---
type: "resource-definitions"
title: "ClinicalUseDefinition Definitions"
resource: "ClinicalUseDefinition"
---
# ClinicalUseDefinition Definitions
## ClinicalUseDefinition
A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
**Definition:** A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.
**Cardinality:** 0..*
**Constraints:** cud-1 | error | Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance | (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2; cud-2 | error | ClinicalUseDefinition.contraindication can only be used when type is 'contraindication' | ClinicalUseDefinition.contraindication.empty() or ClinicalUseDefinition.type='contraindication'; cud-3 | error | ClinicalUseDefinition.indication can only be used when type is 'indication' | ClinicalUseDefinition.indication.empty() or ClinicalUseDefinition.type='indication'; cud-4 | error | ClinicalUseDefinition.undesirableEffect can only be used when type is 'undesirable-effect' | ClinicalUseDefinition.undesirableEffect.empty() or ClinicalUseDefinition.type='undesirable-effect'; cud-5 | error | ClinicalUseDefinition.interaction can only be used when type is 'interaction' | ClinicalUseDefinition.interaction.empty() or ClinicalUseDefinition.type='interaction'; cud-6 | error | ClinicalUseDefinition.warning can only be used when type is 'warning' | ClinicalUseDefinition.warning.empty() or ClinicalUseDefinition.type='warning'
**Mappings:** workflow=Definition; idmp=Contraindication, Therapeutic Indication, Interactions, Undesirable Effects; w5=clinical.general
## ClinicalUseDefinition.identifier
Business identifier for this issue
**Definition:** Business identifier for this issue.
**Cardinality:** 0..*
**Type:** [Identifier](/Identifier)
**Summary:** true
**Mappings:** workflow=Definition.identifier; idmp=n/a; w5=FiveWs.class
## ClinicalUseDefinition.type
indication | contraindication | interaction | undesirable-effect | warning
**Definition:** indication | contraindication | interaction | undesirable-effect | warning.
**Cardinality:** 1..1
**Type:** [code](/code)
**Binding:** required:[clinical-use-definition-type](/valueset-clinical-use-definition-type)
**Summary:** true
**Mappings:** idmp=(the type of IDMP class, out of Contraindication, Therapeutic Indication, Interactions, Undesirable Effects)
## ClinicalUseDefinition.category
A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
**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](/CodeableConcept)
**Binding:** preferred:[clinical-use-definition-category](/valueset-clinical-use-definition-category)
**Summary:** true
**Mappings:** idmp=n/a
## ClinicalUseDefinition.subject
The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
**Definition:** The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning.
**Cardinality:** 1..*
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[medication-codes](/valueset-medication-codes)
**Summary:** true
**Mappings:** workflow=Definition.subject; idmp=(the link between the IDMP class and Medicinal Product)
## ClinicalUseDefinition.status
Whether this is a current issue or one that has been retired etc
**Definition:** Whether this is a current issue or one that has been retired etc.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** preferred:[publication-status](/valueset-publication-status)
**Summary:** true
**Is Modifier:** true (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)
**Mappings:** workflow=Definition.status; idmp=n/a
## ClinicalUseDefinition.undesirableEffect
A possible negative outcome from the use of this treatment
**Definition:** Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.
**Conditions:** cud-1
**Cardinality:** 0..1
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=Undesirable Effects
## ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
The situation in which the undesirable effect may manifest
**Definition:** The situation in which the undesirable effect may manifest.
**Cardinality:** 0..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[undesirable-effect-symptom](/valueset-undesirable-effect-symptom)
**Summary:** true
**Mappings:** idmp=Undesirable Effects.Undesirable Effect as "Symptom / Condition / Effect"
## ClinicalUseDefinition.undesirableEffect.classification
High level classification of the effect
**Definition:** High level classification of the effect.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[undesirable-effect-classification](/valueset-undesirable-effect-classification)
**Summary:** true
**Mappings:** idmp=Undesirable Effects.Symptom / Condition / Effect Classification
## ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
How often the effect is seen
**Definition:** How often the effect is seen.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[undesirable-effect-frequency](/valueset-undesirable-effect-frequency)
**Summary:** true
**Mappings:** idmp=Undesirable Effects.Frequency of Occurrence
## ClinicalUseDefinition.undesirableEffect.management
Actions for managing the undesirable effect
**Definition:** Actions for managing the undesirable effect.
**Cardinality:** 0..*
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[interaction-management](/valueset-interaction-management)
