ARCHETYPE *Adverse Reaction(en) (openEHR-EHR-EVALUATION.adverse_reaction-allergy.v1)

ARCHETYPE IDopenEHR-EHR-EVALUATION.adverse_reaction-allergy.v1
Concept*Adverse Reaction(en)
Description*A harmful or undesirable effect associated with exposure to any substance or agent, including food, plants, animals, insect stings or a medication at therapeutic doses. The range of Adverse Reactions includes both Immune mediated reactions Types I-IV (including allergies and hypersensitivities) and Non-immune mediated reactions (including pseudoallergic reactions, side effects, intolerances, drug toxicities (eg Gentamycin), drug-drug interactions, food-drug interactions, drug-disease interactions and idiosyncratic reactions).(en)
Use*Use to record all information about adverse reactions that are required to support direct clinical care of an individual, safe exchange of information about adverse reactions and to enable computerised knowledge-based activities such as clinical decision support and alerts. Use to provide a single place within the health record to record a range of clinical statements about adverse reactions, including: - record cumulative information about each exposure to a known substance, class of substance or agent; and - record a clinician's opinion that administration of, or exposure to, a substance or agent is absolutely contraindicated. Use to record the information about an adverse reaction that might be exchanged with other systems, including as part of an adverse reaction report sent to statutory authorities. It is likely that a formal Adverse Reaction report will require additional information that will be captured in the health record using other archetypes, for example medication and problem/diagnosis etc . This archetype has been designed to allow recording of information about a more generic substance, class of substance or agent, and then allow more specific details to be recorded including identification of the specific substance on a per exposure basis, including links to other parts of the health record where further details may be located. Note: it is possible on second or subsequent exposures to a previously identified substance for a reaction not to occur and this archetype allows for these events to be closely linked in a way that will assist in determining if the adverse reaction has been incorrectly identified. In addition, it is anticipated that in some very specific clinical situations, such as immunologist assessment or for use in clinical trials, more information about the adverse reaction may be required. Additional details can be added as cluster archetypes using the ‘Further Exposure Details’ and ‘Further Reaction Details’ slots. Similarly, additional details that are required only for reporting can be added using the ‘Reporting Details’ slot. The act of recording an adverse reaction in the health record implies there is a potential hazard for the individual if they are exposed to the same substance/agent in the future - a relative contraindication. If a clinician considers that it is not safe for the individual to be deliberately re-exposed to the substance/agent again, for example, following a manifestation of anaphylaxis, the 'Absolute contraindication' data flag should be recorded as ‘True’. Note: Conversely, a statement about ‘Severity’ of propensity (with possible values such as Mild, Moderate and Severe) has deliberately not been modelled explicitly. Prediction 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.(en)
Misuse*Not to be used for recording the absence (or negative presence) of a reaction to 'any substances' or to identified substances – use the EVALUATION.exclusion family of archetypes to express a positive statement of exclusion. Not to be used for recording that no information was able to be obtained about the Adverse Reaction status of a patient. Use the EVALUATION.absent_information family of archetypes to record a positive statement of absent information about Adverse Reactions was able to be obtained, for example, if a non-cooperative patient refuses to answer questions. Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in administration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose etc. Not to be use for recording alerts.(en)
Purpose*To record health information that will inform a clinical assessment of the propensity of an individual for a future reaction to a substance, class of substance or agent. To record information about exposure events to a substance, building up a persisting and evolving summary over time.(en)
ReferencesAdverse Reactions (Data Specifications) Version 1.0 [Internet]. Sydney, Australia: National E-Health Transition Authority; 2007 Jun 29 [cited 2009 Jul 03]; Available at http://www.nehta.gov.au/DGL/Resources/Downloads/Adverse%20Reaction%20v1.0.pdf
Drug hypersensitivity. Thien FC. Med J Aust. 2006 Sep 18;185(6):333-8. Review. [as at November 3, 2010]
Adverse drug reactions: definitions, diagnosis, and management. Edwards IR, Aronson JK. Lancet. 2000 Oct 7;356(9237):1255-9.
Adverse drug reactions: types and treatment options. Riedl MA, Casillas AM. Am Fam Physician. 2003 Nov 1;68(9):1781-90. Review.
Design Guidance: Displaying Adverse Drug Reaction Risks. Microsoft. 2009 Jan 28.
Royal Australian College of General Practitioners. Fact Sheet: Allergies & Adverse Reactions. 2010.
Mosbys Pocket Dictionary of Medicine, Nursing7 Health Professionals, 6th edition, Moseby Elsevier, 2010.
