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11.20 Resource ClinicalUseIssue - Content

Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

A single item of clinical particulars - an indication, contraindication, interaction etc. for a medicinal product.

ClinicalParticulars is to record an instance of facts about a particular medication in relation to its intended use (indication), situations where it should not normally be used (contrainindication), known side effects (undesirable effects), and clashes with other substances - medications, foods etc (interactions). The resource is used to record one such instance, and all its details.

The ClinicalParticulars resource is designed to represent definitional facts about the potential use of a medication.

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

The particulars don't refer to any actual instance of the medication 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 is appropriate for use
  • Contraindication - A reason why a medicinal product is not to be used in a certain context
  • Interaction - The interactions of the medicinal product with other medicinal products, food, substances etc.
  • Undesirable Effect - A potential negative outcome from the use of a medicinal product. See also AdverseEvent, which is for actual events (or near misses), and AllergyIntolerance.

This resource is referenced by itself, MedicationKnowledge, MedicinalProductDefinition and RegulatedMedicinalProduct.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseIssue ΣTUDomainResourceClinicalUseIssue
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | other
ClinicalUseIssueType (Required)
... subject Σ0..*Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance)The medication or procedure for which this is an indication
... description Σ0..1stringGeneral description
... contraindication Σ0..1BackboneElementSpecifics for when this is a contraindication
.... diseaseSymptomProcedure Σ0..1CodeableConceptThe disease, symptom or procedure for the contraindication
.... diseaseStatus Σ0..1CodeableConceptThe status of the disease or symptom for the contraindication
.... comorbidity Σ0..*CodeableConceptA comorbidity (concurrent condition) or coinfection
.... indication Σ0..*Reference(ClinicalUseIssue)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 indication
..... therapyRelationshipType Σ1..1CodeableConceptThe type of relationship between the medicinal product indication or contraindication and another therapy
..... medication[x] Σ1..1Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
...... medicationCodeableConceptCodeableConcept
...... medicationReferenceReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition)
... indication Σ0..1BackboneElementSpecifics for when this is an indication
.... diseaseSymptomProcedure Σ0..1CodeableConceptThe disease, symptom or procedure for the indication
.... diseaseStatus Σ0..1CodeableConceptThe status of the disease or symptom for the indication
.... comorbidity Σ0..*CodeableConceptA comorbidity (concurrent condition) or coinfection as part of the indication
.... intendedEffect Σ0..1CodeableConceptFor an indication - the intended effect, aim or strategy to be achieved
.... duration Σ0..1QuantityFor an indication - timing or duration information
.... undesirableEffect Σ0..*Reference(ClinicalUseIssue)For an indicaton - 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 contraindication
... interaction Σ0..1BackboneElementSpecifics for when this is an interaction
.... interactant Σ0..*BackboneElementThe specific medication, food 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..1CodeableConceptThe 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..1CodeableConceptActions for managing the interaction
... population Σ0..*PopulationThe population group to which this applies
... undesirableEffect Σ0..1BackboneElementUndesirableEffect
.... symptomConditionEffect Σ0..1CodeableConceptThe symptom, condition or undesirable effect
.... classification Σ0..1CodeableConceptClassification of the effect
.... frequencyOfOccurrence Σ0..1CodeableConceptThe frequency of occurrence of the effect

doco Documentation for this format

UML Diagram (Legend)

