This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). 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 | 
| 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..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 | 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..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 | 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 |