{ "description": "Defines the medication resource for a component of a 'Kombipackung' for the Medication Service in the ePA system. These profiles are intended to inherit from EPAMedication, but due to tooling issues, this inheritance cannot currently be implemented.", "_filename": "StructureDefinition-epa-medication-pharmaceutical-product.json", "package_name": "de.gematik.dev.epa.medication", "date": "2024-06-06", "derivation": "constraint", "publisher": "gematik GmbH", "fhirVersion": "4.0.1", "name": "EPAMedicationPharmaceuticalProduct", "abstract": false, "type": "Medication", "experimental": "false", "resourceType": "StructureDefinition", "title": "EPA Pharmaceutical Product Medication", "package_version": "1.1.0-alpha.4", "status": "active", "id": "7bd43351-1779-4f9a-b270-589e2b77733c", "kind": "resource", "url": "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-pharmaceutical-product", "version": "1.0.2-rc1", "differential": { "element": [ { "id": "Medication", "path": "Medication", "constraint": [ { "key": "epa-med-1", "human": "Medication code, name, or ingredients must be specified", "source": "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-pharmaceutical-product", "severity": "error", "expression": "code.exists() or ingredient.exists()" }, { "key": "epa-med-2", "human": "Extemporaneous preparation medications and 'Kombipackungen' have to reference their components via .ingredient.itemReference", "source": "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-pharmaceutical-product", "severity": "error", "expression": "extension('https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension').value.where(code = '1208954007').exists() or form.coding.where(code = 'KPG').exists() implies ingredient.item.ofType(Reference).exists()" }, { "key": "epa-med-3", "human": "Medicinal product medications (Fertigarzneimittel) are not allowed to reference other medications via .ingredient.itemReference", "source": "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-pharmaceutical-product", "severity": "error", "expression": "extension('https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension').value.where(code = '781405001').exists() and form.coding.where(code = 'KPG').exists().not() implies ingredient.item.ofType(Reference).exists().not()" } ] }, { "id": "Medication.meta", "path": "Medication.meta", "mustSupport": true }, { "id": "Medication.meta.versionId", "path": "Medication.meta.versionId", "mustSupport": true }, { "id": "Medication.meta.lastUpdated", "path": "Medication.meta.lastUpdated", "mustSupport": true }, { "id": "Medication.contained", "max": "0", "path": "Medication.contained" }, { "id": "Medication.extension:rxPrescriptionProcessIdentifier", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/rx-prescription-process-identifier-extension" ] } ], "sliceName": "rxPrescriptionProcessIdentifier", "mustSupport": true }, { "id": "Medication.extension:epaDispensationIdentifier", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/dispensation-identifier-extension" ] } ], "sliceName": "epaDispensationIdentifier", "mustSupport": true }, { "id": "Medication.extension:isVaccine", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-id-vaccine-extension" ] } ], "sliceName": "isVaccine" }, { "id": "Medication.extension:isVaccine.value[x]", "path": "Medication.extension.value[x]", "mustSupport": true }, { "id": "Medication.extension:drugCategory", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/drug-category-extension" ] } ], "sliceName": "drugCategory" }, { "id": "Medication.extension:drugCategory.value[x]", "path": "Medication.extension.value[x]", "mustSupport": true }, { "id": "Medication.extension:drugCategory.value[x].system", "path": "Medication.extension.value[x].system", "mustSupport": true }, { "id": "Medication.extension:drugCategory.value[x].code", "path": "Medication.extension.value[x].code", "mustSupport": true }, { "id": "Medication.extension:normSizeCode", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "http://fhir.de/StructureDefinition/normgroesse" ] } ], "short": "Package size according to N-designation", "sliceName": "normSizeCode", "definition": "Description of the therapy-appropriate package size (e.g., N1)" }, { "id": "Medication.extension:normSizeCode.value[x]", "path": "Medication.extension.value[x]", "mustSupport": true }, { "id": "Medication.extension:packaging", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-formulation-packaging-extension" ] } ], "sliceName": "packaging" }, { "id": "Medication.extension:packaging.value[x]", "path": "Medication.extension.value[x]", "mustSupport": true }, { "id": "Medication.extension:manufacturingInstructions", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-manufacturing-instructions-extension" ] } ], "sliceName": "manufacturingInstructions" }, { "id": "Medication.extension:manufacturingInstructions.value[x]", "path": "Medication.extension.value[x]", "mustSupport": true }, { "id": "Medication.extension:type", "max": "1", "min": 0, "path": "Medication.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-type-extension" ] } ], "sliceName": "type", "mustSupport": true }, { "id": "Medication.extension:type.value[x]", "path": "Medication.extension.value[x]", "binding": { "strength": "required", "valueSet": "https://gematik.de/fhir/epa-medication/ValueSet/epa-medication-type-pharmaceutical-product-vs" } }, { "id": "Medication.identifier", "path": "Medication.identifier", "slicing": { "rules": "open", "discriminator": [ { "path": "$this", "type": "pattern" } ] } }, { "id": "Medication.identifier:EPAMedicationUniqueIdentifier", "max": "1", "min": 0, "path": "Medication.identifier", "type": [ { "code": "Identifier", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/epa-medication-unique-identifier" ] } ], "sliceName": "EPAMedicationUniqueIdentifier", "patternIdentifier": { "system": "https://gematik.de/fhir/epa-medication/sid/epa-medication-unique-identifier" } }, { "id": "Medication.identifier:RxOriginatorProcessIdentifier", "max": "1", "min": 0, "path": "Medication.identifier", "type": [ { "code": "Identifier", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/rx-originator-process-identifier" ] } ], "sliceName": "RxOriginatorProcessIdentifier", "patternIdentifier": { "system": "https://gematik.de/fhir/epa-medication/sid/rx-originator-process-identifier" } }, { "id": "Medication.code", "path": "Medication.code", "short": "Medication in coded form or as free text if necessary", "mustSupport": true }, { "id": "Medication.code.coding", "min": 1, "path": "Medication.code.coding", "slicing": { "rules": "open", "discriminator": [ { "path": "$this", "type": "pattern" } ] }, "mustSupport": true }, { "id": "Medication.code.coding:pzn", "max": "0", "min": 0, "path": "Medication.code.coding", "sliceName": "pzn", "mustSupport": true, "patternCoding": { "system": "http://fhir.de/CodeSystem/ifa/pzn" } }, { "id": "Medication.code.coding:pzn.system", "min": 1, "path": "Medication.code.coding.system", "mustSupport": true }, { "id": "Medication.code.coding:pzn.version", "path": "Medication.code.coding.version", "mustSupport": true }, { "id": "Medication.code.coding:pzn.code", "min": 1, "path": "Medication.code.coding.code", "mustSupport": true }, { "id": "Medication.code.coding:pzn.display", "path": "Medication.code.coding.display", "mustSupport": true }, { "id": "Medication.code.coding:atc-de", "max": "*", "min": 0, "path": "Medication.code.coding", "sliceName": "atc-de", "mustSupport": true, "patternCoding": { "system": "http://fhir.de/CodeSystem/bfarm/atc" } }, { "id": "Medication.code.coding:atc-de.system", "min": 1, "path": "Medication.code.coding.system", "mustSupport": true }, { "id": "Medication.code.coding:atc-de.code", "min": 1, "path": "Medication.code.coding.code", "mustSupport": true }, { "id": "Medication.code.coding:atc-de.display", "path": "Medication.code.coding.display", "mustSupport": true }, { "id": "Medication.code.coding:ask", "max": "*", "min": 0, "path": "Medication.code.coding", "sliceName": "ask", "mustSupport": true, "patternCoding": { "system": "http://fhir.de/CodeSystem/ask" } }, { "id": "Medication.code.coding:ask.system", "min": 1, "path": "Medication.code.coding.system", "mustSupport": true }, { "id": "Medication.code.coding:ask.code", "min": 1, "path": "Medication.code.coding.code", "mustSupport": true }, { "id": "Medication.code.coding:ask.display", "path": "Medication.code.coding.display", "mustSupport": true }, { "id": "Medication.code.coding:snomed", "max": "*", "min": 