ClinicalUseIssue (DomainResource)indication | contraindication | interaction | undesirable-effect | othertype : code [1..1] « Overall defining type of this clinical use issue. (Strength=Required)ClinicalUseIssueType! »The medication or procedure for which this is an indicationsubject : Reference [0..*] « MedicinalProductDefinition|Medication| ActivityDefinition|PlanDefinition|Device|DeviceDefinition| Substance »General descriptiondescription : string [0..1]The population group to which this appliespopulation : Population [0..*]ContraindicationThe disease, symptom or procedure for the contraindicationdiseaseSymptomProcedure : CodeableConcept [0..1]The status of the disease or symptom for the contraindicationdiseaseStatus : CodeableConcept [0..1]A comorbidity (concurrent condition) or coinfectioncomorbidity : CodeableConcept [0..*]The indication which this is a contraidication forindication : Reference [0..*] « ClinicalUseIssue »OtherTherapyThe type of relationship between the medicinal product indication or contraindication and another therapytherapyRelationshipType : CodeableConcept [1..1]Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindicationmedication[x] : Type [1..1] « CodeableConcept|Reference( MedicinalProductDefinition|Medication|Substance| SubstanceDefinition) »IndicationThe disease, symptom or procedure for the indicationdiseaseSymptomProcedure : CodeableConcept [0..1]The status of the disease or symptom for the indicationdiseaseStatus : CodeableConcept [0..1]A comorbidity (concurrent condition) or coinfection as part of the indicationcomorbidity : CodeableConcept [0..*]For an indication - the intended effect, aim or strategy to be achievedintendedEffect : CodeableConcept [0..1]For an indication - timing or duration informationduration : Quantity [0..1]For an indicaton - the specific undesirable effects of the medicinal productundesirableEffect : Reference [0..*] « ClinicalUseIssue »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 : CodeableConcept [0..1]The incidence of the interaction, e.g. theoretical, observedincidence : CodeableConcept [0..1]Actions for managing the interactionmanagement : CodeableConcept [0..1]InteractantThe specific medication, food or laboratory test that interactsitem[x] : Type [1..1] « Reference(MedicinalProductDefinition| Medication|Substance|ObservationDefinition)|CodeableConcept »UndesirableEffectThe symptom, condition or undesirable effectsymptomConditionEffect : CodeableConcept [0..1]Classification of the effectclassification : CodeableConcept [0..1]The frequency of occurrence of the effectfrequencyOfOccurrence : CodeableConcept [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 a contraindicationcontraindication[0..1]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 an indicationindication[0..1]The specific medication, food 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]

XML Template

<ClinicalUseIssue xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <type value="[code]"/><!-- 1..1 indication | contraindication | interaction | undesirable-effect | other -->
 <subject><!-- 0..* Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) The medication or procedure for which this is an indication --></subject>
 <description value="[string]"/><!-- 0..1 General description -->
 <contraindication>  <!-- 0..1 Specifics for when this is a contraindication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The disease, symptom or procedure for the contraindication --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableConcept The status of the disease or symptom for the contraindication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableConcept A comorbidity (concurrent condition) or coinfection --></comorbidity>
  <indication><!-- 0..* Reference(ClinicalUseIssue) 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 indication -->
   <therapyRelationshipType><!-- 1..1 CodeableConcept The type of relationship between the medicinal product indication or contraindication and another therapy --></therapyRelationshipType>
   <medication[x]><!-- 1..1 CodeableConcept|Reference(Medication|
     MedicinalProductDefinition|Substance|SubstanceDefinition) Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication --></medication[x]>
  </otherTherapy>
 </contraindication>
 <indication>  <!-- 0..1 Specifics for when this is an indication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The disease, symptom or procedure for the indication --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableConcept The status of the disease or symptom for the indication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableConcept A comorbidity (concurrent condition) or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableConcept For an indication - the intended effect, aim or strategy to be achieved --></intendedEffect>
  <duration><!-- 0..1 Quantity For an indication - timing or duration information --></duration>
  <undesirableEffect><!-- 0..* Reference(ClinicalUseIssue) For an indicaton - the specific undesirable effects of the medicinal product --></undesirableEffect>
  <otherTherapy><!-- 0..* Content as for ClinicalUseIssue.contraindication.otherTherapy Information about the use of the medicinal product in relation to other therapies described as part of the contraindication --></otherTherapy>
 </indication>
 <interaction>  <!-- 0..1 Specifics for when this is an interaction -->
  <interactant>  <!-- 0..* The specific medication, food 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 CodeableConcept 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..1 CodeableConcept Actions for managing the interaction --></management>
 </interaction>
 <population><!-- 0..* Population The population group to which this applies --></population>
 <undesirableEffect>  <!-- 0..1 UndesirableEffect -->
  <symptomConditionEffect><!-- 0..1 CodeableConcept The symptom, condition or undesirable effect --></symptomConditionEffect>
  <classification><!-- 0..1 CodeableConcept Classification of the effect --></classification>
  <frequencyOfOccurrence><!-- 0..1 CodeableConcept The frequency of occurrence of the effect --></frequencyOfOccurrence>
 </undesirableEffect>
</ClinicalUseIssue>

