--- type: "resource" title: "ClinicalUseDefinition" resource: "ClinicalUseDefinition" --- # ClinicalUseDefinition ## Introduction ## Scope and Usage **_For an overview of this resource and others in the Medication Definition domain, also see the [module page](medication-definition-module)_** ClinicalUseDefinition is to record an instance of facts about a particular medication, substance, device, procedure, biologically derived product or nutrition product, in relation to its intended use (indication), situations where it should not normally be used (contraindication), known side effects (undesirable effects), clashes with other substances - medications, foods etc. (interactions) and critical information about risks or hazards to caution the user or consumer (warnings). The resource is used to record one such instance, and all its details. ## Boundaries and Relationships The ClinicalUseDefinition resource is designed to represent definitional facts about the potential use of a medication, substance, device, procedure, biologically derived product, or nutrition product. These may be used when submitting a product dossier to regulators, as part of an electronic medication or medical device knowledge base, or directly during decision support activities. The clinical issue does not refer to any actual instance of the medication, device or procedure etc. being used, or to any actual patient event. The resource is used to record one instance of one of these: - Indication - A medical situation in which a medicinal product, medical device or procedure etc. is appropriate for use - Contraindication - A reason why a medicinal product, medical device or procedure etc. is not to be used in a certain context - Interaction - The interactions of the medicinal product or medical device etc. with other medicinal products, food, substances etc. - Undesirable Effect - A potential negative outcome from the use of a medicinal product, medical device or procedure etc. See also AdverseEvent, which is for actual events (or near misses), and AllergyIntolerance. - Warning – Critical information about the environmental or health or physical risks or hazards, that serve as caution to the user or consumer. ## StructureDefinition ### Elements (Simplified) - **[ClinicalUseDefinition](/clinicalusedefinition-definitions#ClinicalUseDefinition)** [0..*]: - A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure - **[ClinicalUseDefinition.identifier](/clinicalusedefinition-definitions#ClinicalUseDefinition.identifier)** [0..*]: [Identifier](/Identifier) Business identifier for this issue - **[ClinicalUseDefinition.type](/clinicalusedefinition-definitions#ClinicalUseDefinition.type)** [1..1]: [code](/code) required:[clinical-use-definition-type](/valueset-clinical-use-definition-type) indication | contraindication | interaction | undesirable-effect | warning - **[ClinicalUseDefinition.category](/clinicalusedefinition-definitions#ClinicalUseDefinition.category)** [0..*]: [CodeableConcept](/CodeableConcept) preferred:[clinical-use-definition-category](/valueset-clinical-use-definition-category) A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" - **[ClinicalUseDefinition.subject](/clinicalusedefinition-definitions#ClinicalUseDefinition.subject)** [1..*]: [CodeableReference](/CodeableReference) example:[medication-codes](/valueset-medication-codes) The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning - **[ClinicalUseDefinition.status](/clinicalusedefinition-definitions#ClinicalUseDefinition.status)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[publication-status](/valueset-publication-status) Whether this is a current issue or one that has been retired etc - **[ClinicalUseDefinition.undesirableEffect](/clinicalusedefinition-definitions#ClinicalUseDefinition.undesirableEffect)** [0..1]: [BackboneElement](/BackboneElement) A possible negative outcome from the use of this treatment - **[ClinicalUseDefinition.undesirableEffect.symptomConditionEffect](/clinicalusedefinition-definitions#ClinicalUseDefinition.undesirableEffect.symptomConditionEffect)** [0..1]: [CodeableReference](/CodeableReference) example:[undesirable-effect-symptom](/valueset-undesirable-effect-symptom) The situation in which the undesirable effect may manifest - **[ClinicalUseDefinition.undesirableEffect.classification](/clinicalusedefinition-definitions#ClinicalUseDefinition.undesirableEffect.classification)** [0..1]: [CodeableConcept](/CodeableConcept) example:[undesirable-effect-classification](/valueset-undesirable-effect-classification) High level classification of the effect - **[ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence](/clinicalusedefinition-definitions#ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence)** [0..1]: [CodeableConcept](/CodeableConcept) example:[undesirable-effect-frequency](/valueset-undesirable-effect-frequency) How often the effect is seen - **[ClinicalUseDefinition.undesirableEffect.management](/clinicalusedefinition-definitions#ClinicalUseDefinition.undesirableEffect.management)** [0..