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15.7 Resource ClinicalUseDefinition - Content

Responsible Owner: Biomedical Research and Regulation icon Work Group Maturity Level : 2   Trial Use Normative 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.

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.

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.

Structure

0..* 0..1 CodeableReference ( ObservationDefinition undesirableEffect 0..* Reference ( ClinicalUseDefinition ) 0..1 An expression that returns true or false, indicating whether The 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 )
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . ClinicalUseDefinition TU N 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
+ Rule: ClinicalUseDefinition.contraindication can only be used when type is 'contraindication'
+ Rule: ClinicalUseDefinition.indication can only be used when type is 'indication'
+ Rule: ClinicalUseDefinition.undesirableEffect can only be used when type is 'undesirable-effect'
+ Rule: ClinicalUseDefinition.interaction can only be used when type is 'interaction'
+ Rule: ClinicalUseDefinition.warning can only be used when type is 'warning'

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 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 )
.... management Σ 0..* CodeableConcept Actions for managing the undesirable effect
Binding: Interaction Management ( Example )

... indication Σ C 0..1 BackboneElement Specifics for when this is a contraindication an indication
. . . . diseaseSymptomProcedure Σ 0..1 CodeableReference ( ObservationDefinition ) The situation that is being documented as contraindicating against an indication for this item
Binding: Disease Symptom Procedure ( Example )
. . . . diseaseStatus Σ 0..1 CodeableReference ( ObservationDefinition ) The status of the disease or symptom for the contraindication indication
Binding: Disease Status ( Example )
. . . . comorbidity Σ 0..* CodeableReference ( ObservationDefinition ) A comorbidity (concurrent condition) or coinfection as part of the indication
Binding: Disease Symptom Procedure ( Example )

. . . indication . intendedEffect Σ 0..* Reference CodeableReference ( ClinicalUseDefinition ObservationDefinition ) The indication which 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..* see undesirableEffect An unwanted side effect or negative outcome of the subject of this is a contraindication 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..* 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 | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition ) Reference to a specific medication, substance etc. as part of an indication or contraindication
Binding: Therapy ( Example )
. . indication . contraindication Σ C 0..1 BackboneElement Specifics for when this is an indication a contraindication
. . . . diseaseSymptomProcedure Σ 0..1 CodeableReference ( ObservationDefinition ) The situation that is being documented as an indication for contraindicating against this item
Binding: Disease Symptom Procedure ( Example )
. . . . diseaseStatus Σ 0..1 CodeableReference ( ObservationDefinition ) The status of the disease or symptom for the indication contraindication
Binding: Disease Status ( Example )
. . . . comorbidity Σ 0..* CodeableReference ( ObservationDefinition ) A comorbidity (concurrent condition) or coinfection as part of the indication
Binding: Disease Symptom Procedure ( Example )

. . . intendedEffect . indication Σ 0..* see indication ) The intended effect, aim or strategy to be achieved Binding: Product Intended Use ( Preferred ) indication which this is a contraindication for
duration[x] Σ 0..1 Timing or duration information
. . . . durationRange Range applicability durationString string 0..1 Σ Expression An unwanted side effect expression that returns true or negative outcome of false, indicating whether the subject of this resource when being used for this indication is applicable or not, after having applied its other elements
. . . . applicability management Σ 0..* Expression CodeableConcept Actions for managing the indication is applicable or not, after having applied its other elements contraindication
Binding: Interaction Management ( Example )

. . . . otherTherapy Σ 0..* see otherTherapy Information about use of the medicinal product in relation to other therapies described as part of the indication contraindication

. . . 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 | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )
. . . . . . itemCodeableConcept CodeableConcept
. . . . . route 0..1 CodeableConcept The route by which the item is administered to cause the interaction
Binding: SNOMED CT Route Codes ( Example )
.... 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 )

. . . . severity Σ 0..1 CodeableConcept The severity of the interaction
Binding: Allergy Intolerance Severity ( 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

