TEMPLATE Adverse reaction risk item R1 (Adverse reaction risk item R1)

TEMPLATE IDAdverse reaction risk item R1
ConceptAdverse reaction risk item R1
DescriptionNot Specified
PurposeNot Specified
References
Authorsname: Heather Leslie; organisation: Atomica Informatics; email: heather.leslie@atomicainformatics.com; date: 2020-07-22
Other Details Languagename: Heather Leslie; organisation: Atomica Informatics; email: heather.leslie@atomicainformatics.com; date: 2020-07-22
OtherDetails Language Independent{PARENT:MD5-CAM-1.0.1=879E7E42E431DB7AA87C85144FD6B657, original_language=ISO_639-1::en, MD5-CAM-1.0.1=427a5a227203b48078e0b52732280692}
Language useden
Citeable Identifier1013.26.359
AllOperationalTemplate [rootArchetypeId=openEHR-EHR-EVALUATION.adverse_reaction_risk.v1, otherContributors=null, tshis=[ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1], code=at0000, itemType=EVALUATION, level=0, text=Adverse reaction risk, description=Risk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance., comment=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., uncommonOntologyItems={source=openEHR,FHIR}, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=EVALUATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001], code=at0001, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=1, text=Data, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Substance, description=Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event., comment=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. If the value in 'Substance' is an individual substance, it may be duplicated in 'Specific substance'. It is strongly recommended that both 'Substance' and 'Specific substance' be 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., uncommonOntologyItems={source=openEHR,FHIR,DAM}, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001]/items[at0063], code=at0063, itemType=ELEMENT, level=2, text=Verification status, description=Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction., comment=Decision support would typically raise alerts for 'Suspected', 'Likely', '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. 'Resolved' may be used variably across systems, depending on clinical use and context - there appears to be differing opinion whether this should still be used to raise potential alerts or to display in an Adverse Reaction List. 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., uncommonOntologyItems={source=FHIR, DAM}, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=
  •  Coded Text
    • Suspected  [A low level of clinical certainty about the propensity of a reaction to the identified 'Substance'.]
    • Likely  [A reasonable level of certainty about the propensity for a reaction to the identified 'Substance'.]
    • Confirmed  [A high level of certainty about the propensity for a reaction to the identified 'Substance', which may include clinical evidence by testing or re-challenge.]
    • Resolved  [The previously known reaction to the identified 'Substance' has been clinically reassessed and considered no longer to be an active risk.]
    • Refuted  [The propensity for a reaction to the identified 'Substance' has been clinically reassessed or has been disproved with a high level of clinical certainty by re-exposure or deliberate challenge.]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001]/items[at0101], code=at0101, itemType=ELEMENT, level=2, text=Criticality, description=An indication of the potential for critical system organ damage or life threatening consequence., comment=This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value., uncommonOntologyItems={source=DAM, openEHR}, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • 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.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001]/items[at0006], code=at0006, itemType=ELEMENT, level=2, text=Comment, description=Additional narrative about the propensity for the adverse reaction, not captured in other fields., comment=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., uncommonOntologyItems={source=openEHR}, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001]/items[at0009], code=at0009, itemType=CLUSTER, level=2, text=Reaction event, description=Details about each adverse reaction event linked to exposure to the identified 'Substance'., comment=null, uncommonOntologyItems={source=openEHR,FHIR,DAM}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/data[at0001]/items[at0009]/items[at0011], code=at0011, itemType=ELEMENT, level=3, text=Manifestation, description=Clinical symptoms and/or signs that are observed or associated with the adverse reaction., comment=Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction'may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions, as recommended in the UK NHS CUI guidelines. Terminologies commonly used include, but are not limited to, SNOMED-CT or ICD10., uncommonOntologyItems={source=FHIR, openEHR,DAM}, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-EVALUATION.adverse_reaction_risk.v1]/protocol[at0042], code=at0042, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=1, text=Protocol, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null]], templateType=normal]