Use to record a clinical assessment of a propensity for an adverse reaction upon future exposure to a specified substance or class of substances including, but not limited to, incipients and excipients in medicinal preparations, biological products, metal salts, and organic chemical compounds.
This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening:
- immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or
- non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities.
In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient.
Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT.
Identification of the severity of the manifestation of the reaction, recorded in the CLUSTER.adverse_reaction_event archetype, can inform the 'Criticality' of the adverse reaction risk. For example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures.
This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype.
Use to record information about the positive presence of the risk of an adverse reaction:
- to support the direct clinical care of an individual;
- as part of a managed adverse reaction or allergy/intolerance list;
- to support the exchange of information about the propensity and events related to adverse reactions;
- to inform adverse reaction reporting; and
- to assist with computerised knowledge-based activities such as clinical decision support and alerts.
The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing.
Allergy and Intolerance Domain Analysis Model, Release 1, HL7 [Internet]. Publication pending, expected August 2014; Available at http://wiki.hl7.org/images/1/1b/Allergy_and_Intolerance_INFORM_2013_MAY.pdf (accessed 06 July 2014).
Allergy, clinical element model, GE/Intermountain Healthcare. Clinical Element Model Search. Available at: http://intermountainhealthcare.org/cem/Pages/Detail.aspx?NCID=520861661&k=allergy (accessed Jan 16, 2012).
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. PubMed PMID: 11072960.
HL7 FHIR Resource - AllergyIntolerance R1.2.0 STU3 draft [Internet]. Health Level Seven International; [accessed 2020 Jan 17]. Available from: http://hl7.org/fhir/2016Jan/allergyintolerance.html.
Horsfield P, Sibeko S. Representation in Electronic Patient Records of Allergic Reactions, Adverse Reactions, and Intolerance of Pharmaceutical Products [Internet]. London, UK: National Health Service; 2006 Sep 07 [cited 2011 Jun 21]; Available at https://svn.connectingforhealth.nhs.uk/svn/public/nhscontentmodels/TRUNK/ref/NPfIT/Allergy_ADR_Intolerance%20v%201.2Final.doc.
Long R, Bentley S. SCG Guidance on the Representation of Allergies and Adverse Reaction Information Using NHS Message Templates [Internet]. London, UK: National Health Service; 2008 Apr 30 [cited 2011 Jun 21]; Available at http://www.connectingforhealth.nhs.uk/systemsandservices/data/scg/scg0001.pdf.
Microsoft. Design Guidance: Displaying Adverse Drug Reaction Risks [Internet]. 2009 January 28 [cited 2011 Jun 21]; Available at www.mscui.net/DesignGuide/DisplayingAllergies.aspx.
Microsoft. Design Guidance: Recording Adverse Drug Reaction Risks [Internet]. 2009 March 27 [cited 2011 Jun 21]; Available at www.mscui.net/DesignGuide/RecordingAllergies.aspx.
Mosby. Mosby's Pocket Dictionary of Medicine, Nursing and Health Professions. 6th Edition. USA: Mosby Elsevier; 2010
National E-Health Transition Authority. Adverse Reactions (Data Specifications) Version 1.1 [Internet]. Sydney, Australia: NEHTA; 2008 Feb 29 [cited 2011 Jun 21]; Available at http://www.nehta.gov.au/component/docman/doc_download/453-adverse-reaction-data-specification-v11.
Riedl MA, Casillas AM. Adverse drug reactions: types and treatment options. Am Fam Physician. 2003 Nov 1;68(9):1781-90. Review. PubMed PMID: 14620598.
Royal Australian College of General Practitioners. Fact Sheet: Allergies & Adverse Reactions (Draft). 2010.
Thien FC. Drug hypersensitivity. Med J Aust. 2006 Sep 18;185(6):333-8. Review. PubMed PMID: 16999678.
