type: resourceresource: ClinicalUseDefinition

ClinicalUseDefinition

Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

ClinicalUseDefinition is to record an instance of facts about a particular medication, substance, device, procedure, biologically derived product or nutrition product, in relation to its intended use (indication), situations where it should not normally be used (contraindication), known side effects (undesirable effects), clashes with other substances - medications, foods etc. (interactions) and critical information about risks or hazards to caution the user or consumer (warnings). The resource is used to record one such instance, and all its details.

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 [0..*]: - A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
ClinicalUseDefinition.identifier [0..*]: Identifier Business identifier for this issue
ClinicalUseDefinition.type [1..1]: code required:clinical-use-definition-type indication | contraindication | interaction | undesirable-effect | warning
ClinicalUseDefinition.category [0..*]: CodeableConcept preferred:clinical-use-definition-category A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
ClinicalUseDefinition.subject [1..*]: CodeableReference example:medication-codes The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
ClinicalUseDefinition.status [0..1]: CodeableConcept preferred:publication-status Whether this is a current issue or one that has been retired etc
ClinicalUseDefinition.undesirableEffect [0..1]: BackboneElement A possible negative outcome from the use of this treatment
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect [0..1]: CodeableReference example:undesirable-effect-symptom The situation in which the undesirable effect may manifest
ClinicalUseDefinition.undesirableEffect.classification [0..1]: CodeableConcept example:undesirable-effect-classification High level classification of the effect
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence [0..1]: CodeableConcept example:undesirable-effect-frequency How often the effect is seen
ClinicalUseDefinition.undesirableEffect.management [0..*]: CodeableConcept example:interaction-management Actions for managing the undesirable effect
ClinicalUseDefinition.indication [0..1]: BackboneElement Specifics for when this is an indication
ClinicalUseDefinition.indication.diseaseSymptomProcedure [0..1]: CodeableReference example:disease-symptom-procedure The situation that is being documented as an indication for this item
ClinicalUseDefinition.indication.diseaseStatus [0..1]: CodeableReference example:disease-status The status of the disease or symptom for the indication
ClinicalUseDefinition.indication.comorbidity [0..*]: CodeableReference example:disease-symptom-procedure A comorbidity or coinfection as part of the indication
ClinicalUseDefinition.indication.intendedEffect [0..*]: CodeableReference preferred:product-intended-use The intended effect, aim or strategy to be achieved
ClinicalUseDefinition.indication.duration[x] [0..1]: Range, string Timing or duration information
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 [0..1]: 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 [0..*]: BackboneElement Information about use of the product in relation to other therapies described as part of the contraindication
ClinicalUseDefinition.indication.otherTherapy.relationshipType [1..1]: CodeableConcept preferred:therapy-relationship-type The type of relationship between the product indication/contraindication and another therapy
ClinicalUseDefinition.indication.otherTherapy.treatment [1..1]: CodeableReference example:therapy Reference to a specific medication, substance etc. as part of an indication or contraindication
ClinicalUseDefinition.contraindication [0..1]: BackboneElement Specifics for when this is a contraindication
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure [0..1]: CodeableReference example:disease-symptom-procedure The situation that is being documented as contraindicating against this item
ClinicalUseDefinition.contraindication.diseaseStatus [0..1]: CodeableReference example:disease-status The status of the disease or symptom for the contraindication
ClinicalUseDefinition.contraindication.comorbidity [0..*]: CodeableReference example:disease-symptom-procedure A comorbidity (concurrent condition) or coinfection
ClinicalUseDefinition.contraindication.indication [0..*]: - The indication which this is a contraindication for
ClinicalUseDefinition.contraindication.applicability [0..1]: Expression An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
ClinicalUseDefinition.contraindication.management [0..*]: CodeableConcept example:interaction-management Actions for managing the contraindication
ClinicalUseDefinition.contraindication.otherTherapy [0..*]: - Information about use of the product in relation to other therapies described as part of the contraindication
ClinicalUseDefinition.interaction [0..1]: BackboneElement Specifics for when this is an interaction
ClinicalUseDefinition.interaction.interactant [0..*]: BackboneElement The specific medication, product, food etc. or laboratory test that interacts
ClinicalUseDefinition.interaction.interactant.item[x] [1..1]: [Reference(MedicinalProductDefinition](/Reference(MedicinalProductDefinition), Medication, SubstanceDefinition, NutritionProduct, BiologicallyDerivedProduct, ObservationDefinition)), CodeableConcept example:interactant The specific medication, product, food etc. or laboratory test that interacts
ClinicalUseDefinition.interaction.interactant.route [0..1]: CodeableConcept example:route-codes The route by which the item is administered to cause the interaction
ClinicalUseDefinition.interaction.type [0..1]: CodeableConcept example:interaction-type The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
ClinicalUseDefinition.interaction.effect [0..1]: CodeableReference example:interaction-effect The effect of the interaction, for example "reduced gastric absorption of primary medication"
ClinicalUseDefinition.interaction.incidence [0..1]: CodeableConcept example:interaction-incidence The incidence of the interaction, e.g. theoretical, observed
ClinicalUseDefinition.interaction.management [0..*]: CodeableConcept example:interaction-management Actions for managing the interaction
ClinicalUseDefinition.interaction.severity [0..1]: CodeableConcept example:reaction-event-severity The severity of the interaction
ClinicalUseDefinition.population [0..*]: Reference(Group) The population group to which this applies
ClinicalUseDefinition.library [0..*]: canonical Logic used by the clinical use definition
ClinicalUseDefinition.warning [0..1]: BackboneElement Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
ClinicalUseDefinition.warning.description [0..1]: markdown A textual definition of this warning, with formatting
ClinicalUseDefinition.warning.code [0..1]: CodeableConcept example:warning-type A coded or unformatted textual definition of this warning

