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15.7 Resource ClinicalUseDefinition - Content

Biomedical Research and Regulation icon

Work Group

Maturity Level: 2

Trial Use

Security Category: Anonymous

Compartments: No defined compartments

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

15.7.1 Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

ClinicalUseDefinition is to record an instance of facts about a particular medication, substance, device, procedure, biologically derived product or nutrition product, in relation to its intended use (indication), situations where it should not normally be used (contraindication), known side effects (undesirable effects), clashes with other substances - medications, foods etc. (interactions) and critical information about risks or hazards to caution the user or consumer (warnings). The resource is used to record one such instance, and all its details.

15.7.2 Boundaries and Relationships

The ClinicalUseDefinition resource is designed to represent definitional facts about the potential use of a medication, substance, device, procedure, biologically derived product, or nutrition product.

These may be used when submitting a product dossier to regulators, as part of an electronic medication or medical device knowledge base, or directly during decision support activities.

The clinical issue does not refer to any actual instance of the medication, device or procedure etc. being used, or to any actual patient event.

The resource is used to record one instance of one of these:

Indication - A medical situation in which a medicinal product, medical device or procedure etc. is appropriate for use
Contraindication - A reason why a medicinal product, medical device or procedure etc. is not to be used in a certain context
Interaction - The interactions of the medicinal product or medical device etc. with other medicinal products, food, substances etc.
Undesirable Effect - A potential negative outcome from the use of a medicinal product, medical device or procedure etc. See also AdverseEvent, which is for actual events (or near misses), and AllergyIntolerance.
Warning – Critical information about the environmental or health or physical risks or hazards, that serve as caution to the user or consumer.

15.7.3 References to this Resource

Implements: Definition
Resource References: itself, MedicationKnowledge and RegulatedAuthorization

