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9.9 Resource AdverseEvent - Content

Patient Care icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Patient Compartments: Group, Patient, Practitioner, RelatedPerson

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

9.9.1 Scope and Usage

AdverseEvent is an event resource from a FHIR workflow perspective - see Workflow Event. A single Adverse Event may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events icon and Clinical Research adverse events icon provide important extensions, value-sets and examples for implementing AdverseEvent.

The guides reflect that adverse event tracking in clinical care and clinical research settings can differ. In the former case, the event is tracked to meet business safety concerns and incident reporting. There is a strong interest in factors surrounding the event, if it was prevented, what happened, and if it occurred, how it was resolved or managed. In the clinical research setting, the event is additionally tracked and evaluated as part of the clinical research process for the research study, since the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In clinical research trials, serious adverse events are usually required to be reported to the respective health authorities (e.g., U.S. FDA). For Clinical Care or Clinical Research, the Vulcan accelerator project suggests two AdverseEvent Resource profiles.

This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. There are also events that occur within a care setting that might or might not impact an individual but had the potential to cause an adverse event. Health care organizations monitor and report both adverse events as well as events that had the potential to cause patient harm. Data are often aggregated for reporting purposes and quality improvement initiatives.

An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome.

The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event.

In clinical care, a potential adverse event may also be called a near miss or an error. These are also events but, since they were detected, did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.

For examples and further guidance, it is strongly suggested that an implementer consult the Clinical Care AdverseEvent Implementation Guide icon and the Clinical Research AdverseEvent Implementation Guide icon They contain valuable extensions, value sets and, importantly, examples.

9.9.2 Boundaries and Relationships

The AdverseEvent resource is designed to represent events that had a harmful impact on a subject, or had the potential to cause harm to a subject but were avoided. In the course of medical care, there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore, the AdverseEvent resource may reference multiple other resources to represent the context or details of an adverse event such as Observation, Condition, MedicationAdministration, Immunization, Procedure, or ResearchStudy.

The AdverseEvent resource should not be used when a more specific resource exists.

  • The AllergyIntolerance resource is a case specific means of capturing the condition of an allergy or intolerance and the criticality (or potential for future harm) based on the response of a particular individual.
  • The Clinical Reasoning module provides resources and operations to enable the representation, distribution, and evaluation of clinical knowledge artifacts, such as clinical decision support rules, quality measures, order sets, and protocols. The suite of resources within the clinical reasoning module should be used to capture clinical quality measures and clinical protocols that help drive clinical best practices.
  • The AdverseEvent resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be RiskAssessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history, or list of potential health risks based on a patient's genetic analysis.
  • A DetectedIssue reference is also related to the context of an AdverseEvent to the extent that a known risk for a potential issue, such as a drug-drug interaction, is documented. If, in the context of a known issue, an adverse event occurs, citing this relationship is important for preventing such an occurrence in the future. DetectedIssue only applies to documenting a risk associated with a specific planned or ongoing action, or the lack of an action which should be planned - not a general propensity to risk.
  • Flags highlight highly condensed view of information found in other resources, which may include AdverseEvent. The purpose of these other resources is to provide detailed clinical information. The purpose of a Flag is to alert practitioners to information that is important to influence their interaction with a Patient prior to detailed review of the record.

9.9.3 References to this Resource

9.9.4 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent TU DomainResource An event that may be related to unintended effects on a patient or research participant

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ 0..* Identifier Business identifier for the event

... status ?!Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: Adverse Event Status (Required)
... actuality ?!Σ 1..1 code actual | potential
Binding: Adverse Event Actuality (Required)
... code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
Binding: AdverseEvent Type (Example)
... subject Σ 1..1 Reference(Patient | Group | Practitioner | RelatedPerson) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent
... cause[x] Σ 0..1 When the cause of the AdverseEvent occurred
.... causeDateTime dateTime
.... causePeriod Period
... effect[x] Σ 0..1 When the effect of the AdverseEvent occurred
.... effectDateTime dateTime
.... effectPeriod Period
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingEffect Σ 0..* CodeableReference(Condition | Observation) Effect on the subject due to this event
Binding: SNOMED CT Clinical Findings (Example)

... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness or gravity of the event
Binding: Adverse Event Seriousness (Example)
... outcome Σ 0..* CodeableConcept Type of outcome from the adverse event
Binding: AdverseEvent Outcome (Example)

... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... participant Σ 0..* BackboneElement Who was involved in the adverse event or the potential adverse event and what they did

.... function Σ 0..1 CodeableConcept Type of involvement
Binding: AdverseEvent Participant Function (Example)
.... actor Σ 1..1 Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | Group) 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 Σ 0..* BackboneElement The suspected agent causing the adverse event