0, "path": "Medication.code.coding", "sliceName": "snomed", "patternCoding": { "system": "http://snomed.info/sct" } }, { "id": "Medication.code.coding:snomed.system", "min": 1, "path": "Medication.code.coding.system", "mustSupport": true }, { "id": "Medication.code.coding:snomed.version", "path": "Medication.code.coding.version", "mustSupport": true }, { "id": "Medication.code.coding:snomed.code", "min": 1, "path": "Medication.code.coding.code", "mustSupport": true }, { "id": "Medication.code.coding:snomed.display", "path": "Medication.code.coding.display", "mustSupport": true }, { "id": "Medication.code.coding:product-key", "max": "1", "min": 1, "path": "Medication.code.coding", "sliceName": "product-key", "mustSupport": true, "patternCoding": { "system": "https://terminologieserver.bfarm.de/fhir/CodeSystem/arzneimittel-referenzdaten-pharmazeutisches-produkt" } }, { "id": "Medication.code.coding:product-key.system", "min": 1, "path": "Medication.code.coding.system", "mustSupport": true }, { "id": "Medication.code.coding:product-key.version", "path": "Medication.code.coding.version", "mustSupport": true }, { "id": "Medication.code.coding:product-key.code", "min": 1, "path": "Medication.code.coding.code", "mustSupport": true }, { "id": "Medication.code.coding:product-key.display", "path": "Medication.code.coding.display", "mustSupport": true }, { "id": "Medication.code.text", "path": "Medication.code.text", "mustSupport": true }, { "id": "Medication.status", "path": "Medication.status", "short": "Status of Medication Information", "mustSupport": true }, { "id": "Medication.manufacturer", "path": "Medication.manufacturer", "short": "Manufacturer of the Medication", "comment": "Here, the actual manufacturer of the medication can be named, primarily in the case of active ingredient mixtures (compounding prescriptions), such as the hospital pharmacy. It is important to note that the licensing organization, as mentioned in the PZN (Pharmaceutical Central Number) data, is not considered the manufacturer.", "mustSupport": true }, { "id": "Medication.manufacturer.display", "min": 1, "path": "Medication.manufacturer.display", "mustSupport": true }, { "id": "Medication.form", "path": "Medication.form", "short": "Form of Dispensing", "mustSupport": true }, { "id": "Medication.form.coding", "path": "Medication.form.coding", "slicing": { "rules": "open", "discriminator": [ { "path": "$this", "type": "pattern" } ] }, "mustSupport": true }, { "id": "Medication.form.coding:edqm", "max": "*", "min": 0, "path": "Medication.form.coding", "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform" }, "sliceName": "edqm", "mustSupport": true, "patternCoding": { "system": "http://standardterms.edqm.eu" } }, { "id": "Medication.form.coding:edqm.system", "min": 1, "path": "Medication.form.coding.system", "mustSupport": true }, { "id": "Medication.form.coding:edqm.code", "min": 1, "path": "Medication.form.coding.code", "mustSupport": true }, { "id": "Medication.form.coding:edqm.display", "path": "Medication.form.coding.display", "mustSupport": true }, { "id": "Medication.form.coding:snomed", "max": "*", "min": 0, "path": "Medication.form.coding", "sliceName": "snomed", "patternCoding": { "system": "http://snomed.info/sct" } }, { "id": "Medication.form.coding:snomed.system", "min": 1, "path": "Medication.form.coding.system", "mustSupport": true }, { "id": "Medication.form.coding:snomed.version", "path": "Medication.form.coding.version", "mustSupport": true }, { "id": "Medication.form.coding:snomed.code", "min": 1, "path": "Medication.form.coding.code", "mustSupport": true }, { "id": "Medication.form.coding:snomed.display", "path": "Medication.form.coding.display", "mustSupport": true }, { "id": "Medication.form.coding:kbvDarreichungsform", "max": "*", "min": 0, "path": "Medication.form.coding", "binding": { "strength": "required", "valueSet": "https://fhir.kbv.de/ValueSet/KBV_VS_SFHIR_KBV_DARREICHUNGSFORM" }, "sliceName": "kbvDarreichungsform", "mustSupport": true, "patternCoding": { "system": "https://fhir.kbv.de/CodeSystem/KBV_CS_SFHIR_KBV_DARREICHUNGSFORM" } }, { "id": "Medication.form.coding:kbvDarreichungsform.system", "min": 1, "path": "Medication.form.coding.system", "mustSupport": true }, { "id": "Medication.form.coding:kbvDarreichungsform.code", "min": 1, "path": "Medication.form.coding.code", "mustSupport": true }, { "id": "Medication.form.coding:kbvDarreichungsform.display", "path": "Medication.form.coding.display", "mustSupport": true }, { "id": "Medication.amount", "path": "Medication.amount", "mustSupport": true }, { "id": "Medication.amount.numerator", "path": "Medication.amount.numerator", "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/ucum-units" }, "mustSupport": true }, { "id": "Medication.amount.numerator.extension:packagingSize", "max": "1", "min": 0, "path": "Medication.amount.numerator.