JSON Template

{doco
  "resourceType" : "ClinicalUseIssue",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "type" : "<code>", // R!  indication | contraindication | interaction | undesirable-effect | other
  "subject" : [{ Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) }], // The medication or procedure for which this is an indication
  "description" : "<string>", // General description
  "contraindication" : { // Specifics for when this is a contraindication
    "diseaseSymptomProcedure" : { CodeableConcept }, // The disease, symptom or procedure for the contraindication
    "diseaseStatus" : { CodeableConcept }, // The status of the disease or symptom for the contraindication
    "comorbidity" : [{ CodeableConcept }], // A comorbidity (concurrent condition) or coinfection
    "indication" : [{ Reference(ClinicalUseIssue) }], // 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 indication
      "therapyRelationshipType" : { CodeableConcept }, // R!  The type of relationship between the medicinal product indication or contraindication and another therapy
      // medication[x]: 
       Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. One of these 2:
      "medicationCodeableConcept" : { CodeableConcept }
      "medicationReference" : { Reference(Medication|MedicinalProductDefinition|
     Substance|SubstanceDefinition) }
    }]
  },
  "indication" : { // Specifics for when this is an indication
    "diseaseSymptomProcedure" : { CodeableConcept }, // The disease, symptom or procedure for the indication
    "diseaseStatus" : { CodeableConcept }, // The status of the disease or symptom for the indication
    "comorbidity" : [{ CodeableConcept }], // A comorbidity (concurrent condition) or coinfection as part of the indication
    "intendedEffect" : { CodeableConcept }, // For an indication - the intended effect, aim or strategy to be achieved
    "duration" : { Quantity }, // For an indication - timing or duration information
    "undesirableEffect" : [{ Reference(ClinicalUseIssue) }], // For an indicaton - the specific undesirable effects of the medicinal product
    "otherTherapy" : [{ Content as for ClinicalUseIssue.contraindication.otherTherapy }] // Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
  },
  "interaction" : { // Specifics for when this is an interaction
    "interactant" : [{ // The specific medication, food 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" : { CodeableConcept }, // 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" : [{ Population }], // The population group to which this applies
  "undesirableEffect" : { // UndesirableEffect
    "symptomConditionEffect" : { CodeableConcept }, // The symptom, condition or undesirable effect
    "classification" : { CodeableConcept }, // Classification of the effect
    "frequencyOfOccurrence" : { CodeableConcept } // The frequency of occurrence of the effect
  }
}

