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0029], code=at0029, itemType=SLOT, level=3, text=Additional Reaction Detail, description=Additional detail about the Adverse Reaction, including anatomical location., comment=FHIR: These would be extensions as specified in a profile (same outcome)., 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, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0040], code=at0040, itemType=ELEMENT, level=3, text=Clinical Management Description, description=Narrative description of 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[at0031], code=at0031, itemType=ELEMENT, level=3, 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., uncommonOntologyItems={source=openEHR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_MULTIMEDIA, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0041], code=at0041, itemType=SLOT, level=3, text=Reporting Details, description=Further details required for reporting to regulatory bodies., comment=FHIR: These would be extensions as specified in a profile (same outcome), 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[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], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0070], code=at0070, itemType=ELEMENT, level=2, text=sensitivityTest, description=Observations that confirm or refute , comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null]], context=[], details=[]}, topLevelItems={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], 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=4..*, subCardinalityText=Minimum of 4 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=protocol, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0069], code=at0069, itemType=ELEMENT, level=2, text=recorder, description=Indicates who has responsibility for the record., comment=openEHR: implicit in the reference model ENTRY/provider., uncommonOntologyItems={source=FHIR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0050], code=at0050, itemType=ELEMENT, level=2, text=identifier, description=External Ids for this item. Note: in openEHR, this is implicit in the reference model, comment=null, uncommonOntologyItems={source=FHIR}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0068], code=at0068, itemType=ELEMENT, level=2, text=subject, description=The patient who has the allergy or intolerance., comment=openEHR: implicit in the reference model ENTRY/subject., uncommonOntologyItems={source=FHIR}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=Reaction Reported?, description=Was the Adverse Reaction 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[at0048], code=at0048, itemType=ELEMENT, level=2, text=Report Comment, description=Additional narrative about the Adverse Reaction Report, including the reason for non-reporting, if required., 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=/protocol[at0042]/items[at0045], code=at0045, itemType=ELEMENT, level=2, 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], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0062], code=at0062, itemType=ELEMENT, level=2, text=recordedDate, description=Date when the sensitivity was recorded.. Note: in openEHR, this is implicit in the reference model, 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[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., uncommonOntologyItems={source=FHIR, openEHR}, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]