. . . 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, contraindication, interaction, undesirable effect, or warning subject : Reference CodeableReference [0..*] [1..*] « MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct ; null (Strength=Example) SNOMEDCTMedicationCodes ?? » Whether this is a current issue or one that has been retired etc (this element modifies the meaning of other elements) 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 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 ?? » Actions for managing the undesirable effect management : CodeableConcept [0..*] « null (Strength=Example) InteractionManagement ?? » Indication The situation that is being documented as contraindicating against an indication for this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the contraindication, 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. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present comorbidity : CodeableReference [0..*] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The indication which this is a contraindication for intended effect, aim or strategy to be achieved indication intendedEffect : Reference CodeableReference [0..*] « ClinicalUseDefinition 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 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 | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition ; null (Strength=Example) Therapy ?? » Indication Contraindication The situation that is being documented as an indication for contraindicating against this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the indication, contraindication, for example "chronic" or "metastatic" diseaseStatus : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseStatus ?? » A comorbidity (concurrent condition) or coinfection as part coinfection. Where this repeats it means that any one of the indication these is relevant, rather than all of them needing to be present 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] Actions for managing the contraindication management : CodeableConcept [0..*] « null (Strength=Example) InteractionManagement ?? » 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 ?? » The severity of the interaction severity : CodeableConcept [0..1] « null (Strength=Example) AllergyIntoleranceSeverity ?? » Interactant The specific medication, product, food, substance etc. or laboratory test that interacts item[x] : DataType [1..1] « Reference ( MedicinalProductDefinition | Medication | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )| CodeableConcept ; null (Strength=Example) Interactant ?? » UndesirableEffect The situation in route by 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 item is seen administered to cause the interaction frequencyOfOccurrence route : CodeableConcept [0..1] « null (Strength=Example) UndesirablEffectFrequency SNOMEDCTRouteCodes ?? » 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 ?? » Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment undesirableEffect [0..1] 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 [0..*] 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 an indication indication [0..1] The indication which this is a contraindication for contraindication indication [0..1] [0..*] Information about the use of the medicinal product in relation to other therapies described as part of the indication contraindication otherTherapy [0..*] Specifics for when this is an indication a contraindication indication contraindication [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>
 <</status>
 <
  <</diseaseSymptomProcedure>
  <</diseaseStatus>
  <</comorbidity>
  <</indication>
  <</applicability>
  <
   <</relationshipType>
   <|
     |
     </treatment>
  </otherTherapy>
 </contraindication>

 <subject><!-- 1..* CodeableReference(ActivityDefinition|
   BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
   MedicinalProductDefinition|NutritionProduct|PlanDefinition|
   SubstanceDefinition) 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>
 <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>
  <management><!-- 0..* CodeableConcept Actions for managing the undesirable effect --></management>
 </undesirableEffect>

 <indication>  <!-- I 0..1 Specifics for when this is an indication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as an indication for this item --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the indication --></diseaseStatus>
  <</comorbidity>
  <</intendedEffect>

  <comorbidity><!-- 0..* CodeableReference(ObservationDefinition) A comorbidity or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..* 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>

  <undesirableEffect><!-- 0..* Content as for ClinicalUseDefinition.undesirableEffect 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>

  <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|SubstanceDefinition) Reference to a specific medication, substance etc. as part of an indication or contraindication --></treatment>

  </otherTherapy>

 </indication>
 <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..* Content as for ClinicalUseDefinition.indication The indication which this is a contraindication 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>
  <management><!-- 0..* CodeableConcept Actions for managing the contraindication --></management>
  <otherTherapy><!-- 0..* Content as for ClinicalUseDefinition.indication.otherTherapy Information about use of the product in relation to other therapies described as part of the contraindication --></otherTherapy>
 </contraindication>

 <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|
     SubstanceDefinition)|CodeableConcept The specific medication, product, food etc. or laboratory test that interacts --></item[x]>
   <route><!-- 0..1 CodeableConcept The route by which the item is administered to cause the interaction --></route>