Structure

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition	TU		DomainResource	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure + Rule: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for this issue
type	Σ	1..1	code	indication \| contraindication \| interaction \| undesirable-effect \| warning Binding: Clinical Use Definition Type (Required)
category	Σ	0..*	CodeableConcept	A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: Clinical Use Definition Category (Preferred)
subject	Σ	0..*	Reference(MedicinalProductDefinition \| Medication \| ActivityDefinition \| PlanDefinition \| Device \| DeviceDefinition \| Substance \| NutritionProduct \| BiologicallyDerivedProduct)	The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
status	Σ	0..1	CodeableConcept	Whether this is a current issue or one that has been retired etc Binding: PublicationStatus (Preferred)
contraindication	Σ C	0..1	BackboneElement	Specifics for when this is a contraindication
diseaseSymptomProcedure	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as contraindicating against this item Binding: Disease Symptom Procedure (Example)
diseaseStatus	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the contraindication Binding: Disease Status (Example)
comorbidity	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity (concurrent condition) or coinfection Binding: Disease Symptom Procedure (Example)
indication	Σ	0..*	Reference(ClinicalUseDefinition)	The indication which this is a contraidication for
applicability		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
otherTherapy	Σ	0..*	BackboneElement	Information about use of the product in relation to other therapies described as part of the contraindication
relationshipType	Σ	1..1	CodeableConcept	The type of relationship between the product indication/contraindication and another therapy Binding: Therapy Relationship Type (Preferred)
treatment	Σ	1..1	CodeableReference(MedicinalProductDefinition \| Medication \| Substance \| SubstanceDefinition \| NutritionProduct \| BiologicallyDerivedProduct \| ActivityDefinition)	Reference to a specific medication, substance etc. as part of an indication or contraindication Binding: Therapy (Example)
indication	Σ C	0..1	BackboneElement	Specifics for when this is an indication
diseaseSymptomProcedure	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as an indicaton for this item Binding: Disease Symptom Procedure (Example)
diseaseStatus	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the indication Binding: Disease Status (Example)
comorbidity	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity or coinfection as part of the indication Binding: Disease Symptom Procedure (Example)
intendedEffect	Σ	0..1	CodeableReference(ObservationDefinition)	The intended effect, aim or strategy to be achieved Binding: Product Intended Use (Preferred)
duration[x]	Σ	0..1		Timing or duration information
durationRange			Range
durationString			string
undesirableEffect	Σ	0..*	Reference(ClinicalUseDefinition)	An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
applicability		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
otherTherapy	Σ	0..*	see otherTherapy	The use of the medicinal product in relation to other therapies described as part of the indication
interaction	Σ C	0..1	BackboneElement	Specifics for when this is an interaction
interactant	Σ	0..*	BackboneElement	The specific medication, product, food etc. or laboratory test that interacts
item[x]	Σ	1..1		The specific medication, product, food etc. or laboratory test that interacts Binding: Interactant (Example)
itemReference			Reference(MedicinalProductDefinition \| Medication \| Substance \| NutritionProduct \| BiologicallyDerivedProduct \| ObservationDefinition)
itemCodeableConcept			CodeableConcept
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug interaction, drug-lab test interaction Binding: Interaction Type (Example)
effect	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: Interaction Effect (Example)
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: Interaction Incidence (Example)
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: Interaction Management (Example)
population	Σ	0..*	Reference(Group)	The population group to which this applies
library	Σ	0..*	canonical(Library)	Logic used by the clinical use definition
undesirableEffect	Σ C	0..1	BackboneElement	A possible negative outcome from the use of this treatment
symptomConditionEffect	Σ	0..1	CodeableReference(ObservationDefinition)	The situation in which the undesirable effect may manifest Binding: Undesirable Effect Symptom (Example)
classification	Σ	0..1	CodeableConcept	High level classification of the effect Binding: Undesirable Effect Classification (Example)
frequencyOfOccurrence	Σ	0..1	CodeableConcept	How often the effect is seen Binding: Undesirabl Effect Frequency (Example)
warning	Σ C	0..1	BackboneElement	Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
description	Σ	0..1	markdown	A textual definition of this warning, with formatting
code	Σ	0..1	CodeableConcept	A coded or unformatted textual definition of this warning Binding: Warning Type (Example)
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<ClinicalUseDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for this issue --></identifier>
 <type value="[code]"/><!-- 1..1 indication | contraindication | interaction | undesirable-effect | warning -->
 <category><!-- 0..* CodeableConcept A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" --></category>
 <subject><!-- 0..* Reference(ActivityDefinition|BiologicallyDerivedProduct|
   Device|DeviceDefinition|Medication|MedicinalProductDefinition|
   NutritionProduct|PlanDefinition|Substance) The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning --></subject>
 <status><!-- 0..1 CodeableConcept Whether this is a current issue or one that has been retired etc --></status>
 <contraindication>  <!-- I 0..1 Specifics for when this is a contraindication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as contraindicating against this item --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the contraindication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableReference(ObservationDefinition) A comorbidity (concurrent condition) or coinfection --></comorbidity>
  <indication><!-- 0..* Reference(ClinicalUseDefinition) The indication which this is a contraidication for --></indication>
  <applicability><!-- 0..1 Expression An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements --></applicability>
  <otherTherapy>  <!-- 0..* Information about use of the product in relation to other therapies described as part of the contraindication -->
   <relationshipType><!-- 1..1 CodeableConcept The type of relationship between the product indication/contraindication and another therapy --></relationshipType>
   <treatment><!-- 1..1 CodeableReference(ActivityDefinition|
     BiologicallyDerivedProduct|Medication|MedicinalProductDefinition|
     NutritionProduct|Substance|SubstanceDefinition) Reference to a specific medication, substance etc. as part of an indication or contraindication --></treatment>
  </otherTherapy>
 </contraindication>
 <indication>  <!-- I 0..1 Specifics for when this is an indication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as an indicaton for this item --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the indication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableReference(ObservationDefinition) A comorbidity or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableReference(ObservationDefinition) The intended effect, aim or strategy to be achieved --></intendedEffect>
  <duration[x]><!-- 0..1 Range|string Timing or duration information --></duration[x]>
  <undesirableEffect><!-- 0..* Reference(ClinicalUseDefinition) An unwanted side effect or negative outcome of the subject of this resource when being used for this indication --></undesirableEffect>
  <applicability><!-- 0..1 Expression An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements --></applicability>
  <otherTherapy><!-- 0..* Content as for ClinicalUseDefinition.contraindication.otherTherapy The use of the medicinal product in relation to other therapies described as part of the indication --></otherTherapy>
 </indication>
 <interaction>  <!-- I 0..1 Specifics for when this is an interaction -->
  <interactant>  <!-- 0..* The specific medication, product, food etc. or laboratory test that interacts -->
   <item[x]><!-- 1..1 Reference(BiologicallyDerivedProduct|Medication|
     MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Substance)|
     CodeableConcept The specific medication, product, food etc. or laboratory test that interacts --></item[x]>
  </interactant>
  <type><!-- 0..1 CodeableConcept The type of the interaction e.g. drug-drug interaction, drug-lab test interaction --></type>
  <effect><!-- 0..1 CodeableReference(ObservationDefinition) The effect of the interaction, for example "reduced gastric absorption of primary medication" --></effect>
  <incidence><!-- 0..1 CodeableConcept The incidence of the interaction, e.g. theoretical, observed --></incidence>
  <management><!-- 0..* CodeableConcept Actions for managing the interaction --></management>
 </interaction>
 <population><!-- 0..* Reference(Group) The population group to which this applies --></population>
 <library><!-- 0..* canonical(Library) Logic used by the clinical use definition --></library>
 <undesirableEffect>  <!-- I 0..1 A possible negative outcome from the use of this treatment -->
  <symptomConditionEffect><!-- 0..1 CodeableReference(ObservationDefinition) The situation in which the undesirable effect may manifest --></symptomConditionEffect>
  <classification><!-- 0..1 CodeableConcept High level classification of the effect --></classification>
  <frequencyOfOccurrence><!-- 0..1 CodeableConcept How often the effect is seen --></frequencyOfOccurrence>
 </undesirableEffect>
 <warning>  <!-- I 0..1 Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness' -->
  <description value="[markdown]"/><!-- 0..1 A textual definition of this warning, with formatting -->
  <code><!-- 0..1 CodeableConcept A coded or unformatted textual definition of this warning --></code>
 </warning>
</ClinicalUseDefinition>

