{ "resourceType": "StructureDefinition", "id": "ClinicalUseDefinition", "meta": { "lastUpdated": "2021-01-01T21:58:31.578+00:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Specialized.Medication Definition" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 1 }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "anonymous" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status", "valueCode": ".status=entered-in-error" } ], "url": "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition", "version": "4.6.0", "name": "ClinicalUseDefinition", "status": "draft", "date": "2021-01-01T21:58:31+00:00", "publisher": "Health Level Seven International (Biomedical Research and Regulation)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" } ] }, { "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim/index.cfm" } ] } ], "description": "A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.", "fhirVersion": "4.6.0", "mapping": [ { "identity": "idmp", "uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products", "name": "IDMP Mapping" }, { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" } ], "kind": "resource", "abstract": false, "type": "ClinicalUseDefinition", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "ClinicalUseDefinition", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "-50,200" } ], "path": "ClinicalUseDefinition", "short": "A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure", "definition": "A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.", "min": 0, "max": "*", "constraint": [ { "key": "cud-1", "severity": "error", "human": "Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance", "expression": "(ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraIndication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2", "xpath": "count(f:ClinicalUseDefinition.f:indication|f:ClinicalUseDefinition.f:contraIndication|f:ClinicalUseDefinition.f:interaction|f:ClinicalUseDefinition.f:undesirableEffect|f:ClinicalUseDefinition.f:warning) < 2", "source": "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition" } ], "mapping": [ { "identity": "idmp", "map": "Contraindication, Therapeutic Indication, Interactions, Undesirable Effects" }, { "identity": "w5", "map": "clinical.general" } ] }, { "id": "ClinicalUseDefinition.identifier", "path": "ClinicalUseDefinition.identifier", "short": "Business identifier for this issue", "definition": "Business identifier for this issue.", "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "ClinicalUseDefinition.type", "path": "ClinicalUseDefinition.type", "short": "indication | contraindication | interaction | undesirable-effect | warning", "definition": "indication | contraindication | interaction | undesirable-effect | warning.", "min": 1, "max": "1", "type": [ { "code": "code" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ClinicalUseDefinitionType" } ], "strength": "required", "description": "Overall defining type of this clinical use definition.", "valueSet": "http://hl7.org/fhir/ValueSet/clinical-use-definition-type" }, "mapping": [ { "identity": "idmp", "map": "(the type of IDMP class, out of Contraindication, Therapeutic Indication, Interactions, Undesirable Effects)" } ] }, { "id": "ClinicalUseDefinition.category", "path": "ClinicalUseDefinition.category", "short": "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\"", "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\".", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "ClinicalUseDefinition.subject", "path": "ClinicalUseDefinition.subject", "short": "The medication or procedure for which this is an indication", "definition": "The medication or procedure for which this is an indication.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/ActivityDefinition", "http://hl7.org/fhir/StructureDefinition/PlanDefinition", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/DeviceDefinition", "http://hl7.org/fhir/StructureDefinition/Substance" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(the link between the IDMP class and Medicinal Product)" } ] }, { "id": "ClinicalUseDefinition.status", "path": "ClinicalUseDefinition.status", "short": "Whether this is a current issue or one that has been retired etc", "definition": "Whether this is a current issue or one that has been retired etc.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "ClinicalUseDefinition.contraindication", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "420,140" } ], "path": "ClinicalUseDefinition.contraindication", "short": "Specifics for when this is a contraindication", "definition": "Specifics for when this is a contraindication.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Contraindication" } ] }, { "id": "ClinicalUseDefinition.contraindication.diseaseSymptomProcedure", "path": "ClinicalUseDefinition.contraindication.diseaseSymptomProcedure", "short": "The situation that is being documented as contraindicating against this item", "definition": "The situation that is being documented as contraindicating against this item.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Contraindication.Contraindications as \"Disease / Symptom / Procedure\" and Contraindication.Contraindications Text" } ] }, { "id": "ClinicalUseDefinition.contraindication.diseaseStatus", "path": "ClinicalUseDefinition.contraindication.diseaseStatus", "short": "The status of the disease or symptom for the contraindication", "definition": "The status of the disease or symptom for the contraindication.