HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento
1.0.0 - CI Build
HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento
1.0.0 - CI Build
HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento, published by HL7 Portugal. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-pt/adr-ig/ and changes regularly. See the Directory of published versions
| Official URL: https://hl7.pt/fhir/ADR/StructureDefinition/ReacaoAdversa | Version: 1.0.0 | |||
| Active as of 2024-11-21 | Computable Name: ReacaoAdversa | |||
Perfil para notificação de RAM
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdverseEvent
| Path | Conformance | ValueSet | URI |
| AdverseEvent.code | preferred | meddraVS (a valid code from urn:ietf:rfc:3986)https://hl7.pt/fhir/ADR/ValueSet/meddra-vsfrom this IG | |
| AdverseEvent.seriousness | required | GravidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vsfrom this IG | |
| AdverseEvent.outcome | required | EvolucaoVS (a valid code from Evolução de uma RAM code system)https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vsfrom this IG | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | required | causalidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vsfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
SΣ | 0..* | Identifier | Identificação da reacção |
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. |
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
| code |
SΣ | 1..1 | CodeableConcept | Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred) |
 subject |
SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção |
  occurrence[x] |
SΣ | 0..1 | Data inicio e duração reacção | |
 occurrenceDateTime |
dateTime | |||
| occurrencePeriod |
Period | |||
 occurrenceTiming |
Timing | |||
| seriousness |
SΣ | 0..1 | CodeableConcept | Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required) |
| outcome |
SΣ | 0..* | CodeableConcept | Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required) |
| recorder |
SΣ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador |
| suspectEntity |
SΣ | 1..1 | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance[x] |
SΣ | 1..1 | Medicamento suspeito da reaação adversa | |
| instanceCodeableConcept |
CodeableConcept | |||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
 causality |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessmentMethod |
SΣ | 0..1 | CodeableConcept | Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO. |
| entityRelatedness |
SΣ | 0..1 | CodeableConcept | Grau de causalidade Binding: Causalidade ValueSet (required) |
| preventiveAction |
SΣ | 0..* | BackboneElement | Medida Tomada |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item[x] |
Σ | 1..1 | Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | |
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept |
CodeableConcept | |||
| mitigatingAction |
SΣ | 0..* | BackboneElement | Medida Tomada |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item[x] |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | |
| itemReference |
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept |
CodeableConcept | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.code | preferred | meddraVS (a valid code from urn:ietf:rfc:3986)https://hl7.pt/fhir/ADR/ValueSet/meddra-vsfrom this IG | |
| AdverseEvent.seriousness | required | GravidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vsfrom this IG | |
| AdverseEvent.outcome | required | EvolucaoVS (a valid code from Evolução de uma RAM code system)https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vsfrom this IG | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | required | causalidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vsfrom this IG | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom the FHIR Standard | |
| AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-actionfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 0..* | Identifier | Identificação da reacção | ||||
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. | ||||
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| category |
Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational. | ||||
| code |
SΣ | 1..1 | CodeableConcept | Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred) | ||||
| subject |
SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | ||||
| occurrence[x] |
SΣ | 0..1 | Data inicio e duração reacção | |||||
| occurrenceDateTime |
dateTime | |||||||
| occurrencePeriod |
Period | |||||||
| occurrenceTiming |
Timing | |||||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingEffect |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event | ||||
| location |
Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness |
SΣ | 0..1 | CodeableConcept | Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required) | ||||
| outcome |
SΣ | 0..* | CodeableConcept | Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required) | ||||
| recorder |
SΣ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador | ||||
| participant |
Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| function |
Σ | 0..1 | CodeableConcept | Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event. | ||||
| actor |
Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | ||||
| study |
Σ | 0..* | Reference(ResearchStudy) | Research study that the subject is enrolled in | ||||
| expectedInResearchStudy |
0..1 | boolean | Considered likely or probable or anticipated in the research study | |||||
| suspectEntity |
SΣ | 1..1 | BackboneElement | The suspected agent causing the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance[x] |
SΣ | 1..1 | Medicamento suspeito da reaação adversa | |||||
| instanceCodeableConcept |
CodeableConcept | |||||||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||||||
| causality |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessmentMethod |
SΣ | 0..1 | CodeableConcept | Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| entityRelatedness |
SΣ | 0..1 | CodeableConcept | Grau de causalidade Binding: Causalidade ValueSet (required) | ||||
| author |
Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | ||||
| contributingFactor |
Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| preventiveAction |
SΣ | 0..* | BackboneElement | Medida Tomada | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | |||||
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| mitigatingAction |
SΣ | 0..* | BackboneElement | Medida Tomada | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | |||||
| itemReference |
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| supportingInfo |
Σ | 0..* | BackboneElement | Supporting information relevant to the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| note |
Σ | 0..* | Annotation | Comment on adverse event | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.category | example | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | |
| AdverseEvent.code | preferred | meddraVS (a valid code from urn:ietf:rfc:3986)https://hl7.pt/fhir/ADR/ValueSet/meddra-vsfrom this IG | |
| AdverseEvent.seriousness | required | GravidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vsfrom this IG | |
| AdverseEvent.outcome | required | EvolucaoVS (a valid code from Evolução de uma RAM code system)https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vsfrom this IG | |
| AdverseEvent.participant.function | example | AdverseEventParticipantFunctionhttp://hl7.org/fhir/ValueSet/adverse-event-participant-functionfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | required | causalidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vsfrom this IG | |
| AdverseEvent.contributingFactor.item[x] | example | AdverseEventContributingFactorhttp://hl7.org/fhir/ValueSet/adverse-event-contributing-factorfrom the FHIR Standard | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom the FHIR Standard | |
| AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-actionfrom the FHIR Standard | |
| AdverseEvent.supportingInfo.item[x] | example | AdverseEventSupportingInforationhttp://hl7.org/fhir/ValueSet/adverse-event-supporting-infofrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from AdverseEvent
Differential View
This structure is derived from AdverseEvent
| Path | Conformance | ValueSet | URI |
| AdverseEvent.code | preferred | meddraVS (a valid code from urn:ietf:rfc:3986)https://hl7.pt/fhir/ADR/ValueSet/meddra-vsfrom this IG | |
| AdverseEvent.seriousness | required | GravidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vsfrom this IG | |
| AdverseEvent.outcome | required | EvolucaoVS (a valid code from Evolução de uma RAM code system)https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vsfrom this IG | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | required | causalidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vsfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
SΣ | 0..* | Identifier | Identificação da reacção |
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. |
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. |
| code |
SΣ | 1..1 | CodeableConcept | Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred) |
| subject |
SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção |
| occurrence[x] |
SΣ | 0..1 | Data inicio e duração reacção | |
| occurrenceDateTime |
dateTime | |||
| occurrencePeriod |
Period | |||
| occurrenceTiming |
Timing | |||
| seriousness |
SΣ | 0..1 | CodeableConcept | Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required) |
| outcome |
SΣ | 0..* | CodeableConcept | Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required) |
| recorder |
SΣ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador |
| suspectEntity |
SΣ | 1..1 | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance[x] |
SΣ | 1..1 | Medicamento suspeito da reaação adversa | |
| instanceCodeableConcept |
CodeableConcept | |||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
| causality |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessmentMethod |
SΣ | 0..1 | CodeableConcept | Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO. |
| entityRelatedness |
SΣ | 0..1 | CodeableConcept | Grau de causalidade Binding: Causalidade ValueSet (required) |
| preventiveAction |
SΣ | 0..* | BackboneElement | Medida Tomada |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item[x] |
Σ | 1..1 | Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | |
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept |
CodeableConcept | |||
| mitigatingAction |
SΣ | 0..* | BackboneElement | Medida Tomada |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item[x] |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | |
| itemReference |
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept |
CodeableConcept | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.code | preferred | meddraVS (a valid code from urn:ietf:rfc:3986)https://hl7.pt/fhir/ADR/ValueSet/meddra-vsfrom this IG | |
