Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

15.8 Resource ClinicalUseDefinition - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any 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, device or procedure 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, device or procedure.

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 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 is appropriate for use
  • Contraindication - A reason why a medicinal product, medical device or procedure is not to be used in a certain context
  • Interaction - The interactions of the medicinal product or medical device with other medicinal products, food, substances etc.
  • Undesirable Effect - A potential negative outcome from the use of a medicinal product, medical device or procedure. 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.

This resource is referenced by itself and MedicationKnowledge.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition TUDomainResourceA 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 Σ0..*IdentifierBusiness identifier for this issue
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | warning
ClinicalUseIssueType (Required)
... category Σ0..*CodeableConceptA 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"
... status Σ0..1CodeableConceptWhether this is a current issue or one that has been retired etc
... contraindication Σ0..1BackboneElementSpecifics for when this is a contraindication
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as contraindicating against this item
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the contraindication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection
.... indication Σ0..*Reference(ClinicalUseDefinition)The indication which this is a contraidication for
.... otherTherapy Σ0..*BackboneElementInformation about the use of the medicinal product in relation to other therapies described as part of the contraindication
..... relationshipType Σ1..1CodeableConceptThe type of relationship between the medicinal product indication or contraindication and another therapy
..... therapy Σ1..1CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition)Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
... indication Σ0..1BackboneElementSpecifics for when this is an indication
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as an indicaton for this item
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the indication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection as part of the indication
.... intendedEffect Σ0..1CodeableReference(ObservationDefinition)The intended effect, aim or strategy to be achieved
.... duration Σ0..1QuantityTiming or duration information
.... undesirableEffect Σ0..*Reference(ClinicalUseDefinition)The specific undesirable effects of the medicinal product
.... otherTherapy Σ0..*see otherTherapyInformation about the use of the medicinal product in relation to other therapies described as part of the indication
... interaction Σ0..1BackboneElementSpecifics for when this is an interaction
.... interactant Σ0..*BackboneElementThe specific medication, food, substance or laboratory test that interacts
..... item[x] Σ1..1The specific medication, food or laboratory test that interacts
...... itemReferenceReference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)
...... itemCodeableConceptCodeableConcept
.... type Σ0..1CodeableConceptThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
.... effect Σ0..1CodeableReference(ObservationDefinition)The effect of the interaction, for example "reduced gastric absorption of primary medication"
.... incidence Σ0..1CodeableConceptThe incidence of the interaction, e.g. theoretical, observed
.... management Σ0..*CodeableConceptActions for managing the interaction
... population Σ0..*Reference(Group)The population group to which this applies
... undesirableEffect Σ0..1BackboneElementA possible negative outcome from the use of this treatment
.... symptomConditionEffect Σ0..1CodeableReference(ObservationDefinition)The situation in which the undesirable effect may manifest
.... classification Σ0..1CodeableConceptHigh level classification of the effect
.... frequencyOfOccurrence Σ0..1CodeableConceptHow often the effect is seen
... warning Σ0..1BackboneElementA 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'
.... description Σ0..1markdownA textual definition of this warning, with formatting
.... code Σ0..1CodeableConceptA coded or unformatted textual definition of this warning
WarningType (Example)

doco Documentation for this format

UML Diagram (Legend)