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Contraindication.Disease Status" } ] }, { "id": "ClinicalUseDefinition.contraindication.comorbidity", "path": "ClinicalUseDefinition.contraindication.comorbidity", "short": "A comorbidity (concurrent condition) or coinfection", "definition": "A comorbidity (concurrent condition) or coinfection.", "min": 0, "max": "*", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Contraindication.Comorbidity" } ] }, { "id": "ClinicalUseDefinition.contraindication.indication", "path": "ClinicalUseDefinition.contraindication.indication", "short": "The indication which this is a contraidication for", "definition": "The indication which this is a contraidication for.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(the link from Contraindication to Therapeutic Indication)" } ] }, { "id": "ClinicalUseDefinition.contraindication.otherTherapy", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "820,70" } ], "path": "ClinicalUseDefinition.contraindication.otherTherapy", "short": "Information about the use of the medicinal product in relation to other therapies described as part of the contraindication", "definition": "Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Contraindication.Other Therapy Specifics" } ] }, { "id": "ClinicalUseDefinition.contraindication.otherTherapy.relationshipType", "path": "ClinicalUseDefinition.contraindication.otherTherapy.relationshipType", "short": "The type of relationship between the medicinal product indication or contraindication and another therapy", "definition": "The type of relationship between the medicinal product indication or contraindication and another therapy.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "TherapyRelationshipType" } ], "strength": "preferred", "description": "Classification of relationship between a therapy and a contraindication or an indication.", "valueSet": "http://hl7.org/fhir/ValueSet/therapy-relationship-type" }, "mapping": [ { "identity": "idmp", "map": "Other Therapy Specifics.Therapy Relationship Type" } ] }, { "id": "ClinicalUseDefinition.contraindication.otherTherapy.therapy", "path": "ClinicalUseDefinition.contraindication.otherTherapy.therapy", "short": "Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication", "definition": "Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication.", "min": 1, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition", "http://hl7.org/fhir/StructureDefinition/ActivityDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Other Therapy Specifics.Medication" } ] }, { "id": "ClinicalUseDefinition.indication", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "420,0" } ], "path": "ClinicalUseDefinition.indication", "short": "Specifics for when this is an indication", "definition": "Specifics for when this is an indication.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication" } ] }, { "id": "ClinicalUseDefinition.indication.diseaseSymptomProcedure", "path": "ClinicalUseDefinition.indication.diseaseSymptomProcedure", "short": "The situation that is being documented as an indicaton for this item", "definition": "The situation that is being documented as an indicaton for this item.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Indication as \"Disease / Symptom / Procedure\", and Therapeutic Indication.Indication Text" } ] }, { "id": "ClinicalUseDefinition.indication.diseaseStatus", "path": "ClinicalUseDefinition.indication.diseaseStatus", "short": "The status of the disease or symptom for the indication", "definition": "The status of the disease or symptom for the indication.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Disease Status" } ] }, { "id": "ClinicalUseDefinition.indication.comorbidity", "path": "ClinicalUseDefinition.indication.comorbidity", "short": "A comorbidity (concurrent condition) or coinfection as part of the indication", "definition": "A comorbidity (concurrent condition) or coinfection as part of the indication.", "min": 0, "max": "*", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Comorbidity" } ] }, { "id": "ClinicalUseDefinition.indication.intendedEffect", "path": "ClinicalUseDefinition.indication.intendedEffect", "short": "The intended effect, aim or strategy to be achieved", "definition": "The intended effect, aim or strategy to be achieved.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Intended Effect" } ] }, { "id": "ClinicalUseDefinition.indication.duration", "path": "ClinicalUseDefinition.indication.duration", "short": "Timing or duration information", "definition": "Timing or duration information.", "min": 0, "max": "1", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Timing / Duration" } ] }, { "id": "ClinicalUseDefinition.indication.undesirableEffect", "path": "ClinicalUseDefinition.indication.undesirableEffect", "short": "The specific undesirable effects of the medicinal product", "definition": "The specific undesirable effects of the medicinal product.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Undesirable Effects" } ] }, { "id": "ClinicalUseDefinition.indication.otherTherapy", "path": "ClinicalUseDefinition.indication.otherTherapy", "short": "Information about the use of the medicinal product in relation to other therapies described as part of the indication", "definition": "Information about the use of the medicinal product in relation to other therapies described as part of the indication.", "min": 0, "max": "*", "contentReference": "#ClinicalUseDefinition.contraindication.otherTherapy", "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Therapeutic Indication.Other Therapy Specifics" } ] }, { "id": "ClinicalUseDefinition.interaction", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "420,253" } ], "path": "ClinicalUseDefinition.interaction", "short": "Specifics for when this is an interaction", "definition": "Specifics for when this is an interaction.