- Uppsala Monitoring Centre (WHO): http://www.who-umc.org/
- European Medicines Agency: http://www.ema.europa.eu/ema/
- DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2010-11-08
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2010-11-08
- Licence: This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/.
- Custodian Organisation: openEHR Foundation
- References: Adverse Reaction, draft archetype, Australian Digital Health Agency [Internet]. NEHTA Clinical Knowledge Manager. Authored: 08 Nov 2010. No longer available. Allergy and Intolerance Domain Analysis Model, Release 1, HL7 [Internet]. Publication pending, expected August 2014; Available at http://wiki.hl7.org/images/1/1b/Allergy_and_Intolerance_INFORM_2013_MAY.pdf (accessed 06 July 2014). Allergy, clinical element model, GE/Intermountain Healthcare. Clinical Element Model Search. Available at: http://intermountainhealthcare.org/cem/Pages/Detail.aspx?NCID=520861661&k=allergy (accessed Jan 16, 2012). Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. PubMed PMID: 11072960. HL7 FHIR Resource - AllergyIntolerance R1.2.0 STU3 draft [Internet]. Health Level Seven International; [accessed 2020 Jan 17]. Available from: http://hl7.org/fhir/2016Jan/allergyintolerance.html. Horsfield P, Sibeko S. Representation in Electronic Patient Records of Allergic Reactions, Adverse Reactions, and Intolerance of Pharmaceutical Products [Internet]. London, UK: National Health Service; 2006 Sep 07 [cited 2011 Jun 21]; Available at https://svn.connectingforhealth.nhs.uk/svn/public/nhscontentmodels/TRUNK/ref/NPfIT/Allergy_ADR_Intolerance%20v%201.2Final.doc. Long R, Bentley S. SCG Guidance on the Representation of Allergies and Adverse Reaction Information Using NHS Message Templates [Internet]. London, UK: National Health Service; 2008 Apr 30 [cited 2011 Jun 21]; Available at http://www.connectingforhealth.nhs.uk/systemsandservices/data/scg/scg0001.pdf. Microsoft. Design Guidance: Displaying Adverse Drug Reaction Risks [Internet]. 2009 January 28 [cited 2011 Jun 21]; Available at www.mscui.net/DesignGuide/DisplayingAllergies.aspx. Microsoft. Design Guidance: Recording Adverse Drug Reaction Risks [Internet]. 2009 March 27 [cited 2011 Jun 21]; Available at www.mscui.net/DesignGuide/RecordingAllergies.aspx. Mosby. Mosby's Pocket Dictionary of Medicine, Nursing and Health Professions. 6th Edition. USA: Mosby Elsevier; 2010 National E-Health Transition Authority. Adverse Reactions (Data Specifications) Version 1.1 [Internet]. Sydney, Australia: NEHTA; 2008 Feb 29 [cited 2011 Jun 21]; Available at http://www.nehta.gov.au/component/docman/doc_download/453-adverse-reaction-data-specification-v11. Riedl MA, Casillas AM. Adverse drug reactions: types and treatment options. Am Fam Physician. 2003 Nov 1;68(9):1781-90. Review. PubMed PMID: 14620598. Royal Australian College of General Practitioners. Fact Sheet: Allergies & Adverse Reactions (Draft). 2010. Thien FC. Drug hypersensitivity. Med J Aust. 2006 Sep 18;185(6):333-8. Review. PubMed PMID: 16999678. - Uppsala Monitoring Centre (WHO): http://www.who-umc.org/ - European Medicines Agency: http://www.ema.europa.eu/ema/ - DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf
- Current Contact: Heather Leslie, Atomica Informatics, Australia
- Original Namespace: org.openehr
- Original Publisher: openEHR Foundation
- Custodian Namespace: org.openehr
- MD5-CAM-1.0.1: C8015C0CAA2F425EF80DB7A794F19DB9
- Build Uid: e7a627fa-7d7c-40b4-8ba6-061d631f6a67
- Revision: 2.0.1
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. It is strongly recommended that the 'Substance' is 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.