Turtle Template

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


[ a fhir:ClinicalUseIssue;
  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:ClinicalUseIssue.type [ code ]; # 1..1 indication | contraindication | interaction | undesirable-effect | other
  fhir:ClinicalUseIssue.subject [ Reference(ActivityDefinition|Device|DeviceDefinition|Medication|MedicinalProductDefinition|
  PlanDefinition|Substance) ], ... ; # 0..* The medication or procedure for which this is an indication
  fhir:ClinicalUseIssue.description [ string ]; # 0..1 General description
  fhir:ClinicalUseIssue.contraindication [ # 0..1 Specifics for when this is a contraindication
    fhir:ClinicalUseIssue.contraindication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The disease, symptom or procedure for the contraindication
    fhir:ClinicalUseIssue.contraindication.diseaseStatus [ CodeableConcept ]; # 0..1 The status of the disease or symptom for the contraindication
    fhir:ClinicalUseIssue.contraindication.comorbidity [ CodeableConcept ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:ClinicalUseIssue.contraindication.indication [ Reference(ClinicalUseIssue) ], ... ; # 0..* The indication which this is a contraidication for
    fhir:ClinicalUseIssue.contraindication.otherTherapy [ # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the indication
      fhir:ClinicalUseIssue.contraindication.otherTherapy.therapyRelationshipType [ CodeableConcept ]; # 1..1 The type of relationship between the medicinal product indication or contraindication and another therapy
      # ClinicalUseIssue.contraindication.otherTherapy.medication[x] : 1..1 Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. One of these 2
        fhir:ClinicalUseIssue.contraindication.otherTherapy.medicationCodeableConcept [ CodeableConcept ]
        fhir:ClinicalUseIssue.contraindication.otherTherapy.medicationReference [ Reference(Medication|MedicinalProductDefinition|Substance|SubstanceDefinition) ]
    ], ...;
  ];
  fhir:ClinicalUseIssue.indication [ # 0..1 Specifics for when this is an indication
    fhir:ClinicalUseIssue.indication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The disease, symptom or procedure for the indication
    fhir:ClinicalUseIssue.indication.diseaseStatus [ CodeableConcept ]; # 0..1 The status of the disease or symptom for the indication
    fhir:ClinicalUseIssue.indication.comorbidity [ CodeableConcept ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection as part of the indication
    fhir:ClinicalUseIssue.indication.intendedEffect [ CodeableConcept ]; # 0..1 For an indication - the intended effect, aim or strategy to be achieved
    fhir:ClinicalUseIssue.indication.duration [ Quantity ]; # 0..1 For an indication - timing or duration information
    fhir:ClinicalUseIssue.indication.undesirableEffect [ Reference(ClinicalUseIssue) ], ... ; # 0..* For an indicaton - the specific undesirable effects of the medicinal product
    fhir:ClinicalUseIssue.indication.otherTherapy [ See ClinicalUseIssue.contraindication.otherTherapy ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
  ];
  fhir:ClinicalUseIssue.interaction [ # 0..1 Specifics for when this is an interaction
    fhir:ClinicalUseIssue.interaction.interactant [ # 0..* The specific medication, food or laboratory test that interacts
      # ClinicalUseIssue.interaction.interactant.item[x] : 1..1 The specific medication, food or laboratory test that interacts. One of these 2
        fhir:ClinicalUseIssue.interaction.interactant.itemReference [ Reference(Medication|MedicinalProductDefinition|ObservationDefinition|Substance) ]
        fhir:ClinicalUseIssue.interaction.interactant.itemCodeableConcept [ CodeableConcept ]
    ], ...;