| AdverseEvent.seriousness | required | GravidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vsfrom this IG | |
| AdverseEvent.outcome | required | EvolucaoVS (a valid code from Evolução de uma RAM code system)https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vsfrom this IG | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | required | causalidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vsfrom this IG | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom the FHIR Standard | |
| AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-actionfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent |
0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 0..* | Identifier | Identificação da reacção | ||||
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. | ||||
| actuality |
?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. | ||||
| category |
Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational. | ||||
| code |
SΣ | 1..1 | CodeableConcept | Código da Reacção que aconteceu Binding: MedDRA ValueSet (preferred) | ||||
| subject |
SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Doente sobre o qual existiu uma potencial reacção | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | ||||
| occurrence[x] |
SΣ | 0..1 | Data inicio e duração reacção | |||||
| occurrenceDateTime |
dateTime | |||||||
| occurrencePeriod |
Period | |||||||
| occurrenceTiming |
Timing | |||||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingEffect |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event | ||||
| location |
Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness |
SΣ | 0..1 | CodeableConcept | Seriousness or gravity of the event Binding: Gravidade RAM ValueSet (required) | ||||
| outcome |
SΣ | 0..* | CodeableConcept | Type of outcome from the adverse event Binding: Evolução de uma RAM ValueSet (required) | ||||
| recorder |
SΣ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Notificador | ||||
| participant |
Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| function |
Σ | 0..1 | CodeableConcept | Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event. | ||||
| actor |
Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | ||||
| study |
Σ | 0..* | Reference(ResearchStudy) | Research study that the subject is enrolled in | ||||
| expectedInResearchStudy |
0..1 | boolean | Considered likely or probable or anticipated in the research study | |||||
| suspectEntity |
SΣ | 1..1 | BackboneElement | The suspected agent causing the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance[x] |
SΣ | 1..1 | Medicamento suspeito da reaação adversa | |||||
| instanceCodeableConcept |
CodeableConcept | |||||||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||||||
| causality |
Σ | 0..1 | BackboneElement | Information on the possible cause of the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessmentMethod |
SΣ | 0..1 | CodeableConcept | Método de imputação de causalidade Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| entityRelatedness |
SΣ | 0..1 | CodeableConcept | Grau de causalidade Binding: Causalidade ValueSet (required) | ||||
| author |
Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | ||||
| contributingFactor |
Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| preventiveAction |
SΣ | 0..* | BackboneElement | Medida Tomada | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Action that contributed to avoiding the adverse event Binding: AdverseEventPreventiveAction (example): Codes describing the preventive actions that contributed to avoiding the adverse event. | |||||
| itemReference |
Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| mitigatingAction |
SΣ | 0..* | BackboneElement | Medida Tomada | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | |||||
| itemReference |
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| supportingInfo |
Σ | 0..* | BackboneElement | Supporting information relevant to the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| note |
Σ | 0..* | Annotation | Comment on adverse event | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.category | example | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | |
| AdverseEvent.code | preferred | meddraVS (a valid code from urn:ietf:rfc:3986)https://hl7.pt/fhir/ADR/ValueSet/meddra-vsfrom this IG | |
| AdverseEvent.seriousness | required | GravidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vsfrom this IG | |
| AdverseEvent.outcome | required | EvolucaoVS (a valid code from Evolução de uma RAM code system)https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vsfrom this IG | |
| AdverseEvent.participant.function | example | AdverseEventParticipantFunctionhttp://hl7.org/fhir/ValueSet/adverse-event-participant-functionfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | required | causalidadeVS (a valid code from Causalidade code system)https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vsfrom this IG | |
| AdverseEvent.contributingFactor.item[x] | example | AdverseEventContributingFactorhttp://hl7.org/fhir/ValueSet/adverse-event-contributing-factorfrom the FHIR Standard | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom the FHIR Standard | |
| AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-actionfrom the FHIR Standard | |
| AdverseEvent.supportingInfo.item[x] | example | AdverseEventSupportingInforationhttp://hl7.org/fhir/ValueSet/adverse-event-supporting-infofrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from AdverseEvent
Other representations of profile: CSV, Excel, Schematron
