Modellbiblioteket openEHR Fork
Name
Adverse reaction risk
Description
Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, 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.
Keywords
reaction
allergy
allergic
adverse
event
effect
sensitivity
intolerance
hypersensitivity
side effect
toxicity
drug
food
agent
substance
immune
non-immune
chemical
anaphylaxis
allergen
medication
supplement
medicine
natural remedies
immunological
non-immunological
risk
Purpose
To record the clinical assessment of the propensity for an individual to experience an adverse reaction if exposed, or re-exposed, to a specified substance or class of substances.
Use
Use to record a clinical assessment of a propensity for an adverse reaction upon future exposure to a specified substance or class of substances including, but not limited to, incipients and excipients in medicinal preparations, biological products, metal salts, and organic chemical compounds.
This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening:
- immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or
- non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities.
In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient.
Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT.
Identification of the severity of the manifestation of the reaction, recorded in the CLUSTER.adverse_reaction_event archetype, can inform the 'Criticality' of the adverse reaction risk. For example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures.
This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype.
Use to record information about the positive presence of the risk of an adverse reaction:
- to support the direct clinical care of an individual;
- as part of a managed adverse reaction or allergy/intolerance list;
- to support the exchange of information about the propensity and events related to adverse reactions;
- to inform adverse reaction reporting; and
- to assist with computerised knowledge-based activities such as clinical decision support and alerts.
The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing.
This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening:
- immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or
- non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities.
In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient.
Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT.
Identification of the severity of the manifestation of the reaction, recorded in the CLUSTER.adverse_reaction_event archetype, can inform the 'Criticality' of the adverse reaction risk. For example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures.
This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype.
Use to record information about the positive presence of the risk of an adverse reaction:
- to support the direct clinical care of an individual;
- as part of a managed adverse reaction or allergy/intolerance list;
- to support the exchange of information about the propensity and events related to adverse reactions;
- to inform adverse reaction reporting; and
- to assist with computerised knowledge-based activities such as clinical decision support and alerts.
The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing.
Misuse
Not to be used for recording physiological reactions to physical agents, such as heat, cold, sunlight, vibration, exercise activity, by infectious agents or food contaminants. Use a specific archetype for EVALUATION.problem/diagnosis or CLUSTER.symptom/sign for this purpose.
Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use, incorrect dosage or maladministration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for the purpose.
Not to be used to record an adverse reaction where the substance is unknown. Use EVALUATION.problem_diagnosis or CLUSTER.symptom_sign to record as part of the health record until a possible substance is identified.
Not to be used to record reactions to transfusions of blood products. Use a specific archetype for this purpose.
Not to be used for recording 'alerts'. Use EVALUATION.precaution, EVALUATION.contraindication or related archetypes for this purpose.
Not to be used for recording failed therapy.
Not to be used for the explicit recording of an absence (or negative presence) of a reaction to 'any substances' or to identified substances, for example ‘No known allergies or adverse reactions’ or ‘No known allergies to Penicillin’. Use the EVALUATION.exclusion_global or EVALUATION.exclusion_specific archetypes to express a positive statement of adverse reaction exclusion.
Not to be used for the explicit recording that no information was able to be obtained about the adverse reaction status of a patient. Use the EVALUATION.absence archetype to record that a positive statement that information was not 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, incorrect dosage or maladministration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for the purpose.
Not to be used to record an adverse reaction where the substance is unknown. Use EVALUATION.problem_diagnosis or CLUSTER.symptom_sign to record as part of the health record until a possible substance is identified.
Not to be used to record reactions to transfusions of blood products. Use a specific archetype for this purpose.
Not to be used for recording 'alerts'. Use EVALUATION.precaution, EVALUATION.contraindication or related archetypes for this purpose.
Not to be used for recording failed therapy.
Not to be used for the explicit recording of an absence (or negative presence) of a reaction to 'any substances' or to identified substances, for example ‘No known allergies or adverse reactions’ or ‘No known allergies to Penicillin’. Use the EVALUATION.exclusion_global or EVALUATION.exclusion_specific archetypes to express a positive statement of adverse reaction exclusion.
Not to be used for the explicit recording that no information was able to be obtained about the adverse reaction status of a patient. Use the EVALUATION.absence archetype to record that a positive statement that information was not able to be obtained, for example, if a non-cooperative patient refuses to answer questions.
References
Adverse Reaction, draft archetype, Australian Digital Health Agency [Internet]. NEHTA Clinical Knowledge Manager. Authored: 08 Nov 2010. No longer available.
Allergy and Intolerance Domain Analysis Model, Release 1, HL7 [Internet]. Publication pending, expected August 2014; Available at http://wiki.hl7.org/images/1/1b/Allergy_and_Intolerance_INFORM_2013_MAY.pdf (accessed 06 July 2014).
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.
HL7 FHIR Resource - AllergyIntolerance R1.2.0 STU3 draft [Internet]. Health Level Seven International; [accessed 2020 Jan 17]. Available from: http://hl7.org/fhir/2016Jan/allergyintolerance.html.
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.
- Uppsala Monitoring Centre (WHO): http://www.who-umc.org/
- European Medicines Agency: http://www.ema.europa.eu/ema/
- DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf
Archetype Id
openEHR-EHR-EVALUATION.adverse_reaction_risk.v2
Copyright
© Australian Digital Health Agency, openEHR Foundation, HL7 International, Nasjonal IKT
Licencing
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/.
Original Author
Heather Leslie
Atomica Informatics
Atomica Informatics
Date Originally Authored
To record the clinical assessment of the propensity for an individual to experience an adverse reaction if exposed, or re-exposed, to a specified substance or class of substances.
| Language | Details |
|---|---|
| German |
Natalia Strauch, Darin Leonhardt
Medizinische Hochschule Hannover, PLRI
|
| Swedish |
Emma Malm
Karolinska Universitetssjukhuset
|
| Norwegian Bokmal |
Silje Ljosland Bakke
Helse Vest IKT AS
|
| Portuguese (Brazil) |
Osmeire Chamelette Sanzovo
Hospital Sírio Libanês
|
| Name | Card | Type | Description |
|---|---|---|---|
|
Substance
|
1..1 | DV_TEXT |
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. It is strongly recommended that the 'Substance' is 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.
|
|
Active/inactive status
|
0..1 |
CHOICE OF
DV_CODED_TEXT
DV_TEXT
|
Status about whether the adverse reaction risk statement is active or inactive.
Constraint for DV_CODED_TEXT
|
|
Verification status
|
0..1 |
CHOICE OF
DV_CODED_TEXT
DV_TEXT
|
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 'Unconfirmed' and '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. 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.
Constraint for DV_CODED_TEXT
|
|
Criticality
|
0..1 |
CHOICE OF
DV_CODED_TEXT
DV_TEXT
|
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.
Constraint for DV_CODED_TEXT
|
|
Category
|
0..1 |
CHOICE OF
DV_CODED_TEXT
DV_TEXT
|
Category of the identified 'Substance'.
Comment
This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.
Constraint for DV_CODED_TEXT
|
|
Onset of last reaction
|
0..1 |
CHOICE OF
DV_DATE_TIME
DV_DURATION
DV_INTERVAL<DV_DATE_TIME>
DV_INTERVAL<DV_DURATION>
DV_TEXT
|
The date and/or time of the onset of the last known occurrence of a reaction event.
Comment
For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
DV_DATE_TIME
DV_DURATION
DV_INTERVAL<DV_DATE_TIME>
DV_INTERVAL<DV_DURATION>
|
|
Onset of first reaction
|
0..1 |
CHOICE OF
DV_DATE_TIME
DV_DURATION
DV_TEXT
DV_INTERVAL<DV_DATE_TIME>
DV_INTERVAL<DV_DURATION>
|
The onset of the first known occurrence of a reaction event.
Comment
For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.
DV_DATE_TIME
DV_DURATION
DV_INTERVAL<DV_DATE_TIME>
DV_INTERVAL<DV_DURATION>
|
|
Reaction mechanism
|
0..1 |
CHOICE OF
DV_CODED_TEXT
DV_TEXT
|
Identification of the underlying physiological mechanism for the adverse reaction.
Comment
Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk.
Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity.
It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.
Constraint for DV_CODED_TEXT
|
|
Reaction event summary
|
0..* | Slot (Cluster) |
Summary details about each adverse reaction event linked to exposure to the identified 'Substance'.
Slot
Slot
|
|
Comment
|
0..1 | DV_TEXT |
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.
|
| Name | Card | Type | Description |
|---|---|---|---|
|
Last updated
|
0..1 | DV_DATE_TIME |
Date when the propensity or the reaction event was updated.
DV_DATE_TIME
|
|
Supporting clinical record information
|
0..* | DV_EHR_URI |
Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports.
Comment
For example, presenting symptoms, examination findings, diagnosis etc.
DV_EHR_URI
|
|
Extension
|
0..* | Slot (Cluster) |
Additional information required to capture local content or to align with other reference models/formalisms.
Comment
For example: local information requirements or additional metadata to align with FHIR equivalents.