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-packaging-size-extension" ] } ], "sliceName": "packagingSize" }, { "id": "Medication.amount.numerator.extension:packagingSize.value[x]", "path": "Medication.amount.numerator.extension.value[x]", "mustSupport": true }, { "id": "Medication.amount.numerator.extension:totalQuantity", "max": "1", "min": 0, "path": "Medication.amount.numerator.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-total-quantity-formulation-extension" ] } ], "sliceName": "totalQuantity" }, { "id": "Medication.amount.numerator.extension:totalQuantity.value[x]", "path": "Medication.amount.numerator.extension.value[x]", "mustSupport": true }, { "id": "Medication.amount.numerator.value", "path": "Medication.amount.numerator.value", "mustSupport": true }, { "id": "Medication.amount.numerator.unit", "path": "Medication.amount.numerator.unit", "mustSupport": true }, { "id": "Medication.amount.numerator.system", "path": "Medication.amount.numerator.system", "mustSupport": true }, { "id": "Medication.amount.numerator.code", "path": "Medication.amount.numerator.code", "mustSupport": true }, { "id": "Medication.amount.denominator", "path": "Medication.amount.denominator", "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/ucum-units" }, "mustSupport": true }, { "id": "Medication.amount.denominator.value", "path": "Medication.amount.denominator.value", "mustSupport": true }, { "id": "Medication.amount.denominator.unit", "path": "Medication.amount.denominator.unit", "mustSupport": true }, { "id": "Medication.amount.denominator.system", "path": "Medication.amount.denominator.system", "mustSupport": true }, { "id": "Medication.amount.denominator.code", "path": "Medication.amount.denominator.code", "mustSupport": true }, { "id": "Medication.ingredient", "path": "Medication.ingredient", "short": "Information on Components (Rezeptur)", "mustSupport": true }, { "id": "Medication.ingredient.extension:darreichungsform", "max": "1", "min": 0, "path": "Medication.ingredient.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-ingredient-darreichungsform-extension" ] } ], "sliceName": "darreichungsform" }, { "id": "Medication.ingredient.item[x]", "path": "Medication.ingredient.item[x]", "slicing": { "rules": "open", "ordered": false, "discriminator": [ { "path": "$this", "type": "type" } ] }, "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept", "max": "1", "min": 0, "path": "Medication.ingredient.item[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Component in coded form or, if necessary, as free text", "sliceName": "itemCodeableConcept", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding", "path": "Medication.ingredient.item[x].coding", "slicing": { "rules": "open", "discriminator": [ { "path": "$this", "type": "pattern" } ] }, "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ask", "max": "*", "min": 0, "path": "Medication.ingredient.item[x].coding", "sliceName": "ask", "mustSupport": true, "patternCoding": { "system": "http://fhir.de/CodeSystem/ask" } }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ask.system", "min": 1, "path": "Medication.ingredient.item[x].coding.system", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ask.code", "min": 1, "path": "Medication.ingredient.item[x].coding.code", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ask.display", "path": "Medication.ingredient.item[x].coding.display", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:atc-de", "max": "*", "min": 0, "path": "Medication.ingredient.item[x].coding", "sliceName": "atc-de", "mustSupport": true, "patternCoding": { "system": "http://fhir.de/CodeSystem/bfarm/atc" } }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:atc-de.system", "min": 