| ARCHETYPE ID | openEHR-EHR-EVALUATION.adverse_reaction_nehta.v1 |
|---|---|
| Concept | Adverse Reaction (NEHTA) |
| Description | A harmful or undesirable 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. |
| Use | Use to record all information about adverse reactions (including allergic 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:
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. 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:
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| 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 used for recording alerts. |
| Purpose | 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. To record information about any adverse reaction, including:
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| References | 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 |
| Authors | Author name: Heather Leslie Organisation: Ocean Informatics Email: heather.leslie@oceaninformatics.com Date originally authored: 8-Nov-2010 |
| Other Details Language | Author name: Heather Leslie Organisation: Ocean Informatics Email: heather.leslie@oceaninformatics.com Date originally authored: 8-Nov-2010 |
| Other Details (Language Independent) |
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| Keywords | reaction, allergy, allergic, adverse, event, effect, sensitivity, intolerance, hypersensitivity, side effect, toxicity, interaction, drug, food, medication, agent, substance, immune, non-immune, chemical |
| Lifecycle | OrganisationDraft |
| Language used | en |
| Citeable Identifier | 1013.1.1541 |
| protocol | |
| Reaction Reported? | Reaction Reported?: Was the Adverse Reaction reported to a regulatory body? |
| Report Comment | Report Comment: Additional narrative about the Adverse Reaction Report, including the reason for non-reporting, if required. |
| Adverse Reaction Report | Adverse Reaction Report: Link to an Adverse Reaction Report sent to a regulatory body. |
| Supporting Clinical Record Information | Supporting Clinical Record Information: Link to further information about the presentation and findings that exist elsewhere in the health record. For example, presenting symptoms, examination findings, diagnosis etc. |
| data | |
| Substance/Agent | Substance/Agent: Identification of a substance, agent, or a class of substance, that is considered to be responsible for the Adverse Reaction. Coding of the Substance/Agent with a terminology is desirable, where possible. |
| Absolute Contraindication? | Absolute Contraindication?: Is administration of this Substance/Agent absolutely contraindicated in this individual? 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. Allowed values: {true} |
| Overall Comment | Overall Comment: Additional narrative about the Adverse Reaction not captured in other fields, including reason for flagging an absolute contraindication; and instructions related to future exposure or administration of the Substance/Agent. |
| Reaction Event | Reaction Event: Details about each Adverse Reaction Event. |
| Specific Substance/Agent | Specific Substance/Agent: Specific identification of the actual Substance/Agent considered to be responsible for the Adverse Reaction event. 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. |
| Manifestation | Manifestation: Clinical manifestation of the Adverse Reaction expressed as a single word, phrase or brief description, e.g. nausea or rash. Coding with a terminology is preferred, where possible. The values entered here may be used to display on an application screen as part a list of adverse reactions, as recommended in the NHS CUI guidelines. |
| Reaction Type | Reaction Type: The type of Adverse Reaction as determined by the clinician. 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. |
| Certainty | Certainty: Degree of certainty, as assessed by a clinician, that the specific Substance/Agent was the cause of the Adverse Reaction.
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| Reaction Description | Reaction Description: Narrative description of the Adverse Reaction. |
| Onset of Reaction | Onset of Reaction: Record of the date and/or time of the onset of the Adverse Reaction. |
| Duration of Reaction | Duration of Reaction: The amount of time that the Adverse Reaction was present. |
| Additional Reaction Detail | Additional Reaction Detail: Additional detail about the Adverse Reaction, including anatomical location. Include: openEHR-EHR-CLUSTER.anatomical_ |
| Exposure Description | Exposure Description: Description about exposure to the Substance/Agent. |
| Earliest Exposure | Earliest Exposure: Record of the date and/or time of the earliest or initial exposure to the Substance/Agent. |
| Duration of Exposure | Duration of Exposure: The amount of time of exposure to the Substance/Agent. |
| Additional Exposure Detail | Additional Exposure Detail: Additional detail about exposure/s for this Adverse Reactionevent, including structured medication amount information. Include: openEHR-EHR-CLUSTER.amount.v1 and specialisations or openEHR-EHR-CLUSTER.medication_ openEHR-EHR-CLUSTER.timing.v1 and specialisations |
| Clinical Management Description | Clinical Management Description: Description about the clinical management provided. |
| Multimedia | Multimedia: Inclusion of any multimedia file to support the recording of the Adverse Reaction event. For example, a photo of a rash or presentation with angioneurotic oedema. |
| Reporting Details | Reporting Details: Further details required for reporting to regulatory bodies. Include: All not explicitly excluded archetypes |
| Reaction Comment | Reaction Comment: Additional narrative about the Adverse Reaction event not captured in other fields. |
| Other contributors | 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 |
| Translators |