*]: [CodeableConcept](/CodeableConcept) example:[interaction-management](/valueset-interaction-management) Actions for managing the undesirable effect - **[ClinicalUseDefinition.indication](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication)** [0..1]: [BackboneElement](/BackboneElement) Specifics for when this is an indication - **[ClinicalUseDefinition.indication.diseaseSymptomProcedure](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.diseaseSymptomProcedure)** [0..1]: [CodeableReference](/CodeableReference) example:[disease-symptom-procedure](/valueset-disease-symptom-procedure) The situation that is being documented as an indication for this item - **[ClinicalUseDefinition.indication.diseaseStatus](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.diseaseStatus)** [0..1]: [CodeableReference](/CodeableReference) example:[disease-status](/valueset-disease-status) The status of the disease or symptom for the indication - **[ClinicalUseDefinition.indication.comorbidity](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.comorbidity)** [0..*]: [CodeableReference](/CodeableReference) example:[disease-symptom-procedure](/valueset-disease-symptom-procedure) A comorbidity or coinfection as part of the indication - **[ClinicalUseDefinition.indication.intendedEffect](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.intendedEffect)** [0..*]: [CodeableReference](/CodeableReference) preferred:[product-intended-use](/valueset-product-intended-use) The intended effect, aim or strategy to be achieved - **[ClinicalUseDefinition.indication.duration[x]](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.duration%5Bx%5D)** [0..1]: [Range](/Range), [string](/string) Timing or duration information - **[ClinicalUseDefinition.indication.undesirableEffect](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.undesirableEffect)** [0..*]: - An unwanted side effect or negative outcome of the subject of this resource when being used for this indication - **[ClinicalUseDefinition.indication.applicability](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.applicability)** [0..1]: [Expression](/Expression) An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements - **[ClinicalUseDefinition.indication.otherTherapy](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.otherTherapy)** [0..*]: [BackboneElement](/BackboneElement) Information about use of the product in relation to other therapies described as part of the contraindication - **[ClinicalUseDefinition.indication.otherTherapy.relationshipType](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.otherTherapy.relationshipType)** [1..1]: [CodeableConcept](/CodeableConcept) preferred:[therapy-relationship-type](/valueset-therapy-relationship-type) The type of relationship between the product indication/contraindication and another therapy - **[ClinicalUseDefinition.indication.otherTherapy.treatment](/clinicalusedefinition-definitions#ClinicalUseDefinition.indication.otherTherapy.treatment)** [1..1]: [CodeableReference](/CodeableReference) example:[therapy](/valueset-therapy) Reference to a specific medication, substance etc. as part of an indication or contraindication - **[ClinicalUseDefinition.contraindication](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication)** [0..1]: [BackboneElement](/BackboneElement) Specifics for when this is a contraindication - **[ClinicalUseDefinition.contraindication.diseaseSymptomProcedure](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.diseaseSymptomProcedure)** [0..1]: [CodeableReference](/CodeableReference) example:[disease-symptom-procedure](/valueset-disease-symptom-procedure) The situation that is being documented as contraindicating against this item - **[ClinicalUseDefinition.contraindication.diseaseStatus](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.diseaseStatus)** [0..1]: [CodeableReference](/CodeableReference) example:[disease-status](/valueset-disease-status) The status of the disease or symptom for the contraindication - **[ClinicalUseDefinition.contraindication.comorbidity](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.comorbidity)** [0..