Choice of:
Coded Text- Active [The subject is currently experiencing, or is at risk of, a reaction to the identified substance.]
- Inactive [The subject is no longer at risk of a reaction to the identified substance.]
Text
Decision support would typically raise alerts for 'Unconfirmed' and '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. 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.
Choice of:
- Coded Text
- Unconfirmed [The propensity for a reaction to the identified 'Substance' has not been objectively verified.]
- Confirmed [The propensity for a reaction to the identified 'Substance' has been objectively verified. This may include clinical evidence by testing, re-challenge or observation.]
- Refuted [A propensity for a reaction to the identified 'Substance' has been disputed or disproven with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation.]
- Text
This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.
Choice of:
- Coded Text
- 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.]
- Text
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.
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
For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
Choice of:
Date/Time
Duration
Interval of Date/Time
Interval of Duration
- Text
For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
Choice of:
- Date/Time
- Duration
- Text
- Interval of Date/Time
- Interval of Duration
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.
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
Include:
openEHR-EHR-CLUSTER.adverse_
openEHR-EHR-CLUSTER.adverse_
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.
For example, presenting symptoms, examination findings, diagnosis etc.
For example: local information requirements or additional metadata to align with FHIR equivalents.
Include:
All not explicitly excluded archetypes
Grethe Almenning, Bergen kommune, Norway
Magnus Alsaker, Helsedirektoratet, Norway
Torunn Apelseth, Helse Bergen, Norway
Vebjørn Arntzen, Oslo University Hospital, Norway
Bent Asgeir Larsen, Helsedirektoratet, Norway
Koray Atalag, University of Auckland, New Zealand
Elaine Ayres, US National Institutes of Health, United States
Russell B Leftwich MD, United States (openEHR Editor)
Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor)
John Bennett, NEHTA, Australia
Steve Bentley, Allscripts, United Kingdom
Sharmila Biswas, Dr Sharmila Biswas GP, Australia
Lars Bitsch-Larsen, Haukeland University hospital, Norway
Terje Bless, Helse Nord FIKS, Norway
Laila Bruun, Oslo universitetssykehus HF, Norway
Claire Chalopin, ICCAS, University of Leipzig, Germany
Rong Chen, Cambio Healthcare Systems, Sweden
Stephen Chu, Queensland Health, Australia
Matthew Cordell, NEHTA, Australia
Howard Edidin, Edidin Group, Inc, United States
Brett Esler, Oridashi, Australia
David Evans, Queensland Health, Australia
Jerry Fahrni, Kaweah Delta Health Care District, United States
Shahla Foozonkhah, Iran ministry of health and education, Iran
Einar Fosse, National Centre for Integrated Care and Telemedicine, Norway
Joanne Foster, School of Nursing & Midwifery, QLD University of Technology & Nursing Informatics Australia, Australia
Sebastian Garde, Ocean Informatics, Germany
Jacquie Garton-Smith, Royal Perth Hospital and DoHWA, Australia
Sarah Gaunt, NEHTA, Australia
Andrew Goodchild, NEHTA, Australia
Heather Grain, Llewelyn Grain Informatics, Australia
Trina Gregory, cpc, Australia
Grahame Grieve, Health Intersections, Australia (Editor)
Robert Hausam, Hausam Consulting LLC, United States
