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 | ||||||||