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Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the ClinicalUseIssue resource.

ClinicalUseIssue
Element IdClinicalUseIssue
Definition

A single item of clinical particulars - an indication, contraindication, interaction etc. for a medicinal product.

Cardinality0..*
TypeDomainResource
Summarytrue
ClinicalUseIssue.type
Element IdClinicalUseIssue.type
Definition

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

Cardinality1..1
Terminology BindingClinicalUseIssueType (Required)
Typecode
Summarytrue
ClinicalUseIssue.subject
Element IdClinicalUseIssue.subject
Definition

The medication or procedure for which this is an indication.

Cardinality0..*
TypeReference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance)
PatternsReference(MedicinalProductDefinition,Medication,ActivityDefinition,PlanDefinition,Device,DeviceDefinition,Substance): No common pattern
Summarytrue
ClinicalUseIssue.description
Element IdClinicalUseIssue.description
Definition

General description.

Cardinality0..1
Typestring
Summarytrue
ClinicalUseIssue.contraindication
Element IdClinicalUseIssue.contraindication
Definition

Specifics for when this is a contraindication.

Cardinality0..1
Summarytrue
ClinicalUseIssue.contraindication.diseaseSymptomProcedure
Element IdClinicalUseIssue.contraindication.diseaseSymptomProcedure
Definition

The disease, symptom or procedure for the contraindication.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.contraindication.diseaseStatus
Element IdClinicalUseIssue.contraindication.diseaseStatus
Definition

The status of the disease or symptom for the contraindication.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.contraindication.comorbidity
Element IdClinicalUseIssue.contraindication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection.

Cardinality0..*
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.contraindication.indication
Element IdClinicalUseIssue.contraindication.indication
Definition

The indication which this is a contraidication for.

Cardinality0..*
TypeReference(ClinicalUseIssue)
Summarytrue
ClinicalUseIssue.contraindication.otherTherapy
Element IdClinicalUseIssue.contraindication.otherTherapy
Definition

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

Cardinality0..*
Summarytrue
ClinicalUseIssue.contraindication.otherTherapy.therapyRelationshipType
Element IdClinicalUseIssue.contraindication.otherTherapy.therapyRelationshipType
Definition

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

Cardinality1..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.contraindication.otherTherapy.medication[x]
Element IdClinicalUseIssue.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.

Cardinality1..1
TypeCodeableConcept|Reference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition)
PatternsReference(MedicinalProductDefinition,Medication,Substance,SubstanceDefinition): No common pattern
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
ClinicalUseIssue.indication
Element IdClinicalUseIssue.indication
Definition

Specifics for when this is an indication.

Cardinality0..1
Summarytrue
ClinicalUseIssue.indication.diseaseSymptomProcedure
Element IdClinicalUseIssue.indication.diseaseSymptomProcedure
Definition

The disease, symptom or procedure for the indication.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.indication.diseaseStatus
Element IdClinicalUseIssue.indication.diseaseStatus
Definition

The status of the disease or symptom for the indication.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.indication.comorbidity
Element IdClinicalUseIssue.indication.comorbidity
Definition

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

Cardinality0..*
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.indication.intendedEffect
Element IdClinicalUseIssue.indication.intendedEffect
Definition

For an indication - the intended effect, aim or strategy to be achieved.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.indication.duration
Element IdClinicalUseIssue.indication.duration
Definition

For an indication - timing or duration information.

Cardinality0..1
TypeQuantity
Summarytrue
ClinicalUseIssue.indication.undesirableEffect
Element IdClinicalUseIssue.indication.undesirableEffect
Definition

For an indicaton - the specific undesirable effects of the medicinal product.

Cardinality0..*
TypeReference(ClinicalUseIssue)
Summarytrue
ClinicalUseIssue.indication.otherTherapy
Element IdClinicalUseIssue.indication.otherTherapy
Definition

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

Cardinality0..*
TypeSee ClinicalUseIssue.contraindication.otherTherapy
Summarytrue
ClinicalUseIssue.interaction
Element IdClinicalUseIssue.interaction
Definition

Specifics for when this is an interaction.

Cardinality0..1
Summarytrue
ClinicalUseIssue.interaction.interactant
Element IdClinicalUseIssue.interaction.interactant
Definition

The specific medication, food or laboratory test that interacts.

Cardinality0..*
Summarytrue
ClinicalUseIssue.interaction.interactant.item[x]
Element IdClinicalUseIssue.interaction.interactant.item[x]
Definition

The specific medication, food or laboratory test that interacts.

Cardinality1..1
TypeReference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)|CodeableConcept
PatternsReference(MedicinalProductDefinition,Medication,Substance,ObservationDefinition): No common pattern
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
ClinicalUseIssue.interaction.type
Element IdClinicalUseIssue.interaction.type
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.interaction.effect
Element IdClinicalUseIssue.interaction.effect
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.interaction.incidence
Element IdClinicalUseIssue.interaction.incidence
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.interaction.management
Element IdClinicalUseIssue.interaction.management
Definition

Actions for managing the interaction.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.population
Element IdClinicalUseIssue.population
Definition

The population group to which this applies.

Cardinality0..*
TypePopulation
Summarytrue
ClinicalUseIssue.undesirableEffect
Element IdClinicalUseIssue.undesirableEffect
Definition

Describe the undesirable effects of the medicinal product.

Cardinality0..1
Summarytrue
ClinicalUseIssue.undesirableEffect.symptomConditionEffect
Element IdClinicalUseIssue.undesirableEffect.symptomConditionEffect
Definition

The symptom, condition or undesirable effect.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.undesirableEffect.classification
Element IdClinicalUseIssue.undesirableEffect.classification
Definition

Classification of the effect.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence
Element IdClinicalUseIssue.undesirableEffect.frequencyOfOccurrence
Definition

The frequency of occurrence of the effect.

Cardinality0..1
TypeCodeableConcept
Summarytrue