1, "path": "Medication.ingredient.item[x].coding.system", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:atc-de.code", "min": 1, "path": "Medication.ingredient.item[x].coding.code", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:atc-de.display", "path": "Medication.ingredient.item[x].coding.display", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:snomed", "max": "*", "min": 0, "path": "Medication.ingredient.item[x].coding", "sliceName": "snomed", "patternCoding": { "system": "http://snomed.info/sct" } }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:snomed.system", "min": 1, "path": "Medication.ingredient.item[x].coding.system", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:snomed.version", "path": "Medication.ingredient.item[x].coding.version", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:snomed.code", "min": 1, "path": "Medication.ingredient.item[x].coding.code", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:snomed.display", "path": "Medication.ingredient.item[x].coding.display", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:pzn", "max": "0", "min": 0, "path": "Medication.ingredient.item[x].coding", "sliceName": "pzn", "patternCoding": { "system": "http://fhir.de/CodeSystem/ifa/pzn" } }, { "id": "Medication.ingredient.item[x]:itemCodeableConcept.text", "path": "Medication.ingredient.item[x].text", "mustSupport": true }, { "id": "Medication.ingredient.item[x]:itemReference", "max": "0", "min": 0, "path": "Medication.ingredient.item[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Medication" ] } ], "short": "EPA Medication Pharmaceutical Product can't have child Medications", "sliceName": "itemReference", "mustSupport": true }, { "id": "Medication.ingredient.isActive", "path": "Medication.ingredient.isActive", "short": "Is it an active ingredient?" }, { "id": "Medication.ingredient.strength", "path": "Medication.ingredient.strength", "short": "Strength", "mustSupport": true }, { "id": "Medication.ingredient.strength.extension:amountText", "max": "1", "min": 0, "path": "Medication.ingredient.strength.extension", "type": [ { "code": "Extension", "profile": [ "https://gematik.de/fhir/epa-medication/StructureDefinition/medication-ingredient-amount-extension" ] } ], "sliceName": "amountText" }, { "id": "Medication.ingredient.strength.extension:amountText.value[x]", "path": "Medication.ingredient.strength.extension.value[x]", "mustSupport": true }, { "id": "Medication.ingredient.strength.numerator", "min": 1, "path": "Medication.ingredient.strength.numerator", "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/ucum-units" }, "mustSupport": true }, { "id": "Medication.ingredient.strength.numerator.value", "min": 1, "path": "Medication.ingredient.strength.numerator.value", "mustSupport": true }, { "id": "Medication.ingredient.strength.numerator.unit", "path": "Medication.ingredient.strength.numerator.unit", "mustSupport": true }, { "id": "Medication.ingredient.strength.numerator.system", "min": 1, "path": "Medication.ingredient.strength.numerator.system", "mustSupport": true }, { "id": "Medication.ingredient.strength.numerator.code", "min": 1, "path": "Medication.ingredient.strength.numerator.code", "mustSupport": true }, { "id": "Medication.ingredient.strength.denominator", "path": "Medication.ingredient.strength.denominator", "binding": { "strength": "preferred", "valueSet": "http://hl7.org/fhir/ValueSet/ucum-units" }, "mustSupport": true }, { "id": "Medication.ingredient.strength.denominator.value", "min": 1, "path": "Medication.ingredient.strength.denominator.value", "mustSupport": true }, { "id": "Medication.ingredient.strength.denominator.unit", "path": "Medication.ingredient.strength.denominator.unit", "mustSupport": true }, { "id": "Medication.ingredient.strength.denominator.system", "min": 1, "path": "Medication.ingredient.strength.denominator.system", "mustSupport": true }, { "id": "Medication.ingredient.strength.denominator.code", "min": 1, "path": "Medication.ingredient.strength.denominator.code", "mustSupport": true }, { "id": "Medication.batch", "path": "Medication.batch", "short": "Batch Information" }, { "id": "Medication.batch.lotNumber", "path": "Medication.batch.lotNumber", "short": "Batch Number" } ] }, "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Medication" }