JSON Template

{
  "resourceType" : "ClinicalUseDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this issue
  "type" : "<code>", // R!  indication | contraindication | interaction | undesirable-effect | warning
  "category" : [{ CodeableConcept }], // A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
  "subject" : [{ Reference(ActivityDefinition|BiologicallyDerivedProduct|
   Device|DeviceDefinition|Medication|MedicinalProductDefinition|
   NutritionProduct|PlanDefinition|Substance) }], // The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
  "status" : { CodeableConcept }, // Whether this is a current issue or one that has been retired etc
  "contraindication" : { // I Specifics for when this is a contraindication
    "diseaseSymptomProcedure" : { CodeableReference(ObservationDefinition) }, // The situation that is being documented as contraindicating against this item
    "diseaseStatus" : { CodeableReference(ObservationDefinition) }, // The status of the disease or symptom for the contraindication
    "comorbidity" : [{ CodeableReference(ObservationDefinition) }], // A comorbidity (concurrent condition) or coinfection
    "indication" : [{ Reference(ClinicalUseDefinition) }], // The indication which this is a contraidication for
    "applicability" : { Expression }, // An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    "otherTherapy" : [{ // Information about use of the product in relation to other therapies described as part of the contraindication
      "relationshipType" : { CodeableConcept }, // R!  The type of relationship between the product indication/contraindication and another therapy
      "treatment" : { CodeableReference(ActivityDefinition|
     BiologicallyDerivedProduct|Medication|MedicinalProductDefinition|
     NutritionProduct|Substance|SubstanceDefinition) } // R!  Reference to a specific medication, substance etc. as part of an indication or contraindication
    }]
  },
  "indication" : { // I Specifics for when this is an indication
    "diseaseSymptomProcedure" : { CodeableReference(ObservationDefinition) }, // The situation that is being documented as an indicaton for this item
    "diseaseStatus" : { CodeableReference(ObservationDefinition) }, // The status of the disease or symptom for the indication
    "comorbidity" : [{ CodeableReference(ObservationDefinition) }], // A comorbidity or coinfection as part of the indication
    "intendedEffect" : { CodeableReference(ObservationDefinition) }, // The intended effect, aim or strategy to be achieved
    // duration[x]: Timing or duration information. One of these 2:
    "durationRange" : { Range },
    "durationString" : "<string>",
    "undesirableEffect" : [{ Reference(ClinicalUseDefinition) }], // An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
    "applicability" : { Expression }, // An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    "otherTherapy" : [{ Content as for ClinicalUseDefinition.contraindication.otherTherapy }] // The use of the medicinal product in relation to other therapies described as part of the indication
  },
  "interaction" : { // I Specifics for when this is an interaction
    "interactant" : [{ // The specific medication, product, food etc. or laboratory test that interacts
      // item[x]: The specific medication, product, food etc. or laboratory test that interacts. One of these 2:
      "itemReference" : { Reference(BiologicallyDerivedProduct|Medication|
     MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Substance) },
      "itemCodeableConcept" : { CodeableConcept }
    }],
    "type" : { CodeableConcept }, // The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
    "effect" : { CodeableReference(ObservationDefinition) }, // The effect of the interaction, for example "reduced gastric absorption of primary medication"
    "incidence" : { CodeableConcept }, // The incidence of the interaction, e.g. theoretical, observed
    "management" : [{ CodeableConcept }] // Actions for managing the interaction
  },
  "population" : [{ Reference(Group) }], // The population group to which this applies
  "library" : ["<canonical(Library)>"], // Logic used by the clinical use definition
  "undesirableEffect" : { // I A possible negative outcome from the use of this treatment
    "symptomConditionEffect" : { CodeableReference(ObservationDefinition) }, // The situation in which the undesirable effect may manifest
    "classification" : { CodeableConcept }, // High level classification of the effect
    "frequencyOfOccurrence" : { CodeableConcept } // How often the effect is seen
  },
  "warning" : { // I Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
    "description" : "<markdown>", // A textual definition of this warning, with formatting
    "code" : { CodeableConcept } // A coded or unformatted textual definition of this warning
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:ClinicalUseDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business identifier for this issue
  fhir:type [ code ] ; # 1..1 indication | contraindication | interaction | undesirable-effect | warning
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
  fhir:subject  ( [ Reference(ActivityDefinition|BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
  MedicinalProductDefinition|NutritionProduct|PlanDefinition|Substance) ] ... ) ; # 0..* The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
  fhir:status [ CodeableConcept ] ; # 0..1 Whether this is a current issue or one that has been retired etc
  fhir:contraindication [ # 0..1 I Specifics for when this is a contraindication
    fhir:diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ] ; # 0..1 The situation that is being documented as contraindicating against this item
    fhir:diseaseStatus [ CodeableReference(ObservationDefinition) ] ; # 0..1 The status of the disease or symptom for the contraindication
    fhir:comorbidity  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:indication  ( [ Reference(ClinicalUseDefinition) ] ... ) ; # 0..* The indication which this is a contraidication for
    fhir:applicability [ Expression ] ; # 0..1 An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    fhir:otherTherapy ( [ # 0..* Information about use of the product in relation to other therapies described as part of the contraindication
      fhir:relationshipType [ CodeableConcept ] ; # 1..1 The type of relationship between the product indication/contraindication and another therapy
      fhir:treatment [ CodeableReference(ActivityDefinition|BiologicallyDerivedProduct|Medication|
  MedicinalProductDefinition|NutritionProduct|Substance|SubstanceDefinition) ] ; # 1..1 Reference to a specific medication, substance etc. as part of an indication or contraindication
    ] ... ) ;
  ] ;
  fhir:indication [ # 0..1 I Specifics for when this is an indication
    fhir:diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ] ; # 0..1 The situation that is being documented as an indicaton for this item
    fhir:diseaseStatus [ CodeableReference(ObservationDefinition) ] ; # 0..1 The status of the disease or symptom for the indication
    fhir:comorbidity  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* A comorbidity or coinfection as part of the indication
    fhir:intendedEffect [ CodeableReference(ObservationDefinition) ] ; # 0..1 The intended effect, aim or strategy to be achieved
    # duration[x] : 0..1 Timing or duration information. One of these 2
      fhir:duration [  a fhir:Range ; Range ]
      fhir:duration [  a fhir:string ; string ]
    fhir:undesirableEffect  ( [ Reference(ClinicalUseDefinition) ] ... ) ; # 0..* An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
    fhir:applicability [ Expression ] ; # 0..1 An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    fhir:otherTherapy  ( [ See ClinicalUseDefinition.contraindication.otherTherapy ] ... ) ; # 0..* The use of the medicinal product in relation to other therapies described as part of the indication
  ] ;
  fhir:interaction [ # 0..1 I Specifics for when this is an interaction
    fhir:interactant ( [ # 0..* The specific medication, product, food etc. or laboratory test that interacts
      # item[x] : 1..1 The specific medication, product, food etc. or laboratory test that interacts. One of these 2
        fhir:item [  a fhir:Reference ; Reference(BiologicallyDerivedProduct|Medication|MedicinalProductDefinition|
  NutritionProduct|ObservationDefinition|Substance) ]
        fhir:item [  a fhir:CodeableConcept ; CodeableConcept ]
    ] ... ) ;
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
    fhir:effect [ CodeableReference(ObservationDefinition) ] ; # 0..1 The effect of the interaction, for example "reduced gastric absorption of primary medication"
    fhir:incidence [ CodeableConcept ] ; # 0..1 The incidence of the interaction, e.g. theoretical, observed
    fhir:management  ( [ CodeableConcept ] ... ) ; # 0..* Actions for managing the interaction
  ] ;
  fhir:population  ( [ Reference(Group) ] ... ) ; # 0..* The population group to which this applies
  fhir:library  ( [ canonical(Library) ] ... ) ; # 0..* Logic used by the clinical use definition
  fhir:undesirableEffect [ # 0..1 I A possible negative outcome from the use of this treatment
    fhir:symptomConditionEffect [ CodeableReference(ObservationDefinition) ] ; # 0..1 The situation in which the undesirable effect may manifest
    fhir:classification [ CodeableConcept ] ; # 0..1 High level classification of the effect
    fhir:frequencyOfOccurrence [ CodeableConcept ] ; # 0..1 How often the effect is seen
  ] ;
  fhir:warning [ # 0..1 I Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
    fhir:description [ markdown ] ; # 0..1 A textual definition of this warning, with formatting
    fhir:code [ CodeableConcept ] ; # 0..1 A coded or unformatted textual definition of this warning
  ] ;
]

