This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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 |
Detailed Descriptions for the elements in the ClinicalUseIssue resource.
ClinicalUseIssue | |
Element Id | ClinicalUseIssue |
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. |
Cardinality | 0..* |
Type | DomainResource |
Summary | false |
ClinicalUseIssue.identifier | |
Element Id | ClinicalUseIssue.identifier |
Definition | Business identifier for this issue. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..* |
Type | Identifier |
Summary | true |
ClinicalUseIssue.type | |
Element Id | ClinicalUseIssue.type |
Definition | indication | contraindication | interaction | undesirable-effect | warning. |
Cardinality | 1..1 |
Terminology Binding | ClinicalUseIssueType (Required) |
Type | code |
Summary | true |
ClinicalUseIssue.category | |
Element Id | ClinicalUseIssue.category |
Definition | 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". |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.subject | |
Element Id | ClinicalUseIssue.subject |
Definition | The medication or procedure for which this is an indication. |
Cardinality | 0..* |
Type | Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance) |
Summary | true |
ClinicalUseIssue.status | |
Element Id | ClinicalUseIssue.status |
Definition | Whether this is a current issue or one that has been retired etc. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.description | |
Element Id | ClinicalUseIssue.description |
Definition | 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". |
Cardinality | 0..1 |
Type | markdown |
Summary | true |
ClinicalUseIssue.contraindication | |
Element Id | ClinicalUseIssue.contraindication |
Definition | Specifics for when this is a contraindication. |
Cardinality | 0..1 |
Summary | true |
ClinicalUseIssue.contraindication.diseaseSymptomProcedure | |
Element Id | ClinicalUseIssue.contraindication.diseaseSymptomProcedure |
Definition | The situation that is being documented as contraindicating against this item. |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.contraindication.diseaseStatus | |
Element Id | ClinicalUseIssue.contraindication.diseaseStatus |
Definition | The status of the disease or symptom for the contraindication. |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.contraindication.comorbidity | |
Element Id | ClinicalUseIssue.contraindication.comorbidity |
Definition | A comorbidity (concurrent condition) or coinfection. |
Cardinality | 0..* |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.contraindication.indication | |
Element Id | ClinicalUseIssue.contraindication.indication |
Definition | The indication which this is a contraidication for. |
Cardinality | 0..* |
Type | Reference(ClinicalUseIssue) |
Summary | true |
ClinicalUseIssue.contraindication.otherTherapy | |
Element Id | ClinicalUseIssue.contraindication.otherTherapy |
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the contraindication. |
Cardinality | 0..* |
Summary | true |
ClinicalUseIssue.contraindication.otherTherapy.relationshipType | |
Element Id | ClinicalUseIssue.contraindication.otherTherapy.relationshipType |
Definition | The type of relationship between the medicinal product indication or contraindication and another therapy. |
Cardinality | 1..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.contraindication.otherTherapy.therapy[x] | |
Element Id | ClinicalUseIssue.contraindication.otherTherapy.therapy[x] |
Definition | Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. |
Cardinality | 1..1 |
Type | CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition) |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
ClinicalUseIssue.indication | |
Element Id | ClinicalUseIssue.indication |
Definition | Specifics for when this is an indication. |
Cardinality | 0..1 |
Summary | true |
ClinicalUseIssue.indication.diseaseSymptomProcedure | |
Element Id | ClinicalUseIssue.indication.diseaseSymptomProcedure |
Definition | The situation that is being documented as an indicaton for this item. |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.indication.diseaseStatus | |
Element Id | ClinicalUseIssue.indication.diseaseStatus |
Definition | The status of the disease or symptom for the indication. |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.indication.comorbidity | |
Element Id | ClinicalUseIssue.indication.comorbidity |
Definition | A comorbidity (concurrent condition) or coinfection as part of the indication. |
Cardinality | 0..* |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.indication.intendedEffect | |
Element Id | ClinicalUseIssue.indication.intendedEffect |
Definition | The intended effect, aim or strategy to be achieved. |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.indication.duration | |
Element Id | ClinicalUseIssue.indication.duration |
Definition | Timing or duration information. |
Cardinality | 0..1 |
Type | Quantity |
Summary | true |
ClinicalUseIssue.indication.undesirableEffect | |
Element Id | ClinicalUseIssue.indication.undesirableEffect |
Definition | The specific undesirable effects of the medicinal product. |
Cardinality | 0..* |
Type | Reference(ClinicalUseIssue) |
Summary | true |
ClinicalUseIssue.indication.otherTherapy | |
Element Id | ClinicalUseIssue.indication.otherTherapy |
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the indication. |
Cardinality | 0..* |
Type | See ClinicalUseIssue.contraindication.otherTherapy |
Summary | true |
ClinicalUseIssue.interaction | |
Element Id | ClinicalUseIssue.interaction |
Definition | Specifics for when this is an interaction. |
Cardinality | 0..1 |
Summary | true |
ClinicalUseIssue.interaction.interactant | |
Element Id | ClinicalUseIssue.interaction.interactant |
Definition | The specific medication, food, substance or laboratory test that interacts. |
Cardinality | 0..* |
Summary | true |
ClinicalUseIssue.interaction.interactant.item[x] | |
Element Id | ClinicalUseIssue.interaction.interactant.item[x] |
Definition | The specific medication, food or laboratory test that interacts. |
Cardinality | 1..1 |
Type | Reference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)|CodeableConcept |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
ClinicalUseIssue.interaction.type | |
Element Id | ClinicalUseIssue.interaction.type |
Definition | The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.interaction.effect | |
Element Id | ClinicalUseIssue.interaction.effect |
Definition | The effect of the interaction, for example "reduced gastric absorption of primary medication". |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.interaction.incidence | |
Element Id | ClinicalUseIssue.interaction.incidence |
Definition | The incidence of the interaction, e.g. theoretical, observed. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.interaction.management | |
Element Id | ClinicalUseIssue.interaction.management |
Definition | Actions for managing the interaction. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.population | |
Element Id | ClinicalUseIssue.population |
Definition | The population group to which this applies. |
Cardinality | 0..* |
Type | Population |
Summary | true |
ClinicalUseIssue.undesirableEffect | |
Element Id | ClinicalUseIssue.undesirableEffect |
Definition | Describe the undesirable effects of the medicinal product. |
Cardinality | 0..1 |
Summary | true |
ClinicalUseIssue.undesirableEffect.symptomConditionEffect | |
Element Id | ClinicalUseIssue.undesirableEffect.symptomConditionEffect |
Definition | The situation in which the undesirable effect may manifest. |
Cardinality | 0..1 |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
ClinicalUseIssue.undesirableEffect.classification | |
Element Id | ClinicalUseIssue.undesirableEffect.classification |
Definition | High level classification of the effect. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence | |
Element Id | ClinicalUseIssue.undesirableEffect.frequencyOfOccurrence |
Definition | How often the effect is seen. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |