This page is part of the FHIR Specification (v4.5.0: R5 Preview #3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.17 Resource ClinicalUseIssue - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

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

11.17.1 Scope and Usage

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.

11.17.2 Boundaries and Relationships

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.

11.17.3 References

This resource is referenced by itself, MedicationKnowledge and RegulatedAuthorization.

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseIssue	Σ TU		DomainResource	A single item of clinical particulars - an indication, contraindication, interaction etc. for a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for this issue
type	Σ	1..1	code	indication \| contraindication \| interaction \| undesirable-effect \| warning ClinicalUseIssueType (Required)
category	Σ	0..1	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	Σ	0..*	Reference(MedicinalProductDefinition \| Medication \| ActivityDefinition \| PlanDefinition \| Device \| DeviceDefinition \| Substance)	The medication or procedure for which this is an indication
status	Σ	0..1	CodeableConcept	Whether this is a current issue or one that has been retired etc
description	Σ	0..1	markdown	General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive"
contraindication	Σ	0..1	BackboneElement	Specifics for when this is a contraindication
diseaseSymptomProcedure	Σ	0..1	CodeableConcept	The situation that is being documented as contraindicating against this item
diseaseStatus	Σ	0..1	CodeableConcept	The status of the disease or symptom for the contraindication
comorbidity	Σ	0..*	CodeableConcept	A comorbidity (concurrent condition) or coinfection
indication	Σ	0..*	Reference(ClinicalUseIssue)	The indication which this is a contraidication for
otherTherapy	Σ	0..*	BackboneElement	Information about the use of the medicinal product in relation to other therapies described as part of the indication
therapyRelationshipType	Σ	1..1	CodeableConcept	The type of relationship between the medicinal product indication or contraindication and another therapy
medication[x]	Σ	1..1		Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
medicationCodeableConcept			CodeableConcept
medicationReference			Reference(MedicinalProductDefinition \| Medication \| Substance \| SubstanceDefinition)
indication	Σ	0..1	BackboneElement	Specifics for when this is an indication
diseaseSymptomProcedure	Σ	0..1	CodeableConcept	The situation that is being documented as an indicaton for this item
diseaseStatus	Σ	0..1	CodeableConcept	The status of the disease or symptom for the indication
comorbidity	Σ	0..*	CodeableConcept	A comorbidity (concurrent condition) or coinfection as part of the indication
intendedEffect	Σ	0..1	CodeableConcept	For an indication - the intended effect, aim or strategy to be achieved
duration	Σ	0..1	Quantity	For an indication - timing or duration information
undesirableEffect	Σ	0..*	Reference(ClinicalUseIssue)	For an indicaton - the specific undesirable effects of the medicinal product
otherTherapy	Σ	0..*	see otherTherapy	Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
interaction	Σ	0..1	BackboneElement	Specifics for when this is an interaction
interactant	Σ	0..*	BackboneElement	The specific medication, food or laboratory test that interacts
item[x]	Σ	1..1		The specific medication, food or laboratory test that interacts
itemReference			Reference(MedicinalProductDefinition \| Medication \| Substance \| ObservationDefinition)
itemCodeableConcept			CodeableConcept
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
effect	Σ	0..1	CodeableConcept	The effect of the interaction, for example "reduced gastric absorption of primary medication"
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed
management	Σ	0..1	CodeableConcept	Actions for managing the interaction
population	Σ	0..*	Population	The population group to which this applies
undesirableEffect	Σ	0..1	BackboneElement	A possible negative outcome from the use of this treatment
symptomConditionEffect	Σ	0..1	CodeableConcept	The situation in which the undesirable effect may manifest
classification	Σ	0..1	CodeableConcept	High level classification of the effect
frequencyOfOccurrence	Σ	0..1	CodeableConcept	How often the effect is seen
Documentation for this format

UML Diagram (Legend)

XML Template

<ClinicalUseIssue xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for this issue --></identifier>
 <type value="[code]"/><!-- 1..1 indication | contraindication | interaction | undesirable-effect | warning -->
 <category><!-- 0..1 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>
 <description value="[markdown]"/><!-- 0..1 General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using  Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive" -->
 <contraindication>  <!-- 0..1 Specifics for when this is a contraindication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The situation that is being documented as contraindicating against this item --></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 situation that is being documented as an indicaton for this item --></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 A possible negative outcome from the use of this treatment -->
  <symptomConditionEffect><!-- 0..1 CodeableConcept 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>
</ClinicalUseIssue>

