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

Use 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.

To 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.

• 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

• at0054::fatal [Likely to result in death if re-exposed.]
• at0055::high [Likely to result in reactions that will need to be treated if re-exposed.]
• at0056::medium [Likely to result in reactions that will inconvenience the subject]
• at0057::low [Not likely to result in any inconveniences for the subject]

• at0059::allergy [Allergic Reaction]
• at0060::intolerance [Non-Allergic Reaction]
• at0061::unknown [Unknown type]

• at0064::suspected [A suspected sensitivity to a substance]
• at0065::confirmed [The sensitivity has been confirmed and is active]
• at0066::refuted [The sensitivity has been shown to never have existed]
• at0067::resolved [The sensitivity used to exist but no longer does]

• at0090::severe [Severe complications arose due to the reaction]
• at0091::serious [Serious inconvenience to the subject]
• at0092::moderate [Moderate inconvenience to the subject]
• at0093::minor [Minor inconvenience to the subject]

• at0095::Unlikely [*]
• at0022::Suspected [Possibly the causative agent.]
• at0023::Probable [Likely to be the causative agent, but not confirmed by testing or rechallenge.]
• at0024::Confirmed [Confirmed as the causative agent, by testing or rechallenge.]

• unknown