Sam Heard, Ocean Informatics, Australia
Kristian Heldal, Telemark Hospital Trust, Norway
Anca Heyd, DIPS ASA, Norway
Hilde Hollås, Norway
Roar Holm, Helse Vest IKT A/S, Norway
Andrew James, University of Toronto, Canada
Julie James, Blue Wave Informatics LLP, United Kingdom
Tom Jarl Jakobsen, Helse Bergen, Norway
Ivor Jones, Queensalnd Helath, Australia
Lars Jostein Silihagen, Sopra Steria / Sykehuspartner / Sykehuset Innlandet, Norway
Silje Kaada, Helse-Bergen, Avdeling for immunologi og transfusjonsmedisin, Norway
Konstantinos Kalliamvakos, Cambio Healthcare Systems, Sweden
Lars Karlsen, DIPS ASA, Norway
Lars Morgan Karlsen, DIPS ASA, Norway
Goran Karlstrom, County Of Värmland, Sweden
Mary Kelaher, NEHTA, Australia
Diane Kirkham, NEHTA, Australia
Shinji Kobayashi, NPO openEHR Japan, 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
Chris Mitchell, RACGP, Australia
Stewart Morrison, NEHTA, Australia
Jörg Niggemann, Compugroup, Germany
Bjørn Næss, DIPS ASA, Norway
Tom Oniki, Intermountain Healthcare, United States
Chris Pearce, Melbourne East GP Network, Australia
Rune Pedersen, Universitetssykehuset i Nord Norge, Norway
General Practice Computing Group, Australia
Camilla Preeston, Royal Australian College of General Practitioners, Australia
Margaret Prichard, NEHTA, Australia
Jodie Pycroft, Adelaide Northern Division of General Practice Ltd, Australia
Cathy Richardson, NEHTA, Australia
Robyn Richards, NEHTA - Clinical Terminology, Australia
Tanja Riise, Nasjonal IKT HF, Norway
Jussara Rotzsch, Hospital Alemão Oswaldo Cruz, Brazil
Stefan Sauermann, University of Applied Sciences Technikum Wien, Austria
Thomas Schopf, University Hospital of North-Norway, Norway
Thilo Schuler, Australia
Jason Scott, Plymouth Hospitals NHS Trust, United Kingdom
Peter Scott, Medical Objects, Australia
Elena Shabanova, UMMSSOft, Russian Federation
Anoop Shah, University College London, United Kingdom
Elizabeth Stanick, Hobart Anaesthetic Group, Australia
Laila Storesund, Haraldsplass diakonale sykehus, Norway
Norwegian Review Summary, Norwegian Public Hospitals, Norway
Line Sæle, Nasjonal IKT HF, Norway
Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore
John Taylor, NEHTA, Australia
Micaela Thierley, Helse Bergen, Norway
Gordon Tomes, Australian Institute of Health and Welfare, Australia
John Tore Valand, Haukeland Universitetssjukehus, Norway (Nasjonal IKT redaktør)
Richard Townley-O'Neill, Australian Digital Health Agency, Australia
Ines Vaz, UFN, Portugal
Nils Widnes, Helse-Bergen, Norway
Andrew Yap, Australia
Kylie Young, The Royal Australian College of General Practitioners, Australia
Lin Zhang, Taikang Insurance Group, China
- German: Natalia Strauch, Darin Leonhardt, Severin Kohler, Medizinische Hochschule Hannover, PLRI, Strauch.Natalia@mh-hannover.de, leonhardt.darin@mh-hannover.de, kohlerseverin@posteo.de
- Swedish: Emma Malm, Rikard Lovstrom, Karolinska Universitetssjukhuset, Karolinska University Hospital, emma.malm@cambio.se, rikard.lovstrom@gmail.com
- Norwegian Bokmål: Silje Ljosland Bakke, Helse Vest IKT AS, silje.ljosland.bakke@helse-vest-ikt.no
- Portuguese (Brazil): Osmeire Chamelette Sanzovo, Hospital Sírio Libanês, osmeire.acsanzovo@hsl.org.br
- Greek: Christos Antoniadis, SigmaSoft, c.antoniadis@sigmasoft.gr
- Catalan: Manuel José Zafra Doménech, TRADCREA, S.L., mzafra@tradcrea.com
Other Contributors: Servei Català de la Salut - Spanish (Spain): Laura Moral Lopez, Sistema de Salut de Catalunya, lauramoral@catsalut.cat
Other Contributors: Tradcrea