JSON Template

{
  "resourceType" : "ClinicalUseIssue",
  // 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
  "description" : "<markdown>", // General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using  Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive"
  "contraindication" : { // Specifics for when this is a contraindication
    "diseaseSymptomProcedure" : { CodeableConcept }, // The situation that is being documented as contraindicating against this item
    "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 situation that is being documented as an indicaton for this item
    "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" : { // A possible negative outcome from the use of this treatment
    "symptomConditionEffect" : { CodeableConcept }, // 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
  }
}

Turtle Template

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


[ 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.identifier [ Identifier ], ... ; # 0..* Business identifier for this issue
  fhir:ClinicalUseIssue.type [ code ]; # 1..1 indication | contraindication | interaction | undesirable-effect | warning
  fhir:ClinicalUseIssue.category [ CodeableConcept ]; # 0..1 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:ClinicalUseIssue.subject [ Reference(ActivityDefinition|Device|DeviceDefinition|Medication|MedicinalProductDefinition|
  PlanDefinition|Substance) ], ... ; # 0..* The medication or procedure for which this is an indication
  fhir:ClinicalUseIssue.status [ CodeableConcept ]; # 0..1 Whether this is a current issue or one that has been retired etc
  fhir:ClinicalUseIssue.description [ markdown ]; # 0..1 General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using  Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive"
  fhir:ClinicalUseIssue.contraindication [ # 0..1 Specifics for when this is a contraindication
    fhir:ClinicalUseIssue.contraindication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The situation that is being documented as contraindicating against this item
    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 situation that is being documented as an indicaton for this item
    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 A possible negative outcome from the use of this treatment
    fhir:ClinicalUseIssue.undesirableEffect.symptomConditionEffect [ CodeableConcept ]; # 0..1 The situation in which the undesirable effect may manifest
    fhir:ClinicalUseIssue.undesirableEffect.classification [ CodeableConcept ]; # 0..1 High level classification of the effect
    fhir:ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 How often the effect is seen
  ];
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
ClinicalUseIssue	Σ TU		DomainResource	A single item of clinical particulars - an indication, contraindication, interaction etc. for a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for this issue
type	Σ	1..1	code	indication \| contraindication \| interaction \| undesirable-effect \| warning ClinicalUseIssueType (Required)
category	Σ	0..1	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	Σ	0..*	Reference(MedicinalProductDefinition \| Medication \| ActivityDefinition \| PlanDefinition \| Device \| DeviceDefinition \| Substance)	The medication or procedure for which this is an indication
status	Σ	0..1	CodeableConcept	Whether this is a current issue or one that has been retired etc
description	Σ	0..1	markdown	General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive"
contraindication	Σ	0..1	BackboneElement	Specifics for when this is a contraindication
diseaseSymptomProcedure	Σ	0..1	CodeableConcept	The situation that is being documented as contraindicating against this item
diseaseStatus	Σ	0..1	CodeableConcept	The status of the disease or symptom for the contraindication
comorbidity	Σ	0..*	CodeableConcept	A comorbidity (concurrent condition) or coinfection
indication	Σ	0..*	Reference(ClinicalUseIssue)	The indication which this is a contraidication for
otherTherapy	Σ	0..*	BackboneElement	Information about the use of the medicinal product in relation to other therapies described as part of the indication
therapyRelationshipType	Σ	1..1	CodeableConcept	The type of relationship between the medicinal product indication or contraindication and another therapy
medication[x]	Σ	1..1		Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
medicationCodeableConcept			CodeableConcept
medicationReference			Reference(MedicinalProductDefinition \| Medication \| Substance \| SubstanceDefinition)
indication	Σ	0..1	BackboneElement	Specifics for when this is an indication
diseaseSymptomProcedure	Σ	0..1	CodeableConcept	The situation that is being documented as an indicaton for this item
diseaseStatus	Σ	0..1	CodeableConcept	The status of the disease or symptom for the indication
comorbidity	Σ	0..*	CodeableConcept	A comorbidity (concurrent condition) or coinfection as part of the indication
intendedEffect	Σ	0..1	CodeableConcept	For an indication - the intended effect, aim or strategy to be achieved
duration	Σ	0..1	Quantity	For an indication - timing or duration information
undesirableEffect	Σ	0..*	Reference(ClinicalUseIssue)	For an indicaton - the specific undesirable effects of the medicinal product
otherTherapy	Σ	0..*	see otherTherapy	Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
interaction	Σ	0..1	BackboneElement	Specifics for when this is an interaction
interactant	Σ	0..*	BackboneElement	The specific medication, food or laboratory test that interacts
item[x]	Σ	1..1		The specific medication, food or laboratory test that interacts
itemReference			Reference(MedicinalProductDefinition \| Medication \| Substance \| ObservationDefinition)
itemCodeableConcept			CodeableConcept
type	Σ	0..1	CodeableConcept	The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction
effect	Σ	0..1	CodeableConcept	The effect of the interaction, for example "reduced gastric absorption of primary medication"
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction, e.g. theoretical, observed
management	Σ	0..1	CodeableConcept	Actions for managing the interaction
population	Σ	0..*	Population	The population group to which this applies
undesirableEffect	Σ	0..1	BackboneElement	A possible negative outcome from the use of this treatment
symptomConditionEffect	Σ	0..1	CodeableConcept	The situation in which the undesirable effect may manifest
classification	Σ	0..1	CodeableConcept	High level classification of the effect
frequencyOfOccurrence	Σ	0..1	CodeableConcept	How often the effect is seen
Documentation for this format