*]: [CodeableReference](/CodeableReference) example:[disease-symptom-procedure](/valueset-disease-symptom-procedure) A comorbidity (concurrent condition) or coinfection - **[ClinicalUseDefinition.contraindication.indication](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.indication)** [0..*]: - The indication which this is a contraindication for - **[ClinicalUseDefinition.contraindication.applicability](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.applicability)** [0..1]: [Expression](/Expression) An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements - **[ClinicalUseDefinition.contraindication.management](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.management)** [0..*]: [CodeableConcept](/CodeableConcept) example:[interaction-management](/valueset-interaction-management) Actions for managing the contraindication - **[ClinicalUseDefinition.contraindication.otherTherapy](/clinicalusedefinition-definitions#ClinicalUseDefinition.contraindication.otherTherapy)** [0..*]: - Information about use of the product in relation to other therapies described as part of the contraindication - **[ClinicalUseDefinition.interaction](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction)** [0..1]: [BackboneElement](/BackboneElement) Specifics for when this is an interaction - **[ClinicalUseDefinition.interaction.interactant](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.interactant)** [0..*]: [BackboneElement](/BackboneElement) The specific medication, product, food etc. or laboratory test that interacts - **[ClinicalUseDefinition.interaction.interactant.item[x]](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.interactant.item%5Bx%5D)** [1..1]: [Reference(MedicinalProductDefinition](/Reference(MedicinalProductDefinition), [Medication](/Medication), [SubstanceDefinition](/SubstanceDefinition), [NutritionProduct](/NutritionProduct), [BiologicallyDerivedProduct](/BiologicallyDerivedProduct), [ObservationDefinition)](/ObservationDefinition)), [CodeableConcept](/CodeableConcept) example:[interactant](/valueset-interactant) The specific medication, product, food etc. or laboratory test that interacts - **[ClinicalUseDefinition.interaction.interactant.route](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.interactant.route)** [0..1]: [CodeableConcept](/CodeableConcept) example:[route-codes](/valueset-route-codes) The route by which the item is administered to cause the interaction - **[ClinicalUseDefinition.interaction.type](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.type)** [0..1]: [CodeableConcept](/CodeableConcept) example:[interaction-type](/valueset-interaction-type) The type of the interaction e.g. drug-drug interaction, drug-lab test interaction - **[ClinicalUseDefinition.interaction.effect](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.effect)** [0..1]: [CodeableReference](/CodeableReference) example:[interaction-effect](/valueset-interaction-effect) The effect of the interaction, for example "reduced gastric absorption of primary medication" - **[ClinicalUseDefinition.interaction.incidence](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.incidence)** [0..1]: [CodeableConcept](/CodeableConcept) example:[interaction-incidence](/valueset-interaction-incidence) The incidence of the interaction, e.g. theoretical, observed - **[ClinicalUseDefinition.interaction.management](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.management)** [0..*]: [CodeableConcept](/CodeableConcept) example:[interaction-management](/valueset-interaction-management) Actions for managing the interaction - **[ClinicalUseDefinition.interaction.severity](/clinicalusedefinition-definitions#ClinicalUseDefinition.interaction.severity)** [0..1]: [CodeableConcept](/CodeableConcept) example:[reaction-event-severity](/valueset-reaction-event-severity) The severity of the interaction - **[ClinicalUseDefinition.population](/clinicalusedefinition-definitions#ClinicalUseDefinition.population)** [0..*]: Reference([Group](/Group)) The population group to which this applies - **[ClinicalUseDefinition.library](/clinicalusedefinition-definitions#ClinicalUseDefinition.library)** [0..