ClinicalUseDefinition (DomainResource)Business identifier for this issueidentifier : Identifier [0..*]indication | contraindication | interaction | undesirable-effect | warningtype : code [1..1] « null (Strength=Required)ClinicalUseIssueType! »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..*]The medication or procedure for which this is an indicationsubject : Reference [0..*] « MedicinalProductDefinition|Medication| ActivityDefinition|PlanDefinition|Device|DeviceDefinition| Substance »Whether this is a current issue or one that has been retired etcstatus : CodeableConcept [0..1]The population group to which this appliespopulation : Reference [0..*] « Group »ContraindicationThe situation that is being documented as contraindicating against this itemdiseaseSymptomProcedure : DataType [0..1] « ObservationDefinition »The status of the disease or symptom for the contraindicationdiseaseStatus : DataType [0..1] « ObservationDefinition »A comorbidity (concurrent condition) or coinfectioncomorbidity : DataType [0..*] « ObservationDefinition »The indication which this is a contraidication forindication : Reference [0..*] « ClinicalUseDefinition »OtherTherapyThe type of relationship between the medicinal product indication or contraindication and another therapyrelationshipType : CodeableConcept [1..1]Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindicationtherapy : DataType [1..1] « MedicinalProductDefinition|Medication| Substance|SubstanceDefinition|ActivityDefinition »IndicationThe situation that is being documented as an indicaton for this itemdiseaseSymptomProcedure : DataType [0..1] « ObservationDefinition »The status of the disease or symptom for the indicationdiseaseStatus : DataType [0..1] « ObservationDefinition »A comorbidity (concurrent condition) or coinfection as part of the indicationcomorbidity : DataType [0..*] « ObservationDefinition »The intended effect, aim or strategy to be achievedintendedEffect : DataType [0..1] « ObservationDefinition »Timing or duration informationduration : Quantity [0..1]The specific undesirable effects of the medicinal productundesirableEffect : Reference [0..*] « ClinicalUseDefinition »InteractionThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interactiontype : CodeableConcept [0..1]The effect of the interaction, for example "reduced gastric absorption of primary medication"effect : DataType [0..1] « ObservationDefinition »The incidence of the interaction, e.g. theoretical, observedincidence : CodeableConcept [0..1]Actions for managing the interactionmanagement : CodeableConcept [0..*]InteractantThe specific medication, food or laboratory test that interactsitem[x] : DataType [1..1] « Reference(MedicinalProductDefinition| Medication|Substance|ObservationDefinition)|CodeableConcept »UndesirableEffectThe situation in which the undesirable effect may manifestsymptomConditionEffect : DataType [0..1] « ObservationDefinition »High level classification of the effectclassification : CodeableConcept [0..1]How often the effect is seenfrequencyOfOccurrence : CodeableConcept [0..1]WarningA textual definition of this warning, with formattingdescription : markdown [0..1]A coded or unformatted textual definition of this warningcode : 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 contraindicationotherTherapy[0..*]Specifics for when this is a contraindicationcontraindication[0..1]Information about the use of the medicinal product in relation to other therapies described as part of the indicationotherTherapy[0..*]Specifics for when this is an indicationindication[0..1]The specific medication, food, substance or laboratory test that interactsinteractant[0..*]Specifics for when this is an interactioninteraction[0..1]Describe the undesirable effects of the medicinal productundesirableEffect[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 and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines" --></category>
 <subject><!-- 0..* Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) The medication or procedure for which this is an indication --></subject>
 <status><!-- 0..1 CodeableConcept Whether this is a current issue or one that has been retired etc --></status>
 <contraindication>  <!-- 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>
  <otherTherapy>  <!-- 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication -->
   <relationshipType><!-- 1..1 CodeableConcept The type of relationship between the medicinal product indication or contraindication and another therapy --></relationshipType>
   <therapy><!-- 1..1 CodeableReference(ActivityDefinition|Medication|
     MedicinalProductDefinition|Substance|SubstanceDefinition) Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication --></therapy>
  </otherTherapy>
 </contraindication>
 <indication>  <!-- 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 (concurrent condition) or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableReference(ObservationDefinition) The intended effect, aim or strategy to be achieved --></intendedEffect>
  <duration><!-- 0..1 Quantity Timing or duration information --></duration>