Changes from both R4 and R4B

This resource did not exist in Release R4

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseDefinition	TU		DomainResource	A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure + Rule: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for this issue
type	Σ	1..1	code	indication \| contraindication \| interaction \| undesirable-effect \| warning Binding: Clinical Use Definition Type (Required)
category	Σ	0..*	CodeableConcept	A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" Binding: Clinical Use Definition Category (Preferred)
subject	Σ	0..*	Reference(MedicinalProductDefinition \| Medication \| ActivityDefinition \| PlanDefinition \| Device \| DeviceDefinition \| Substance \| NutritionProduct \| BiologicallyDerivedProduct)	The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
status	Σ	0..1	CodeableConcept	Whether this is a current issue or one that has been retired etc Binding: PublicationStatus (Preferred)
contraindication	Σ C	0..1	BackboneElement	Specifics for when this is a contraindication
diseaseSymptomProcedure	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as contraindicating against this item Binding: Disease Symptom Procedure (Example)
diseaseStatus	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the contraindication Binding: Disease Status (Example)
comorbidity	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity (concurrent condition) or coinfection Binding: Disease Symptom Procedure (Example)
indication	Σ	0..*	Reference(ClinicalUseDefinition)	The indication which this is a contraidication for
applicability		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
otherTherapy	Σ	0..*	BackboneElement	Information about use of the product in relation to other therapies described as part of the contraindication
relationshipType	Σ	1..1	CodeableConcept	The type of relationship between the product indication/contraindication and another therapy Binding: Therapy Relationship Type (Preferred)
treatment	Σ	1..1	CodeableReference(MedicinalProductDefinition \| Medication \| Substance \| SubstanceDefinition \| NutritionProduct \| BiologicallyDerivedProduct \| ActivityDefinition)	Reference to a specific medication, substance etc. as part of an indication or contraindication Binding: Therapy (Example)
indication	Σ C	0..1	BackboneElement	Specifics for when this is an indication
diseaseSymptomProcedure	Σ	0..1	CodeableReference(ObservationDefinition)	The situation that is being documented as an indicaton for this item Binding: Disease Symptom Procedure (Example)
diseaseStatus	Σ	0..1	CodeableReference(ObservationDefinition)	The status of the disease or symptom for the indication Binding: Disease Status (Example)
comorbidity	Σ	0..*	CodeableReference(ObservationDefinition)	A comorbidity or coinfection as part of the indication Binding: Disease Symptom Procedure (Example)
intendedEffect	Σ	0..1	CodeableReference(ObservationDefinition)	The intended effect, aim or strategy to be achieved Binding: Product Intended Use (Preferred)
duration[x]	Σ	0..1		Timing or duration information
durationRange			Range
durationString			string
undesirableEffect	Σ	0..*	Reference(ClinicalUseDefinition)	An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
applicability		0..1	Expression	An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
otherTherapy	Σ	0..*	see otherTherapy	The use of the medicinal product in relation to other therapies described as part of the indication
interaction	Σ C	0..1	BackboneElement	Specifics for when this is an interaction
interactant	Σ	0..*	BackboneElement	The specific medication, product, food etc. or laboratory test that interacts
item[x]	Σ	1..1		The specific medication, product, food etc. or laboratory test that interacts Binding: Interactant (Example)
itemReference			Reference(MedicinalProductDefinition \| Medication \| Substance \| NutritionProduct \| BiologicallyDerivedProduct \| ObservationDefinition)
itemCodeableConcept			CodeableConcept
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug interaction, drug-lab test interaction Binding: Interaction Type (Example)
effect	Σ	0..1	CodeableReference(ObservationDefinition)	The effect of the interaction, for example "reduced gastric absorption of primary medication" Binding: Interaction Effect (Example)
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed Binding: Interaction Incidence (Example)
management	Σ	0..*	CodeableConcept	Actions for managing the interaction Binding: Interaction Management (Example)
population	Σ	0..*	Reference(Group)	The population group to which this applies
library	Σ	0..*	canonical(Library)	Logic used by the clinical use definition
undesirableEffect	Σ C	0..1	BackboneElement	A possible negative outcome from the use of this treatment
symptomConditionEffect	Σ	0..1	CodeableReference(ObservationDefinition)	The situation in which the undesirable effect may manifest Binding: Undesirable Effect Symptom (Example)
classification	Σ	0..1	CodeableConcept	High level classification of the effect Binding: Undesirable Effect Classification (Example)
frequencyOfOccurrence	Σ	0..1	CodeableConcept	How often the effect is seen Binding: Undesirabl Effect Frequency (Example)
warning	Σ C	0..1	BackboneElement	Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
description	Σ	0..1	markdown	A textual definition of this warning, with formatting