  </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>
  <severity><!-- 0..1 CodeableConcept The severity of the interaction --></severity>

 </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>
 <
  <</symptomConditionEffect>
  <</classification>
  <</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" : [{ CodeableReference(ActivityDefinition|
   BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
   MedicinalProductDefinition|NutritionProduct|PlanDefinition|
   SubstanceDefinition) }], // R!  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
  "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
    "management" : [{ CodeableConcept }] // Actions for managing the undesirable effect

  },
  "indication" : { // I Specifics for when this is an indication
    "diseaseSymptomProcedure" : { CodeableReference(ObservationDefinition) }, // The situation that is being documented as an indication 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" : [{ Content as for ClinicalUseDefinition.undesirableEffect }], // 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" : [{ // 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|SubstanceDefinition) } // R!  Reference to a specific medication, substance etc. as part of an indication or contraindication

    }]
  },
  "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" : [{ Content as for ClinicalUseDefinition.indication }], // The indication which this is a contraindication for
    "applicability" : { Expression }, // An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    "management" : [{ CodeableConcept }], // Actions for managing the contraindication
    "otherTherapy" : [{ Content as for ClinicalUseDefinition.indication.otherTherapy }] // Information about use of the product in relation to other therapies described as part of the contraindication

  },
  "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|
     SubstanceDefinition) },
      " }

      "itemCodeableConcept" : { CodeableConcept },
      "route" : { CodeableConcept } // The route by which the item is administered to cause the interaction

    }],
    "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
    "severity" : { CodeableConcept } // The severity of the interaction

  },
  "population" : [{ Reference(Group) }], // The population group to which this applies
  "library" : ["<canonical(Library)>"], // Logic used by the clinical use definition
  "
    "
    "
    "
  },

  "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 
  # from 

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir: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:
  fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:|
  
    ] ... ) ;

  fhir:subject  ( [ CodeableReference(ActivityDefinition|BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
  MedicinalProductDefinition|NutritionProduct|PlanDefinition|SubstanceDefinition) ] ... ) ; # 1..* 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: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:management  ( [ CodeableConcept ] ... ) ; # 0..* Actions for managing the undesirable effect

  ] ;
  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 indication for this item
    fhir:diseaseStatus [ CodeableReference(ObservationDefinition) ] ; # 0..1 The status of the disease or symptom for the indication
    fhir:
    fhir:

    fhir:comorbidity  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* A comorbidity or coinfection as part of the indication
    fhir:intendedEffect  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* 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: ]
    fhir:

      fhir:duration [  a fhir:String ; string ]
    fhir:undesirableEffect  ( [ See ClinicalUseDefinition.undesirableEffect ] ... ) ; # 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:

    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|SubstanceDefinition) ] ; # 1..1 Reference to a specific medication, substance etc. as part of an indication or contraindication

    ] ... ) ;
  ] ;
  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  ( [ See ClinicalUseDefinition.indication ] ... ) ; # 0..* The indication which this is a contraindication 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:management  ( [ CodeableConcept ] ... ) ; # 0..* Actions for managing the contraindication
    fhir:otherTherapy  ( [ See ClinicalUseDefinition.indication.otherTherapy ] ... ) ; # 0..* Information about use of the product in relation to other therapies described as part of the contraindication

  ] ;
  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|SubstanceDefinition) ]
        fhir:item [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:route [ CodeableConcept ] ; # 0..1 The route by which the item is administered to cause the interaction

    ] ... ) ;
    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:severity [ CodeableConcept ] ; # 0..1 The severity of 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:
    fhir:
    fhir:
    fhir:
  ] ;

  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

0..* 0..1 CodeableReference ( ObservationDefinition undesirableEffect 0..* Reference ( ClinicalUseDefinition ) 0..1 An expression that returns true or false, indicating whether The 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 )
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . ClinicalUseDefinition TU N 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
+ Rule: ClinicalUseDefinition.contraindication can only be used when type is 'contraindication'
+ Rule: ClinicalUseDefinition.indication can only be used when type is 'indication'
+ Rule: ClinicalUseDefinition.undesirableEffect can only be used when type is 'undesirable-effect'
+ Rule: ClinicalUseDefinition.interaction can only be used when type is 'interaction'
+ Rule: ClinicalUseDefinition.warning can only be used when type is 'warning'