    fhir:ClinicalUseIssue.interaction.type [ CodeableConcept ]; # 0..1 The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
    fhir:ClinicalUseIssue.interaction.effect [ CodeableConcept ]; # 0..1 The effect of the interaction, for example "reduced gastric absorption of primary medication"
    fhir:ClinicalUseIssue.interaction.incidence [ CodeableConcept ]; # 0..1 The incidence of the interaction, e.g. theoretical, observed
    fhir:ClinicalUseIssue.interaction.management [ CodeableConcept ]; # 0..1 Actions for managing the interaction
  ];
  fhir:ClinicalUseIssue.population [ Population ], ... ; # 0..* The population group to which this applies
  fhir:ClinicalUseIssue.undesirableEffect [ # 0..1 UndesirableEffect
    fhir:ClinicalUseIssue.undesirableEffect.symptomConditionEffect [ CodeableConcept ]; # 0..1 The symptom, condition or undesirable effect
    fhir:ClinicalUseIssue.undesirableEffect.classification [ CodeableConcept ]; # 0..1 Classification of the effect
    fhir:ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 The frequency of occurrence of the effect
  ];
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ClinicalUseIssue ΣTUDomainResourceClinicalUseIssue
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... type Σ1..1codeindication | contraindication | interaction | undesirable-effect | other
ClinicalUseIssueType (Required)
... subject Σ0..*Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance)The medication or procedure for which this is an indication
... description Σ0..1stringGeneral description
... contraindication Σ0..1BackboneElementSpecifics for when this is a contraindication
.... diseaseSymptomProcedure Σ0..1CodeableConceptThe disease, symptom or procedure for the contraindication
.... diseaseStatus Σ0..1CodeableConceptThe status of the disease or symptom for the contraindication
.... comorbidity Σ0..*CodeableConceptA comorbidity (concurrent condition) or coinfection
.... indication Σ0..*Reference(ClinicalUseIssue)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 indication
..... therapyRelationshipType Σ1..1CodeableConceptThe type of relationship between the medicinal product indication or contraindication and another therapy
..... medication[x] Σ1..1Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
...... medicationCodeableConceptCodeableConcept
...... medicationReferenceReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition)
... indication Σ0..1BackboneElementSpecifics for when this is an indication
.... diseaseSymptomProcedure Σ0..1CodeableConceptThe disease, symptom or procedure for the indication
.... diseaseStatus Σ0..1CodeableConceptThe status of the disease or symptom for the indication
.... comorbidity Σ0..*CodeableConceptA comorbidity (concurrent condition) or coinfection as part of the indication
.... intendedEffect Σ0..1CodeableConceptFor an indication - the intended effect, aim or strategy to be achieved
.... duration Σ0..1QuantityFor an indication - timing or duration information
.... undesirableEffect Σ0..*Reference(ClinicalUseIssue)For an indicaton - 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 contraindication
... interaction Σ0..1BackboneElementSpecifics for when this is an interaction
.... interactant Σ0..*BackboneElementThe specific medication, food 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..1CodeableConceptThe 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..1CodeableConceptActions for managing the interaction
... population Σ0..*PopulationThe population group to which this applies
... undesirableEffect Σ0..1BackboneElementUndesirableEffect
.... symptomConditionEffect Σ0..1CodeableConceptThe symptom, condition or undesirable effect
.... classification Σ0..1CodeableConceptClassification of the effect
.... frequencyOfOccurrence Σ0..1CodeableConceptThe frequency of occurrence of the effect