  <undesirableEffect><!-- 0..* Reference(ClinicalUseDefinition) The specific undesirable effects of the medicinal product --></undesirableEffect>
  <otherTherapy><!-- 0..* Content as for ClinicalUseDefinition.contraindication.otherTherapy Information about the use of the medicinal product in relation to other therapies described as part of the indication --></otherTherapy>
 </indication>
 <interaction>  <!-- 0..1 Specifics for when this is an interaction -->
  <interactant>  <!-- 0..* The specific medication, food, substance or laboratory test that interacts -->
   <item[x]><!-- 1..1 Reference(Medication|MedicinalProductDefinition|
     ObservationDefinition|Substance)|CodeableConcept The specific medication, food or laboratory test that interacts --></item[x]>
  </interactant>
  <type><!-- 0..1 CodeableConcept The type of the interaction e.g. drug-drug interaction, drug-food 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>
 <undesirableEffect>  <!-- 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>  <!-- 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' -->
  <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 and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines"
  "subject" : [{ Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) }], // The medication or procedure for which this is an indication
  "status" : { CodeableConcept }, // Whether this is a current issue or one that has been retired etc
  "contraindication" : { // 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
    "otherTherapy" : [{ // Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
      "relationshipType" : { CodeableConcept }, // R!  The type of relationship between the medicinal product indication or contraindication and another therapy
      "therapy" : { CodeableReference(ActivityDefinition|Medication|
     MedicinalProductDefinition|Substance|SubstanceDefinition) } // R!  Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
    }]
  },
  "indication" : { // 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 (concurrent condition) or coinfection as part of the indication
    "intendedEffect" : { CodeableReference(ObservationDefinition) }, // The intended effect, aim or strategy to be achieved
    "duration" : { Quantity }, // Timing or duration information
    "undesirableEffect" : [{ Reference(ClinicalUseDefinition) }], // The specific undesirable effects of the medicinal product
    "otherTherapy" : [{ Content as for ClinicalUseDefinition.contraindication.otherTherapy }] // Information about the use of the medicinal product in relation to other therapies described as part of the indication
  },
  "interaction" : { // Specifics for when this is an interaction
    "interactant" : [{ // The specific medication, food, substance or laboratory test that interacts
      // item[x]: The specific medication, food or laboratory test that interacts. One of these 2:
      "itemReference" : { Reference(Medication|MedicinalProductDefinition|
     ObservationDefinition|Substance) }
      "itemCodeableConcept" : { CodeableConcept }
    }],
    "type" : { CodeableConcept }, // The type of the interaction e.g. drug-drug interaction, drug-food 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
  "undesirableEffect" : { // 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" : { // 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'
    "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:ClinicalUseDefinition.identifier [ Identifier ], ... ; # 0..* Business identifier for this issue
  fhir:ClinicalUseDefinition.type [ code ]; # 1..1 indication | contraindication | interaction | undesirable-effect | warning
  fhir:ClinicalUseDefinition.category [ CodeableConcept ], ... ; # 0..* 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"
  fhir:ClinicalUseDefinition.subject [ Reference(ActivityDefinition|Device|DeviceDefinition|Medication|MedicinalProductDefinition|
  PlanDefinition|Substance) ], ... ; # 0..* The medication or procedure for which this is an indication
  fhir:ClinicalUseDefinition.status [ CodeableConcept ]; # 0..1 Whether this is a current issue or one that has been retired etc
  fhir:ClinicalUseDefinition.contraindication [ # 0..1 Specifics for when this is a contraindication
    fhir:ClinicalUseDefinition.contraindication.diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ]; # 0..1 The situation that is being documented as contraindicating against this item
    fhir:ClinicalUseDefinition.contraindication.diseaseStatus [ CodeableReference(ObservationDefinition) ]; # 0..1 The status of the disease or symptom for the contraindication
    fhir:ClinicalUseDefinition.contraindication.comorbidity [ CodeableReference(ObservationDefinition) ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:ClinicalUseDefinition.contraindication.indication [ Reference(ClinicalUseDefinition) ], ... ; # 0..* The indication which this is a contraidication for