Slot
Slot
|
archetype (adl_version=1.4; uid=6c812c8c-ca00-496a-97dd-6e4916bd1ccf) openEHR-EHR-EVALUATION.adverse_reaction_risk.v2 concept [at0000] -- Adverse reaction risk language original_language = <[ISO_639-1::en]> translations = < ["de"] = < language = <[ISO_639-1::de]> author = < ["name"] = <"Natalia Strauch, Darin Leonhardt"> ["organisation"] = <"Medizinische Hochschule Hannover, PLRI"> ["email"] = <"Strauch.Natalia@mh-hannover.de, leonhardt.darin@mh-hannover.de"> > > ["sv"] = < language = <[ISO_639-1::sv]> author = < ["name"] = <"Emma Malm"> ["organisation"] = <"Karolinska Universitetssjukhuset"> ["email"] = <"emma.malm@cambio.se"> > > ["nb"] = < language = <[ISO_639-1::nb]> author = < ["name"] = <"Silje Ljosland Bakke"> ["organisation"] = <"Helse Vest IKT AS"> ["email"] = <"silje.ljosland.bakke@helse-vest-ikt.no"> > > ["pt-br"] = < language = <[ISO_639-1::pt-br]> author = < ["name"] = <"Osmeire Chamelette Sanzovo"> ["organisation"] = <"Hospital Sírio Libanês"> ["email"] = <"osmeire.acsanzovo@hsl.org.br"> > > > description original_author = < ["name"] = <"Heather Leslie"> ["organisation"] = <"Atomica Informatics"> ["email"] = <"heather.leslie@atomicainformatics.com"> ["date"] = <"2010-11-08"> > details = < ["de"] = < language = <[ISO_639-1::de]> purpose = <"Zur Aufzeichnung der klinischen Beurteilung der Neigung einer Person, eine unerwünschte Reaktion zu verspüren, wenn sie einem bestimmten Stoff oder einer bestimmten Stoffklasse ausgesetzt oder erneut ausgesetzt wird."> use = <"Wird verwendet, um eine klinische Bewertung der Neigung zu unerwünschten Reaktionen bei künftiger Exposition gegenüber einem bestimmten Stoff oder einer bestimmten Stoffklasse aufzuzeichnen, einschließlich, aber nicht beschränkt auf Ausgangs- und Hilfsstoffe in Arzneimitteln, biologischen Produkten, Metallsalzen und organischen chemischen Verbindungen. Dieser Archetyp soll einen einzigen Ort in der Gesundheitsakte bieten, um die Neigung zu allen möglichen Reaktionen, von trivial bis lebensbedrohlich, zu dokumentieren: - immunvermittelt: Typ I-IV (einschließlich allergischer Reaktionen und Überempfindlichkeiten); oder - nicht immunvermittelt: einschließlich pseudoallergischer Reaktionen, Nebenwirkungen, Unverträglichkeiten und Arzneimitteltoxizitäten. In der klinischen Praxis kann es schwierig sein, zwischen immunvermittelten und nicht immunvermittelten Reaktionen zu unterscheiden. Die Identifizierung der Art der Reaktion ist kein Indikator für die Schwere oder das Risiko einer Schädigung des Patienten. Wenn eine Neigung identifiziert wird, können Informationen oder Beweise zu einem oder mehreren Reaktionsereignissen mithilfe des Archetyps CLUSTER.adverse_reaction_event im SLOT „Zusammenfassung des Reaktionsereignisses“ aufgezeichnet werden. Die Identifizierung der Schwere der Manifestation der Reaktion, die im Archetyp CLUSTER.adverse_reaction_event aufgezeichnet wird, kann Aufschluss über die „Kritikalität“ des Nebenwirkungsrisikos geben. Wenn beispielsweise bei der ersten Exposition gegenüber einer Substanz eine Anaphylaxie auftritt, müsste die „Kritikalität“ auf „hoch“ gesetzt werden, da das Risiko hoch ist, dass die Anaphylaxie bei der zweiten und weiteren Expositionen erneut auftritt. Dieser Archetyp wurde entwickelt, um die Aufzeichnung von Informationen über eine bestimmte Substanz (Amoxicillin, Austern oder Bienenstichgift) oder alternativ eine Substanzklasse (z. B. Penicilline) zu ermöglichen. Wenn eine Substanzklasse erfasst wird, kann mithilfe des Archetyps CLUSTER.adverse_reaction_event die Identifizierung der genauen Substanz pro Reaktion erfasst werden. Zur Aufzeichnung von Informationen über das positive Vorliegen des Risikos einer Nebenwirkung: - zur Unterstützung der direkten klinischen Versorgung einer Person; - als Teil einer Liste verwalteter Nebenwirkungen oder Allergien/Unverträglichkeiten; - den Austausch von Informationen über die Neigung und Ereignisse im Zusammenhang mit Nebenwirkungen zu unterstützen; - um die Meldung von Nebenwirkungen zu informieren; Und - Unterstützung bei computergestützten wissensbasierten Aktivitäten wie klinischer Entscheidungsunterstützung und Warnungen. Das Risiko einer unerwünschten Reaktion oder Manifestation muss immer auf einen auslösenden Stoff oder eine auslösende Stoffklasse schließen lassen. Wenn ein gewisser Grad an Unsicherheit darüber besteht, dass ein bestimmter Stoff die Ursache ist, kann der Grad der Unsicherheit mithilfe des Datenelements „Verifizierungsstatus“ erfasst werden. Wenn mehr als eine mögliche Substanz eine Reaktion/Manifestation verursacht haben könnte, sollte jede Substanz mithilfe einer separaten Instanz dieses Archetyps des Nebenwirkungsrisikos aufgezeichnet werden, wobei der „Verifizierungsstatus“ auf den Anfangsstatus „Unbestätigt“ gesetzt ist, damit die Nebenwirkungsprüfung durchgeführt werden kann in klinischen Systemen aktiviert werden. Wenn sich später herausstellt, dass die Substanz nicht ursächlich ist, kann der „Verifizierungsstatus“ auf „Widerlegt“ geändert werden – beispielsweise nach einem Allergietest."> keywords = <"Reaktion", "Allergie", "allergisch", "unerwünscht", "Ereignis", "Wirkung", "Empfindlichkeit", "Intoleranz", "Überempfindlichkeit", "Nebenwirkung", "Toxizität", "Arzneimittel", "Lebensmittel", "Agent", "Substanz", "immun", "nicht immun", "chemisch", "Anaphylaxie", "Allergen", "Medikation", "Ergänzung", "Medizin", "Naturarzneimittel", "immunologisch", "nicht immunologisch", "Risiko"> misuse = <"Nicht zur Aufzeichnung physiologischer Reaktionen auf physikalische Einwirkungen wie Hitze, Kälte, Sonnenlicht, Vibration, körperliche Betätigung, Infektionserreger oder Lebensmittelverunreinigungen geeignet. Verwenden Sie zu diesem Zweck einen bestimmten Archetyp für EVALUATION.problem/diagnosis oder CLUSTER.symptom/sign. Nicht zur Aufzeichnung unerwünschter Ereignisse, einschließlich Fehlern bei klinischen Prozessen, Interventionen oder Produkten, geeignet. Zum Beispiel: anormaler Gebrauch, falsche Dosierung oder fehlerhafte Verabreichung eines Wirkstoffs oder einer Substanz; falsche Etikettierung; Schäden oder Verletzungen, die durch einen Eingriff oder eine Prozedur verursacht werden; Überdosis/Vergiftung usw. Verwenden Sie für diesen Zweck einen bestimmten Archetyp. Darf nicht zur Aufzeichnung einer Nebenwirkung verwendet werden, bei der der Stoff unbekannt ist. Verwenden Sie EVALUATION.problem_diagnosis oder CLUSTER.symptom_sign, um als Teil der Gesundheitsakte aufzuzeichnen, bis eine mögliche Substanz identifiziert wird. Nicht zur Aufzeichnung von Reaktionen auf Transfusionen von Blutprodukten geeignet. Verwenden Sie zu diesem Zweck einen bestimmten Archetyp. Darf nicht für die Aufzeichnung von „Alarmen“ verwendet werden. Verwenden Sie zu diesem Zweck EVALUATION.precaution, EVALUATION.contraindication oder verwandte Archetypen. Nicht für die Aufzeichnung fehlgeschlagener Therapien geeignet. Darf nicht für die explizite Aufzeichnung des Fehlens (oder des negativen Vorliegens) einer Reaktion auf „irgendeine Substanz“ oder auf identifizierte Substanzen verwendet werden, zum Beispiel „Keine bekannten Allergien oder Nebenwirkungen“ oder „Keine bekannten Allergien gegen Penicillin“. Verwenden Sie die Archetypen EVALUATION.exclusion_global oder EVALUATION.exclusion_special, um eine positive Aussage zum Ausschluss von Nebenwirkungen auszudrücken. Nicht zu verwenden für die explizite Erfassung, dass keine Informationen über den Nebenwirkungsstatus eines Patienten eingeholt werden konnten. Verwenden Sie den Archetyp EVALUATION.absence, um eine positive Aussage zu erfassen, dass Informationen nicht eingeholt werden konnten, beispielsweise wenn ein nicht kooperativer Patient sich weigert, Fragen zu beantworten."> > ["sv"] = < language = <[ISO_639-1::sv]> purpose = <"*To record the clinical assessment of the propensity for an individual to experience an adverse reaction if exposed, or re-exposed, to a specified substance or class of substances. (en)"> use = <"*Use to record a clinical assessment of a propensity for an adverse reaction upon future exposure to a specified substance or class of substances including, but not limited to, incipients and excipients in medicinal preparations, biological products, metal salts, and organic chemical compounds. This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening: - immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or - non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities. In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient. Identification of the severity of the manifestation of the reaction can inform the 'Criticality' of the adverse reaction risk - for example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures. Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT. This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype. Use to record information about the positive presence of the risk of an adverse reaction: - to support the direct clinical care of an individual; - as part of a managed adverse reaction or allergy/intolerance list; - to support the exchange of information about the propensity and events related to adverse reactions; - to inform adverse reaction reporting; and - to assist with computerised knowledge-based activities such as clinical decision support and alerts. The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial. (en)"> keywords = <"reaktion", "allergi", "allergisk", "ogynnsam", "händelse", "effekt", "känslighet", "intolerans", "överkänslighet", "sidoeffekt", "giftighet", "läkemedel", "mat", "ombud", "ämne", "immun", "icke-immun", "kemisk", "anafylaxi", "allergen", "medicin", "tillägg", "läkemedel", "naturläkemedel", "immunologiska", "icke-immunologiska", "risk"> misuse = <"*Not to be used for recording physiological reactions to physical agents, such as heat, cold, sunlight, vibration, exercise activity, by infectious agents or food contaminants. Use a specific archetype for EVALUATION.problem/diagnosis or CLUSTER.symptom/sign for this purpose. Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use, incorrect dosage or maladministration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for the purpose. Not to be used to record an adverse reaction where the substance is unknown. Use EVALUATION.problem_diagnosis or CLUSTER.symptom_sign to record as part of the health record until a possible substance is identified. Not to be used to record reactions to transfusions of blood products. Use a specific archetype for this purpose. Not to be used for recording 'alerts'. Use EVALUATION.precaution, EVALUATION.contraindication or related archetypes for this purpose. Not to be used for recording failed therapy. Not to be used for the explicit recording of an absence (or negative presence) of a reaction to 'any substances' or to identified substances, for example ‘No known allergies or adverse reactions’ or ‘No known allergies to Penicillin’. Use the EVALUATION.exclusion_global or EVALUATION.exclusion_specific archetypes to express a positive statement of adverse reaction exclusion. Not to be used for the explicit recording that no information was able to be obtained about the adverse reaction status of a patient. Use the EVALUATION.absence archetype to record that a positive statement that information was not able to be obtained, for example, if a non-cooperative patient refuses to answer questions. (en)"> > ["nb"] = < language = <[ISO_639-1::nb]> purpose = <"For å registrere en klinisk vurdering om et individs tendens til overfølsomhetsreaksjoner ved eksponering eller re-eksponering for en angitt substans eller substansklasse."> use = <"Brukes for å registrere en klinisk vurdering om et individs tendens til overfølsomhetsreaksjoner ved fremtidig eksponering for en substans eller substansklasse. Substanser kan omfatte men er ikke begrenset til: aktive stoffer eller hjelpestoffer i legemidler, biologiske produkter, metallsalter eller organiske substanser. Arketypen gir ett enkelt sted i pasientjournalen for å dokumentere tendensen til hele spekteret av reaksjoner, fra trivielle til livstruende: - immunmediert reaksjon - Typene I-IV (allergiske reaksjoner og hypersensitivitet) - ikke-immunmediert reaksjon - inkludert annen overfølsomhet, bivirkninger, intoleranse og legemiddeltoksisitet I klinisk praksis kan det være vanskelig å skille mellom immunmedierte og ikke-immunmedierte reaksjoner. Identifisering av reaksjonstypen er ikke et substitutt for alvorlighetsgrad eller risiko for skade på pasienten. Der en tendens er identifisert, kan informasjon eller evidens om en eller flere reaksjonshendelser registreres ved hjelp av arketypen CLUSTER.adverse_reaction_event brukt i SLOTet \"Sammendrag av reaksjonshendelse\". Reaksjonsmanifestasjonens alvorlighetsgrad, dokumentert ved hjelp av arketypen CLUSTER.adverse_reaction_event, kan brukes til å utlede reaksjonsrisikoens alvorlighetsgrad. For eksempel kan anafylakse ved første eksponering for en substans være grunnlag for å sette alvorlighetsgraden til \"høy\", siden det da vil være høy risiko for en anafylaktisk reaksjon også ved andre gangs eller senere eksponeringer. Denne arketypen er designet for å tillate registrering av informasjon om en bestemt substans (f.eks. amoxycillin, østers eller biegift) eller en substansklasse (f.eks. Penicilliner). Hvis en substansklasse registreres kan den spesifikke substansen registreres per reaksjon ved hjelp av arketypen CLUSTER.adverse_reaction_event. Brukes til å registrere informasjon om at en risiko for en overfølsomhetsreaksjon er tilstede: - for å støtte direkte klinisk omsorg for et individ - som en del av en vedlikeholdt liste over overfølsomhetsreaksjoner - for å støtte utveksling av informasjon om tendenser og hendelser knyttet til overfølsomhetsreaksjoner - for å støtte rapportering av reaksjonshendelser - for å støtte kunnskapsbaserte aktiviteter som klinisk beslutningsstøtte og varsler Risikoen for en reaksjonshendelse eller reaksjonsmanifestasjon må alltid foreslår en utløsende substans eller substansklasse. Hvis det er usikkerhet om hvilken spesifikke substans som er årsak til overfølsomhetsreaksjonen, kan denne usikkerheten angis ved hjelp dataelementet \"Verifikasjonsstatus\". Dersom flere mulige substanser kan ha forårsaket en reaksjon/manifestasjon bør hver substans registreres for seg i denne arketypen med \"Verifikasjonsstatus\" i utgangspunktet satt til \"Ubekreftet\", slik at kontroll av overfølsomhetsreaksjoner kan aktiveres i kliniske systemer. Dersom en substans eller substansklasse senere viser seg å ikke være årsaken til reaksjonen, kan \"Verifikasjonsstatus\" endres til \"Avkreftet\"."> keywords = <"reaksjon", "allergi", "allergisk", "uønsket", "hendelse", "virkning", "effekt", "følsomhet", "intoleranse", "hypersensitivtet", "bivirkning", "toksisitet", "legemiddel", "mat", "medisinering", "medisin", "substans", "immun", "non-immun", "kjemisk", "anafylakse", "allergen", "naturmedisin", "immunologisk", "ikke-immunologisk", "non-immunologisk", "risk", "risiko", "supplement", "kosttilskudd", "tilskudd", "anafylaksi", "anafylaktisk", "naturmidler", "medikament", "ernæring", "stoff", "rusmiddel", "agens", "overfølsomhet", "atopi", "cave"> misuse = <"Brukes ikke til registrering av fysiologiske reaksjoner på fysiske fenomener, som for eksempel varme, kulde, sollys, vibrasjon, treningsaktivitet, smittestoffer eller forurensninger i mat. Til dette brukes en spesifikk arketype som EVALUATION.problem_diagnosis eller CLUSTER.symptom_sign. Brukes ikke til å registrere avvik, inkludert svikt i kliniske prosesser, intervensjoner eller produkter. For eksempel: Feil bruk, feil dosering eller feil administrasjon av en substans, feilmerking, skade forårsaket av en intervensjon eller prosedyre, overdose/forgiftning etc. Bruk en spesifikk arketype for dette formålet. Brukes ikke til å registerere en uønsket reaksjon hvor substansen er ukjent. Bruk arketypen EVALUATION.problem_diagnosis eller CLUSTER.symptom_sign for å registrere disse inntil substansen blir identifisert. Brukes ikke til å registrere reaksjoner på transfusjoner av blodkomponenter. Bruk en spesifikk arketype for dette formålet. Brukes ikke for å registrere generiske 'varsler'. Bruk EVALUATION.precaution, EVALUATION.contraindication eller relaterte arketyper for dette formålet. Brukes ikke til å registrere mislykket behandling. Skal ikke brukes for eksplisitt registrering av et fravær (eller negativ tilstedeværelse) av en reaksjon på en hvilken som helst substans eller til spesifikke substanser, for eksempel \"Ingen kjente allergier eller uønskede reaksjoner\" eller \"Ingen kjent allergi mot penicillin\". Bruk arketypene EVALUATION.exclusion_global eller EVALUATION.exclusion_specific til å uttrykke et eksplisitt utsagn om fravær av uønskede reaksjoner. Skal ikke brukes for eksplisitt registrering av at ingen informasjon er tilgjengelig om et individs status med tanke på uønskede reaksjoner. Bruk arketypen EVALUATION.absence til å registrere at informasjon ikke er tilgjengelig, for eksempel dersom en ikke-samarbeidsvillig pasient nekter å svare på spørsmål."> > ["pt-br"] = < language = <[ISO_639-1::pt-br]> purpose = <"*To record the clinical assessment of the propensity for an individual to experience an adverse reaction if exposed, or re-exposed, to a specified substance or class of substances. (en)"> use = <"*Use to record a clinical assessment of a propensity for an adverse reaction upon future exposure to a specified substance or class of substances including, but not limited to, incipients and excipients in medicinal preparations, biological products, metal salts, and organic chemical compounds. This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening: - immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or - non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities. In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient. Identification of the severity of the manifestation of the reaction can inform the 'Criticality' of the adverse reaction risk - for example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures. Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT. This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype. Use to record information about the positive presence of the risk of an adverse reaction: - to support the direct clinical care of an individual; - as part of a managed adverse reaction or allergy/intolerance list; - to support the exchange of information about the propensity and events related to adverse reactions; - to inform adverse reaction reporting; and - to assist with computerised knowledge-based activities such as clinical decision support and alerts. The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing. The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial. (en)"> keywords = <"reação", "alergia", "alérgico", "adversa", "evento", "efeito", "sensibilidade", "intolerância", "hipersensibilidade", "efeito colateral", "toxicidade", "droga", "alimento", "agente", "substância", "imune", "não imune", "químico", "anafilaxia", "alérgeno", "medicação", "suplemento", "medicamento", "remédio natural", "imunológico", "não imunológico", "risco"> misuse = <"*Not to be used for recording physiological reactions to physical agents, such as heat, cold, sunlight, vibration, exercise activity, by infectious agents or food contaminants. Use a specific archetype for EVALUATION.problem/diagnosis or CLUSTER.symptom/sign for this purpose. Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use, incorrect dosage or maladministration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for the purpose. Not to be used to record an adverse reaction where the substance is unknown. Use EVALUATION.problem_diagnosis or CLUSTER.symptom_sign to record as part of the health record until a possible substance is identified. Not to be used to record reactions to transfusions of blood products. Use a specific archetype for this purpose. Not to be used for recording 'alerts'. Use EVALUATION.precaution, EVALUATION.contraindication or related archetypes for this purpose. Not to be used for recording failed therapy. Not to be used for the explicit recording of an absence (or negative presence) of a reaction to 'any substances' or to identified substances, for example ‘No known allergies or adverse reactions’ or ‘No known allergies to Penicillin’. Use the EVALUATION.exclusion_global or EVALUATION.exclusion_specific archetypes to express a positive statement of adverse reaction exclusion. Not to be used for the explicit recording that no information was able to be obtained about the adverse reaction status of a patient. Use the EVALUATION.absence archetype to record that a positive statement that information was not able to be obtained, for example, if a non-cooperative patient refuses to answer questions. (en)"> > ["en"] = < language = <[ISO_639-1::en]> purpose = <"To record the clinical assessment of the propensity for an individual to experience an adverse reaction if exposed, or re-exposed, to a specified substance or class of substances."