doco Documentation for this format

UML Diagram (Legend)

ClinicalUseIssue (DomainResource)indication | contraindication | interaction | undesirable-effect | othertype : code [1..1] « Overall defining type of this clinical use issue. (Strength=Required)ClinicalUseIssueType! »The medication or procedure for which this is an indicationsubject : Reference [0..*] « MedicinalProductDefinition|Medication| ActivityDefinition|PlanDefinition|Device|DeviceDefinition| Substance »General descriptiondescription : string [0..1]The population group to which this appliespopulation : Population [0..*]ContraindicationThe disease, symptom or procedure for the contraindicationdiseaseSymptomProcedure : CodeableConcept [0..1]The status of the disease or symptom for the contraindicationdiseaseStatus : CodeableConcept [0..1]A comorbidity (concurrent condition) or coinfectioncomorbidity : CodeableConcept [0..*]The indication which this is a contraidication forindication : Reference [0..*] « ClinicalUseIssue »OtherTherapyThe type of relationship between the medicinal product indication or contraindication and another therapytherapyRelationshipType : CodeableConcept [1..1]Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindicationmedication[x] : Type [1..1] « CodeableConcept|Reference( MedicinalProductDefinition|Medication|Substance| SubstanceDefinition) »IndicationThe disease, symptom or procedure for the indicationdiseaseSymptomProcedure : CodeableConcept [0..1]The status of the disease or symptom for the indicationdiseaseStatus : CodeableConcept [0..1]A comorbidity (concurrent condition) or coinfection as part of the indicationcomorbidity : CodeableConcept [0..*]For an indication - the intended effect, aim or strategy to be achievedintendedEffect : CodeableConcept [0..1]For an indication - timing or duration informationduration : Quantity [0..1]For an indicaton - the specific undesirable effects of the medicinal productundesirableEffect : Reference [0..*] « ClinicalUseIssue »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 : CodeableConcept [0..1]The incidence of the interaction, e.g. theoretical, observedincidence : CodeableConcept [0..1]Actions for managing the interactionmanagement : CodeableConcept [0..1]InteractantThe specific medication, food or laboratory test that interactsitem[x] : Type [1..1] « Reference(MedicinalProductDefinition| Medication|Substance|ObservationDefinition)|CodeableConcept »UndesirableEffectThe symptom, condition or undesirable effectsymptomConditionEffect : CodeableConcept [0..1]Classification of the effectclassification : CodeableConcept [0..1]The frequency of occurrence of the effectfrequencyOfOccurrence : CodeableConcept [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 a contraindicationcontraindication[0..1]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 an indicationindication[0..1]The specific medication, food 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]

XML Template

<ClinicalUseIssue xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <type value="[code]"/><!-- 1..1 indication | contraindication | interaction | undesirable-effect | other -->
 <subject><!-- 0..* Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) The medication or procedure for which this is an indication --></subject>
 <description value="[string]"/><!-- 0..1 General description -->
 <contraindication>  <!-- 0..1 Specifics for when this is a contraindication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The disease, symptom or procedure for the contraindication --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableConcept The status of the disease or symptom for the contraindication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableConcept A comorbidity (concurrent condition) or coinfection --></comorbidity>
  <indication><!-- 0..* Reference(ClinicalUseIssue) 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 indication -->
   <therapyRelationshipType><!-- 1..1 CodeableConcept The type of relationship between the medicinal product indication or contraindication and another therapy --></therapyRelationshipType>
   <medication[x]><!-- 1..1 CodeableConcept|Reference(Medication|
     MedicinalProductDefinition|Substance|SubstanceDefinition) Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication --></medication[x]>
  </otherTherapy>
 </contraindication>
 <indication>  <!-- 0..1 Specifics for when this is an indication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The disease, symptom or procedure for the indication --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableConcept The status of the disease or symptom for the indication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableConcept A comorbidity (concurrent condition) or coinfection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableConcept For an indication - the intended effect, aim or strategy to be achieved --></intendedEffect>
  <duration><!-- 0..1 Quantity For an indication - timing or duration information --></duration>
  <undesirableEffect><!-- 0..* Reference(ClinicalUseIssue) For an indicaton - the specific undesirable effects of the medicinal product --></undesirableEffect>
  <otherTherapy><!-- 0..* Content as for ClinicalUseIssue.contraindication.otherTherapy Information about the use of the medicinal product in relation to other therapies described as part of the contraindication --></otherTherapy>
 </indication>
 <interaction>  <!-- 0..1 Specifics for when this is an interaction -->
  <interactant>  <!-- 0..* The specific medication, food 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 CodeableConcept 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..1 CodeableConcept Actions for managing the interaction --></management>
 </interaction>
 <population><!-- 0..* Population The population group to which this applies --></population>
 <undesirableEffect>  <!-- 0..1 UndesirableEffect -->
  <symptomConditionEffect><!-- 0..1 CodeableConcept The symptom, condition or undesirable effect --></symptomConditionEffect>
  <classification><!-- 0..1 CodeableConcept Classification of the effect --></classification>
  <frequencyOfOccurrence><!-- 0..1 CodeableConcept The frequency of occurrence of the effect --></frequencyOfOccurrence>
 </undesirableEffect>
</ClinicalUseIssue>

