This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). 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 usage issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. |
| Cardinality | 0..* |
| Type | DomainResource |
| Summary | true |
| 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 Ability to Drive and Use Machines". |
| Cardinality | 0..1 |
| 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 | General description. |
| Cardinality | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| ClinicalUseIssue.description | |
| Element Id | ClinicalUseIssue.description |
| Definition | General description. |
| 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 | CodeableConcept |
| 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 | CodeableConcept |
| Summary | true |
| ClinicalUseIssue.contraindication.comorbidity | |
| Element Id | ClinicalUseIssue.contraindication.comorbidity |
| Definition | A comorbidity (concurrent condition) or coinfection. |
| Cardinality | 0..* |
| Type | CodeableConcept |
| 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 indication. |
| Cardinality | 0..* |
| Summary | true |
| ClinicalUseIssue.contraindication.otherTherapy.therapyRelationshipType | |
| Element Id | ClinicalUseIssue.contraindication.otherTherapy.therapyRelationshipType |
| 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.medication[x] | |
| Element Id | ClinicalUseIssue.contraindication.otherTherapy.medication[x] |
| 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 | CodeableConcept|Reference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition) |
| Patterns | Reference(MedicinalProductDefinition,Medication,Substance,SubstanceDefinition): No common pattern |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| 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 | CodeableConcept |
| 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 | CodeableConcept |
| 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 | CodeableConcept |
| Summary | true |
| ClinicalUseIssue.indication.intendedEffect | |
| Element Id | ClinicalUseIssue.indication.intendedEffect |
| Definition | For an indication - the intended effect, aim or strategy to be achieved. |
| Cardinality | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| ClinicalUseIssue.indication.duration | |
| Element Id | ClinicalUseIssue.indication.duration |
| Definition | For an indication - timing or duration information. |
| Cardinality | 0..1 |
| Type | Quantity |
| Summary | true |
| ClinicalUseIssue.indication.undesirableEffect | |
| Element Id | ClinicalUseIssue.indication.undesirableEffect |
| Definition | For an indicaton - 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 contraindication. |
| 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 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 | CodeableConcept |
| 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..1 |
| 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 | CodeableConcept |
| 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 |