| TEMPLATE ID | *CL 7.4 Adverse Reaction List |
|---|---|
| Concept | *CL 7.4 Adverse Reaction List |
| Description | Not Specified |
| Purpose | Not Specified |
| References | |
| Other Details (Language Independent) |
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| Language used | en |
| Citeable Identifier | 1013.26.806 |
| Root archetype id | openEHR-EHR-COMPOSITION.adverse_reaction_list.v1 |
| Adverse reaction list | Adverse reaction list: A persistent and managed list of adverse reactions experienced by the subject that may influence clinical decision-making and care provision. |
| Adverse reaction risk | Adverse reaction risk: Risk of harmful or undesirable physiological response which is unique to an individual and associated with exposure to a substance. 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. Optional[{source=openEHR,FHIR}] |
| Data | |
| Substance | Substance: Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event. Both an individual substance and a substance class are valid entries in 'Substance'. 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. Optional[{source=openEHR,FHIR,DAM}] |
| Status | Status: Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction. 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. Optional[{source=FHIR, DAM}]
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| Onset of last reaction | Onset of last reaction: The date and/or time of the onset of the last known occurrence of a reaction event. This date may be be a duplicate of the most recent 'Onset of reaction' date. Where a textual representation of the date of last occurrence is required e.g 'In Childhood, '10 years ago' the Comment element should be used. Optional[{source=IMH}] |
| Comment | Comment: Additional narrative about the propensity for the adverse reaction, not captured in other fields. 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. Optional[{source=openEHR}] |
| Reaction event | Reaction event: Details about each adverse reaction event linked to exposure to the identified 'Substance'. Optional[{source=openEHR,FHIR,DAM}] |
| Manifestation | Manifestation: Clinical symptoms and/or signs that are observed or associated with the adverse reaction. 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. Optional[{source=FHIR, openEHR,DAM}] |
| Protocol | |
| Last updated | Last updated: Date when the propensity or the reaction event was updated. Note: maps to recordedDate in FHIR. Optional[{source=openEHR, FHIR, DAM}] |
| Supporting clinical record information | Supporting clinical record information: Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports. For example, presenting symptoms, examination findings, diagnosis etc. [Note: FHIR,DAM: Maps to Sensitivity Test.] Optional[{source=FHIR, openEHR, DAM}] |
| Reaction reported? | Reaction reported?: Has the adverse reaction ever been reported to a regulatory body? Optional[{source=openEHR}] |
| Report summary | Report summary: Structured details about reports that have been forwarded to regulatory bodies. |
| Date of report | Date of report: Date that the report was sent to the regulatory authority. |
| Report comment | Report comment: Narrative about the adverse reaction report or reporting process. For example, the reason for non-reporting. Optional[{source=openEHR}] |
| Adverse reaction report | Adverse reaction report: Link to an adverse reaction Report sent to a regulatory body. Optional[{source=openEHR}] |
| Exclusion of an Adverse Reaction | Exclusion of an Adverse Reaction: Positive statement/s about adverse reactions that need to be recorded as clinically excluded from the health record at a specific point in time. |
| Data | |
| Exclusion Statement | Exclusion Statement: A statement about exclusion of known adverse reactions in the health record. For example: "No known adverse reactions"; "No known adverse reaction to" (penicillin).
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| Protocol | |
| Date Last Updated | Date Last Updated: The date at which the exclusion was last clinically asserted, affirmed or confirmed. |
| Absence of Information | Absence of Information: Statement that specified health information is not available for inclusion in the health record or extract at the time of recording. |
| Data | |
| Absence statement | Absence statement: Positive statement that no information is available. For example: "No information available about adverse reactions"; No information available about problems or diagnoses"; "No information available about previous procedures performed"; or "No information available about medications used".
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| Protocol | |
| Last updated | Last updated: The date at which the absence was last updated. |