> use = <"Use to record a clinical assessment of a propensity for an adverse reaction upon future exposure to a specified substance or class of substances including, but not limited to, incipients and excipients in medicinal preparations, biological products, metal salts, and organic chemical compounds. This archetype is intended to provide a single place within the health record to document the propensity for the full range of reactions, from trivial to life-threatening: - immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or - non-immune-mediated: including pseudo-allergic reactions, side effects, intolerances, and drug toxicities. In clinical practice distinguishing between immune-mediated and non-immune-mediated reactions can be difficult. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient. Where a propensity is identified, information or evidence about one or more reaction events can be recorded using the CLUSTER.adverse_reaction_event archetype in the 'Reaction event summary' SLOT. Identification of the severity of the manifestation of the reaction, recorded in the CLUSTER.adverse_reaction_event archetype, can inform the 'Criticality' of the adverse reaction risk. For example, experiencing anaphylaxis on first exposure to a substance would warrant setting a 'Criticality' of 'high', due to the high risk that anaphylaxis is likely to recur on second and subsequent exposures. This archetype has been designed to allow the recording of information about a specific substance (amoxycillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g. Penicillins). If a class of substance is recorded, identification of the exact substance can be recorded on a per-reaction basis using the CLUSTER.adverse_reaction_event archetype. Use to record information about the positive presence of the risk of an adverse reaction: - to support the direct clinical care of an individual; - as part of a managed adverse reaction or allergy/intolerance list; - to support the exchange of information about the propensity and events related to adverse reactions; - to inform adverse reaction reporting; and - to assist with computerised knowledge-based activities such as clinical decision support and alerts. The risk of an adverse reaction event or manifestation must always propose a causative substance or class of substance. If there is a degree of uncertainty that a specific substance is the cause, the level of uncertainty can be recorded using the ‘Verification status’ data element. If more than one possible substance may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this adverse reaction risk archetype with the ‘Verification status’ set to an initial state of ‘Unconfirmed’ so that adverse reaction checking can be activated in clinical systems. If the substance is later proven not to be causal then the ‘Verification status’ can be modified to ‘Refuted’ - for example, after allergy testing."> keywords = <"reaction", "allergy", "allergic", "adverse", "event", "effect", "sensitivity", "intolerance", "hypersensitivity", "side effect", "toxicity", "drug", "food", "agent", "substance", "immune", "non-immune", "chemical", "anaphylaxis", "allergen", "medication", "supplement", "medicine", "natural remedies", "immunological", "non-immunological", "risk"> misuse = <"Not to be used for recording physiological reactions to physical agents, such as heat, cold, sunlight, vibration, exercise activity, by infectious agents or food contaminants. Use a specific archetype for EVALUATION.problem/diagnosis or CLUSTER.symptom/sign for this purpose. Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use, incorrect dosage or maladministration of an agent or substance; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for the purpose. Not to be used to record an adverse reaction where the substance is unknown. Use EVALUATION.problem_diagnosis or CLUSTER.symptom_sign to record as part of the health record until a possible substance is identified. Not to be used to record reactions to transfusions of blood products. Use a specific archetype for this purpose. Not to be used for recording 'alerts'. Use EVALUATION.precaution, EVALUATION.contraindication or related archetypes for this purpose. Not to be used for recording failed therapy. Not to be used for the explicit recording of an absence (or negative presence) of a reaction to 'any substances' or to identified substances, for example ‘No known allergies or adverse reactions’ or ‘No known allergies to Penicillin’. Use the EVALUATION.exclusion_global or EVALUATION.exclusion_specific archetypes to express a positive statement of adverse reaction exclusion. Not to be used for the explicit recording that no information was able to be obtained about the adverse reaction status of a patient. Use the EVALUATION.absence archetype to record that a positive statement that information was not able to be obtained, for example, if a non-cooperative patient refuses to answer questions."> copyright = <"© Australian Digital Health Agency, openEHR Foundation, HL7 International, Nasjonal IKT"> > > lifecycle_state = <"published"> other_contributors = <"Fatima Almeida, Critical SW, Portugal", "Grethe Almenning, Bergen kommune, Norway", "Magnus Alsaker, Helsedirektoratet, Norway", "Torunn Apelseth, Helse Bergen, Norway", "Vebjørn Arntzen, Oslo University Hospital, Norway", "Bent Asgeir Larsen, Helsedirektoratet, Norway", "Koray Atalag, University of Auckland, New Zealand", "Elaine Ayres, US National Institutes of Health, United States", "Russell B Leftwich MD, United States (openEHR Editor)", "Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor)", "John Bennett, NEHTA, Australia", "Steve Bentley, Allscripts, United Kingdom", "Sharmila Biswas, Dr Sharmila Biswas GP, Australia", "Lars Bitsch-Larsen, Haukeland University hospital, Norway", "Terje Bless, Helse Nord FIKS, Norway", "Laila Bruun, Oslo universitetssykehus HF, Norway", "Claire Chalopin, ICCAS, University of Leipzig, Germany", "Rong Chen, Cambio Healthcare Systems, Sweden", "Stephen Chu, Queensland Health, Australia", "Matthew Cordell, NEHTA, Australia", "Howard Edidin, Edidin Group, Inc, United States", "Brett Esler, Oridashi, Australia", "David Evans, Queensland Health, Australia", "Jerry Fahrni, Kaweah Delta Health Care District, United States", "Shahla Foozonkhah, Iran ministry of health and education, Iran", "Einar Fosse, National Centre for Integrated Care and Telemedicine, Norway", "Joanne Foster, School of Nursing & Midwifery, QLD University of Technology & Nursing Informatics Australia, Australia", "Sebastian Garde, Ocean Informatics, Germany", "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, Health Intersections, Australia (Editor)", "Robert Hausam, Hausam Consulting LLC, United States", "Sam Heard, Ocean Informatics, Australia", "Kristian Heldal, Telemark Hospital Trust, Norway", "Anca Heyd, DIPS ASA, Norway", "Hilde Hollås, Norway", "Roar Holm, Helse Vest IKT A/S, Norway", "Andrew James, University of Toronto, Canada", "Julie James, Blue Wave Informatics LLP, United Kingdom", "Tom Jarl Jakobsen, Helse Bergen, Norway", "Ivor Jones, Queensalnd Helath, Australia", "Lars Jostein Silihagen, Sopra Steria / Sykehuspartner / Sykehuset Innlandet, Norway", "Silje Kaada, Helse-Bergen, Avdeling for immunologi og transfusjonsmedisin, Norway", "Konstantinos Kalliamvakos, Cambio Healthcare Systems, Sweden", "Lars Karlsen, DIPS ASA, Norway", "Lars Morgan Karlsen, DIPS ASA, Norway", "Goran Karlstrom, County Of Värmland, Sweden", "Mary Kelaher, NEHTA, Australia", "Diane Kirkham, NEHTA, Australia", "Shinji Kobayashi, NPO openEHR Japan, Japan", "Robert L'egan, NEHTA, Australia", "Jobst Landgrebe, ii4sm, Switzerland", "Russell Leftwich, Russell B Leftwich MD, United States", "Fest Legemiddelverket, Statens Legemiddelverk, Norway", "Heather Leslie, Atomica Informatics, Australia (openEHR Editor)", "Hugh Leslie, Ocean Informatics, Australia", "Rikard Lovstrom, Swedish Medical Association, Sweden", "Hallvard Lærum, Oslo Universitetssykehus HF, Norway", "Arne Løberg Sæter, DIPS ASA, Norway", "Sarah Mahoney, Australia", "Luis Marco Ruiz, Norwegian Center for Integrated Care and Telemedicine, Norway", "Siv Marie Lien, DIPS ASA, Norway", "Mike Martyn, The Hobart Anaesthetic Group, Australia", "Lloyd McKenzie, Gordon Point Informatics, Canada", "David McKillop, NEHTA, Australia", "Ian McNicoll, freshEHR Clinical Informatics, United Kingdom", "Chris Mitchell, RACGP, Australia", "Stewart Morrison, NEHTA, Australia", "Jörg Niggemann, Compugroup, Germany", "Bjørn Næss, DIPS ASA, Norway", "Tom Oniki, Intermountain Healthcare, United States", "Chris Pearce, Melbourne East GP Network, Australia", "Rune Pedersen, Universitetssykehuset i Nord Norge, Norway", "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", "Tanja Riise, Nasjonal IKT HF, Norway", "Jussara Rotzsch, Hospital Alemão Oswaldo Cruz, Brazil", "Stefan Sauermann, University of Applied Sciences Technikum Wien, Austria", "Thomas Schopf, University Hospital of North-Norway, Norway", "Thilo Schuler, Australia", "Jason Scott, Plymouth Hospitals NHS Trust, United Kingdom", "Peter Scott, Medical Objects, Australia", "Elena Shabanova, UMMSSOft, Russian Federation", "Anoop Shah, University College London, United Kingdom", "Elizabeth Stanick, Hobart Anaesthetic Group, Australia", "Laila Storesund, Haraldsplass diakonale sykehus, Norway", "Norwegian Review Summary, Norwegian Public Hospitals, Norway", "Line Sæle, Nasjonal IKT HF, Norway", "Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore", "John Taylor, NEHTA, Australia", "Micaela Thierley, Helse Bergen, Norway", "Gordon Tomes, Australian Institute of Health and Welfare, Australia", "John Tore Valand, Haukeland Universitetssjukehus, Norway (Nasjonal IKT redaktør)", "Richard Townley-O'Neill, Australian Digital Health Agency, Australia", "Ines Vaz, UFN, Portugal", "Nils Widnes, Helse-Bergen, Norway", "Andrew Yap, Australia", "Kylie Young, The Royal Australian College of General Practitioners, Australia", "Lin Zhang, Taikang Insurance Group, China"> other_details = < ["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"> ["references"] = <"Adverse Reaction, draft archetype, Australian Digital Health Agency [Internet]. NEHTA Clinical Knowledge Manager. Authored: 08 Nov 2010. No longer available. Allergy and Intolerance Domain Analysis Model, Release 1, HL7 [Internet]. Publication pending, expected August 2014; Available at http://wiki.hl7.org/images/1/1b/Allergy_and_Intolerance_INFORM_2013_MAY.pdf (accessed 06 July 2014). 