code	Σ	0..1	CodeableConcept	A coded or unformatted textual definition of this warning Binding: Warning Type (Example)
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<ClinicalUseDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for this issue --></identifier>
 <type value="[code]"/><!-- 1..1 indication | contraindication | interaction | undesirable-effect | warning -->
 <category><!-- 0..* CodeableConcept A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" --></category>
 <subject><!-- 0..* Reference(ActivityDefinition|BiologicallyDerivedProduct|
   Device|DeviceDefinition|Medication|MedicinalProductDefinition|
   NutritionProduct|PlanDefinition|Substance) The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning --></subject>
 <status><!-- 0..1 CodeableConcept Whether this is a current issue or one that has been retired etc --></status>
 <contraindication>  <!-- I 0..1 Specifics for when this is a contraindication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as contraindicating against this item --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the contraindication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableReference(ObservationDefinition) A comorbidity (concurrent condition) or coinfection --></comorbidity>
  <indication><!-- 0..* Reference(ClinicalUseDefinition) The indication which this is a contraidication for --></indication>
  <applicability><!-- 0..1 Expression An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements --></applicability>
  <otherTherapy>  <!-- 0..* Information about use of the product in relation to other therapies described as part of the contraindication -->
   <relationshipType><!-- 1..1 CodeableConcept The type of relationship between the product indication/contraindication and another therapy --></relationshipType>
   <treatment><!-- 1..1 CodeableReference(ActivityDefinition|
     BiologicallyDerivedProduct|Medication|MedicinalProductDefinition|
     NutritionProduct|Substance|SubstanceDefinition) Reference to a specific medication, substance etc. as part of an indication or contraindication --></treatment>
  </otherTherapy>
 </contraindication>
 <indication>  <!-- I 0..1 Specifics for when this is an indication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as an indicaton for this item --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the indication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableReference(ObservationDefinition) A comorbidity or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableReference(ObservationDefinition) The intended effect, aim or strategy to be achieved --></intendedEffect>
  <duration[x]><!-- 0..1 Range|string Timing or duration information --></duration[x]>
  <undesirableEffect><!-- 0..* Reference(ClinicalUseDefinition) An unwanted side effect or negative outcome of the subject of this resource when being used for this indication --></undesirableEffect>
  <applicability><!-- 0..1 Expression An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements --></applicability>
  <otherTherapy><!-- 0..* Content as for ClinicalUseDefinition.contraindication.otherTherapy The use of the medicinal product in relation to other therapies described as part of the indication --></otherTherapy>
 </indication>
 <interaction>  <!-- I 0..1 Specifics for when this is an interaction -->
  <interactant>  <!-- 0..* The specific medication, product, food etc. or laboratory test that interacts -->
   <item[x]><!-- 1..1 Reference(BiologicallyDerivedProduct|Medication|
     MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Substance)|
     CodeableConcept The specific medication, product, food etc. or laboratory test that interacts --></item[x]>
  </interactant>
  <type><!-- 0..1 CodeableConcept The type of the interaction e.g. drug-drug interaction, drug-lab test interaction --></type>
  <effect><!-- 0..1 CodeableReference(ObservationDefinition) The effect of the interaction, for example "reduced gastric absorption of primary medication" --></effect>
  <incidence><!-- 0..1 CodeableConcept The incidence of the interaction, e.g. theoretical, observed --></incidence>
  <management><!-- 0..* CodeableConcept Actions for managing the interaction --></management>
 </interaction>
 <population><!-- 0..* Reference(Group) The population group to which this applies --></population>
 <library><!-- 0..* canonical(Library) Logic used by the clinical use definition --></library>
 <undesirableEffect>  <!-- I 0..1 A possible negative outcome from the use of this treatment -->
  <symptomConditionEffect><!-- 0..1 CodeableReference(ObservationDefinition) The situation in which the undesirable effect may manifest --></symptomConditionEffect>
  <classification><!-- 0..1 CodeableConcept High level classification of the effect --></classification>
  <frequencyOfOccurrence><!-- 0..1 CodeableConcept How often the effect is seen --></frequencyOfOccurrence>
 </undesirableEffect>
 <warning>  <!-- I 0..1 Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness' -->
  <description value="[markdown]"/><!-- 0..1 A textual definition of this warning, with formatting -->
  <code><!-- 0..1 CodeableConcept A coded or unformatted textual definition of this warning --></code>
 </warning>
</ClinicalUseDefinition>