Mappings

ClinicalUseDefinition Mappings — 48 mapping entries

Resource Packs

list-ClinicalUseDefinition-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="ClinicalUseIssue-packs"/>
  <status value="current"/>
  <mode value="working"/>
</List>

Search Parameters

contraindication — token — The situation that is being documented as contraindicating against this item, as a code — ClinicalUseDefinition.contraindication.diseaseSymptomProcedure.concept
contraindication-reference — reference — The situation that is being documented as contraindicating against this item, as a reference — ClinicalUseDefinition.contraindication.diseaseSymptomProcedure.reference
effect — token — The situation in which the undesirable effect may manifest, as a code — ClinicalUseDefinition.undesirableEffect.symptomConditionEffect.concept
effect-reference — reference — The situation in which the undesirable effect may manifest, as a reference — ClinicalUseDefinition.undesirableEffect.symptomConditionEffect.reference
identifier — token — Business identifier for this issue — ClinicalUseDefinition.identifier
indication — token — The situation that is being documented as an indicaton for this item, as a code — ClinicalUseDefinition.indication.diseaseSymptomProcedure.concept
indication-reference — reference — The situation that is being documented as an indicaton for this item, as a reference — ClinicalUseDefinition.indication.diseaseSymptomProcedure.reference
interaction — token — The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction — ClinicalUseDefinition.interaction.type
product — reference — The medicinal product for which this is a clinical usage issue — ClinicalUseDefinition.subject.reference.where(resolve() is MedicinalProductDefinition)
subject — reference — The resource for which this is a clinical usage issue — ClinicalUseDefinition.subject.reference
subject-code — token — The coded item for which this is a clinical usage issue — ClinicalUseDefinition.subject.concept
type — token — indication | contraindication | interaction | undesirable-effect | warning — ClinicalUseDefinition.type
status — token — Whether this is a current issue or one that has been retired etc. — ClinicalUseDefinition.status

Full Search Parameters

Examples

clinicalusedefinition-example — clinicalusedefinition-example
clinicalusedefinition-examples-header — clinicalusedefinition-examples-header
example — clinicalusedefinition-example — Contraindication example
example-contraindication — clinicalusedefinition-contraindication-example — Contraindication example 2
example-indication — clinicalusedefinition-indication-example — Indication example
example-interaction — clinicalusedefinition-interaction-example — Interaction effect example
example-undesirable — clinicalusedefinition-undesirable-example — Undesirable effect example
example-warning — clinicalusedefinition-warning-example — Warning example

Full Examples

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