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Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

Detailed Descriptions for the elements in the ClinicalUseDefinition resource.

ClinicalUseDefinition
Element Id ClinicalUseDefinition
Definition

A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.

Short Display 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
Defined on this element
cud-1Rule 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
ClinicalUseDefinition.identifier
Element Id ClinicalUseDefinition.identifier
Definition

Business identifier for this issue.

Short Display Business identifier for this issue
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Summary true
ClinicalUseDefinition.type
Element Id ClinicalUseDefinition.type
Definition

indication | contraindication | interaction | undesirable-effect | warning.

Short Display indication | contraindication | interaction | undesirable-effect | warning
Cardinality 1..1
Terminology Binding Clinical Use Definition Type (Required)
Type code
Summary true
ClinicalUseDefinition.category
Element Id ClinicalUseDefinition.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".

Short Display A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
Cardinality 0..*
Terminology Binding Clinical Use Definition Category (Preferred)
Type CodeableConcept
Summary true
ClinicalUseDefinition.subject
Element Id ClinicalUseDefinition.subject
Definition

The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning.

Short Display The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
Cardinality 0..*
Type Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct)
Summary true
ClinicalUseDefinition.status
Element Id ClinicalUseDefinition.status
Definition

Whether this is a current issue or one that has been retired etc.

Short Display Whether this is a current issue or one that has been retired etc
Cardinality 0..1
Terminology Binding PublicationStatus (Preferred)
Type CodeableConcept
Summary true
ClinicalUseDefinition.contraindication
Element Id ClinicalUseDefinition.contraindication
Definition

Specifics for when this is a contraindication.

Short Display Specifics for when this is a contraindication
Cardinality 0..1
Summary true
Invariants
Affect this element
cud-1Rule 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
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure
Element Id ClinicalUseDefinition.contraindication.diseaseSymptomProcedure
Definition

The situation that is being documented as contraindicating against this item.

Short Display The situation that is being documented as contraindicating against this item
Cardinality 0..1
Terminology Binding Disease Symptom Procedure (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.contraindication.diseaseStatus
Element Id ClinicalUseDefinition.contraindication.diseaseStatus
Definition

The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic".

Short Display The status of the disease or symptom for the contraindication
Cardinality 0..1
Terminology Binding Disease Status (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.contraindication.comorbidity
Element Id ClinicalUseDefinition.contraindication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection.

Short Display A comorbidity (concurrent condition) or coinfection
Cardinality 0..*
Terminology Binding Disease Symptom Procedure (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.contraindication.indication
Element Id ClinicalUseDefinition.contraindication.indication
Definition

The indication which this is a contraidication for.

Short Display The indication which this is a contraidication for
Cardinality 0..*
Type Reference(ClinicalUseDefinition)
Summary true
ClinicalUseDefinition.contraindication.applicability
Element Id ClinicalUseDefinition.contraindication.applicability
Definition

An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.

Short Display An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
Cardinality 0..1
Type Expression
Summary false
Comments

The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.

ClinicalUseDefinition.contraindication.otherTherapy
Element Id ClinicalUseDefinition.contraindication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.

Short Display Information about use of the product in relation to other therapies described as part of the contraindication
Cardinality 0..*
Summary true
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType
Element Id ClinicalUseDefinition.contraindication.otherTherapy.relationshipType
Definition

The type of relationship between the medicinal product indication or contraindication and another therapy.

Short Display The type of relationship between the product indication/contraindication and another therapy
Cardinality 1..1
Terminology Binding Therapy Relationship Type (Preferred)
Type CodeableConcept
Summary true
ClinicalUseDefinition.contraindication.otherTherapy.treatment
Element Id ClinicalUseDefinition.contraindication.otherTherapy.treatment
Definition

Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication.

Short Display Reference to a specific medication, substance etc. as part of an indication or contraindication
Cardinality 1..1
Terminology Binding Therapy (Example)
Type CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition)
Summary true
ClinicalUseDefinition.indication
Element Id ClinicalUseDefinition.indication
Definition

Specifics for when this is an indication.

Short Display Specifics for when this is an indication
Cardinality 0..1
Summary true
Invariants
Affect this element
cud-1Rule 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
ClinicalUseDefinition.indication.diseaseSymptomProcedure
Element Id ClinicalUseDefinition.indication.diseaseSymptomProcedure
Definition

The situation that is being documented as an indicaton for this item.

Short Display The situation that is being documented as an indicaton for this item
Cardinality 0..1
Terminology Binding Disease Symptom Procedure (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.indication.diseaseStatus
Element Id ClinicalUseDefinition.indication.diseaseStatus
Definition

The status of the disease or symptom for the indication, for example "chronic" or "metastatic".

Short Display The status of the disease or symptom for the indication
Cardinality 0..1
Terminology Binding Disease Status (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.indication.comorbidity
Element Id ClinicalUseDefinition.indication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection as part of the indication.

Short Display A comorbidity or coinfection as part of the indication
Cardinality 0..*
Terminology Binding Disease Symptom Procedure (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.indication.intendedEffect
Element Id ClinicalUseDefinition.indication.intendedEffect
Definition

The intended effect, aim or strategy to be achieved.

Short Display The intended effect, aim or strategy to be achieved
Cardinality 0..1
Terminology Binding Product Intended Use (Preferred)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.indication.duration[x]
Element Id ClinicalUseDefinition.indication.duration[x]
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).

Short Display Timing or duration information
Cardinality 0..1
Type Range|string
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
ClinicalUseDefinition.indication.undesirableEffect
Element Id ClinicalUseDefinition.indication.undesirableEffect
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.

Short Display An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
Cardinality 0..*
Type Reference(ClinicalUseDefinition)
Summary true
ClinicalUseDefinition.indication.applicability
Element Id ClinicalUseDefinition.indication.applicability
Definition

An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.

Short Display An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
Cardinality 0..1
Type Expression
Summary false
Comments

The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.

ClinicalUseDefinition.indication.otherTherapy
Element Id ClinicalUseDefinition.indication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the indication.

Short Display The use of the medicinal product in relation to other therapies described as part of the indication
Cardinality 0..*
Type See ClinicalUseDefinition.contraindication.otherTherapy
Summary true
ClinicalUseDefinition.interaction
Element Id ClinicalUseDefinition.interaction
Definition

Specifics for when this is an interaction.

Short Display Specifics for when this is an interaction
Cardinality 0..1
Summary true
Invariants
Affect this element
cud-1Rule 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
ClinicalUseDefinition.interaction.interactant
Element Id ClinicalUseDefinition.interaction.interactant
Definition

The specific medication, product, food, substance etc. or laboratory test that interacts.

Short Display The specific medication, product, food etc. or laboratory test that interacts
Cardinality 0..*
Summary true
ClinicalUseDefinition.interaction.interactant.item[x]
Element Id ClinicalUseDefinition.interaction.interactant.item[x]
Definition

The specific medication, product, food, substance etc. or laboratory test that interacts.

Short Display The specific medication, product, food etc. or laboratory test that interacts
Cardinality 1..1
Terminology Binding Interactant (Example)
Type Reference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition)|CodeableConcept
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
ClinicalUseDefinition.interaction.type
Element Id ClinicalUseDefinition.interaction.type
Definition

The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.

Short Display The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
Cardinality 0..1
Terminology Binding Interaction Type (Example)
Type CodeableConcept
Summary true
ClinicalUseDefinition.interaction.effect
Element Id ClinicalUseDefinition.interaction.effect
Definition

The effect of the interaction, for example "reduced gastric absorption of primary medication".

Short Display The effect of the interaction, for example "reduced gastric absorption of primary medication"
Cardinality 0..1
Terminology Binding Interaction Effect (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.interaction.incidence
Element Id ClinicalUseDefinition.interaction.incidence
Definition

The incidence of the interaction, e.g. theoretical, observed.

Short Display The incidence of the interaction, e.g. theoretical, observed
Cardinality 0..1
Terminology Binding Interaction Incidence (Example)
Type CodeableConcept
Summary true
ClinicalUseDefinition.interaction.management
Element Id ClinicalUseDefinition.interaction.management
Definition

Actions for managing the interaction.

Short Display Actions for managing the interaction
Cardinality 0..*
Terminology Binding Interaction Management (Example)
Type CodeableConcept
Summary true
ClinicalUseDefinition.population
Element Id ClinicalUseDefinition.population
Definition

The population group to which this applies.

Short Display The population group to which this applies
Cardinality 0..*
Type Reference(Group)
Summary true
ClinicalUseDefinition.library
Element Id ClinicalUseDefinition.library
Definition

Logic used by the clinical use definition.

Short Display Logic used by the clinical use definition
Cardinality 0..*
Type canonical(Library)
Summary true
ClinicalUseDefinition.undesirableEffect
Element Id ClinicalUseDefinition.undesirableEffect
Definition

Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.

Short Display A possible negative outcome from the use of this treatment
Cardinality 0..1
Summary true
Invariants
Affect this element
cud-1Rule 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
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Element Id ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Definition

The situation in which the undesirable effect may manifest.

Short Display The situation in which the undesirable effect may manifest
Cardinality 0..1
Terminology Binding Undesirable Effect Symptom (Example)
Type CodeableReference(ObservationDefinition)
Summary true
ClinicalUseDefinition.undesirableEffect.classification
Element Id ClinicalUseDefinition.undesirableEffect.classification
Definition

High level classification of the effect.

Short Display High level classification of the effect
Cardinality 0..1
Terminology Binding Undesirable Effect Classification (Example)
Type CodeableConcept
Summary true
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Element Id ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Definition

How often the effect is seen.

Short Display How often the effect is seen
Cardinality 0..1
Terminology Binding Undesirabl Effect Frequency (Example)
Type CodeableConcept
Summary true
ClinicalUseDefinition.warning
Element Id ClinicalUseDefinition.warning
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'.

Short Display Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
Cardinality 0..1
Summary true
Invariants
Affect this element
cud-1Rule 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
ClinicalUseDefinition.warning.description
Element Id ClinicalUseDefinition.warning.description
Definition

A textual definition of this warning, with formatting.

Short Display A textual definition of this warning, with formatting
Cardinality 0..1
Type markdown
Summary true
ClinicalUseDefinition.warning.code
Element Id ClinicalUseDefinition.warning.code
Definition

A coded or unformatted textual definition of this warning.

Short Display A coded or unformatted textual definition of this warning
Cardinality 0..1
Terminology Binding Warning Type (Example)
Type CodeableConcept
Summary true