UML Diagram (Legend)

XML Template

<ClinicalUseIssue xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for this issue --></identifier>
 <type value="[code]"/><!-- 1..1 indication | contraindication | interaction | undesirable-effect | warning -->
 <category><!-- 0..1 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>
 <description value="[markdown]"/><!-- 0..1 General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using  Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive" -->
 <contraindication>  <!-- 0..1 Specifics for when this is a contraindication -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The situation that is being documented as contraindicating against this item --></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 situation that is being documented as an indicaton for this item --></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 A possible negative outcome from the use of this treatment -->
  <symptomConditionEffect><!-- 0..1 CodeableConcept 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>
</ClinicalUseIssue>

JSON Template

{
  "resourceType" : "ClinicalUseIssue",
  // 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
  "description" : "<markdown>", // General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using  Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive"
  "contraindication" : { // Specifics for when this is a contraindication
    "diseaseSymptomProcedure" : { CodeableConcept }, // The situation that is being documented as contraindicating against this item
    "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 situation that is being documented as an indicaton for this item
    "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" : { // A possible negative outcome from the use of this treatment
    "symptomConditionEffect" : { CodeableConcept }, // 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
  }
}

Turtle Template

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


[ 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.identifier [ Identifier ], ... ; # 0..* Business identifier for this issue
  fhir:ClinicalUseIssue.type [ code ]; # 1..1 indication | contraindication | interaction | undesirable-effect | warning
  fhir:ClinicalUseIssue.category [ CodeableConcept ]; # 0..1 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:ClinicalUseIssue.subject [ Reference(ActivityDefinition|Device|DeviceDefinition|Medication|MedicinalProductDefinition|
  PlanDefinition|Substance) ], ... ; # 0..* The medication or procedure for which this is an indication
  fhir:ClinicalUseIssue.status [ CodeableConcept ]; # 0..1 Whether this is a current issue or one that has been retired etc
  fhir:ClinicalUseIssue.description [ markdown ]; # 0..1 General description of an effect (particularly for a general warning, rather than any of the more specific types such as indication) for when a distinct coded or textual description is not appropriate using  Indication.diseaseSymptomProcedure.text, Contraindication.diseaseSymptomProcedure.text etc. For example "May affect ability to drive"
  fhir:ClinicalUseIssue.contraindication [ # 0..1 Specifics for when this is a contraindication
    fhir:ClinicalUseIssue.contraindication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The situation that is being documented as contraindicating against this item
    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 situation that is being documented as an indicaton for this item
    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 A possible negative outcome from the use of this treatment
    fhir:ClinicalUseIssue.undesirableEffect.symptomConditionEffect [ CodeableConcept ]; # 0..1 The situation in which the undesirable effect may manifest
    fhir:ClinicalUseIssue.undesirableEffect.classification [ CodeableConcept ]; # 0..1 High level classification of the effect
    fhir:ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 How often the effect is seen
  ];
]

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

11.17.4.1 Terminology Bindings

Path	Definition	Type	Reference
ClinicalUseIssue.type	Overall defining type of this clinical use issue.	Required	ClinicalUseIssueType

Path

Definition

Type

Reference

ClinicalUseIssue.type

Overall defining type of this clinical use issue.

Required

ClinicalUseIssueType

11.17.5 Search Parameters

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

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