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 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 )
.... management Σ 0..* CodeableConcept Actions for managing the undesirable effect
Binding: Interaction Management ( Example )

... indication Σ C 0..1 BackboneElement Specifics for when this is a contraindication an indication
. . . . diseaseSymptomProcedure Σ 0..1 CodeableReference ( ObservationDefinition ) The situation that is being documented as contraindicating against an indication for this item
Binding: Disease Symptom Procedure ( Example )
. . . . diseaseStatus Σ 0..1 CodeableReference ( ObservationDefinition ) The status of the disease or symptom for the contraindication indication
Binding: Disease Status ( Example )
. . . . comorbidity Σ 0..* CodeableReference ( ObservationDefinition ) A comorbidity (concurrent condition) or coinfection as part of the indication
Binding: Disease Symptom Procedure ( Example )

. . . indication . intendedEffect Σ 0..* Reference CodeableReference ( ClinicalUseDefinition ObservationDefinition ) The indication which 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..* see undesirableEffect An unwanted side effect or negative outcome of the subject of this is a contraindication 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..* 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 | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition ) Reference to a specific medication, substance etc. as part of an indication or contraindication
Binding: Therapy ( Example )
. . indication . contraindication Σ C 0..1 BackboneElement Specifics for when this is an indication a contraindication
. . . . diseaseSymptomProcedure Σ 0..1 CodeableReference ( ObservationDefinition ) The situation that is being documented as an indication for contraindicating against this item
Binding: Disease Symptom Procedure ( Example )
. . . . diseaseStatus Σ 0..1 CodeableReference ( ObservationDefinition ) The status of the disease or symptom for the indication contraindication
Binding: Disease Status ( Example )
. . . . comorbidity Σ 0..* CodeableReference ( ObservationDefinition ) A comorbidity (concurrent condition) or coinfection as part of the indication
Binding: Disease Symptom Procedure ( Example )

. . . intendedEffect . indication Σ 0..* see indication ) The intended effect, aim or strategy to be achieved Binding: Product Intended Use ( Preferred ) indication which this is a contraindication for
duration[x] Σ 0..1 Timing or duration information
. . . . durationRange Range applicability durationString string 0..1 Σ Expression An unwanted side effect expression that returns true or negative outcome of false, indicating whether the subject of this resource when being used for this indication is applicable or not, after having applied its other elements
. . . . applicability management Σ 0..* Expression CodeableConcept Actions for managing the indication is applicable or not, after having applied its other elements contraindication
Binding: Interaction Management ( Example )

. . . . otherTherapy Σ 0..* see otherTherapy Information about use of the medicinal product in relation to other therapies described as part of the indication contraindication

. . . 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 | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )
. . . . . . itemCodeableConcept CodeableConcept
. . . . . route 0..1 CodeableConcept The route by which the item is administered to cause the interaction
Binding: SNOMED CT Route Codes ( Example )
.... 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 )

. . . . severity Σ 0..1 CodeableConcept The severity of the interaction
Binding: Allergy Intolerance Severity ( 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