**Summary:** true
## ClinicalUseDefinition.indication
Specifics for when this is an indication
**Definition:** Specifics for when this is an indication.
**Conditions:** cud-1
**Cardinality:** 0..1
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=Therapeutic Indication
## ClinicalUseDefinition.indication.diseaseSymptomProcedure
The situation that is being documented as an indication for this item
**Definition:** The situation that is being documented as an indication for this item.
**Cardinality:** 0..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[disease-symptom-procedure](/valueset-disease-symptom-procedure)
**Summary:** true
**Mappings:** idmp=Therapeutic Indication.Indication as "Disease / Symptom / Procedure", and Therapeutic Indication.Indication Text
## ClinicalUseDefinition.indication.diseaseStatus
The status of the disease or symptom for the indication
**Definition:** The status of the disease or symptom for the indication, for example "chronic" or "metastatic".
**Cardinality:** 0..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[disease-status](/valueset-disease-status)
**Summary:** true
**Mappings:** idmp=Therapeutic Indication.Disease Status
## ClinicalUseDefinition.indication.comorbidity
A comorbidity or coinfection as part of the indication
**Definition:** A comorbidity (concurrent condition) or coinfection as part of the indication. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present.
**Cardinality:** 0..*
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[disease-symptom-procedure](/valueset-disease-symptom-procedure)
**Summary:** true
**Mappings:** idmp=Therapeutic Indication.Comorbidity
## ClinicalUseDefinition.indication.intendedEffect
The intended effect, aim or strategy to be achieved
**Definition:** The intended effect, aim or strategy to be achieved.
**Cardinality:** 0..*
**Type:** [CodeableReference](/CodeableReference)
**Binding:** preferred:[product-intended-use](/valueset-product-intended-use)
**Summary:** true
**Mappings:** idmp=Therapeutic Indication.Intended Effect
## ClinicalUseDefinition.indication.duration[x]
Timing or duration information
**Definition:** Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months).
**Cardinality:** 0..1
**Type:** [Range](/Range), [string](/string)
**Summary:** true
**Mappings:** idmp=Therapeutic Indication.Timing / Duration
## ClinicalUseDefinition.indication.undesirableEffect
An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
**Definition:** An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication.
**Cardinality:** 0..*
**Summary:** true
**Mappings:** idmp=Therapeutic Indication.Undesirable Effects
## ClinicalUseDefinition.indication.applicability
An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
**Definition:** An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.
**Comments:** The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.
**Cardinality:** 0..1
**Type:** [Expression](/Expression)
**Mappings:** idmp=n/a
## ClinicalUseDefinition.indication.otherTherapy
Information about use of the product in relation to other therapies described as part of the contraindication
**Definition:** Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.
**Cardinality:** 0..*
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=Contraindication.Other Therapy Specifics
## ClinicalUseDefinition.indication.otherTherapy.relationshipType
The type of relationship between the product indication/contraindication and another therapy
**Definition:** The type of relationship between the medicinal product indication or contraindication and another therapy.
**Cardinality:** 1..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** preferred:[therapy-relationship-type](/valueset-therapy-relationship-type)
**Summary:** true
**Mappings:** idmp=Other Therapy Specifics.Therapy Relationship Type
## ClinicalUseDefinition.indication.otherTherapy.treatment
Reference to a specific medication, substance etc. as part of an indication or contraindication
**Definition:** Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication.
**Cardinality:** 1..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[therapy](/valueset-therapy)
**Summary:** true
**Mappings:** idmp=Other Therapy Specifics.Medication
## ClinicalUseDefinition.contraindication
Specifics for when this is a contraindication
**Definition:** Specifics for when this is a contraindication.
**Conditions:** cud-1
**Cardinality:** 0..1
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=Contraindication
## ClinicalUseDefinition.contraindication.diseaseSymptomProcedure
The situation that is being documented as contraindicating against this item
**Definition:** The situation that is being documented as contraindicating against this item.
**Cardinality:** 0..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[disease-symptom-procedure](/valueset-disease-symptom-procedure)
**Summary:** true
**Mappings:** idmp=Contraindication.Contraindications as "Disease / Symptom / Procedure" and Contraindication.Contraindications Text
## ClinicalUseDefinition.contraindication.diseaseStatus
The status of the disease or symptom for the contraindication
**Definition:** The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic".
**Cardinality:** 0..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[disease-status](/valueset-disease-status)
**Summary:** true
**Mappings:** idmp=Contraindication.Disease Status
## ClinicalUseDefinition.contraindication.comorbidity
A comorbidity (concurrent condition) or coinfection
**Definition:** A comorbidity (concurrent condition) or coinfection. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present.
