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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

15.7.4 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . 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 )

. . . 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 )

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

ClinicalUseDefinition ( DomainResource ) Business identifier for this issue identifier : Identifier [0..*] indication | contraindication | interaction | undesirable-effect | warning type : code [1..1] « null (Strength=Required) ClinicalUseDefinitionType ! » 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" category : CodeableConcept [0..*] « null (Strength=Preferred) ClinicalUseDefinitionCategory ? » The medication, product, substance, device, procedure etc. for which this is an indication indication, contraindication, interaction, undesirable effect, or warning subject : Reference [0..*] « MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct » Whether this is a current issue or one that has been retired etc status : CodeableConcept [0..1] « null (Strength=Preferred) PublicationStatus ? » The population group to which this applies population : Reference [0..*] « Group » Logic used by the clinical use definition library : canonical [0..*] « Library » Contraindication The situation that is being documented as contraindicating against this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic" diseaseStatus : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseStatus ?? » A comorbidity (concurrent condition) or coinfection comorbidity : CodeableReference [0..*] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The indication which this is a contraidication for indication : Reference [0..*] « ClinicalUseDefinition » An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements applicability : Expression [0..1] OtherTherapy The type of relationship between the medicinal product indication or contraindication and another therapy relationshipType : CodeableConcept [1..1] « null (Strength=Preferred) TherapyRelationshipType ? » Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication treatment : CodeableReference [1..1] « MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition ; null (Strength=Example) Therapy ?? » Indication The situation that is being documented as an indicaton for this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the indication, for example "chronic" or "metastatic" diseaseStatus : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseStatus ?? » A comorbidity (concurrent condition) or coinfection as part of the indication comorbidity : CodeableReference [0..*] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The intended effect, aim or strategy to be achieved intendedEffect : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Preferred) ProductIntendedUse ? » 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) duration[x] : DataType [0..1] « Range | string » An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication undesirableEffect : Reference [0..*] « ClinicalUseDefinition » An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements applicability : Expression [0..1] Interaction The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction type : CodeableConcept [0..1] « null (Strength=Example) InteractionType ?? » The effect of the interaction, for example "reduced gastric absorption of primary medication" effect : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) InteractionEffect ?? » The incidence of the interaction, e.g. theoretical, observed incidence : CodeableConcept [0..1] « null (Strength=Example) InteractionIncidence ?? » Actions for managing the interaction management : CodeableConcept [0..*] « null (Strength=Example) InteractionManagement ?? » Interactant The specific medication, product, food, substance etc. or laboratory test that interacts item[x] : DataType [1..1] « Reference ( MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )| CodeableConcept ; null (Strength=Example) Interactant ?? » UndesirableEffect The situation in which the undesirable effect may manifest symptomConditionEffect : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) UndesirableEffectSymptom ?? » High level classification of the effect classification : CodeableConcept [0..1] « null (Strength=Example) UndesirableEffectClassificati... ?? » How often the effect is seen frequencyOfOccurrence : CodeableConcept [0..1] « null (Strength=Example) UndesirablEffectFrequency ?? » Warning A textual definition of this warning, with formatting description : markdown [0..1] A coded or unformatted textual definition of this warning code : CodeableConcept [0..1] « null (Strength=Example) WarningType ?? » Information about the use of the medicinal product in relation to other therapies described as part of the contraindication otherTherapy [0..*] Specifics for when this is a contraindication contraindication [0..1] Information about the use of the medicinal product in relation to other therapies described as part of the indication otherTherapy [0..*] Specifics for when this is an indication indication [0..1] The specific medication, product, food, substance etc. or laboratory test that interacts interactant [0..*] Specifics for when this is an interaction interaction [0..1] Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment undesirableEffect [0..1] 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' warning [0..1]

XML Template 

<ClinicalUseDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- 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|
   </subject>

   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 

{doco
  "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/> .doco


[ 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:|
  

  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 doco
. . 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 )

. . . 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 )