. . . 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, contraindication, interaction, undesirable effect, or warning subject : Reference CodeableReference [0..*] [1..*] « MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct ; null (Strength=Example) SNOMEDCTMedicationCodes ?? » Whether this is a current issue or one that has been retired etc (this element modifies the meaning of other elements) 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 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 ?? » Actions for managing the undesirable effect management : CodeableConcept [0..*] « null (Strength=Example) InteractionManagement ?? » Indication The situation that is being documented as contraindicating against an indication for this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the contraindication, 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. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present comorbidity : CodeableReference [0..*] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The indication which this is a contraindication for intended effect, aim or strategy to be achieved indication intendedEffect : Reference CodeableReference [0..*] « ClinicalUseDefinition 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 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 | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition ; null (Strength=Example) Therapy ?? » Indication Contraindication The situation that is being documented as an indication for contraindicating against this item diseaseSymptomProcedure : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseSymptomProcedure ?? » The status of the disease or symptom for the indication, contraindication, for example "chronic" or "metastatic" diseaseStatus : CodeableReference [0..1] « ObservationDefinition ; null (Strength=Example) DiseaseStatus ?? » A comorbidity (concurrent condition) or coinfection as part coinfection. Where this repeats it means that any one of the indication these is relevant, rather than all of them needing to be present 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] Actions for managing the contraindication management : CodeableConcept [0..*] « null (Strength=Example) InteractionManagement ?? » 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 ?? » The severity of the interaction severity : CodeableConcept [0..1] « null (Strength=Example) AllergyIntoleranceSeverity ?? » Interactant The specific medication, product, food, substance etc. or laboratory test that interacts item[x] : DataType [1..1] « Reference ( MedicinalProductDefinition | Medication | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )| CodeableConcept ; null (Strength=Example) Interactant ?? » UndesirableEffect The situation in route by 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 item is seen administered to cause the interaction frequencyOfOccurrence route : CodeableConcept [0..1] « null (Strength=Example) UndesirablEffectFrequency SNOMEDCTRouteCodes ?? » 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 ?? » Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment undesirableEffect [0..1] 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 [0..*] 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 an indication indication [0..1] The indication which this is a contraindication for contraindication indication [0..1] [0..*] Information about the use of the medicinal product in relation to other therapies described as part of the indication contraindication otherTherapy [0..*] Specifics for when this is an indication a contraindication indication contraindication [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>
 <</status>
 <
  <</diseaseSymptomProcedure>
  <</diseaseStatus>
  <</comorbidity>
  <</indication>
  <</applicability>
  <
   <</relationshipType>
   <|
     |
     </treatment>
  </otherTherapy>
 </contraindication>

 <subject><!-- 1..* CodeableReference(ActivityDefinition|
   BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
   MedicinalProductDefinition|NutritionProduct|PlanDefinition|
   SubstanceDefinition) 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>
 <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>
  <management><!-- 0..* CodeableConcept Actions for managing the undesirable effect --></management>
 </undesirableEffect>

 <indication>  <!-- I 0..1 Specifics for when this is an indication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as an indication for this item --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the indication --></diseaseStatus>
  <</comorbidity>
  <</intendedEffect>

  <comorbidity><!-- 0..* CodeableReference(ObservationDefinition) A comorbidity or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..* 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>

  <undesirableEffect><!-- 0..* Content as for ClinicalUseDefinition.undesirableEffect 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>

  <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|SubstanceDefinition) Reference to a specific medication, substance etc. as part of an indication or contraindication --></treatment>

  </otherTherapy>

 </indication>
 <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..* Content as for ClinicalUseDefinition.indication The indication which this is a contraindication 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>
  <management><!-- 0..* CodeableConcept Actions for managing the contraindication --></management>
  <otherTherapy><!-- 0..* Content as for ClinicalUseDefinition.indication.otherTherapy Information about use of the product in relation to other therapies described as part of the contraindication --></otherTherapy>
 </contraindication>

 <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|
     SubstanceDefinition)|CodeableConcept The specific medication, product, food etc. or laboratory test that interacts --></item[x]>
   <route><!-- 0..1 CodeableConcept The route by which the item is administered to cause the interaction --></route>

  </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>
  <severity><!-- 0..1 CodeableConcept The severity of the interaction --></severity>

 </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>
 <
  <</symptomConditionEffect>
  <</classification>
  <</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" : [{ CodeableReference(ActivityDefinition|
   BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
   MedicinalProductDefinition|NutritionProduct|PlanDefinition|
   SubstanceDefinition) }], // R!  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
  "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
    "management" : [{ CodeableConcept }] // Actions for managing the undesirable effect