JSON Template

{
  "resourceType" : "ClinicalUseDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this issue
  "type" : "<code>", // R!  indication | contraindication | interaction | undesirable-effect | warning
  "category" : [{ CodeableConcept }], // A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
  "subject" : [{ Reference(ActivityDefinition|BiologicallyDerivedProduct|
   Device|DeviceDefinition|Medication|MedicinalProductDefinition|
   NutritionProduct|PlanDefinition|Substance) }], // The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
  "status" : { CodeableConcept }, // Whether this is a current issue or one that has been retired etc
  "contraindication" : { // I Specifics for when this is a contraindication
    "diseaseSymptomProcedure" : { CodeableReference(ObservationDefinition) }, // The situation that is being documented as contraindicating against this item
    "diseaseStatus" : { CodeableReference(ObservationDefinition) }, // The status of the disease or symptom for the contraindication
    "comorbidity" : [{ CodeableReference(ObservationDefinition) }], // A comorbidity (concurrent condition) or coinfection
    "indication" : [{ Reference(ClinicalUseDefinition) }], // The indication which this is a contraidication for
    "applicability" : { Expression }, // An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    "otherTherapy" : [{ // Information about use of the product in relation to other therapies described as part of the contraindication
      "relationshipType" : { CodeableConcept }, // R!  The type of relationship between the product indication/contraindication and another therapy
      "treatment" : { CodeableReference(ActivityDefinition|
     BiologicallyDerivedProduct|Medication|MedicinalProductDefinition|
     NutritionProduct|Substance|SubstanceDefinition) } // R!  Reference to a specific medication, substance etc. as part of an indication or contraindication
    }]
  },
  "indication" : { // I Specifics for when this is an indication
    "diseaseSymptomProcedure" : { CodeableReference(ObservationDefinition) }, // The situation that is being documented as an indicaton for this item
    "diseaseStatus" : { CodeableReference(ObservationDefinition) }, // The status of the disease or symptom for the indication
    "comorbidity" : [{ CodeableReference(ObservationDefinition) }], // A comorbidity or coinfection as part of the indication
    "intendedEffect" : { CodeableReference(ObservationDefinition) }, // The intended effect, aim or strategy to be achieved
    // duration[x]: Timing or duration information. One of these 2:
    "durationRange" : { Range },
    "durationString" : "<string>",
    "undesirableEffect" : [{ Reference(ClinicalUseDefinition) }], // An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
    "applicability" : { Expression }, // An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    "otherTherapy" : [{ Content as for ClinicalUseDefinition.contraindication.otherTherapy }] // The use of the medicinal product in relation to other therapies described as part of the indication
  },
  "interaction" : { // I Specifics for when this is an interaction
    "interactant" : [{ // The specific medication, product, food etc. or laboratory test that interacts
      // item[x]: The specific medication, product, food etc. or laboratory test that interacts. One of these 2:
      "itemReference" : { Reference(BiologicallyDerivedProduct|Medication|
     MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Substance) },
      "itemCodeableConcept" : { CodeableConcept }
    }],
    "type" : { CodeableConcept }, // The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
    "effect" : { CodeableReference(ObservationDefinition) }, // The effect of the interaction, for example "reduced gastric absorption of primary medication"
    "incidence" : { CodeableConcept }, // The incidence of the interaction, e.g. theoretical, observed
    "management" : [{ CodeableConcept }] // Actions for managing the interaction
  },
  "population" : [{ Reference(Group) }], // The population group to which this applies
  "library" : ["<canonical(Library)>"], // Logic used by the clinical use definition
  "undesirableEffect" : { // I A possible negative outcome from the use of this treatment
    "symptomConditionEffect" : { CodeableReference(ObservationDefinition) }, // The situation in which the undesirable effect may manifest
    "classification" : { CodeableConcept }, // High level classification of the effect
    "frequencyOfOccurrence" : { CodeableConcept } // How often the effect is seen
  },
  "warning" : { // I Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
    "description" : "<markdown>", // A textual definition of this warning, with formatting
    "code" : { CodeableConcept } // A coded or unformatted textual definition of this warning
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:ClinicalUseDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business identifier for this issue