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

ClinicalUseDefinition ( DomainResource ) Business identifier for this issue identifier : Identifier [0..*] indication | contraindication | interaction | undesirable-effect | warning type : code [1..1] « null (Strength=Required) ClinicalUseDefinitionType ! » 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" category : CodeableConcept [0..*] « null (Strength=Preferred) ClinicalUseDefinitionCategory ? » The medication, product, substance, device, procedure etc. for which this is an indication indication, contraindication, interaction, undesirable effect, or warning subject : Reference [0..*] « MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct » Whether this is a current issue or one that has been retired etc status : CodeableConcept [0..1] « null (Strength=Preferred) PublicationStatus ? » The population group to which this applies population : Reference [0..*] « Group » Logic used by the clinical use definition library : canonical [0..*] « Library » Contraindication The situation that is being documented as contraindicating against this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic" diseaseStatus : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseStatus ?? » A comorbidity (concurrent condition) or coinfection comorbidity : CodeableReference [0..*] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The indication which this is a contraidication for indication : Reference [0..*] « ClinicalUseDefinition » An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements applicability : Expression [0..1] OtherTherapy The type of relationship between the medicinal product indication or contraindication and another therapy relationshipType : CodeableConcept [1..1] « null (Strength=Preferred) TherapyRelationshipType ? » Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication treatment : CodeableReference [1..1] « MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition ; null (Strength=Example) Therapy ?? » Indication The situation that is being documented as an indicaton for this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the indication, for example "chronic" or "metastatic" diseaseStatus : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseStatus ?? » A comorbidity (concurrent condition) or coinfection as part of the indication comorbidity : CodeableReference [0..*] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The intended effect, aim or strategy to be achieved intendedEffect : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Preferred) ProductIntendedUse ? » 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) duration[x] : DataType [0..1] « Range | string » An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication undesirableEffect : Reference [0..*] « ClinicalUseDefinition » An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements applicability : Expression [0..1] Interaction The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction type : CodeableConcept [0..1] « null (Strength=Example) InteractionType ?? » The effect of the interaction, for example "reduced gastric absorption of primary medication" effect : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) InteractionEffect ?? » The incidence of the interaction, e.g. theoretical, observed incidence : CodeableConcept [0..1] « null (Strength=Example) InteractionIncidence ?? » Actions for managing the interaction management : CodeableConcept [0..*] « null (Strength=Example) InteractionManagement ?? » Interactant The specific medication, product, food, substance etc. or laboratory test that interacts item[x] : DataType [1..1] « Reference ( MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )| CodeableConcept ; null (Strength=Example) Interactant ?? » UndesirableEffect The situation in which the undesirable effect may manifest symptomConditionEffect : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) UndesirableEffectSymptom ?? » High level classification of the effect classification : CodeableConcept [0..1] « null (Strength=Example) UndesirableEffectClassificati... ?? » How often the effect is seen frequencyOfOccurrence : CodeableConcept [0..1] « null (Strength=Example) UndesirablEffectFrequency ?? » Warning A textual definition of this warning, with formatting description : markdown [0..1] A coded or unformatted textual definition of this warning code : CodeableConcept [0..1] « null (Strength=Example) WarningType ?? » Information about the use of the medicinal product in relation to other therapies described as part of the contraindication otherTherapy [0..*] Specifics for when this is a contraindication contraindication [0..1] Information about the use of the medicinal product in relation to other therapies described as part of the indication otherTherapy [0..*] Specifics for when this is an indication indication [0..1] The specific medication, product, food, substance etc. or laboratory test that interacts interactant [0..*] Specifics for when this is an interaction interaction [0..1] Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment undesirableEffect [0..1] 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' warning [0..1]

XML Template 

<ClinicalUseDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- 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|
   </subject>

   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 

{doco
  "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/> .doco


[ 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:|
  

  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.

15.7.4.2 Constraints

UniqueKey Level Location Description Expression
img  cud-1 Rule (base) 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



15.7.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

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