    fhir:ClinicalUseDefinition.contraindication.otherTherapy [ # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
      fhir:ClinicalUseDefinition.contraindication.otherTherapy.relationshipType [ CodeableConcept ]; # 1..1 The type of relationship between the medicinal product indication or contraindication and another therapy
      fhir:ClinicalUseDefinition.contraindication.otherTherapy.therapy [ CodeableReference(ActivityDefinition|Medication|MedicinalProductDefinition|Substance|
  SubstanceDefinition) ]; # 1..1 Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
    ], ...;
  ];
  fhir:ClinicalUseDefinition.indication [ # 0..1 Specifics for when this is an indication
    fhir:ClinicalUseDefinition.indication.diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ]; # 0..1 The situation that is being documented as an indicaton for this item
    fhir:ClinicalUseDefinition.indication.diseaseStatus [ CodeableReference(ObservationDefinition) ]; # 0..1 The status of the disease or symptom for the indication
    fhir:ClinicalUseDefinition.indication.comorbidity [ CodeableReference(ObservationDefinition) ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection as part of the indication
    fhir:ClinicalUseDefinition.indication.intendedEffect [ CodeableReference(ObservationDefinition) ]; # 0..1 The intended effect, aim or strategy to be achieved
    fhir:ClinicalUseDefinition.indication.duration [ Quantity ]; # 0..1 Timing or duration information
    fhir:ClinicalUseDefinition.indication.undesirableEffect [ Reference(ClinicalUseDefinition) ], ... ; # 0..* The specific undesirable effects of the medicinal product
    fhir:ClinicalUseDefinition.indication.otherTherapy [ See ClinicalUseDefinition.contraindication.otherTherapy ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the indication
  ];
  fhir:ClinicalUseDefinition.interaction [ # 0..1 Specifics for when this is an interaction
    fhir:ClinicalUseDefinition.interaction.interactant [ # 0..* The specific medication, food, substance or laboratory test that interacts
      # ClinicalUseDefinition.interaction.interactant.item[x] : 1..1 The specific medication, food or laboratory test that interacts. One of these 2
        fhir:ClinicalUseDefinition.interaction.interactant.itemReference [ Reference(Medication|MedicinalProductDefinition|ObservationDefinition|Substance) ]
        fhir:ClinicalUseDefinition.interaction.interactant.itemCodeableConcept [ CodeableConcept ]
    ], ...;
    fhir:ClinicalUseDefinition.interaction.type [ CodeableConcept ]; # 0..1 The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
    fhir:ClinicalUseDefinition.interaction.effect [ CodeableReference(ObservationDefinition) ]; # 0..1 The effect of the interaction, for example "reduced gastric absorption of primary medication"
    fhir:ClinicalUseDefinition.interaction.incidence [ CodeableConcept ]; # 0..1 The incidence of the interaction, e.g. theoretical, observed
    fhir:ClinicalUseDefinition.interaction.management [ CodeableConcept ], ... ; # 0..* Actions for managing the interaction
  ];
  fhir:ClinicalUseDefinition.population [ Reference(Group) ], ... ; # 0..* The population group to which this applies
  fhir:ClinicalUseDefinition.undesirableEffect [ # 0..1 A possible negative outcome from the use of this treatment
    fhir:ClinicalUseDefinition.undesirableEffect.symptomConditionEffect [ CodeableReference(ObservationDefinition) ]; # 0..1 The situation in which the undesirable effect may manifest
    fhir:ClinicalUseDefinition.undesirableEffect.classification [ CodeableConcept ]; # 0..1 High level classification of the effect
    fhir:ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 How often the effect is seen
  ];
  fhir:ClinicalUseDefinition.warning [ # 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'
    fhir:ClinicalUseDefinition.warning.description [ markdown ]; # 0..1 A textual definition of this warning, with formatting
    fhir:ClinicalUseDefinition.warning.code [ CodeableConcept ]; # 0..1 A coded or unformatted textual definition of this warning
  ];
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseDefinition TUDomainResourceA 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 Σ0..*IdentifierBusiness identifier for this issue
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | warning
ClinicalUseIssueType (Required)
... category Σ0..*CodeableConceptA 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"
... status Σ0..1CodeableConceptWhether this is a current issue or one that has been retired etc
... contraindication Σ0..1BackboneElementSpecifics for when this is a contraindication
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as contraindicating against this item