  },
  "indication" : { // I Specifics for when this is an indication
    "diseaseSymptomProcedure" : { CodeableReference(ObservationDefinition) }, // The situation that is being documented as an indication 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" : [{ Content as for ClinicalUseDefinition.undesirableEffect }], // 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" : [{ // 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|SubstanceDefinition) } // R!  Reference to a specific medication, substance etc. as part of an indication or contraindication

    }]
  },
  "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" : [{ Content as for ClinicalUseDefinition.indication }], // The indication which this is a contraindication for
    "applicability" : { Expression }, // An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
    "management" : [{ CodeableConcept }], // Actions for managing the contraindication
    "otherTherapy" : [{ Content as for ClinicalUseDefinition.indication.otherTherapy }] // Information about use of the product in relation to other therapies described as part of the contraindication

  },
  "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|
     SubstanceDefinition) },
      " }

      "itemCodeableConcept" : { CodeableConcept },
      "route" : { CodeableConcept } // The route by which the item is administered to cause the interaction

    }],
    "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
    "severity" : { CodeableConcept } // The severity of the interaction

  },
  "population" : [{ Reference(Group) }], // The population group to which this applies
  "library" : ["<canonical(Library)>"], // Logic used by the clinical use definition
  "
    "
    "
    "
  },

  "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 
  # from 

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir: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:
  fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
      fhir:
      fhir:|
  
    ] ... ) ;

  fhir:subject  ( [ CodeableReference(ActivityDefinition|BiologicallyDerivedProduct|Device|DeviceDefinition|Medication|
  MedicinalProductDefinition|NutritionProduct|PlanDefinition|SubstanceDefinition) ] ... ) ; # 1..* 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: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:management  ( [ CodeableConcept ] ... ) ; # 0..* Actions for managing the undesirable effect

  ] ;
  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 indication for this item
    fhir:diseaseStatus [ CodeableReference(ObservationDefinition) ] ; # 0..1 The status of the disease or symptom for the indication
    fhir:
    fhir:

    fhir:comorbidity  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* A comorbidity or coinfection as part of the indication
    fhir:intendedEffect  ( [ CodeableReference(ObservationDefinition) ] ... ) ; # 0..* 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: ]
    fhir:

      fhir:duration [  a fhir:String ; string ]
    fhir:undesirableEffect  ( [ See ClinicalUseDefinition.undesirableEffect ] ... ) ; # 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:

    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|SubstanceDefinition) ] ; # 1..1 Reference to a specific medication, substance etc. as part of an indication or contraindication

    ] ... ) ;
  ] ;
  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  ( [ See ClinicalUseDefinition.indication ] ... ) ; # 0..* The indication which this is a contraindication 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:management  ( [ CodeableConcept ] ... ) ; # 0..* Actions for managing the contraindication
    fhir:otherTherapy  ( [ See ClinicalUseDefinition.indication.otherTherapy ] ... ) ; # 0..* Information about use of the product in relation to other therapies described as part of the contraindication

  ] ;
  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|SubstanceDefinition) ]
        fhir:item [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:route [ CodeableConcept ] ; # 0..1 The route by which the item is administered to cause the interaction

    ] ... ) ;
    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:severity [ CodeableConcept ] ; # 0..1 The severity of 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:
    fhir:
    fhir:
    fhir:
  ] ;

  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

ClinicalUseDefinition.indication.intendedEffect 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
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.subject SNOMEDCTMedicationCodes Example

This value set includes all drug or medicament substance codes and all pharmaceutical/biologic products from SNOMED CT - provided as an exemplar value set.

ClinicalUseDefinition.status PublicationStatus Preferred

The lifecycle status of an artifact.

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.undesirableEffect.management InteractionManagement Example

A type of management for an interaction, contraindication or undesirable effect of a medication or other substance.

ClinicalUseDefinition.contraindication.diseaseSymptomProcedure ClinicalUseDefinition.indication.diseaseSymptomProcedure DiseaseSymptomProcedure Example

A symptom, disease or procedure.