*]: [canonical](/canonical) Logic used by the clinical use definition - **[ClinicalUseDefinition.warning](/clinicalusedefinition-definitions#ClinicalUseDefinition.warning)** [0..1]: [BackboneElement](/BackboneElement) Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness' - **[ClinicalUseDefinition.warning.description](/clinicalusedefinition-definitions#ClinicalUseDefinition.warning.description)** [0..1]: [markdown](/markdown) A textual definition of this warning, with formatting - **[ClinicalUseDefinition.warning.code](/clinicalusedefinition-definitions#ClinicalUseDefinition.warning.code)** [0..1]: [CodeableConcept](/CodeableConcept) example:[warning-type](/valueset-warning-type) A coded or unformatted textual definition of this warning ## Mappings - [ClinicalUseDefinition Mappings](/clinicalusedefinition-mappings) — 48 mapping entries ## Resource Packs ### list-ClinicalUseDefinition-packs.xml ```xml ``` ## Search Parameters - [contraindication](/clinicalusedefinition-search#contraindication) — **token** — The situation that is being documented as contraindicating against this item, as a code — `ClinicalUseDefinition.contraindication.diseaseSymptomProcedure.concept` - [contraindication-reference](/clinicalusedefinition-search#contraindication-reference) — **reference** — The situation that is being documented as contraindicating against this item, as a reference — `ClinicalUseDefinition.contraindication.diseaseSymptomProcedure.reference` - [effect](/clinicalusedefinition-search#effect) — **token** — The situation in which the undesirable effect may manifest, as a code — `ClinicalUseDefinition.undesirableEffect.symptomConditionEffect.concept` - [effect-reference](/clinicalusedefinition-search#effect-reference) — **reference** — The situation in which the undesirable effect may manifest, as a reference — `ClinicalUseDefinition.undesirableEffect.symptomConditionEffect.reference` - [identifier](/clinicalusedefinition-search#identifier) — **token** — Business identifier for this issue — `ClinicalUseDefinition.identifier` - [indication](/clinicalusedefinition-search#indication) — **token** — The situation that is being documented as an indicaton for this item, as a code — `ClinicalUseDefinition.indication.diseaseSymptomProcedure.concept` - [indication-reference](/clinicalusedefinition-search#indication-reference) — **reference** — The situation that is being documented as an indicaton for this item, as a reference — `ClinicalUseDefinition.indication.diseaseSymptomProcedure.reference` - [interaction](/clinicalusedefinition-search#interaction) — **token** — The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction — `ClinicalUseDefinition.interaction.type` - [product](/clinicalusedefinition-search#product) — **reference** — The medicinal product for which this is a clinical usage issue — `ClinicalUseDefinition.subject.reference.where(resolve() is MedicinalProductDefinition)` - [subject](/clinicalusedefinition-search#subject) — **reference** — The resource for which this is a clinical usage issue — `ClinicalUseDefinition.subject.reference` - [subject-code](/clinicalusedefinition-search#subject-code) — **token** — The coded item for which this is a clinical usage issue — `ClinicalUseDefinition.subject.concept` - [type](/clinicalusedefinition-search#type) — **token** — indication | contraindication | interaction | undesirable-effect | warning — `ClinicalUseDefinition.type` - [status](/clinicalusedefinition-search#status) — **token** — Whether this is a current issue or one that has been retired etc. — `ClinicalUseDefinition.status` [Full Search Parameters](/clinicalusedefinition-search) ## Examples - [clinicalusedefinition-example](/clinicalusedefinition-example-clinicalusedefinition-example) — clinicalusedefinition-example - [clinicalusedefinition-examples-header](/clinicalusedefinition-example-clinicalusedefinition-examples-header) — clinicalusedefinition-examples-header - [example](/clinicalusedefinition-example-example) — clinicalusedefinition-example — Contraindication example - [example-contraindication](/clinicalusedefinition-example-example-contraindication) — clinicalusedefinition-contraindication-example — Contraindication example 2 - [example-indication](/clinicalusedefinition-example-example-indication) — clinicalusedefinition-indication-example — Indication example - [example-interaction](/clinicalusedefinition-example-example-interaction) — clinicalusedefinition-interaction-example — Interaction effect example - [example-undesirable](/clinicalusedefinition-example-example-undesirable) — clinicalusedefinition-undesirable-example — Undesirable effect example - [example-warning](/clinicalusedefinition-example-example-warning) — clinicalusedefinition-warning-example — Warning example [Full Examples](/clinicalusedefinition-examples) ## Mapping Exceptions ### clinicalusedefinition-definition-mapping-exceptions.xml ### Divergent Elements - **Definition.identifier** → **ClinicalUseDefinition.identifier** - shortUnmatched | reason=Unknown | pattern=Business identifier for clinical use definition | resource=Business identifier for this issue - definitionUnmatched | reason=Unknown | pattern=A formal identifier that is used to identify this clinical use definition when it is represented in other formats, or referenced in a specification, model, design or an instance. | resource=Business identifier for this issue. - commentsUnmatched | reason=Unknown | pattern=Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this clinical use definition outside of FHIR, where it is not possible to use the logical URI. - requirementsUnmatched | reason=Unknown | pattern=Allows externally provided and/or usable business identifiers to be easily associated with the clinical use definition. - **Definition.status** → **ClinicalUseDefinition.status** - missingTypes | reason=Unknown | pattern=code - extraTypes | reason=Unknown - bindingStrength | reason=Unknown | pattern=required - shortUnmatched | reason=Unknown | pattern=draft | active | retired | unknown | resource=Whether this is a current issue or one that has been retired etc - definitionUnmatched | reason=Unknown | pattern=The current state of this clinical use definition. | resource=Whether this is a current issue or one that has been retired etc. - commentsUnmatched | reason=Unknown | pattern=A nominal state-transition diagram can be found in the] documentation Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is. - requirementsUnmatched | reason=Unknown | pattern=Enables tracking the lifecycle of the content and filtering of clinical use definitions that are appropriate for use versus not. - **Definition.subject** → **ClinicalUseDefinition.subject** - shortUnmatched | reason=Unknown | pattern=Type of individual the defined service is for | resource=The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning - definitionUnmatched | reason=Unknown | pattern=A code or group definition that describes the intended subject of instantiations of this definition. | resource=The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning. - requirementsUnmatched | reason=Unknown | pattern=Many protocols, order sets and guidelines are intended for use only with specific types of patients or subjects. ### Unmapped Elements - **Definition.contact** — Unknown - **Definition.derivedFromCanonical** — Unknown - **Definition.approvalDate** — Unknown - **Definition.name** — Unknown - **Definition.description** — Unknown - **Definition.jurisdiction** — Unknown - **Definition.copyrightLabel** — Unknown - **Definition.effectivePeriod** — Unknown - **Definition.product** — Unknown - **Definition.code** — Unknown - **Definition.title** — Unknown - **Definition.date** — Unknown - **Definition.url** — Unknown - **Definition.copyright** — Unknown - **Definition.lastReviewDate** — Unknown - **Definition.purpose** — Unknown - **Definition.derivedFromUri** — Unknown - **Definition.versionAlgorithm** — Unknown - **Definition.publisher** — Unknown - **Definition.performerType** — Unknown - **Definition.partOf** — Unknown - **Definition.topic** — Unknown - **Definition.useContext** — Unknown - **Definition.experimental** — Unknown - **Definition.version** — Unknown ### clinicalusedefinition-fivews-mapping-exceptions.xml ### Unmapped Elements - **FiveWs.what** — Unknown - **FiveWs.recorded** — Unknown - **FiveWs.author** — Unknown - **FiveWs.actor** — Unknown - **FiveWs.cause** — Unknown - **FiveWs.version** — Unknown - **FiveWs.witness** — Unknown - **FiveWs.where** — Unknown - **FiveWs.context** — Unknown - **FiveWs.init** — Unknown - **FiveWs.why** — Unknown - **FiveWs.identifier** — Unknown - **FiveWs.source** — Unknown - **FiveWs.who** — Unknown - **FiveWs.grade** — Unknown - **FiveWs.status** — Unknown - **FiveWs.planned** — Unknown - **FiveWs.done** — Unknown - **FiveWs.subject** — Unknown