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the contraindication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection
.... indication Σ0..*Reference(ClinicalUseDefinition)The indication which this is a contraidication for
.... otherTherapy Σ0..*BackboneElementInformation about the use of the medicinal product in relation to other therapies described as part of the contraindication
..... relationshipType Σ1..1CodeableConceptThe type of relationship between the medicinal product indication or contraindication and another therapy
..... therapy Σ1..1CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition)Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
... indication Σ0..1BackboneElementSpecifics for when this is an indication
.... diseaseSymptomProcedure Σ0..1CodeableReference(ObservationDefinition)The situation that is being documented as an indicaton for this item
.... diseaseStatus Σ0..1CodeableReference(ObservationDefinition)The status of the disease or symptom for the indication
.... comorbidity Σ0..*CodeableReference(ObservationDefinition)A comorbidity (concurrent condition) or coinfection as part of the indication
.... intendedEffect Σ0..1CodeableReference(ObservationDefinition)The intended effect, aim or strategy to be achieved
.... duration Σ0..1QuantityTiming or duration information
.... undesirableEffect Σ0..*Reference(ClinicalUseDefinition)The specific undesirable effects of the medicinal product
.... otherTherapy Σ0..*see otherTherapyInformation about the use of the medicinal product in relation to other therapies described as part of the indication
... interaction Σ0..1BackboneElementSpecifics for when this is an interaction
.... interactant Σ0..*BackboneElementThe specific medication, food, substance or laboratory test that interacts
..... item[x] Σ1..1The specific medication, food or laboratory test that interacts
...... itemReferenceReference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)
...... itemCodeableConceptCodeableConcept
.... type Σ0..1CodeableConceptThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
.... effect Σ0..1CodeableReference(ObservationDefinition)The effect of the interaction, for example "reduced gastric absorption of primary medication"
.... incidence Σ0..1CodeableConceptThe incidence of the interaction, e.g. theoretical, observed
.... management Σ0..*CodeableConceptActions for managing the interaction
... population Σ0..*Reference(Group)The population group to which this applies
... undesirableEffect Σ0..1BackboneElementA possible negative outcome from the use of this treatment
.... symptomConditionEffect Σ0..1CodeableReference(ObservationDefinition)The situation in which the undesirable effect may manifest
.... classification Σ0..1CodeableConceptHigh level classification of the effect
.... frequencyOfOccurrence Σ0..1CodeableConceptHow often the effect is seen
... warning Σ0..1BackboneElementA 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'
.... description Σ0..1markdownA textual definition of this warning, with formatting
.... code Σ0..1CodeableConceptA coded or unformatted textual definition of this warning
WarningType (Example)

doco Documentation for this format

UML Diagram (Legend)

ClinicalUseDefinition (DomainResource)Business identifier for this issueidentifier : Identifier [0..*]indication | contraindication | interaction | undesirable-effect | warningtype : code [1..1] « null (Strength=Required)ClinicalUseIssueType! »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..*]The medication or procedure for which this is an indicationsubject : Reference [0..*] « MedicinalProductDefinition|Medication| ActivityDefinition|PlanDefinition|Device|DeviceDefinition| Substance »Whether this is a current issue or one that has been retired etcstatus : CodeableConcept [0..1]The population group to which this appliespopulation : Reference [0..*] « Group »ContraindicationThe situation that is being documented as contraindicating against this itemdiseaseSymptomProcedure : DataType [0..1] « ObservationDefinition »The status of the disease or symptom for the contraindicationdiseaseStatus : DataType [0..1] « ObservationDefinition »A comorbidity (concurrent condition) or coinfectioncomorbidity : DataType [0..*] « ObservationDefinition »The indication which this is a contraidication forindication : Reference [0..*] « ClinicalUseDefinition »OtherTherapyThe type of relationship between the medicinal product indication or contraindication and another therapyrelationshipType : CodeableConcept [1..1]Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindicationtherapy : DataType [1..1] « MedicinalProductDefinition|Medication| Substance|SubstanceDefinition|ActivityDefinition »IndicationThe situation that is being documented as an indicaton for this itemdiseaseSymptomProcedure : DataType [0..1] « ObservationDefinition »The status of the disease or symptom for the indicationdiseaseStatus : DataType [0..1] « ObservationDefinition »A comorbidity (concurrent condition) or coinfection as part of the indicationcomorbidity : DataType [0..