Copyright*copyright (c) 2010 NEHTA(en)
AuthorsIme avtorja: Heather Leslie
Organizacija: NEHTA
e-Pošta: heather.leslie@oceaninformatics.com
Datum izvora: 8/11/2010
Other Details LanguageIme avtorja: Heather Leslie
Organizacija: NEHTA
e-Pošta: heather.leslie@oceaninformatics.com
Datum izvora: 8/11/2010
OtherDetails Language Independent{references=Adverse Reactions (Data Specifications) Version 1.0 [Internet]. Sydney, Australia: National E-Health Transition Authority; 2007 Jun 29 [cited 2009 Jul 03]; Available at http://www.nehta.gov.au/DGL/Resources/Downloads/Adverse%20Reaction%20v1.0.pdf Drug hypersensitivity. Thien FC. Med J Aust. 2006 Sep 18;185(6):333-8. Review. [as at November 3, 2010] Adverse drug reactions: definitions, diagnosis, and management. Edwards IR, Aronson JK. Lancet. 2000 Oct 7;356(9237):1255-9. Adverse drug reactions: types and treatment options. Riedl MA, Casillas AM. Am Fam Physician. 2003 Nov 1;68(9):1781-90. Review. Design Guidance: Displaying Adverse Drug Reaction Risks. Microsoft. 2009 Jan 28. Royal Australian College of General Practitioners. Fact Sheet: Allergies & Adverse Reactions. 2010. Mosbys Pocket Dictionary of Medicine, Nursing7 Health Professionals, 6th edition, Moseby Elsevier, 2010., MD5-CAM-1.0.1=15D77CA99EA6B30EA9AD9E2A87821073}
Keywords*reaction(en), *allergy(en), *allergic(en), *adverse(en), *event(en), *effect(en), *sensitivity(en), *intolerance(en), *hypersensitivity(en), *side effect(en), *toxicity(en), *interaction(en), *drug(en), *food(en), *medication(en), *agent(en), *substance(en)
LifecycleCommitteeDraft
Language usedsl
Citeable Identifier1075.67.1258
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=*A harmful or undesirable effect associated with exposure to any substance or agent, including food, plants, animals, insect stings or a medication at therapeutic doses. The range of Adverse Reactions includes both Immune mediated reactions Types I-IV (including allergies and hypersensitivities) and Non-immune mediated reactions (including pseudoallergic reactions, side effects, intolerances, drug toxicities (eg Gentamycin), drug-drug interactions, food-drug interactions, drug-disease interactions and idiosyncratic reactions).(en), archetypeConceptComment=null, otherContributors=John Bennett, NEHTA, Australia
Rong Chen, Cambio Healthcare System, Sweden
Stephen Chu, NEHTA, Australia (Editor)
Matthew Cordell, NEHTA, Australia
David Evans, Queensland Health, Australia
Shahla Foozonkhah, Ocean Informatics, Australia
Sarah Gaunt, NEHTA, Australia
Heather Grain, Llewelyn Grain Informatics, Australia
Grahame Grieve, Australia
Sam Heard, Ocean Informatics, Australia
Andrew James, University of Toronto, Canada
Julie James, Blue Wave Informatics LLP, United Kingdom
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
David McKillop, NEHTA, Australia
Ian McNicoll, Ocean Informatics, United Kingdom
Chris Mitchell, RACGP, Australia
Jörg Niggemann, Compugroup, Germany
General Practice Computing Group, Australia
Camilla Preeston, Royal Australian College of General Practitioners, Australia
Cathy Richardson, NEHTA, Australia
Peter Scott, Medical Objects, Australia
Elena Shabanova, UMMSSOft, Russian Federation
Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore
John Taylor, NEHTA, Australia
Kylie Young, The Royal Australian College of General Practitioners, Australia, originalLanguage=en, translators=Slovenski: ?
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  • Ni [*No clinical effect observed.(en)]
  • Nepomembno [*Little noticeable clinical effect observed.(en)]
  • Pomembno [*Obvious clinical effect observed.(en)]
  • Življensko nevarno [*Life-threatening effect observed.(en)]
  • Smrtno [*Individual died.(en)]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0021], code=at0021, itemType=ELEMENT, level=3, text=Status, description=*Degree of certainty, as assessed by clinician, that the substance/agent was the cause of the reaction.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Sum [*Possible to be the causative agent, but without evidence.(en)]
  • Potrjeno [*Confirmed as the causative agent, by testing or rechallenge.(en)]
  • Zavrnjeno [*]
  • Izzvenelo [*]
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openEHR-EHR-CLUSTER.amount.v1 in specializacije ali
openEHR-EHR-CLUSTER.medication_admin.v1 in specializacije ali
openEHR-EHR-CLUSTER.timing.v1 in specializacije, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0040], code=at0040, itemType=ELEMENT, level=3, text=*Description of clinical management(en), description=*Narrative description about the clinical management provided.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, 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(en), description=*Inclusion of any multimedia file to support the recording of the reaction event, for example, a photo of a rash or presentation with angioneurotic oedema.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Neobvezen, ponavljam, 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(en), description=*Further details required for reporting to regulatory bodies.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Neobvezen, ponavljam, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Vključi:
Vsi neizrecno izključeni arhetipi, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0009]/items[at0032], code=at0032, itemType=ELEMENT, level=3, text=*Comment(en), description=*Further comment about the reaction event.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], credentials=[], items=[], protocol=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=*Reaction reported?(en), description=*Was the adverse reaction reported to a regulatory body?(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0045], code=at0045, itemType=ELEMENT, level=2, text=*Link to Adverse Reaction Report(en), description=*Link to the Adverse Reaction Report sent to the regulatory body.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0047], code=at0047, itemType=ELEMENT, level=2, text=*Links to supporting clinical record information(en), description=*Link to further information about about the presentation and findings that exist elsewhere in the health record, for example, presenting symptoms, examination findings, diagnosis etc.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null]], target=[]}, 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=Obvezno, cardinalityFormal=0..1, cardinalityText=neobvezen, 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=Obvezno, cardinalityFormal=0..1, cardinalityText=neobvezen, subCardinalityFormal=0..*, subCardinalityText=Minimum of 0 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=protocol, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0044], code=at0044, itemType=ELEMENT, level=2, text=*Reaction reported?(en), description=*Was the adverse reaction reported to a regulatory body?(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0045], code=at0045, itemType=ELEMENT, level=2, text=*Link to Adverse Reaction Report(en), description=*Link to the Adverse Reaction Report sent to the regulatory body.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/protocol[at0042]/items[at0047], code=at0047, itemType=ELEMENT, level=2, text=*Links to supporting clinical record information(en), description=*Link to further information about about the presentation and findings that exist elsewhere in the health record, for example, presenting symptoms, examination findings, diagnosis etc.(en), comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Neobvezen, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_URI, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]