This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions
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.
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:
This resource is referenced by itself, MedicationKnowledge and RegulatedAuthorization.
This resource does not implement any patterns.
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ClinicalUseIssue | ΣTU | 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 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 | General description |
description | Σ | 0..1 | markdown | General description |
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 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 General description --></status> <description value="[markdown]"/><!-- 0..1 General description --> <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 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 }, // General description "description" : "<markdown>", // General description "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 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 General description fhir:ClinicalUseIssue.description [ markdown ]; # 0..1 General description 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 ]; ]
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ClinicalUseIssue | ΣTU | 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 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 | General description |
description | Σ | 0..1 | markdown | General description |
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 |
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 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 General description --></status> <description value="[markdown]"/><!-- 0..1 General description --> <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 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 }, // General description "description" : "<markdown>", // General description "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 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 General description fhir:ClinicalUseIssue.description [ markdown ]; # 0..1 General description 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 ]; ]
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
Path | Definition | Type | Reference |
---|---|---|---|
ClinicalUseIssue.type | Overall defining type of this clinical use issue. | Required | ClinicalUseIssueType |
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 |