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. HL7 FHIR Resource - AllergyIntolerance R1.2.0 STU3 draft [Internet]. Health Level Seven International; [accessed 2020 Jan 17]. Available from: http://hl7.org/fhir/2016Jan/allergyintolerance.html. 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. - Uppsala Monitoring Centre (WHO): http://www.who-umc.org/ - European Medicines Agency: http://www.ema.europa.eu/ema/ - DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf"> ["current_contact"] = <"Heather Leslie, Atomica Informatics, Australia"> ["original_namespace"] = <"org.openehr"> ["original_publisher"] = <"openEHR Foundation"> ["custodian_namespace"] = <"org.openehr"> ["MD5-CAM-1.0.1"] = <"19F2BC4F565422749861B468594E50E7"> ["build_uid"] = <"63592b37-306a-4201-a529-181128ace219"> ["revision"] = <"2.0.0"> > definition EVALUATION[at0000] matches { -- Adverse reaction risk data matches { ITEM_TREE[at0001] matches { -- Tree items cardinality matches {1..*; unordered} matches { ELEMENT[at0002] matches { -- Substance value matches { DV_TEXT matches {*} } } ELEMENT[at0130] occurrences matches {0..1} matches { -- Active/inactive status value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0131, -- Active at0132] -- Inactive } } DV_TEXT matches {*} } } ELEMENT[at0063] occurrences matches {0..1} matches { -- Verification status value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0064, -- Unconfirmed at0065, -- Confirmed at0066] -- Refuted } } DV_TEXT matches {*} } } ELEMENT[at0101] occurrences matches {0..1} matches { -- Criticality value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0102, -- Low at0103, -- High at0124] -- Indeterminate } } DV_TEXT matches {*} } } ELEMENT[at0120] occurrences matches {0..1} matches { -- Category value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0121, -- Food at0122, -- Medication at0123] -- Other } } DV_TEXT matches {*} } } ELEMENT[at0117] occurrences matches {0..1} matches { -- Onset of last reaction value matches { DV_DATE_TIME matches {*} DV_DURATION matches {*} DV_INTERVAL<DV_DATE_TIME> matches {*} DV_INTERVAL<DV_DURATION> matches {*} DV_TEXT matches {*} } } ELEMENT[at0133] occurrences matches {0..1} matches { -- Onset of first reaction value matches { DV_DATE_TIME matches {*} DV_DURATION matches {*} DV_TEXT matches {*} DV_INTERVAL<DV_DATE_TIME> matches {*} DV_INTERVAL<DV_DURATION> matches {*} } } ELEMENT[at0058] occurrences matches {0..1} matches { -- Reaction mechanism value matches { DV_CODED_TEXT matches { defining_code matches { [local:: at0059, -- Immune mediated at0060, -- Non-immune mediated at0126] -- Indeterminate } } DV_TEXT matches {*} } } allow_archetype CLUSTER[at0129] occurrences matches {0..*} matches { -- Reaction event summary include archetype_id/value matches {/openEHR-EHR-CLUSTER\.adverse_reaction_event(-[a-zA-Z0-9_]+)*\.v0|openEHR-EHR-CLUSTER\.adverse_reaction_event(-[a-zA-Z0-9_]+)*\.v1/} } ELEMENT[at0006] occurrences matches {0..1} matches { -- Comment value matches { DV_TEXT matches {*} } } } } } protocol matches { ITEM_TREE[at0042] matches { -- Tree items cardinality matches {1..*; unordered} matches { ELEMENT[at0062] occurrences matches {0..1} matches { -- Last updated value matches { DV_DATE_TIME matches {*} } } ELEMENT[at0047] occurrences matches {0..*} matches { -- Supporting clinical record information value matches { DV_EHR_URI matches {*} } } allow_archetype CLUSTER[at0128] occurrences matches {0..*} matches { -- Extension include archetype_id/value matches {/.*/} } } } } } ontology term_definitions = < ["en"] = < items = < ["at0000"] = < text = <"Adverse reaction risk"> description = <"Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, 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."> source = <"openEHR,FHIR"> > ["at0001"] = < text = <"Tree"> description = <"@ internal @"> > ["at0002"] = < 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. It is strongly recommended that the 'Substance' is 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."> > ["at0006"] = < 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."> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0047"] = < text = <"Supporting clinical record information"> description = <"Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports."> comment = <"For example, presenting symptoms, examination findings, diagnosis etc."> > ["at0058"] = < text = <"Reaction mechanism"> description = <"Identification of the underlying physiological mechanism for the adverse reaction."> comment = <"Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk. Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity. It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute."> > ["at0059"] = < text = <"Immune mediated"> description = <"Immune mediated reaction, including allergic reactions and hypersensitivities."> > ["at0060"] = < text = <"Non-immune mediated"> description = <"A non-immune mediated reaction, which can include pseudo-allergic reactions, side effects, intolerances, drug toxicities (for example, to Gentamicin)."> > ["at0062"] = < text = <"Last updated"> description = <"Date when the propensity or the reaction event was updated."> > ["at0063"] = < 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 'Unconfirmed' and '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. 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."> > ["at0064"] = < text = <"Unconfirmed"> description = <"The propensity for a reaction to the identified 'Substance' has not been objectively verified."> > ["at0065"] = < text = <"Confirmed"> description = <"The propensity for a reaction to the identified 'Substance' has been objectively verified. This may include clinical evidence by testing, re-challenge or observation."> > ["at0066"] = < text = <"Refuted"> description = <"A propensity for a reaction to the identified 'Substance' has been disputed or disproven with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation."> > ["at0101"] = < 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."> > ["at0102"] = < text = <"Low"> description = <"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."> > ["at0103"] = < text = <"High"> description = <"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."> > ["at0117"] = < text = <"Onset of last reaction"> description = <"The date and/or time of the onset of the last known occurrence of a reaction event."> comment = <"For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year."> > ["at0120"] = < text = <"Category"> description = <"Category of the identified 'Substance'."> comment = <"This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation."> > ["at0121"] = < text = <"Food"> description = <"Any substance consumed to provide nutritional support for the body, such as peanut or egg."> > ["at0122"] = < text = <"Medication"> description = <"Any substance administered to achieve a physiological effect."> > ["at0123"] = < text = <"Other"> description = <"Any other substance encountered including venom, latex and other environmental substances."> > ["at0124"] = < text = <"Indeterminate"> description = <"Unable to assess with information available."> > ["at0126"] = < text = <"Indeterminate"> description = <"The physiological mechanism could not be determined."> > ["at0128"] = < text = <"Extension"> description = <"Additional information required to capture local content or to align with other reference models/formalisms."> comment = <"For example: local information requirements or additional metadata to align with FHIR equivalents."> > ["at0129"] = < text = <"Reaction event summary"> description = <"Summary details about each adverse reaction event linked to exposure to the identified 'Substance'."> > ["at0130"] = < text = <"Active/inactive status"> description = <"Status about whether the adverse reaction risk statement is active or inactive."> > ["at0131"] = < text = <"Active"> description = <"The subject is currently experiencing, or is at risk of, a reaction to the identified substance."> > ["at0132"] = < text = <"Inactive"> description = <"The subject is no longer at risk of a reaction to the identified substance."> > ["at0133"] = < text = <"Onset of first reaction"> description = <"The onset of the first known occurrence of a reaction event."> comment = <"For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year."> > > > ["pt-br"] = < items = < ["at0000"] = < text = <"Risco de Reação Adversa"> description = <"*Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, to a substance. (en)"> comment = <"As substâncias incluem , mas não estão limitadas a: uma substância terapêutica administrada corretamente a uma dosagem apropriada para o indivíduo; alimento; material derivado de plantas ou animais ; ou veneno de picadas de insetos"> > ["at0001"] = < text = <"Tree"> description = <"@ internal @"> > ["at0002"] = < text = <"*Substance(en)"> description = <"*Identification of a substance, or substance class, that is considered to put the individual at risk of an adverse reaction event.(en)"> 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. It is strongly recommended that the 'Substance' is 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. (en)"> source = <"*openEHR,FHIR,DAM(en)"> > ["at0006"] = < text = <"Comentários"> description = <"Narrativa adicional sobre a propensão para a reação adversa, não capturada em outros campos."