**Cardinality:** 0..*
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[disease-symptom-procedure](/valueset-disease-symptom-procedure)
**Summary:** true
**Mappings:** idmp=Contraindication.Comorbidity
## ClinicalUseDefinition.contraindication.indication
The indication which this is a contraindication for
**Definition:** The indication which this is a contraindication for.
**Cardinality:** 0..*
**Summary:** true
**Mappings:** idmp=(the link from Contraindication to Therapeutic Indication)
## ClinicalUseDefinition.contraindication.applicability
An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
**Definition:** An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.
**Comments:** The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.
**Cardinality:** 0..1
**Type:** [Expression](/Expression)
**Mappings:** idmp=n/a
## ClinicalUseDefinition.contraindication.management
Actions for managing the contraindication
**Definition:** Actions for managing the contraindication.
**Cardinality:** 0..*
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[interaction-management](/valueset-interaction-management)
**Summary:** true
## ClinicalUseDefinition.contraindication.otherTherapy
Information about use of the product in relation to other therapies described as part of the contraindication
**Definition:** Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.
**Cardinality:** 0..*
**Summary:** true
**Mappings:** idmp=Contraindication.Other Therapy Specifics
## ClinicalUseDefinition.interaction
Specifics for when this is an interaction
**Definition:** Specifics for when this is an interaction.
**Conditions:** cud-1
**Cardinality:** 0..1
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=Interactions
## ClinicalUseDefinition.interaction.interactant
The specific medication, product, food etc. or laboratory test that interacts
**Definition:** The specific medication, product, food, substance etc. or laboratory test that interacts.
**Cardinality:** 0..*
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=Interactions.Interactant and Interactions.Interactions Text
## ClinicalUseDefinition.interaction.interactant.item[x]
The specific medication, product, food etc. or laboratory test that interacts
**Definition:** The specific medication, product, food, substance etc. or laboratory test that interacts.
**Cardinality:** 1..1
**Type:** Reference([MedicinalProductDefinition](/MedicinalProductDefinition), [Medication](/Medication), [SubstanceDefinition](/SubstanceDefinition), [NutritionProduct](/NutritionProduct), [BiologicallyDerivedProduct](/BiologicallyDerivedProduct), [ObservationDefinition](/ObservationDefinition)), [CodeableConcept](/CodeableConcept)
**Binding:** example:[interactant](/valueset-interactant)
**Summary:** true
**Mappings:** idmp=Interactions.Interactant and Interactions.Interactions Text
## ClinicalUseDefinition.interaction.interactant.route
The route by which the item is administered to cause the interaction
**Definition:** The route by which the item is administered to cause the interaction.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[route-codes](/valueset-route-codes)
**Summary:** false
**Mappings:** idmp=n/a
## ClinicalUseDefinition.interaction.type
The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
**Definition:** The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[interaction-type](/valueset-interaction-type)
**Summary:** true
**Mappings:** idmp=Interactions.Interactions Type
## ClinicalUseDefinition.interaction.effect
The effect of the interaction, for example "reduced gastric absorption of primary medication"
**Definition:** The effect of the interaction, for example "reduced gastric absorption of primary medication".
**Cardinality:** 0..1
**Type:** [CodeableReference](/CodeableReference)
**Binding:** example:[interaction-effect](/valueset-interaction-effect)
**Summary:** true
**Mappings:** idmp=Interactions.Interactions Effect
## ClinicalUseDefinition.interaction.incidence
The incidence of the interaction, e.g. theoretical, observed
**Definition:** The incidence of the interaction, e.g. theoretical, observed.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[interaction-incidence](/valueset-interaction-incidence)
**Summary:** true
**Mappings:** idmp=Interactions.Interactions Incidence
## ClinicalUseDefinition.interaction.management
Actions for managing the interaction
**Definition:** Actions for managing the interaction.
**Cardinality:** 0..*
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[interaction-management](/valueset-interaction-management)
**Summary:** true
**Mappings:** idmp=Interactions.Management Actions
## ClinicalUseDefinition.interaction.severity
The severity of the interaction
**Definition:** The severity of the interaction.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[reaction-event-severity](/valueset-reaction-event-severity)
**Summary:** true
**Mappings:** idmp=n/a
## ClinicalUseDefinition.population
The population group to which this applies
**Definition:** The population group to which this applies.
**Cardinality:** 0..*
**Type:** Reference([Group](/Group))
**Summary:** true
**Mappings:** idmp=Population Specifics
## ClinicalUseDefinition.library
Logic used by the clinical use definition
**Definition:** Logic used by the clinical use definition.
**Cardinality:** 0..*
**Type:** [canonical](/canonical)
**Summary:** true
**Mappings:** idmp=n/a
## ClinicalUseDefinition.warning
Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
**Definition:** A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.
**Conditions:** cud-1
**Cardinality:** 0..1
**Type:** [BackboneElement](/BackboneElement)
**Summary:** true
**Mappings:** idmp=n/a
## ClinicalUseDefinition.warning.description
A textual definition of this warning, with formatting
**Definition:** A textual definition of this warning, with formatting.
**Cardinality:** 0..1
**Type:** [markdown](/markdown)
**Summary:** true
**Mappings:** idmp=n/a
## ClinicalUseDefinition.warning.code
A coded or unformatted textual definition of this warning
**Definition:** A coded or unformatted textual definition of this warning.
**Cardinality:** 0..1
**Type:** [CodeableConcept](/CodeableConcept)
**Binding:** example:[warning-type](/valueset-warning-type)
**Summary:** true
**Mappings:** idmp=n/a