*] « ObservationDefinition »The intended effect, aim or strategy to be achievedintendedEffect : DataType [0..1] « ObservationDefinition »Timing or duration informationduration : Quantity [0..1]The specific undesirable effects of the medicinal productundesirableEffect : Reference [0..*] « ClinicalUseDefinition »InteractionThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interactiontype : CodeableConcept [0..1]The effect of the interaction, for example "reduced gastric absorption of primary medication"effect : DataType [0..1] « ObservationDefinition »The incidence of the interaction, e.g. theoretical, observedincidence : CodeableConcept [0..1]Actions for managing the interactionmanagement : CodeableConcept [0..*]InteractantThe specific medication, food or laboratory test that interactsitem[x] : DataType [1..1] « Reference(MedicinalProductDefinition| Medication|Substance|ObservationDefinition)|CodeableConcept »UndesirableEffectThe situation in which the undesirable effect may manifestsymptomConditionEffect : DataType [0..1] « ObservationDefinition »High level classification of the effectclassification : CodeableConcept [0..1]How often the effect is seenfrequencyOfOccurrence : CodeableConcept [0..1]WarningA textual definition of this warning, with formattingdescription : markdown [0..1]A coded or unformatted textual definition of this warningcode : 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 contraindicationotherTherapy[0..*]Specifics for when this is a contraindicationcontraindication[0..1]Information about the use of the medicinal product in relation to other therapies described as part of the indicationotherTherapy[0..*]Specifics for when this is an indicationindication[0..1]The specific medication, food, substance or laboratory test that interactsinteractant[0..*]Specifics for when this is an interactioninteraction[0..1]Describe the undesirable effects of the medicinal productundesirableEffect[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 and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines" --></category>
 <subject><!-- 0..* Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) The medication or procedure for which this is an indication --></subject>
 <status><!-- 0..1 CodeableConcept Whether this is a current issue or one that has been retired etc --></status>
 <contraindication>  <!-- 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>
  <otherTherapy>  <!-- 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication -->
   <relationshipType><!-- 1..1 CodeableConcept The type of relationship between the medicinal product indication or contraindication and another therapy --></relationshipType>
   <therapy><!-- 1..1 CodeableReference(ActivityDefinition|Medication|
     MedicinalProductDefinition|Substance|SubstanceDefinition) Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication --></therapy>
  </otherTherapy>
 </contraindication>
 <indication>  <!-- 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 (concurrent condition) or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableReference(ObservationDefinition) The intended effect, aim or strategy to be achieved --></intendedEffect>
  <duration><!-- 0..1 Quantity Timing or duration information --></duration>
  <undesirableEffect><!-- 0..* Reference(ClinicalUseDefinition) The specific undesirable effects of the medicinal product --></undesirableEffect>
  <otherTherapy><!-- 0..* Content as for ClinicalUseDefinition.contraindication.otherTherapy Information about the use of the medicinal product in relation to other therapies described as part of the indication --></otherTherapy>
 </indication>
 <interaction>  <!-- 0..1 Specifics for when this is an interaction -->
  <interactant>  <!-- 0..* The specific medication, food, substance or laboratory test that interacts -->
   <item[x]><!-- 1..1 Reference(Medication|MedicinalProductDefinition|
     ObservationDefinition|Substance)|CodeableConcept The specific medication, food or laboratory test that interacts --></item[x]>
  </interactant>
  <type><!-- 0..1 CodeableConcept The type of the interaction e.g. drug-drug interaction, drug-food 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>
 <undesirableEffect>  <!-- 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>  <!-- 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' -->
  <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 and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines"
  "subject" : [{ Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) }], // The medication or procedure for which this is an indication
  "status" : { CodeableConcept }, // Whether this is a current issue or one that has been retired etc