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions" } ] }, { "id": "ClinicalUseDefinition.interaction.interactant", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "720,266" } ], "path": "ClinicalUseDefinition.interaction.interactant", "short": "The specific medication, food, substance or laboratory test that interacts", "definition": "The specific medication, food, substance or laboratory test that interacts.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions.Interactant and Interactions.Interactions Text" } ] }, { "id": "ClinicalUseDefinition.interaction.interactant.item[x]", "path": "ClinicalUseDefinition.interaction.interactant.item[x]", "short": "The specific medication, food or laboratory test that interacts", "definition": "The specific medication, food or laboratory test that interacts.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] }, { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions.Interactant and Interactions.Interactions Text" } ] }, { "id": "ClinicalUseDefinition.interaction.type", "path": "ClinicalUseDefinition.interaction.type", "short": "The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction", "definition": "The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions.Interactions Type" } ] }, { "id": "ClinicalUseDefinition.interaction.effect", "path": "ClinicalUseDefinition.interaction.effect", "short": "The effect of the interaction, for example \"reduced gastric absorption of primary medication\"", "definition": "The effect of the interaction, for example \"reduced gastric absorption of primary medication\".", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions.Interactions Effect" } ] }, { "id": "ClinicalUseDefinition.interaction.incidence", "path": "ClinicalUseDefinition.interaction.incidence", "short": "The incidence of the interaction, e.g. theoretical, observed", "definition": "The incidence of the interaction, e.g. theoretical, observed.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions.Interactions Incidence" } ] }, { "id": "ClinicalUseDefinition.interaction.management", "path": "ClinicalUseDefinition.interaction.management", "short": "Actions for managing the interaction", "definition": "Actions for managing the interaction.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Interactions.Management Actions" } ] }, { "id": "ClinicalUseDefinition.population", "path": "ClinicalUseDefinition.population", "short": "The population group to which this applies", "definition": "The population group to which this applies.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Population Specifics" } ] }, { "id": "ClinicalUseDefinition.undesirableEffect", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "420,370" } ], "path": "ClinicalUseDefinition.undesirableEffect", "short": "A possible negative outcome from the use of this treatment", "definition": "Describe the undesirable effects of the medicinal product.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Undesirable Effects" } ] }, { "id": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect", "path": "ClinicalUseDefinition.undesirableEffect.symptomConditionEffect", "short": "The situation in which the undesirable effect may manifest", "definition": "The situation in which the undesirable effect may manifest.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ObservationDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Undesirable Effects.Undesirable Effect as \"Symptom / Condition / Effect\"" } ] }, { "id": "ClinicalUseDefinition.undesirableEffect.classification", "path": "ClinicalUseDefinition.undesirableEffect.classification", "short": "High level classification of the effect", "definition": "High level classification of the effect.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Undesirable Effects.Symptom / Condition / Effect Classification" } ] }, { "id": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence", "path": "ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence", "short": "How often the effect is seen", "definition": "How often the effect is seen.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Undesirable Effects.Frequency of Occurrence" } ] }, { "id": "ClinicalUseDefinition.warning", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "420,470" } ], "path": "ClinicalUseDefinition.warning", "short": "A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness' or 'Get medical advice/attention if you feel unwell'", "definition": "A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "ClinicalUseDefinition.warning.description", "path": "ClinicalUseDefinition.warning.description", "short": "A textual definition of this warning, with formatting", "definition": "A textual definition of this warning, with formatting.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "ClinicalUseDefinition.warning.code", "path": "ClinicalUseDefinition.warning.code", "short": "A coded or unformatted textual definition of this warning", "definition": "A coded or unformatted textual definition of this warning.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "WarningType" } ], "strength": "example", "description": "Classification of warning type.", "valueSet": "http://hl7.org/fhir/ValueSet/warning-type" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] } ] } }