ARCHETYPE Adverse reaction monitoring (openEHR-EHR-OBSERVATION.adverse_reaction_monitoring.v1)

Type: openEHR ARCHETYPE
Purpose: To record information about the outcome of monitoring for adverse reactions, during or after the administration of a substance.
Use: Use to record information about the outcome of monitoring for adverse reactions, during or after the administration of a substance. This can include both immune mediated or non-immune mediated reactions. This archetype has been designed to capture whether a reaction occurred after administration of an agent to an individual. This includes but is not limited to montoring during or after vaccinations, chemotherapy, or blood transfusions. It includes details about any mitigation efforts in the context of administration, such as corticosteroid cover, or ICU admission. Details about a reaction that occurred can be recorded using the CLUSTER.reaction_event archetype in the 'Reaction event' SLOT.
Misuse: Not to be used to record a propensity of the individual to have adverse reactions to specific substances or groups or classes of substances. Use the EVALUATION.adverse_reaction_risk archetype for this purpose. Not to be used to record the result of the administration of a substance with the intention of provoking a reaction, for example Mantoux or skin prick tests. Use other appropriate OBSERVATION archetypes for this purpose. Not to be used to record details about an adverse reaction event. Use the CLUSTER.adverse_reaction_event archetype for this purpose.

Available formats: ADL XML

ARCHETYPE IDopenEHR-EHR-OBSERVATION.adverse_reaction_monitoring.v1
ConceptAdverse reaction monitoring
DescriptionInformation about the outcome of monitoring for adverse reactions, during or after the administration of a substance.
UseUse to record information about the outcome of monitoring for adverse reactions, during or after the administration of a substance. This can include both immune mediated or non-immune mediated reactions. This archetype has been designed to capture whether a reaction occurred after administration of an agent to an individual. This includes but is not limited to montoring during or after vaccinations, chemotherapy, or blood transfusions. It includes details about any mitigation efforts in the context of administration, such as corticosteroid cover, or ICU admission. Details about a reaction that occurred can be recorded using the CLUSTER.reaction_event archetype in the 'Reaction event' SLOT.
MisuseNot to be used to record a propensity of the individual to have adverse reactions to specific substances or groups or classes of substances. Use the EVALUATION.adverse_reaction_risk archetype for this purpose. Not to be used to record the result of the administration of a substance with the intention of provoking a reaction, for example Mantoux or skin prick tests. Use other appropriate OBSERVATION archetypes for this purpose. Not to be used to record details about an adverse reaction event. Use the CLUSTER.adverse_reaction_event archetype for this purpose.
PurposeTo record information about the outcome of monitoring for adverse reactions, during or after the administration of a substance.
References
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2021-08-04
Other Details LanguageAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2021-08-04
Other Details (Language Independent)
  • 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
  • Original Namespace: org.openehr
  • Original Publisher: openEHR Foundation
  • Custodian Namespace: org.openehr
  • MD5-CAM-1.0.1: B62FAE424720790C4ECEAF83A0C90E4B
  • Build Uid: 0ac4a842-2bfc-4875-b2dd-13c469ecd501
  • Revision: 1.0.2
Keywords
Lifecyclepublished
UID579713aa-f7e7-4853-a1b3-6d47eb3abc20
Language useden
Citeable Identifier1246.145.2296
Revision Number1.0.2
Archetype Concept CommentSubstances include, but are not limited to: a therapeutic substance administered correctly at an appropriate dosage for the individual; food; material derived from plants or animals; or venom from insect stings.
events
Monitoring intervalMonitoring interval: The interval of time from onset of monitoring to end of monitoring.
state
Mitigation factorMitigation factor: Description of actions undertaken prior to or during substance administration to prevent an anticipated reaction or reduce an actual reaction.
For example, that the substance was administered in ICU, at half of normal administration rate, and under cover of high dose corticosteroids.
protocol
MethodMethod: The method of how the presence or absence of an adverse reaction was assessed.
For example: clinical observation, spirometry, or a laboratory test.
ExtensionExtension: Additional information required to extend the model with local content or to align with other reference models or formalisms.
For example: local information requirements; or additional metadata to align with FHIR.
Slot archetypes
This slot is open to all Cluster archetypes.
data
PurposePurpose: The reason why the reaction monitoring was carried out.
For example: vaccination, transfusion, chemotherapy, allergy desensitisation. Coding of the purpose with a terminology is preferred, where possible.
SubstanceSubstance: Identification of a substance administered to the individual.
Substances include, but are not limited to: a therapeutic substance administered correctly at an appropriate dosage for the individual; food; material derived from plants or animals; or venom from insect stings. Coding of the substance with a terminology is preferred, where possible.
Reaction?Reaction?: Was there a reaction to the agent administered?
The 'text' data type can be used where a different value set, for example a local terminology, is needed.
Choice of:
  •  Coded Text
    • Yes [The individual reacted.]
    • No [The individual did not react.]
    • Indeterminate [It cannot be determined whether the individual reacted or not.]
  •  Text
Substance detailsSubstance details: Structured details about the substance administered to the individual.
Slot archetypes
CLUSTER.medication.v2 and specialisations

This slot is also open to other Cluster archetypes.
Reaction eventReaction event: Details about the adverse reaction event.
The onset time, duration, severity and certainty of the reaction can be recorded using the 'Adverse reaction event' archetype in this SLOT. This SLOT deliberately allows only one instance of  the Adverse event reaction archetype to describe the details of each monitoring event.
Slot archetypes
  • CLUSTER.adverse_reaction_event.v0 and specialisations
  • CLUSTER.adverse_reaction_event.v1 and specialisations

This slot is also open to other Cluster archetypes.
CommentComment: Additional narrative about the monitoring, not captured in other fields.
Other contributorsMarit Alice Venheim, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Vebjørn Arntzen, Oslo universitetssykehus HF, Norway (Nasjonal IKT redaktør)
Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor)
Ivar Berge, Oslo Universitetssykehus, Norway
SB Bhattacharyya, Bhattacharyyas Clinical Records Research & Informatics LLP, India
Gunn Elin Blakkisrud, DIPS ASA, Norway
Fabian Franzeck, University Hospital Basel, Switzerland
Ana Garcia, cONSULTANT, Portugal
Heather Grain, Llewelyn Grain Informatics, Australia
Evelyn Hovenga, EJSH Consulting, Australia
Mikkel Johan Gaup Grønmo, Regional forvaltning EPJ, Helse Nord, Norway (Nasjonal IKT redaktør)
Mika Kiviaho, Tietoevry, Finland
Kanika Kuwelker, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Jörgen Kuylenstierna, eWeave AB, Sweden
Liv Laugen, Oslo universitetssykehus, Norway (Nasjonal IKT redaktør)
Heather Leslie, Atomica Informatics, Australia (openEHR Editor)
Hanne Marte Bårholm, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Svenne Naumann, Finnmarkssykehuset, Norway
Mikael Nyström, Cambio Healthcare Systems AB, Sweden
Marte Rime Bø, Direktoratet for e-helse, Norway
Terje Sagmyr, Helse Vest IKT, Norway
Natalia Strauch, Medizinische Hochschule Hannover, Germany
Norwegian Review Summary, Norwegian Public Hospitals, Norway
Anders Thurin, VGR, Sweden
John Tore Valand, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Translators
  • German: Maximilian Meixner, Severin Kohler, Berlin Institute of Health - BIH @ Charité, maximilian.meixner@bih-charite.de, kohlerseverin@posteo.de
  • Norwegian Bokmal: Silje Ljosland Bakke, Helse Vest IKT AS, silje.ljosland.bakke@helse-vest-ikt.no