ClinicalUseDefinition.contraindication.diseaseStatus ClinicalUseDefinition.indication.diseaseStatus DiseaseStatus Example

The status of a disease or symptom.

ClinicalUseDefinition.contraindication.comorbidity ClinicalUseDefinition.indication.comorbidity DiseaseSymptomProcedure Example

A symptom, disease or procedure.

ClinicalUseDefinition.indication.intendedEffect ProductIntendedUse Preferred

The overall intended use of a product.

ClinicalUseDefinition.contraindication.otherTherapy.relationshipType ClinicalUseDefinition.indication.otherTherapy.relationshipType TherapyRelationshipType Preferred

Classification of relationship between a therapy and a contraindication or an indication.

ClinicalUseDefinition.contraindication.otherTherapy.treatment ClinicalUseDefinition.indication.otherTherapy.treatment Therapy Example

A therapy.

ClinicalUseDefinition.indication.diseaseSymptomProcedure ClinicalUseDefinition.contraindication.diseaseSymptomProcedure DiseaseSymptomProcedure Example

A symptom, disease or procedure.

ClinicalUseDefinition.indication.diseaseStatus ClinicalUseDefinition.contraindication.diseaseStatus DiseaseStatus Example

The status of a disease or symptom.

ClinicalUseDefinition.indication.comorbidity ClinicalUseDefinition.contraindication.comorbidity DiseaseSymptomProcedure Example

A symptom, disease or procedure.

ClinicalUseDefinition.contraindication.management ProductIntendedUse InteractionManagement Preferred Example

The overall intended use A type of management for an interaction, contraindication or undesirable effect of a product. medication or other substance.

ClinicalUseDefinition.interaction.interactant.item[x] Interactant Example

An interactant - a substance that may have a clinically significant effect on another.

ClinicalUseDefinition.interaction.interactant.route SNOMEDCTRouteCodes Example

This value set includes all Route codes from SNOMED CT - provided as an exemplar.

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 interaction, contraindication or undesirable effect of a medication or other substance.

ClinicalUseDefinition.interaction.severity UndesirablEffectFrequency AllergyIntoleranceSeverity Example

A categorisation for a frequency Clinical assessment of occurence the severity of an undesirable effect. a reaction event as a whole, potentially considering multiple different manifestations.

ClinicalUseDefinition.warning.code WarningType Example

Classification of warning type.

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
img  cud-2 Rule (base) ClinicalUseDefinition.contraindication can only be used when type is 'contraindication' ClinicalUseDefinition.contraindication.empty() or ClinicalUseDefinition.type='contraindication'
img  cud-3 Rule (base) ClinicalUseDefinition.indication can only be used when type is 'indication' ClinicalUseDefinition.indication.empty() or ClinicalUseDefinition.type='indication'
img  cud-4 Rule (base) ClinicalUseDefinition.undesirableEffect can only be used when type is 'undesirable-effect' ClinicalUseDefinition.undesirableEffect.empty() or ClinicalUseDefinition.type='undesirable-effect'
img  cud-5 Rule (base) ClinicalUseDefinition.interaction can only be used when type is 'interaction' ClinicalUseDefinition.interaction.empty() or ClinicalUseDefinition.type='interaction'
img  cud-6 Rule (base) ClinicalUseDefinition.warning can only be used when type is 'warning' ClinicalUseDefinition.warning.empty() or ClinicalUseDefinition.type='warning'



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() ClinicalUseDefinition.subject.reference.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 ( SubstanceDefinition , MedicinalProductDefinition , NutritionProduct , BiologicallyDerivedProduct , Device , Medication , DeviceDefinition , PlanDefinition , ActivityDefinition ) ClinicalUseDefinition.subject.reference
subject-code token The coded item for which this is a clinical usage issue ClinicalUseDefinition.subject.concept
type token indication | contraindication | interaction | undesirable-effect | warning ClinicalUseDefinition.type