JSON Template

{doco
  "resourceType" : "ClinicalUseIssue",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "type" : "<code>", // R!  indication | contraindication | interaction | undesirable-effect | other
  "subject" : [{ Reference(ActivityDefinition|Device|DeviceDefinition|
   Medication|MedicinalProductDefinition|PlanDefinition|Substance) }], // The medication or procedure for which this is an indication
  "description" : "<string>", // General description
  "contraindication" : { // Specifics for when this is a contraindication
    "diseaseSymptomProcedure" : { CodeableConcept }, // The disease, symptom or procedure for the contraindication
    "diseaseStatus" : { CodeableConcept }, // The status of the disease or symptom for the contraindication
    "comorbidity" : [{ CodeableConcept }], // A comorbidity (concurrent condition) or coinfection
    "indication" : [{ Reference(ClinicalUseIssue) }], // 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 indication
      "therapyRelationshipType" : { CodeableConcept }, // R!  The type of relationship between the medicinal product indication or contraindication and another therapy
      // medication[x]: 
       Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. One of these 2:
      "medicationCodeableConcept" : { CodeableConcept }
      "medicationReference" : { Reference(Medication|MedicinalProductDefinition|
     Substance|SubstanceDefinition) }
    }]
  },
  "indication" : { // Specifics for when this is an indication
    "diseaseSymptomProcedure" : { CodeableConcept }, // The disease, symptom or procedure for the indication
    "diseaseStatus" : { CodeableConcept }, // The status of the disease or symptom for the indication
    "comorbidity" : [{ CodeableConcept }], // A comorbidity (concurrent condition) or coinfection as part of the indication
    "intendedEffect" : { CodeableConcept }, // For an indication - the intended effect, aim or strategy to be achieved
    "duration" : { Quantity }, // For an indication - timing or duration information
    "undesirableEffect" : [{ Reference(ClinicalUseIssue) }], // For an indicaton - the specific undesirable effects of the medicinal product
    "otherTherapy" : [{ Content as for ClinicalUseIssue.contraindication.otherTherapy }] // Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
  },
  "interaction" : { // Specifics for when this is an interaction
    "interactant" : [{ // The specific medication, food 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" : { CodeableConcept }, // 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" : [{ Population }], // The population group to which this applies
  "undesirableEffect" : { // UndesirableEffect
    "symptomConditionEffect" : { CodeableConcept }, // The symptom, condition or undesirable effect
    "classification" : { CodeableConcept }, // Classification of the effect
    "frequencyOfOccurrence" : { CodeableConcept } // The frequency of occurrence of the effect
  }
}