> comment = <"Por exemplo: incluir motivo para sinalizar uma criticidade de alto risco; e instruções relacionadas com a exposição futura ou a administração da substância, tais como a administração dentro de uma unidade de terapia intensiva ou sob cobertura de corticosteróide"> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0047"] = < text = <"Apoio às informações clínicas do registro"> description = <"Link para mais informações sobre a apresentação e as conclusões que existe em outro lugar no registro de saúde, incluindo relatórios de teste de alergia."> comment = <"*For example, presenting symptoms, examination findings, diagnosis etc. (en)"> > ["at0058"] = < text = <"Mecanismo da Reação"> description = <"Identificação do mecanismo fisiológico subjacente para a reação adversa"> comment = <"Respostas imune-mediada tem sido tradicionalmente consideradas como um indicador para a escalada de risco significativo no futuro. Conhecimentos atuais sugerem que algumas reações que previamente se pensava serem imunes são na verdade não imunes e ainda carregam o risco de ameaça à vida. Testes imunológicos podem fornecer elementos de prova para o mecanismo e a substância causal, mas os testes não são 100% sensíveis ou específicos para uma sensibilidade. É reconhecido que a maioria dos clínicos não serão capazes de distinguir o mecanismo de qualquer reação específica. No entanto, este elemento de dados está incluído porque muitos sistemas legados tem capturado esse atributo"> > ["at0059"] = < text = <"Imune - mediada"> description = <"Reação imune-mediada, incluindo hipersensibilidade e reações alérgicas."> > ["at0060"] = < text = <"Não imune-mediada"> description = <"Reação Não Imuno-mediada, que inclui pseudo alergias, intolerâncias, efeitos colaterais, toxicidade de drogas (por exemplo, a gentamicina)."> > ["at0062"] = < text = <"Ultima atualização"> description = <"Data quando a propensão ou o evento de reação foi atualizado."> > ["at0063"] = < text = <"*Verification status (en)"> description = <"Declaração sobre a certeza da propensão ou potenciais riscos futuros, da substância identificada para causar uma reação."> comment = <"*Decision support would typically raise alerts for 'Unconfirmed' and '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. 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. (en)"> > ["at0064"] = < text = <"*Unconfirmed (en)"> description = <"*The propensity for a reaction to the identified 'Substance' has not been objectively verified. (en)"> > ["at0065"] = < text = <"Confirmada"> description = <"*The propensity for a reaction to the identified 'Substance' has been objectively verified. This may include clinical evidence by testing, re-challenge or observation. (en)"> > ["at0066"] = < text = <"Refutada"> description = <"*A propensity for a reaction to the identified 'Substance' has been disputed or disproven with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation. (en)"> > ["at0101"] = < text = <"Criticidade"> description = <"Uma indicação do potencial de danos nos órgãos críticos do sistema ou conseqüência de ameaça à vida"> 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. (en)"> > ["at0102"] = < text = <"Baixo"> description = <"Exposição a substâncias passíveis de danos nos órgãos críticos do sistema ou conseqüência de ameaça à vida. Futura exposição à substância identificada deve ser considerada uma contra-indicação relativa em circunstâncias clínicas normais."> > ["at0103"] = < text = <"Alto"> description = <"Exposição à substância pode resultar em danos ao sistema, órgão crítico ou conseqüência de ameaça à vida. Futura exposição à substância identificada deve ser considerada uma contra-indicação absoluta em circunstâncias clínicas normais."> > ["at0117"] = < text = <"Início da última reação"> description = <"A data e/ou hora do início da última ocorrência de um evento de reação conhecida."> comment = <"*For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year. (en)"> > ["at0120"] = < text = <"Categoria"> description = <"Categoria da substância identificada"> comment = <"Este elemento de dados foi incluído porque atualmente está sendo capturado em alguns sistemas clínicos. Esses dados podem ser derivados da substância onde são utilizados sistemas de codificação e é efetivamente redundante nessa situação."> > ["at0121"] = < text = <"Alimentos"> description = <"Qualquer substância consumida para fornecer suporte nutricional para o organismo, tais como o amendoim ou ovo."> > ["at0122"] = < text = <"Medicação"> description = <"Qualquer substância administrada para alcançar um efeito fisiológico."> > ["at0123"] = < text = <"Outros"> description = <"Qualquer outra substância encontrada incluindo veneno, látex e outras substâncias ambientais."> > ["at0124"] = < text = <"Indeterminado"> description = <"Não é possível avaliar com informações disponíveis."> > ["at0126"] = < text = <"Indeterminada"> description = <"O mecanismo fisiológico não pôde ser determinado."> > ["at0128"] = < text = <"*Extension(en)"> description = <"*Additional information required to capture local content or to align with other reference models/formalisms.(en)"> comment = <"*For example: local information requirements or additional metadata to align with FHIR equivalents. (en)"> > ["at0129"] = < text = <"*Reaction event summary (en)"> description = <"*Summary details about each adverse reaction event linked to exposure to the identified 'Substance'. (en)"> > ["at0130"] = < text = <"*Active/inactive status (en)"> description = <"*Status about whether the adverse reaction risk statement is active or inactive. (en)"> > ["at0131"] = < text = <"*Active (en)"> description = <"*The subject is currently experiencing, or is at risk of, a reaction to the identified substance. (en)"> > ["at0132"] = < text = <"*Inactive (en)"> description = <"*The subject is no longer at risk of a reaction to the identified substance. (en)"> > ["at0133"] = < text = <"*Onset of first reaction (en)"> description = <"*The onset of the first known occurrence of a reaction event. (en)"> comment = <"*For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year. (en)"> > > > ["nb"] = < items = < ["at0000"] = < text = <"Risiko for overfølsomhetsreaksjon"> description = <"Klinisk vurdering av tendensen for et individ til å oppleve en skadelig eller uønsket fysiologisk reaksjon ved eksponering eller re-eksponering for en substans."> comment = <"Substanser omfatter men er ikke begrenset til: terapeutiske substanser korrekt administrert ved en passende dose for individet, mat, materiale fra planter eller dyr, eller gift fra insektstikk."> > ["at0001"] = < text = <"Tree"> description = <"@ internal @"> > ["at0002"] = < text = <"Substans"> description = <"Den spesifikke substansen eller substansklassen som setter individet i faresonen for en reaksjonshendelse."> comment = <"Feltet tillater en registrering av enten en spesifikk substans eller en substansklasse. En substans kan være en blanding av enkeltsubstanser, for eksempel et legemiddelprodukt. Det er sterkt anbefalt at \"Substans\" kodes med en terminologi som kan utløse beslutningsstøtte, der det er mulig. For eksempel: FEST, ATC eller SNOMED CT. Fritekst bør bare brukes hvis en hensiktsmessig terminologi ikke er tilgjengelig."> > ["at0006"] = < text = <"Kommentar"> description = <"Ytterligere fritekstbeskrivelse om risikoen for overfølsomhetsreaksjon, som ikke fanges opp i andre felter."> comment = <"For eksempel: Grunnlag for at \"Alvorlighetsgrad\" er satt til \"Høy\", instruksjoner relatert til fremtidige eksponeringer for eller administrasjon av substansen, som administrasjon ved en intensivenhet eller under kortikosteroidbehandling."> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0047"] = < text = <"Understøttende klinisk informasjon"> description = <"Lenke til ytterligere informasjon om symptomer, tegn og funn som finnes andre steder i journalen, inklusiv allergitestrapporter."> comment = <"For eksempel symptomer, undersøkelsesfunn eller diagnoser."> > ["at0058"] = < text = <"Reaksjonsmekanisme"> description = <"Identifisering av overfølsomhetsreaksjonens underliggende fysiologiske mekanisme."> comment = <"Immunmediert respons har tradisjonelt blitt ansett som en indikator for eskalering av signifikant fremtidig risiko. Moderne kunnskap tyder på at noen reaksjoner tidligere antatt å være immune faktisk er ikke-immune og likevel innebærer livstruende risiko. I tillegg kan mange antatt ikke-immunologiske reaksjoner faktisk være immunologiske, siden det finnes mangler i vårt diagnostiske apparat som gjør at vi ikke klarer å identifisere mekanismen. Immunologiske tester kan gi evidens for identifisering av mekanisme og årsakssubstans, men ingen tester er 100% sensitive eller spesifikke. Det erkjennes at klinikere ofte ikke kan identifisere mekanismen for en gitt reaksjon. Dette dataelementet er likevel inkludert fordi det blir brukt i mange eldre systemer."> > ["at0059"] = < text = <"Immunmediert"> description = <"Immunmediert reaksjon, inklusive allergiske reaksjoner og hypersensitiviteter."> > ["at0060"] = < text = <"Ikke-immunmediert"> description = <"En ikke-immunmediert reaksjon, som kan omfatte pseudoallergiske reaksjoner, bivirkninger, intoleranser eller legemiddeltoksisitet (f.eks gentamicin)."> > ["at0062"] = < text = <"Sist oppdatert"> description = <"Dato da informasjonen sist ble oppdatert."> > ["at0063"] = < text = <"Verifikasjonsstatus"> description = <"Påstand om hvor sikkert det er at individet har en tendens eller framtidig risiko på få en overfølsomhetsreaksjon på den angitte substansen."> comment = <"Beslutningsstøttesystemer vil typisk reagere på statusene \"Ubekreftet\" og \"Bekreftet\", og ignorere \"Avkreftet\". Kliniske systemer kan velge å ikke vise overfølsomhetsreaksjoner som har status \"Avkreftet\" i listen over overfølsomhetsreaksjoner. Imidlertid kan \"Avkreftet\" være nyttig for samstemming av listen over overfølsomhetsreaksjoner, eller ved kommunikasjon mellom systemer. Noen implementasjoner kan velge å gjøre dette elementet obligatorisk. Fritekst-datatypen tillater lokal variasjon ved å gjøre det mulig å legge til andre verdisett i et templat. I disse tilfellene er det anbefalt at verdiene kodes med en terminologi."> > ["at0064"] = < text = <"Ubekreftet"> description = <"Tendensen til reaksjon på den angitte substansen har ikke blitt objektivt verifisert."