  "contraindication" : { // 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
    "otherTherapy" : [{ // Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
      "relationshipType" : { CodeableConcept }, // R!  The type of relationship between the medicinal product indication or contraindication and another therapy
      "therapy" : { CodeableReference(ActivityDefinition|Medication|
     MedicinalProductDefinition|Substance|SubstanceDefinition) } // R!  Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
    }]
  },
  "indication" : { // 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 (concurrent condition) or coinfection as part of the indication
    "intendedEffect" : { CodeableReference(ObservationDefinition) }, // The intended effect, aim or strategy to be achieved
    "duration" : { Quantity }, // Timing or duration information
    "undesirableEffect" : [{ Reference(ClinicalUseDefinition) }], // The specific undesirable effects of the medicinal product
    "otherTherapy" : [{ Content as for ClinicalUseDefinition.contraindication.otherTherapy }] // Information about the use of the medicinal product in relation to other therapies described as part of the indication
  },
  "interaction" : { // Specifics for when this is an interaction
    "interactant" : [{ // The specific medication, food, substance or laboratory test that interacts
      // item[x]: The specific medication, food or laboratory test that interacts. One of these 2:
      "itemReference" : { Reference(Medication|MedicinalProductDefinition|
     ObservationDefinition|Substance) }
      "itemCodeableConcept" : { CodeableConcept }
    }],
    "type" : { CodeableConcept }, // The type of the interaction e.g. drug-drug interaction, drug-food 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
  "undesirableEffect" : { // 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" : { // 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'
    "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:ClinicalUseDefinition.identifier [ Identifier ], ... ; # 0..* Business identifier for this issue
  fhir:ClinicalUseDefinition.type [ code ]; # 1..1 indication | contraindication | interaction | undesirable-effect | warning
  fhir:ClinicalUseDefinition.category [ CodeableConcept ], ... ; # 0..* 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"
  fhir:ClinicalUseDefinition.subject [ Reference(ActivityDefinition|Device|DeviceDefinition|Medication|MedicinalProductDefinition|
  PlanDefinition|Substance) ], ... ; # 0..* The medication or procedure for which this is an indication
  fhir:ClinicalUseDefinition.status [ CodeableConcept ]; # 0..1 Whether this is a current issue or one that has been retired etc
  fhir:ClinicalUseDefinition.contraindication [ # 0..1 Specifics for when this is a contraindication
    fhir:ClinicalUseDefinition.contraindication.diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ]; # 0..1 The situation that is being documented as contraindicating against this item
    fhir:ClinicalUseDefinition.contraindication.diseaseStatus [ CodeableReference(ObservationDefinition) ]; # 0..1 The status of the disease or symptom for the contraindication
    fhir:ClinicalUseDefinition.contraindication.comorbidity [ CodeableReference(ObservationDefinition) ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:ClinicalUseDefinition.contraindication.indication [ Reference(ClinicalUseDefinition) ], ... ; # 0..* The indication which this is a contraidication for
    fhir:ClinicalUseDefinition.contraindication.otherTherapy [ # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
      fhir:ClinicalUseDefinition.contraindication.otherTherapy.relationshipType [ CodeableConcept ]; # 1..1 The type of relationship between the medicinal product indication or contraindication and another therapy
      fhir:ClinicalUseDefinition.contraindication.otherTherapy.therapy [ CodeableReference(ActivityDefinition|Medication|MedicinalProductDefinition|Substance|
  SubstanceDefinition) ]; # 1..1 Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
    ], ...;
  ];
  fhir:ClinicalUseDefinition.indication [ # 0..1 Specifics for when this is an indication
    fhir:ClinicalUseDefinition.indication.diseaseSymptomProcedure [ CodeableReference(ObservationDefinition) ]; # 0..1 The situation that is being documented as an indicaton for this item
    fhir:ClinicalUseDefinition.indication.diseaseStatus [ CodeableReference(ObservationDefinition) ]; # 0..1 The status of the disease or symptom for the indication
    fhir:ClinicalUseDefinition.indication.comorbidity [ CodeableReference(ObservationDefinition) ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection as part of the indication
    fhir:ClinicalUseDefinition.indication.intendedEffect [ CodeableReference(ObservationDefinition) ]; # 0..1 The intended effect, aim or strategy to be achieved