Turtle Template

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


[ a fhir:ClinicalUseIssue;
  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:ClinicalUseIssue.type [ code ]; # 1..1 indication | contraindication | interaction | undesirable-effect | other
  fhir:ClinicalUseIssue.subject [ Reference(ActivityDefinition|Device|DeviceDefinition|Medication|MedicinalProductDefinition|
  PlanDefinition|Substance) ], ... ; # 0..* The medication or procedure for which this is an indication
  fhir:ClinicalUseIssue.description [ string ]; # 0..1 General description
  fhir:ClinicalUseIssue.contraindication [ # 0..1 Specifics for when this is a contraindication
    fhir:ClinicalUseIssue.contraindication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The disease, symptom or procedure for the contraindication
    fhir:ClinicalUseIssue.contraindication.diseaseStatus [ CodeableConcept ]; # 0..1 The status of the disease or symptom for the contraindication
    fhir:ClinicalUseIssue.contraindication.comorbidity [ CodeableConcept ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:ClinicalUseIssue.contraindication.indication [ Reference(ClinicalUseIssue) ], ... ; # 0..* The indication which this is a contraidication for
    fhir:ClinicalUseIssue.contraindication.otherTherapy [ # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the indication
      fhir:ClinicalUseIssue.contraindication.otherTherapy.therapyRelationshipType [ CodeableConcept ]; # 1..1 The type of relationship between the medicinal product indication or contraindication and another therapy
      # ClinicalUseIssue.contraindication.otherTherapy.medication[x] : 1..1 Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. One of these 2
        fhir:ClinicalUseIssue.contraindication.otherTherapy.medicationCodeableConcept [ CodeableConcept ]
        fhir:ClinicalUseIssue.contraindication.otherTherapy.medicationReference [ Reference(Medication|MedicinalProductDefinition|Substance|SubstanceDefinition) ]
    ], ...;
  ];
  fhir:ClinicalUseIssue.indication [ # 0..1 Specifics for when this is an indication
    fhir:ClinicalUseIssue.indication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The disease, symptom or procedure for the indication
    fhir:ClinicalUseIssue.indication.diseaseStatus [ CodeableConcept ]; # 0..1 The status of the disease or symptom for the indication
    fhir:ClinicalUseIssue.indication.comorbidity [ CodeableConcept ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection as part of the indication
    fhir:ClinicalUseIssue.indication.intendedEffect [ CodeableConcept ]; # 0..1 For an indication - the intended effect, aim or strategy to be achieved
    fhir:ClinicalUseIssue.indication.duration [ Quantity ]; # 0..1 For an indication - timing or duration information
    fhir:ClinicalUseIssue.indication.undesirableEffect [ Reference(ClinicalUseIssue) ], ... ; # 0..* For an indicaton - the specific undesirable effects of the medicinal product
    fhir:ClinicalUseIssue.indication.otherTherapy [ See ClinicalUseIssue.contraindication.otherTherapy ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
  ];
  fhir:ClinicalUseIssue.interaction [ # 0..1 Specifics for when this is an interaction
    fhir:ClinicalUseIssue.interaction.interactant [ # 0..* The specific medication, food or laboratory test that interacts
      # ClinicalUseIssue.interaction.interactant.item[x] : 1..1 The specific medication, food or laboratory test that interacts. One of these 2
        fhir:ClinicalUseIssue.interaction.interactant.itemReference [ Reference(Medication|MedicinalProductDefinition|ObservationDefinition|Substance) ]
        fhir:ClinicalUseIssue.interaction.interactant.itemCodeableConcept [ CodeableConcept ]
    ], ...;
    fhir:ClinicalUseIssue.interaction.type [ CodeableConcept ]; # 0..1 The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
    fhir:ClinicalUseIssue.interaction.effect [ CodeableConcept ]; # 0..1 The effect of the interaction, for example "reduced gastric absorption of primary medication"
    fhir:ClinicalUseIssue.interaction.incidence [ CodeableConcept ]; # 0..1 The incidence of the interaction, e.g. theoretical, observed
    fhir:ClinicalUseIssue.interaction.management [ CodeableConcept ]; # 0..1 Actions for managing the interaction
  ];
  fhir:ClinicalUseIssue.population [ Population ], ... ; # 0..* The population group to which this applies
  fhir:ClinicalUseIssue.undesirableEffect [ # 0..1 UndesirableEffect
    fhir:ClinicalUseIssue.undesirableEffect.symptomConditionEffect [ CodeableConcept ]; # 0..1 The symptom, condition or undesirable effect
    fhir:ClinicalUseIssue.undesirableEffect.classification [ CodeableConcept ]; # 0..1 Classification of the effect
    fhir:ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 The frequency of occurrence of the effect
  ];
]

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
ClinicalUseIssue.type Overall defining type of this clinical use issue.RequiredClinicalUseIssueType

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

NameTypeDescriptionExpressionIn Common
subjectreferenceThe medication for which this is a clinical particularClinicalUseIssue.subject
(MedicinalProductDefinition, Device, Medication, DeviceDefinition, PlanDefinition, Substance, ActivityDefinition)