This page is part of the FHIR Specification (v5.0.0-snapshot1: R5 Snapshot #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions
Biomedical Research and Regulation Work Group | Maturity Level: 1 | Trial Use | Security Category: Anonymous | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the ClinicalUseIssue resource.
ClinicalUseIssue | |||||||||
Element Id | ClinicalUseIssue | ||||||||
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. | ||||||||
Cardinality | 0..* | ||||||||
Type | DomainResource | ||||||||
Summary | false | ||||||||
Invariants |
| ||||||||
ClinicalUseIssue.identifier | |||||||||
Element Id | ClinicalUseIssue.identifier | ||||||||
Definition | Business identifier for this issue. | ||||||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||||||
Cardinality | 0..* | ||||||||
Type | Identifier | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.type | |||||||||
Element Id | ClinicalUseIssue.type | ||||||||
Definition | indication | contraindication | interaction | undesirable-effect | warning. | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | ClinicalUseIssueType (Required) | ||||||||
Type | code | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.category | |||||||||
Element Id | ClinicalUseIssue.category | ||||||||
Definition | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines". | ||||||||
Cardinality | 0..* | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.subject | |||||||||
Element Id | ClinicalUseIssue.subject | ||||||||
Definition | The medication or procedure for which this is an indication. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance) | ||||||||
Patterns | Reference(MedicinalProductDefinition,Medication,ActivityDefinition,PlanDefinition,Device,DeviceDefinition,Substance): No common pattern | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.status | |||||||||
Element Id | ClinicalUseIssue.status | ||||||||
Definition | Whether this is a current issue or one that has been retired etc. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.description | |||||||||
Element Id | ClinicalUseIssue.description | ||||||||
Definition | General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive". | ||||||||
Cardinality | 0..1 | ||||||||
Type | markdown | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication | |||||||||
Element Id | ClinicalUseIssue.contraindication | ||||||||
Definition | Specifics for when this is a contraindication. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.diseaseSymptomProcedure | |||||||||
Element Id | ClinicalUseIssue.contraindication.diseaseSymptomProcedure | ||||||||
Definition | The situation that is being documented as contraindicating against this item. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.diseaseStatus | |||||||||
Element Id | ClinicalUseIssue.contraindication.diseaseStatus | ||||||||
Definition | The status of the disease or symptom for the contraindication. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.comorbidity | |||||||||
Element Id | ClinicalUseIssue.contraindication.comorbidity | ||||||||
Definition | A comorbidity (concurrent condition) or coinfection. | ||||||||
Cardinality | 0..* | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.indication | |||||||||
Element Id | ClinicalUseIssue.contraindication.indication | ||||||||
Definition | The indication which this is a contraidication for. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(ClinicalUseIssue) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.otherTherapy | |||||||||
Element Id | ClinicalUseIssue.contraindication.otherTherapy | ||||||||
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the contraindication. | ||||||||
Cardinality | 0..* | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.otherTherapy.relationshipType | |||||||||
Element Id | ClinicalUseIssue.contraindication.otherTherapy.relationshipType | ||||||||
Definition | The type of relationship between the medicinal product indication or contraindication and another therapy. | ||||||||
Cardinality | 1..1 | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.contraindication.otherTherapy.therapy | |||||||||
Element Id | ClinicalUseIssue.contraindication.otherTherapy.therapy | ||||||||
Definition | Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. | ||||||||
Cardinality | 1..1 | ||||||||
Type | CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition) | ||||||||
Patterns | CodeableReference(MedicinalProductDefinition,Medication,Substance,SubstanceDefinition,ActivityDefinition): No common pattern | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication | |||||||||
Element Id | ClinicalUseIssue.indication | ||||||||
Definition | Specifics for when this is an indication. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.diseaseSymptomProcedure | |||||||||
Element Id | ClinicalUseIssue.indication.diseaseSymptomProcedure | ||||||||
Definition | The situation that is being documented as an indicaton for this item. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.diseaseStatus | |||||||||
Element Id | ClinicalUseIssue.indication.diseaseStatus | ||||||||
Definition | The status of the disease or symptom for the indication. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.comorbidity | |||||||||
Element Id | ClinicalUseIssue.indication.comorbidity | ||||||||
Definition | A comorbidity (concurrent condition) or coinfection as part of the indication. | ||||||||
Cardinality | 0..* | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.intendedEffect | |||||||||
Element Id | ClinicalUseIssue.indication.intendedEffect | ||||||||
Definition | The intended effect, aim or strategy to be achieved. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.duration | |||||||||
Element Id | ClinicalUseIssue.indication.duration | ||||||||
Definition | Timing or duration information. | ||||||||
Cardinality | 0..1 | ||||||||
Type | Quantity | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.undesirableEffect | |||||||||
Element Id | ClinicalUseIssue.indication.undesirableEffect | ||||||||
Definition | The specific undesirable effects of the medicinal product. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(ClinicalUseIssue) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.indication.otherTherapy | |||||||||
Element Id | ClinicalUseIssue.indication.otherTherapy | ||||||||
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the indication. | ||||||||
Cardinality | 0..* | ||||||||
Type | See ClinicalUseIssue.contraindication.otherTherapy | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction | |||||||||
Element Id | ClinicalUseIssue.interaction | ||||||||
Definition | Specifics for when this is an interaction. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction.interactant | |||||||||
Element Id | ClinicalUseIssue.interaction.interactant | ||||||||
Definition | The specific medication, food, substance or laboratory test that interacts. | ||||||||
Cardinality | 0..* | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction.interactant.item[x] | |||||||||
Element Id | ClinicalUseIssue.interaction.interactant.item[x] | ||||||||
Definition | The specific medication, food or laboratory test that interacts. | ||||||||
Cardinality | 1..1 | ||||||||
Type | Reference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)|CodeableConcept | ||||||||
Patterns | Reference(MedicinalProductDefinition,Medication,Substance,ObservationDefinition): No common pattern | ||||||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction.type | |||||||||
Element Id | ClinicalUseIssue.interaction.type | ||||||||
Definition | The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction.effect | |||||||||
Element Id | ClinicalUseIssue.interaction.effect | ||||||||
Definition | The effect of the interaction, for example "reduced gastric absorption of primary medication". | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction.incidence | |||||||||
Element Id | ClinicalUseIssue.interaction.incidence | ||||||||
Definition | The incidence of the interaction, e.g. theoretical, observed. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.interaction.management | |||||||||
Element Id | ClinicalUseIssue.interaction.management | ||||||||
Definition | Actions for managing the interaction. | ||||||||
Cardinality | 0..* | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.population | |||||||||
Element Id | ClinicalUseIssue.population | ||||||||
Definition | The population group to which this applies. | ||||||||
Cardinality | 0..* | ||||||||
Type | Population | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.undesirableEffect | |||||||||
Element Id | ClinicalUseIssue.undesirableEffect | ||||||||
Definition | Describe the undesirable effects of the medicinal product. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.undesirableEffect.symptomConditionEffect | |||||||||
Element Id | ClinicalUseIssue.undesirableEffect.symptomConditionEffect | ||||||||
Definition | The situation in which the undesirable effect may manifest. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.undesirableEffect.classification | |||||||||
Element Id | ClinicalUseIssue.undesirableEffect.classification | ||||||||
Definition | High level classification of the effect. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence | |||||||||
Element Id | ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence | ||||||||
Definition | How often the effect is seen. | ||||||||
Cardinality | 0..1 | ||||||||
Type | CodeableConcept | ||||||||
Summary | true |