.... instance Σ 1..1 CodeableReference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) Refers to the specific entity that caused the adverse event
.... causality Σ 0..1 BackboneElement Information on the possible cause of the event
..... assessmentMethod Σ 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Method (Example)
..... entityRelatedness Σ 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Assessment (Example)
..... author Σ 0..1 Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) Author of the information on the possible cause of the event
... contributingFactor Σ 0..* CodeableReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) Contributing factors suspected to have increased the probability or severity of the adverse event
Binding: AdverseEvent Contributing Factor (Example)

... preventiveAction Σ 0..* CodeableReference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) Preventive actions that contributed to avoiding the adverse event
Binding: AdverseEvent Preventive Action (Example)

... mitigatingAction Σ 0..* CodeableReference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
Binding: AdverseEvent Mitigating Action (Example)

... supportingInfo Σ 0..* CodeableReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) Subject medical history or document relevant to this adverse event
Binding: AdverseEvent Supporting Information (Example)

... note 0..* Annotation Comment on adverse event


doco Documentation for this format icon

See the Extensions for this resource

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

9.9.4.1 Terminology Bindings

Path ValueSet Type Documentation
AdverseEvent.status AdverseEventStatus Required

Codes identifying the lifecycle stage of an adverse event.
AdverseEvent.actuality AdverseEventActuality Required

Overall nature of the adverse event, e.g. real or potential.
AdverseEvent.category AdverseEventCategory Example

Overall categorization of the event, e.g. product-related or situational.
AdverseEvent.code AdverseEventType Example

This value set includes codes that describe the adverse event or incident that occurred or was averted.
AdverseEvent.resultingEffect SNOMEDCTClinicalFindings Example

This value set includes all the "Clinical finding" SNOMED CT icon codes - concepts where concept is-a 404684003 (Clinical finding (finding)).
AdverseEvent.seriousness AdverseEventSeriousness Example

Overall seriousness of this event for the patient.
AdverseEvent.outcome AdverseEventOutcome Example

This value set includes codes that describe the type of outcome from the adverse event.
AdverseEvent.participant.function AdverseEventParticipantFunction Example

This value set includes codes that describe the type of involvement of the actor in the adverse event.
AdverseEvent.suspectEntity.causality.assessmentMethod AdverseEventCausalityMethod Example

Codes for the method of evaluating the relatedness of the suspected entity to the adverse event
AdverseEvent.suspectEntity.causality.entityRelatedness AdverseEventCausalityAssessment Example

Codes for the assessment of whether the entity caused the event.
AdverseEvent.contributingFactor AdverseEventContributingFactor Example

This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event.
AdverseEvent.preventiveAction AdverseEventPreventiveAction Example

This value set includes codes that describe the preventive actions that contributed to avoiding the adverse event.
AdverseEvent.mitigatingAction AdverseEventMitigatingAction Example

This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.
AdverseEvent.supportingInfo AdverseEventSupportingInforation Example

This value set includes codes that describe the supporting information relevant to the event.



9.9.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
actuality token actual | potential AdverseEvent.actuality
category token wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site AdverseEvent.category
cause date When the cause of the event occurred AdverseEvent.cause.ofType(dateTime) | AdverseEvent.cause.ofType(Period)
code token Event or incident that occurred or was averted AdverseEvent.code 21 Resources
effect date When the effect of the event occurred AdverseEvent.effect.ofType(dateTime) | AdverseEvent.effect.ofType(Period)
identifier token Business identifier for the event AdverseEvent.identifier 65 Resources
location reference Location where adverse event occurred AdverseEvent.location
(Location)
patient reference Subject impacted by event AdverseEvent.subject.where(resolve() is Patient)
(Patient)		 65 Resources
recorder reference Who recorded the adverse event AdverseEvent.recorder
(Practitioner, Patient, PractitionerRole, RelatedPerson)
resultingeffect-code token Effect on the subject due to this event AdverseEvent.resultingEffect.concept
resultingeffect-reference reference Effect on the subject due to this event AdverseEvent.resultingEffect.reference
seriousness token Seriousness or gravity of the event AdverseEvent.seriousness
status token in-progress | completed | entered-in-error | unknown AdverseEvent.status
study reference Research study that the subject is enrolled in AdverseEvent.study
(ResearchStudy)
subject reference Subject impacted by event AdverseEvent.subject
(Practitioner, Group, Patient, RelatedPerson)
substance reference Refers to the specific entity that caused the adverse event AdverseEvent.suspectEntity.instance.reference