> > ["at0065"] = < text = <"Bekreftet"> description = <"Tendensen til reaksjon på den angitte substansen har blitt objektivt verifisert. Dette kan omfatte klinisk evidens fra testing, provokasjonstesting eller observasjon."> > ["at0066"] = < text = <"Avkreftet"> description = <"Tendensen til å reagere på den angitte substansen har blitt avkreftet med tilstrekkelig nivå av klinisk sikkerhet til at utsagnet kan invalideres. Dette kan omfatte klinisk evidens fra testing, provokasjonstesting eller observasjon."> > ["at0101"] = < text = <"Alvorlighetsgrad"> description = <"En indikasjon på potensialet for kritisk organskade eller livstruende konsekvenser."> comment = <"Dette kan ses på som en vurdering av et \"worst case scenario\". I de fleste kontekster vil \"Lav\" være en standardverdi."> > ["at0102"] = < text = <"Lav"> description = <"Eksponering for substansen vil sannsynligvis ikke resultere i kritisk organskade eller livstruende konsekvenser. Fremtidig eksponering for den angitte substansen bør regnes som en relativ kontraindikasjon under ordinære kliniske omstendigheter."> > ["at0103"] = < text = <"Høy"> description = <"Eksponering for substansen kan resultere i kritisk organskade eller livstruende konsekvenser. Fremtidig eksponering for den angitte substansen bør regnes som en absolutt kontraindikasjon under ordinære kliniske omstendigheter."> > ["at0117"] = < text = <"Debut av siste reaksjon"> description = <"Dato og/eller tid da den siste kjente reaksjonshendelsen startet."> comment = <"For eksempel: Den faktiske datoen og/eller tidspunktet for debuten, tidsintervallet debuten inntraff innenfor, individets alder da debuten inntraff, eller tid siden debuten inntraff. Det kan registreres deldatoer ved å bruke datatypen DV_DATE_TIME, for å registrere kun et årstall."> > ["at0120"] = < text = <"Kategori"> description = <"Kategorien til den angitte substansen."> comment = <"Dette dataelementet er inkludert fordi det brukes i enkelte kliniske systemer. Dataene kan avledes fra substansen dersom man bruker hierarkiske kodesystemer, og er i slike tilfeller overflødig."> > ["at0121"] = < text = <"Mat"> description = <"Enhver substans som spises eller drikkes som næring for kroppen, som f.eks. peanøtter eller egg."> > ["at0122"] = < text = <"Legemiddel"> description = <"Enhver substans som administreres for å oppnå en fysiologisk effekt."> > ["at0123"] = < text = <"Annet"> description = <"Enhver annen substans, inklusive animalsk gift, latex og andre substanser i omgivelsene."> > ["at0124"] = < text = <"Ubestemt"> description = <"Umulig å vurdere med tilgjengelig informasjon."> > ["at0126"] = < text = <"Uviss"> description = <"Den fysiologiske mekanismen kunne ikke fastslås."> > ["at0128"] = < text = <"Utvidelse"> description = <"Ytterligere informasjon som trengs for å kunne registrere lokalt definert innhold eller for å tilpasse til andre referansemodeller/formalismer."> comment = <"For eksempel lokale informasjonsbehov eller ytterligere metadata for å kunne tilpasse til tilsvarende konsepter i FHIR."> > ["at0129"] = < text = <"Sammendrag av reaksjonshendelse"> description = <"Detaljert sammendrag om hver enkelt reaksjonshendelse, koblet til eksponering for den angitte substansen."> > ["at0130"] = < text = <"Aktiv/inaktiv status"> description = <"Status for hvorvidt risikoen for overfølsomhetsreaksjon er aktiv eller inaktiv."> > ["at0131"] = < text = <"Aktiv"> description = <"Individet har ved registreringstidspunktet en risiko for å få en reaksjon på den angitte substansen."> > ["at0132"] = < text = <"Inaktiv"> description = <"Individet har ved registreringstidspunktet ikke lenger en risiko for å få en reaksjon på den angitte substansen."> > ["at0133"] = < text = <"Debut av første reaksjon"> description = <"Dato og/eller tid da den første kjente reaksjonshendelsen startet."> comment = <"For eksempel: Den faktiske datoen og/eller tidspunktet for debuten, tidsintervallet debuten inntraff innenfor, individets alder da debuten inntraff, eller tid siden debuten inntraff. Det kan registreres deldatoer ved å bruke datatypen DV_DATE_TIME, for å registrere kun et årstall."> > > > ["de"] = < items = < ["at0000"] = < text = <"Nebenwirkungsrisiko"> description = <"Klinische Beurteilung der Neigung einer Person, eine schädliche oder unerwünschte physiologische Reaktion zu erfahren, wenn sie einer Substanz ausgesetzt oder erneut ausgesetzt wird."> comment = <"Zu den Substanzen gehören, ohne darauf beschränkt zu sein: eine therapeutische Substanz, die korrekt in einer für die Person geeigneten Dosierung verabreicht wird; Lebensmittel; pflanzliche oder tierische Rohstoffe; oder Gift von Insektenstichen."> source = <"openEHR, FHIR"> > ["at0001"] = < text = <"Tree"> description = <"@ internal @"> > ["at0002"] = < text = <"Substanz"> description = <"Identifizierung einer Substanz oder Substanzklasse, von der angenommen wird, dass sie die Person einem Risiko für ein Auftreten von unerwünschter Reaktion aussetzt."> comment = <"Sowohl ein einzelner Stoff als auch eine Stoffklasse sind gültige Einträge in „Stoff“. Ein Stoff kann eine Verbindung einfacherer Stoffe sein, beispielsweise ein Arzneimittel. Es wird dringend empfohlen, die „Substanz“ nach Möglichkeit mit einer Terminologie zu kodieren, die eine Entscheidungsunterstützung auslösen kann. Zum Beispiel: Snomed CT, DM+D, RxNorm, NDFRT, ATC, New Zealand Universal List of Medicines und Australian Medicines Terminology. Die Freitexteingabe sollte nur dann genutzt werden, wenn keine entsprechende Terminologie verfügbar ist."> source = <"openEHR, FHIR, DAM"> > ["at0006"] = < text = <"Kommentar"> description = <"Zusätzliche Beschreibung ber die Tendenz zur Nebenwirkung, die in anderen Bereichen nicht erfasst wurde."> comment = <"Zum Beispiel: einschließlich des Grundes für die Kennzeichnung des Risikos mit einer hohen \"Gefährlichkeit\" und Anweisungen in Bezug auf die zukünftige Exposition oder Verabreichung der Substanz, wie zum Beispiel die Verabreichung auf einer Intensivstation oder unter Kortikosteroidabdeckung."> source = <"openEHR"> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0047"] = < text = <"Unterstützung von klinischen Informationen"> description = <"Link zu weiteren Informationen über die Präsentation und den Befunden, die an anderer Stelle in der Gesundheitsakte vorhanden sind, einschließlich Allergietestberichten."> comment = <"Zum Beispiel Darstellung von Symptomen, Untersuchungsbefunden, Diagnose etc."> source = <"FHIR, openEHR, DAM"> > ["at0058"] = < text = <"Reaktionsmechanismus"> description = <"Identifizierung des zugrunde liegenden physiologischen Mechanismus für die Nebenwirkung."> comment = <"Immunvermittelte Reaktionen wurden üblicherweise als Indikator für die Eskalation eines signifikanten künftigen Risikos betrachtet. Aktuelles Wissen führt zur Annahme, dass einige bisher als immun betrachteten Reaktionen, tatsächlich nicht immun sind und dennoch ein lebensbedrohliches Risiko bergen. Immunologische Tests können Belege für den Mechanismus und die verursachende Substanz liefern, aber keine Tests sind 100% sensitiv oder spezifisch für eine Sensitivität. Es wird anerkannt, dass die meisten Kliniker den Mechanismus einer bestimmten Reaktion NICHT unterscheiden können. Dieses Datenelement ist jedoch enthalten, da viele veraltete Systeme diese Eigenschaft erfasst haben."> source = <"FHIR, DAM"> > ["at0059"] = < text = <"Immunvermittelt"> description = <"Immunvermittelte Reaktion, einschließlich allergischer Reaktionen und Überempfindlichkeit."> > ["at0060"] = < text = <"Nicht-Immunvermittelt"> description = <"Eine nicht immunvermittelte Reaktion, die pseudoallergische Reaktionen, Nebenwirkungen, Unverträglichkeiten und Arzneimitteltoxizitäten (z. B. gegen Gentamicin) umfassen kann."> > ["at0062"] = < text = <"Letzte Aktualisierung"> description = <"Datum, an dem die Neigung zur Reaktion oder der Fall einer Reaktion aktualisiert wurde."> source = <"openEHR, FHIR, DAM"> > ["at0063"] = < text = <"Verifizierungsstatus"> description = <"Aussage zur Sicherheit über die Tendenz oder über das potenzielle zukünftige Risiko der identifizierten „Substanz“, eine Reaktion auszulösen."> comment = <"Die Entscheidungsunterstützung löst in der Regel Warnungen für „Unbestätigt“ und „Bestätigt“ aus und ignoriert eine „Widerlegt“-Reaktion. Klinische Systeme können sich dafür entscheiden, Einträge zu Nebenwirkungen mit dem Status „Widerlegt“ in der Liste der Nebenwirkungen nicht anzuzeigen. „Widerlegt“ kann jedoch für den Abgleich der Nebenwirkungsliste oder bei der Kommunikation zwischen Systemen nützlich sein. Einige Implementierungen entscheiden sich möglicherweise dafür, dieses Feld obligatorisch zu machen. Der Freitext-Datentyp ermöglicht lokale Variationen, indem er die Anwendung anderer Wertesätze auf dieses Datenelement in einer Vorlage ermöglicht. In dieser Situation wird empfohlen, Werte mithilfe einer Terminologie zu codieren."> source = <"FHIR, DAM"> > ["at0064"] = < text = <"Nicht bestätigt"> description = <"*The propensity for a reaction to the identified 'Substance' has not been objectively verified. (en)"> > ["at0065"] = < text = <"Bestätigt"> description = <"*The propensity for a reaction to the identified 'Substance' has been objectively verified. This may include clinical evidence by testing, re-challenge or observation. (en)"> > ["at0066"] = < text = <"Widerlegt"> description = <"*A propensity for a reaction to the identified 'Substance' has been disputed or disproven with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation. (en)"> > ["at0101"] = < text = <"Kritikalität"> description = <"Ein Hinweis auf das Potenzial für kritische Systemorganschäden oder lebensbedrohliche Folgen."> comment = <"Dies kann als vorausschauende Beurteilung eines „Worst-Case-Szenarios“ angesehen werden. In den meisten Zusammenhängen wird „Niedrig“ als Standardwert angesehen."> source = <"DAM, openEHR"> > ["at0102"] = < text = <"Niedrig"> description = <"Die Exposition gegenüber Substanzen führt wahrscheinlich nicht zu kritischen Schäden von Systemorganen oder zu lebensbedrohlichen Folgen. Eine künftige Exposition gegenüber der identifizierten „Substanz“ sollte unter normalen klinischen Umständen als relative Kontraindikation angesehen werden."