type: resource-definitionsresource: 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

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

Binding: required: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

Binding: preferred: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

Binding: example: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

Binding: preferred: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

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

Binding: example: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

Binding: example: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

Binding: example: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

Binding: example: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

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

Binding: example: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

Binding: example: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

Binding: example: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

Binding: preferred: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, 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

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

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

Binding: preferred: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

Binding: example: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

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

Binding: example: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

Binding: example: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

Binding: example: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

Mappings: idmp=n/a

ClinicalUseDefinition.contraindication.management

Actions for managing the contraindication

Definition: Actions for managing the contraindication.

Cardinality: 0..*

Type: CodeableConcept

Binding: example: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

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

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, Medication, SubstanceDefinition, NutritionProduct, BiologicallyDerivedProduct, ObservationDefinition), CodeableConcept

Binding: example: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

Binding: example: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

Binding: example: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

Binding: example: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

Binding: example: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

Binding: example: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

Binding: example: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)

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

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

Summary: true

Mappings: idmp=n/a