  fhir:type [ code ] ; # 1..1 indication | contraindication | interaction | undesirable-effect | warning
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
  fhir:subject  ( [ Reference(ActivityDefinition|BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
  MedicinalProductDefinition|NutritionProduct|PlanDefinition|Substance) ] ... ) ; # 0..* The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
  fhir:status [ CodeableConcept ] ; # 0..1 Whether this is a current issue or one that has been retired etc
  fhir:contraindication [ # 0..1 I Specifics for when this is a contraindication
    fhir:diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ] ; # 0..1 The situation that is being documented as contraindicating against this item
    fhir:diseaseStatus [ CodeableReference(ObservationDefinition) ] ; # 0..1 The status of the disease or symptom for the contraindication
    fhir:comorbidity  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:indication  ( [ Reference(ClinicalUseDefinition) ] ... ) ; # 0..* The indication which this is a contraidication for
    fhir:applicability [ Expression ] ; # 0..1 An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    fhir:otherTherapy ( [ # 0..* Information about use of the product in relation to other therapies described as part of the contraindication
      fhir:relationshipType [ CodeableConcept ] ; # 1..1 The type of relationship between the product indication/contraindication and another therapy
      fhir:treatment [ CodeableReference(ActivityDefinition|BiologicallyDerivedProduct|Medication|
  MedicinalProductDefinition|NutritionProduct|Substance|SubstanceDefinition) ] ; # 1..1 Reference to a specific medication, substance etc. as part of an indication or contraindication
    ] ... ) ;
  ] ;
  fhir:indication [ # 0..1 I Specifics for when this is an indication
    fhir:diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ] ; # 0..1 The situation that is being documented as an indicaton for this item
    fhir:diseaseStatus [ CodeableReference(ObservationDefinition) ] ; # 0..1 The status of the disease or symptom for the indication
    fhir:comorbidity  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* A comorbidity or coinfection as part of the indication
    fhir:intendedEffect [ CodeableReference(ObservationDefinition) ] ; # 0..1 The intended effect, aim or strategy to be achieved
    # duration[x] : 0..1 Timing or duration information. One of these 2
      fhir:duration [  a fhir:Range ; Range ]
      fhir:duration [  a fhir:string ; string ]
    fhir:undesirableEffect  ( [ Reference(ClinicalUseDefinition) ] ... ) ; # 0..* An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
    fhir:applicability [ Expression ] ; # 0..1 An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    fhir:otherTherapy  ( [ See ClinicalUseDefinition.contraindication.otherTherapy ] ... ) ; # 0..* The use of the medicinal product in relation to other therapies described as part of the indication
  ] ;
  fhir:interaction [ # 0..1 I Specifics for when this is an interaction
    fhir:interactant ( [ # 0..* The specific medication, product, food etc. or laboratory test that interacts
      # item[x] : 1..1 The specific medication, product, food etc. or laboratory test that interacts. One of these 2
        fhir:item [  a fhir:Reference ; Reference(BiologicallyDerivedProduct|Medication|MedicinalProductDefinition|
  NutritionProduct|ObservationDefinition|Substance) ]
        fhir:item [  a fhir:CodeableConcept ; CodeableConcept ]
    ] ... ) ;
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
    fhir:effect [ CodeableReference(ObservationDefinition) ] ; # 0..1 The effect of the interaction, for example "reduced gastric absorption of primary medication"
    fhir:incidence [ CodeableConcept ] ; # 0..1 The incidence of the interaction, e.g. theoretical, observed
    fhir:management  ( [ CodeableConcept ] ... ) ; # 0..* Actions for managing the interaction
  ] ;
  fhir:population  ( [ Reference(Group) ] ... ) ; # 0..* The population group to which this applies
  fhir:library  ( [ canonical(Library) ] ... ) ; # 0..* Logic used by the clinical use definition
  fhir:undesirableEffect [ # 0..1 I A possible negative outcome from the use of this treatment
    fhir:symptomConditionEffect [ CodeableReference(ObservationDefinition) ] ; # 0..1 The situation in which the undesirable effect may manifest
    fhir:classification [ CodeableConcept ] ; # 0..1 High level classification of the effect
    fhir:frequencyOfOccurrence [ CodeableConcept ] ; # 0..1 How often the effect is seen
  ] ;
  fhir:warning [ # 0..1 I Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
    fhir:description [ markdown ] ; # 0..1 A textual definition of this warning, with formatting
    fhir:code [ CodeableConcept ] ; # 0..1 A coded or unformatted textual definition of this warning
  ] ;
]