> > ["at0103"] = < text = <"Hoch"> description = <"Die Exposition gegenüber Substanzen kann zu kritischen Schäden von Systemorganen oder zu lebensbedrohlichen Folgen führen. Eine künftige Exposition gegenüber der identifizierten „Substanz“ sollte unter normalen klinischen Umständen als absolute Kontraindikation angesehen werden."> > ["at0117"] = < text = <"Beginn der letzten Reaktion"> description = <"Datum und/ oder Uhrzeit des Beginns des letzten bekannten Auftretens eines Reaktionsereignisses."> comment = <"Zum Beispiel: das tatsächliche Datum und/oder die tatsächliche Uhrzeit des Beginns; das Zeitintervall, in dem der Beginn erfolgte; das Alter der Person zum Zeitpunkt des Ausbruchs; oder die Zeitspanne seit dem Ausbruch. Bei Verwendung des Datentyps DV_DATE_TIME ist ein Teildatum gültig, um nur ein Jahr aufzuzeichnen."> source = <"IMH"> > ["at0120"] = < text = <"Kategorie"> description = <"Kategorie der identifizierten \"Substanz\"."> comment = <"Dieses Datenelement wurde aufgenommen, da es derzeit in einigen klinischen Systemen erfasst wird. Diese Daten können von der Substanz abgeleitet werden, in der Codierungssysteme verwendet werden und sind in dieser Situation effektiv redundant."> > ["at0121"] = < text = <"Lebensmittel"> description = <"Jede Substanz, die konsumiert wird, um dem Körper Nahrung zu liefern, wie Erdnuss oder Ei."> > ["at0122"] = < text = <"Medikament"> description = <"Jede Substanz, die verabreicht wird, um eine physiologische Wirkung zu erzielen."> > ["at0123"] = < text = <"Andere"> description = <"Alle anderen auftretende Substanzen, einschließlich Gift, Latex und anderer Substanzen aus der Umwelt."> > ["at0124"] = < text = <"Unbestimmt"> description = <"Eine Bewertung ist mit verfügbaren Informationen nicht möglich."> > ["at0126"] = < text = <"Unbestimmt"> description = <"Der physiologische Mechanismus konnte nicht bestimmt werden."> > ["at0128"] = < text = <"Erweiterung"> description = <"Zusätzliche Informationen zur Erfassung lokaler Inhalte oder Anpassung an andere Referenzmodelle/Formalismen."> comment = <"Zum Beispiel: lokale Informationsanforderungen oder zusätzliche Metadaten zur Anpassung an FHIR-Äquivalente."> > ["at0129"] = < text = <"Zusammenfassung des Reaktionsereignis"> description = <"Zusammenfassende Details zu jedem Nebenwirkungsereignis im Zusammenhang mit der Exposition gegenüber dem identifizierten „Stoff“."> > ["at0130"] = < text = <"Aktiver/inaktiver Status"> description = <"Status darüber, ob die Risikoerklärung zu Nebenwirkungen aktiv oder inaktiv ist."> > ["at0131"] = < text = <"Aktiv"> description = <"Bei der Person kommt es derzeit zu einer Reaktion auf die identifizierte Substanz oder es besteht die Gefahr einer solchen."> > ["at0132"] = < text = <"Inaktiv"> description = <"Für den Probanden besteht kein Risiko mehr, dass er auf den identifizierten Stoff reagiert."> > ["at0133"] = < text = <"Beginn der ersten Reaktion"> description = <"Der Beginn des ersten bekannten Auftretens eines Reaktionsereignisses."> comment = <"Zum Beispiel: das tatsächliche Datum und/oder die tatsächliche Uhrzeit des Beginns; das Zeitintervall, in dem der Beginn erfolgte; das Alter der Person zum Zeitpunkt des Ausbruchs; oder die Zeitspanne seit dem Ausbruch. Bei Verwendung des Datentyps DV_DATE_TIME ist ein Teildatum gültig, um nur ein Jahr aufzuzeichnen."> > > > ["sv"] = < items = < ["at0000"] = < text = <"Biverkningsrisk"> description = <"*Clinical assessment of the propensity for an individual to experience a harmful or undesirable physiological response if exposed, or re-exposed, to a substance. (en)"> comment = <"Dessa substanser inkluderar bland annat: ett terapeutiskt ämne som administreras korrekt i en lämplig dos för individen; mat; material härrörande från växter eller djur; eller gift från insektsstick."> > ["at0001"] = < text = <"Tree"> description = <"@ internal @"> > ["at0002"] = < text = <"Substans"> description = <"Identifiering av ett ämne eller ämnesklass som anses utgöra en risk för en enskild reaktion."> 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. It is strongly recommended that the 'Substance' is 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. (en)"> source = <"openEHR,FHIR,DAM"> > ["at0006"] = < text = <"Kommentar"> description = <"Kommentarer avseende benägenheten för biverkningen som inte beskrivs i övriga fält."> comment = <"Exempelvis skäl för markering av \"Kritisk nivå\" som \"Hög risk\"; och instruktioner relaterade till framtida exponering eller administrering av ämnet, såsom administrering inom en intensivvårdsavdelning eller under kortikosteroidskydd."> source = <"openEHR"> > ["at0042"] = < text = <"Tree"> description = <"@ internal @"> > ["at0047"] = < text = <"Stöd till information i hälsojournal"> description = <"Koppling till ytterligare information om presentationen och fynd lokaliserad på annan plats i hälsojournalen, inklusive allergitestrapporter."> comment = <"*For example, presenting symptoms, examination findings, diagnosis etc. (en)"> source = <"FHIR, openEHR, DAM"> > ["at0058"] = < text = <"Reaktionsmekanism"> description = <"Identifiering av den underliggande fysiologiska mekanismen för biverkningen."> comment = <"Immunmedierad respons har traditionellt betraktats som en indikator för upptrappning av framtida risk. Dagens forskning tyder på att vissa reaktioner som man tidigare trodde var immuna i stället är icke-immuna och bär livshotande risk. Immunologiska tester kan ge bevis för mekanismen och orsakssubstansen. Inga tester kan dock erhålla 100% sensitivitet eller specificitet. Att de flesta kliniker INTE kommer att kunna skilja mekanismen för en specifik reaktion är välkänt. Detta dataelement ingår dock då många äldre system har fångat upp detta attribut."> source = <"FHIR, DAM"> > ["at0059"] = < text = <"Immunmedierad"> description = <"Immunmedierad reaktion, inklusive allergiska reaktioner och överkänslighet."> > ["at0060"] = < text = <"Icke immunmedierad"> description = <"En icke immunförmedlad reaktion, vilken kan inkludera pseudoallergiska reaktioner, biverkningar, intoleranser, läkemedeltoxicitet (exempelvis gentamicin)."> > ["at0062"] = < text = <"Senast uppdaterad"> description = <"Datum då benägenheten eller reaktionshändelsen uppdaterades."> > ["at0063"] = < text = <"*Verification status (en)"> description = <"Angivelse om sannolikheten att det identifierade ämnet som orsakar en reaktion även medför potentiella risker."> comment = <"*Decision support would typically raise alerts for 'Unconfirmed' and '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. 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. (en)"> source = <"FHIR, DAM"> > ["at0064"] = < text = <"*Unconfirmed (en)"> description = <"*The propensity for a reaction to the identified 'Substance' has not been objectively verified. (en)"> > ["at0065"] = < text = <"Bekräftat"> description = <"*The propensity for a reaction to the identified 'Substance' has been objectively verified. This may include clinical evidence by testing, re-challenge or observation. (en)"> > ["at0066"] = < text = <"Vederlagt"> description = <"*A propensity for a reaction to the identified 'Substance' has been disputed or disproven with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation. (en)"> > ["at0101"] = < text = <"Kritisk nivå"> description = <"En indikation på potentialen för kritiska organskador eller livshotande konsekvenser."> 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. (en)"> source = <"DAM, openEHR"> > ["at0102"] = < text = <"Låg"> description = <"Exponering för ämnet som sannolikt inte kan leda till kritiska organskador eller livshotande konsekvenser. Framtida exponering för det identifierade ämnet bör betraktas som en relativt kontraindikation under normala kliniska omständigheter."> > ["at0103"] = < text = <"Hög"> description = <"Exponering för ämnet kan leda till kritiska organskador eller livshotande konsekvenser. Framtida exponering för det identifierade ämnet bör betraktas som en absolut kontraindikation under normala kliniska omständigheter."> > ["at0117"] = < text = <"Debut av sista reaktionen"> description = <"Datum och/eller tid då den senast kända förekomsten av en reaktionshändelse började."> comment = <"*For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year. (en)"> source = <"IMH"> > ["at0120"] = < text = <"Kategori"> description = <"Kategori för identifierad \"Substans\"."> comment = <"Detta dataelement har inkluderats då det för närvarande registreras i vissa kliniska system. Denna data kan härledas från substansen där kodningssystem används, och är därför överflödigt i sådana situationer."> > ["at0121"] = < text = <"Mat"> description = <"Alla ämnen som konsumeras för att ge kroppen näringsstöd, såsom jordnötter eller ägg."> > ["at0122"] = < text = <"Läkemedel"> description = <"Alla substanser som administreras för att uppnå en fysiologisk effekt."> > ["at0123"] = < text = <"Annat"> description = <"Alla andra ämnen som påträffas inklusive gift, latex och andra miljöämnen."> > ["at0124"] = < text = <"Obestämbar"> description = <"Det går inte att bedöma med tillgänglig information."> > ["at0126"] = < text = <"Obestämd"> description = <"Den fysiologiska mekanismen kunde inte bestämmas."> > ["at0128"] = < text = <"Tilläggsinformation"> description = <"Plats för att infoga tilläggsinformation som krävs för lokala anpassningar eller anpassning till andra referensmodeller eller formella krav."> comment = <"*For example: local information requirements or additional metadata to align with FHIR equivalents. (en)"> > ["at0129"] = < text = <"*Reaction event summary (en)"> description = <"*Summary details about each adverse reaction event linked to exposure to the identified 'Substance'. (en)"> > ["at0130"] = < text = <"*Active/inactive status (en)"> description = <"*Status about whether the adverse reaction risk statement is active or inactive. (en)"> > ["at0131"] = < text = <"*Active (en)"> description = <"*The subject is currently experiencing, or is at risk of, a reaction to the identified substance. (en)"> > ["at0132"] = < text = <"*Inactive (en)"> description = <"*The subject is no longer at risk of a reaction to the identified substance. (en)"> > ["at0133"] = < text = <"*Onset of first reaction (en)"> description = <"*The onset of the first known occurrence of a reaction event. (en)"> comment = <"*For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year. (en)"> > > > >