    fhir:ClinicalUseDefinition.indication.duration [ Quantity ]; # 0..1 Timing or duration information
    fhir:ClinicalUseDefinition.indication.undesirableEffect [ Reference(ClinicalUseDefinition) ], ... ; # 0..* The specific undesirable effects of the medicinal product
    fhir:ClinicalUseDefinition.indication.otherTherapy [ See ClinicalUseDefinition.contraindication.otherTherapy ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the indication
  ];
  fhir:ClinicalUseDefinition.interaction [ # 0..1 Specifics for when this is an interaction
    fhir:ClinicalUseDefinition.interaction.interactant [ # 0..* The specific medication, food, substance or laboratory test that interacts
      # ClinicalUseDefinition.interaction.interactant.item[x] : 1..1 The specific medication, food or laboratory test that interacts. One of these 2
        fhir:ClinicalUseDefinition.interaction.interactant.itemReference [ Reference(Medication|MedicinalProductDefinition|ObservationDefinition|Substance) ]
        fhir:ClinicalUseDefinition.interaction.interactant.itemCodeableConcept [ CodeableConcept ]
    ], ...;
    fhir:ClinicalUseDefinition.interaction.type [ CodeableConcept ]; # 0..1 The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
    fhir:ClinicalUseDefinition.interaction.effect [ CodeableReference(ObservationDefinition) ]; # 0..1 The effect of the interaction, for example "reduced gastric absorption of primary medication"
    fhir:ClinicalUseDefinition.interaction.incidence [ CodeableConcept ]; # 0..1 The incidence of the interaction, e.g. theoretical, observed
    fhir:ClinicalUseDefinition.interaction.management [ CodeableConcept ], ... ; # 0..* Actions for managing the interaction
  ];
  fhir:ClinicalUseDefinition.population [ Reference(Group) ], ... ; # 0..* The population group to which this applies
  fhir:ClinicalUseDefinition.undesirableEffect [ # 0..1 A possible negative outcome from the use of this treatment
    fhir:ClinicalUseDefinition.undesirableEffect.symptomConditionEffect [ CodeableReference(ObservationDefinition) ]; # 0..1 The situation in which the undesirable effect may manifest
    fhir:ClinicalUseDefinition.undesirableEffect.classification [ CodeableConcept ]; # 0..1 High level classification of the effect
    fhir:ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 How often the effect is seen
  ];
  fhir:ClinicalUseDefinition.warning [ # 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'
    fhir:ClinicalUseDefinition.warning.description [ markdown ]; # 0..1 A textual definition of this warning, with formatting
    fhir:ClinicalUseDefinition.warning.code [ CodeableConcept ]; # 0..1 A coded or unformatted textual definition of this warning
  ];
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a

PathDefinitionTypeReference
ClinicalUseDefinition.type RequiredClinicalUseIssueType
ClinicalUseDefinition.warning.code ExampleWarningType

idLevelLocationDescriptionExpression
cud-1Rule (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

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
contraindicationtokenThe situation that is being documented as contraindicating against this item, as a codeClinicalUseDefinition.contraindication.diseaseSymptomProcedure
contraindication-referencereferenceThe situation that is being documented as contraindicating against this item, as a referenceClinicalUseDefinition.contraindication.diseaseSymptomProcedure
effecttokenThe situation in which the undesirable effect may manifest, as a codeClinicalUseDefinition.undesirableEffect.symptomConditionEffect
effect-referencereferenceThe situation in which the undesirable effect may manifest, as a referenceClinicalUseDefinition.undesirableEffect.symptomConditionEffect
identifiertokenBusiness identifier for this issueClinicalUseDefinition.identifier
indicationtokenThe situation that is being documented as an indicaton for this item, as a codeClinicalUseDefinition.indication.diseaseSymptomProcedure
indication-referencereferenceThe situation that is being documented as an indicaton for this item, as a referenceClinicalUseDefinition.indication.diseaseSymptomProcedure
interactiontokenThe type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interactionClinicalUseDefinition.interaction.type
productreferenceThe medicinal product for which this is a clinical usage issueClinicalUseDefinition.subject.where(resolve() is MedicinalProductDefinition)
(MedicinalProductDefinition, Device, Medication, DeviceDefinition, PlanDefinition, Substance, ActivityDefinition)
subjectreferenceThe resource for which this is a clinical usage issueClinicalUseDefinition.subject
(MedicinalProductDefinition, Device, Medication, DeviceDefinition, PlanDefinition, Substance, ActivityDefinition)
type Ntokenindication | contraindication | interaction | undesirable-effect | warningClinicalUseDefinition.type