Changes from both R4 and R4B

This resource did not exist in Release R4

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

15.7.4.1 Terminology Bindings

Path	ValueSet	Type	Documentation
ClinicalUseDefinition.type	ClinicalUseDefinitionType	Required	Overall defining type of this clinical use definition.
ClinicalUseDefinition.category	ClinicalUseDefinitionCategory	Preferred	A categorisation for a clinical use information item.
ClinicalUseDefinition.status	PublicationStatus	Preferred	The lifecycle status of an artifact.
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure	DiseaseSymptomProcedure	Example	A symptom, disease or procedure.
ClinicalUseDefinition.contraindication.diseaseStatus	DiseaseStatus	Example	The status of a disease or symptom.
ClinicalUseDefinition.contraindication.comorbidity	DiseaseSymptomProcedure	Example	A symptom, disease or procedure.
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType	TherapyRelationshipType	Preferred	Classification of relationship between a therapy and a contraindication or an indication.
ClinicalUseDefinition.contraindication.otherTherapy.treatment	Therapy	Example	A therapy.
ClinicalUseDefinition.indication.diseaseSymptomProcedure	DiseaseSymptomProcedure	Example	A symptom, disease or procedure.
ClinicalUseDefinition.indication.diseaseStatus	DiseaseStatus	Example	The status of a disease or symptom.
ClinicalUseDefinition.indication.comorbidity	DiseaseSymptomProcedure	Example	A symptom, disease or procedure.
ClinicalUseDefinition.indication.intendedEffect	ProductIntendedUse	Preferred	The overall intended use of a product.
ClinicalUseDefinition.interaction.interactant.item[x]	Interactant	Example	An interactant - a substance that may have a clinically significant effect on another.
ClinicalUseDefinition.interaction.type	InteractionType	Example	A categorisation for an interaction between two substances.
ClinicalUseDefinition.interaction.effect	InteractionEffect	Example	A interaction effect of clinical use of a medication or other substance.
ClinicalUseDefinition.interaction.incidence	InteractionIncidence	Example	A categorisation for incidence of occurence of an interaction.
ClinicalUseDefinition.interaction.management	InteractionManagement	Example	A type of management for an interaction of a medication or other substance.
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect	UndesirableEffectSymptom	Example	An undesirable effect of clinical use.
ClinicalUseDefinition.undesirableEffect.classification	UndesirableEffectClassification	Example	A categorisation for an undesirable effect.
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence	UndesirablEffectFrequency	Example	A categorisation for a frequency of occurence of an undesirable effect.
ClinicalUseDefinition.warning.code	WarningType	Example	Classification of warning type.

Path

ValueSet

Type

Documentation

ClinicalUseDefinition.type

ClinicalUseDefinitionType

Required

Overall defining type of this clinical use definition.

ClinicalUseDefinition.category

ClinicalUseDefinitionCategory

Preferred

A categorisation for a clinical use information item.

ClinicalUseDefinition.status

PublicationStatus

Preferred

The lifecycle status of an artifact.

ClinicalUseDefinition.contraindication.diseaseSymptomProcedure

Name	Type	Description	Expression	In Common
contraindication	token	The situation that is being documented as contraindicating against this item, as a code	ClinicalUseDefinition.contraindication.diseaseSymptomProcedure.concept
contraindication-reference	reference	The situation that is being documented as contraindicating against this item, as a reference	ClinicalUseDefinition.contraindication.diseaseSymptomProcedure.reference
effect	token	The situation in which the undesirable effect may manifest, as a code	ClinicalUseDefinition.undesirableEffect.symptomConditionEffect.concept
effect-reference	reference	The situation in which the undesirable effect may manifest, as a reference	ClinicalUseDefinition.undesirableEffect.symptomConditionEffect.reference
identifier	token	Business identifier for this issue	ClinicalUseDefinition.identifier
indication	token	The situation that is being documented as an indicaton for this item, as a code	ClinicalUseDefinition.indication.diseaseSymptomProcedure.concept
indication-reference	reference	The situation that is being documented as an indicaton for this item, as a reference	ClinicalUseDefinition.indication.diseaseSymptomProcedure.reference
interaction	token	The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction	ClinicalUseDefinition.interaction.type
product	reference	The medicinal product for which this is a clinical usage issue	ClinicalUseDefinition.subject.where(resolve() is MedicinalProductDefinition) (MedicinalProductDefinition)
status	token	Whether this is a current issue or one that has been retired etc.	ClinicalUseDefinition.status
subject	reference	The resource for which this is a clinical usage issue	ClinicalUseDefinition.subject (MedicinalProductDefinition, NutritionProduct, BiologicallyDerivedProduct, Device, Medication, DeviceDefinition, PlanDefinition, Substance, ActivityDefinition)
type	token	indication \| contraindication \| interaction \| undesirable-effect \| warning	ClinicalUseDefinition.type